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Prescribing guide recommends fewer opioids after colorectal surgery
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
One in five chest tube placements/removals goes awry
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
Bariatric surgery as safe in adolescents as it is in adults
LAS VEGAS – Bariatric surgery in adolescents was about as safe as it was in adults in the largest U.S. database assembled so far for the procedure in this younger age group.
The data from 1,983 patients aged 10-19 years who underwent bariatric surgery at an accredited U.S. center also showed, not unexpectedly, that laparoscopic sleeve gastrectomy was significantly safer during the perioperative and immediate postoperative periods, compared with the other main surgical option, laparoscopic Roux-en-Y gastric bypass.
The incidence of serious adverse events that occurred in adolescents either during surgery or in the 30 days after surgery was 2.9% in the 1,552 patients (78%) who underwent sleeve gastrectomy and 6.5% in the 431 (22%) patients who underwent gastric bypass, Keith J. King, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Despite this safety disparity, “the decision to undergo sleeve gastrectomy or Roux-en-Y gastric bypass should be individualized to account for other factors, such as excess weight loss and long-term success,” said Dr. King, a bariatric surgeon at St. Luke’s Hospital, Allentown, Pa. But he acknowledged that having these recent safety data from a relatively large number of adolescents will help families that are trying to decide on treatment for their child.
The data came from records kept by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, begun in 2012 by the American College of Surgeons and the American Society for Bariatric and Metabolic Surgery, and a registry for every bariatric surgical procedure done at an accredited U.S. program. The database encompassed 840 surgical programs in 2019.
The incidence of perioperative and postoperative complications in the adolescent patients during the first 30 days after surgery was not statistically significant for any measured safety parameter, compared with 353,726 adults (at least 20 years old) enrolled in the same database during 2015-2017, except for the average duration of surgery, which was 8 minutes shorter in adolescents, Dr. King reported. The data showed that adolescents and adults had roughly similar rates of serious adverse events, organ space infections, and need for reoperation, intervention, or hospital readmission. The way in which clinicians applied bariatric surgery to adolescents also seemed similar to their use of the surgery in adults. The average body mass index of adult patients was about 45 kg/m2, and about 48 kg/m2 in adolescents, and in both age groups, nearly 80% of patients were women or girls.
In contrast, the comparison of sleeve gastrectomy and gastric bypass surgery in adolescents showed several statistically significant differences in safety and procedural characteristics. In addition to a more than twofold difference in the incidence of serious adverse events that favored the sleeve, the data also showed a twofold difference in the need for reoperation, 1% with the sleeve and 2% with bypass; and a threefold difference in the need for at least one intervention during 30-day follow-up, 1% in the sleeve recipients and 3% in those treated with gastric bypass. Patients required at least one hospital readmission within 30 days in 3% of the sleeve cases and in 6% of the bypass cases. Average hospital length of stay was 2 days in both groups.
An efficacy review from a different, large, U.S. database that included 544 adolescents who underwent bariatric surgery during 2005-2015 showed that at 3 years after surgery, average reductions in body mass index were 29% for patients who underwent gastric bypass and 25% in those treated with sleeve gastrectomy (Surg Obes Relat Dis. 2018;14[9]:1374-86).
The study received no commercial support. Dr. King had no disclosures.
SOURCE: El Chaar M et al. Obesity Week 2019, Abstract A138.
The comparison of safety outcomes between sleeve gastrectomy and Roux-en-Y gastric bypass appears to favor using sleeves. In obese adolescents the most common complications we see are nonalcoholic fatty liver disease and obstructive sleep apnea, and prior reports have documented that both often improve following sleeve gastrectomy. That fact, plus these new safety findings, may help push the field toward greater sleeve use in adolescents, although the data also show that sleeve gastrectomy is already used in nearly four-fifths of adolescent cases.
Corrigan McBride, MD, is a professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
The comparison of safety outcomes between sleeve gastrectomy and Roux-en-Y gastric bypass appears to favor using sleeves. In obese adolescents the most common complications we see are nonalcoholic fatty liver disease and obstructive sleep apnea, and prior reports have documented that both often improve following sleeve gastrectomy. That fact, plus these new safety findings, may help push the field toward greater sleeve use in adolescents, although the data also show that sleeve gastrectomy is already used in nearly four-fifths of adolescent cases.
Corrigan McBride, MD, is a professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
The comparison of safety outcomes between sleeve gastrectomy and Roux-en-Y gastric bypass appears to favor using sleeves. In obese adolescents the most common complications we see are nonalcoholic fatty liver disease and obstructive sleep apnea, and prior reports have documented that both often improve following sleeve gastrectomy. That fact, plus these new safety findings, may help push the field toward greater sleeve use in adolescents, although the data also show that sleeve gastrectomy is already used in nearly four-fifths of adolescent cases.
Corrigan McBride, MD, is a professor of surgery and director of bariatric surgery at the University of Nebraska Medical Center in Omaha. She had no disclosures. She made these comments in an interview.
LAS VEGAS – Bariatric surgery in adolescents was about as safe as it was in adults in the largest U.S. database assembled so far for the procedure in this younger age group.
The data from 1,983 patients aged 10-19 years who underwent bariatric surgery at an accredited U.S. center also showed, not unexpectedly, that laparoscopic sleeve gastrectomy was significantly safer during the perioperative and immediate postoperative periods, compared with the other main surgical option, laparoscopic Roux-en-Y gastric bypass.
The incidence of serious adverse events that occurred in adolescents either during surgery or in the 30 days after surgery was 2.9% in the 1,552 patients (78%) who underwent sleeve gastrectomy and 6.5% in the 431 (22%) patients who underwent gastric bypass, Keith J. King, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Despite this safety disparity, “the decision to undergo sleeve gastrectomy or Roux-en-Y gastric bypass should be individualized to account for other factors, such as excess weight loss and long-term success,” said Dr. King, a bariatric surgeon at St. Luke’s Hospital, Allentown, Pa. But he acknowledged that having these recent safety data from a relatively large number of adolescents will help families that are trying to decide on treatment for their child.
The data came from records kept by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, begun in 2012 by the American College of Surgeons and the American Society for Bariatric and Metabolic Surgery, and a registry for every bariatric surgical procedure done at an accredited U.S. program. The database encompassed 840 surgical programs in 2019.
The incidence of perioperative and postoperative complications in the adolescent patients during the first 30 days after surgery was not statistically significant for any measured safety parameter, compared with 353,726 adults (at least 20 years old) enrolled in the same database during 2015-2017, except for the average duration of surgery, which was 8 minutes shorter in adolescents, Dr. King reported. The data showed that adolescents and adults had roughly similar rates of serious adverse events, organ space infections, and need for reoperation, intervention, or hospital readmission. The way in which clinicians applied bariatric surgery to adolescents also seemed similar to their use of the surgery in adults. The average body mass index of adult patients was about 45 kg/m2, and about 48 kg/m2 in adolescents, and in both age groups, nearly 80% of patients were women or girls.
In contrast, the comparison of sleeve gastrectomy and gastric bypass surgery in adolescents showed several statistically significant differences in safety and procedural characteristics. In addition to a more than twofold difference in the incidence of serious adverse events that favored the sleeve, the data also showed a twofold difference in the need for reoperation, 1% with the sleeve and 2% with bypass; and a threefold difference in the need for at least one intervention during 30-day follow-up, 1% in the sleeve recipients and 3% in those treated with gastric bypass. Patients required at least one hospital readmission within 30 days in 3% of the sleeve cases and in 6% of the bypass cases. Average hospital length of stay was 2 days in both groups.
An efficacy review from a different, large, U.S. database that included 544 adolescents who underwent bariatric surgery during 2005-2015 showed that at 3 years after surgery, average reductions in body mass index were 29% for patients who underwent gastric bypass and 25% in those treated with sleeve gastrectomy (Surg Obes Relat Dis. 2018;14[9]:1374-86).
The study received no commercial support. Dr. King had no disclosures.
SOURCE: El Chaar M et al. Obesity Week 2019, Abstract A138.
LAS VEGAS – Bariatric surgery in adolescents was about as safe as it was in adults in the largest U.S. database assembled so far for the procedure in this younger age group.
The data from 1,983 patients aged 10-19 years who underwent bariatric surgery at an accredited U.S. center also showed, not unexpectedly, that laparoscopic sleeve gastrectomy was significantly safer during the perioperative and immediate postoperative periods, compared with the other main surgical option, laparoscopic Roux-en-Y gastric bypass.
The incidence of serious adverse events that occurred in adolescents either during surgery or in the 30 days after surgery was 2.9% in the 1,552 patients (78%) who underwent sleeve gastrectomy and 6.5% in the 431 (22%) patients who underwent gastric bypass, Keith J. King, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Despite this safety disparity, “the decision to undergo sleeve gastrectomy or Roux-en-Y gastric bypass should be individualized to account for other factors, such as excess weight loss and long-term success,” said Dr. King, a bariatric surgeon at St. Luke’s Hospital, Allentown, Pa. But he acknowledged that having these recent safety data from a relatively large number of adolescents will help families that are trying to decide on treatment for their child.
The data came from records kept by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, begun in 2012 by the American College of Surgeons and the American Society for Bariatric and Metabolic Surgery, and a registry for every bariatric surgical procedure done at an accredited U.S. program. The database encompassed 840 surgical programs in 2019.
The incidence of perioperative and postoperative complications in the adolescent patients during the first 30 days after surgery was not statistically significant for any measured safety parameter, compared with 353,726 adults (at least 20 years old) enrolled in the same database during 2015-2017, except for the average duration of surgery, which was 8 minutes shorter in adolescents, Dr. King reported. The data showed that adolescents and adults had roughly similar rates of serious adverse events, organ space infections, and need for reoperation, intervention, or hospital readmission. The way in which clinicians applied bariatric surgery to adolescents also seemed similar to their use of the surgery in adults. The average body mass index of adult patients was about 45 kg/m2, and about 48 kg/m2 in adolescents, and in both age groups, nearly 80% of patients were women or girls.
In contrast, the comparison of sleeve gastrectomy and gastric bypass surgery in adolescents showed several statistically significant differences in safety and procedural characteristics. In addition to a more than twofold difference in the incidence of serious adverse events that favored the sleeve, the data also showed a twofold difference in the need for reoperation, 1% with the sleeve and 2% with bypass; and a threefold difference in the need for at least one intervention during 30-day follow-up, 1% in the sleeve recipients and 3% in those treated with gastric bypass. Patients required at least one hospital readmission within 30 days in 3% of the sleeve cases and in 6% of the bypass cases. Average hospital length of stay was 2 days in both groups.
An efficacy review from a different, large, U.S. database that included 544 adolescents who underwent bariatric surgery during 2005-2015 showed that at 3 years after surgery, average reductions in body mass index were 29% for patients who underwent gastric bypass and 25% in those treated with sleeve gastrectomy (Surg Obes Relat Dis. 2018;14[9]:1374-86).
The study received no commercial support. Dr. King had no disclosures.
SOURCE: El Chaar M et al. Obesity Week 2019, Abstract A138.
REPORTING FROM OBESITY WEEK 2019
Orthopedic ambulatory surgery centers beat inpatient services on cost
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
NATIONAL HARBOR, MD. – Hospital outpatient departments (HOPDs) and (IPs) with similar levels of postoperative opioid use, according to a new study.
Fanta Waterman, PhD, director of medical and health sciences at Pacira Pharmaceuticals, and colleagues retrospectively published the results of their investigation in the Journal of Managed Care & Specialty Pharmacy supplement for the annual meeting of the Academy of Managed Care Pharmacy.
Investigators evaluated data from 126,172 commercially insured patients who underwent one of six orthopedic surgical procedures between April 2012 and December 2017. Using the Optum Research Database, they pooled data from patients who had received total knee arthroplasty (TKA), partial knee arthroplasty, total hip arthroplasty (THA), rotator cuff repair (RCR), total shoulder arthroplasty, and lumbar spine fusion.
More than half (51%) of the patients were male, and the patients averaged 58 years of age. Most patients who underwent any of the six surgical interventions had the procedures performed at IPs (68%), while 18% had their operations at HOPDs and 14% were perfomed at ASCs.
TKA, RCR, and THA were the most common procedures performed (32%, 27%, and 20%, respectively). While no fluctuation was observed in the total number of IP procedures performed during 2012-2017, researchers noted a marked increase in ASCs (58%) and HOPDs (15%).
At the 30-day mark, the total all-cause postsurgical costs associated with IPs ($44,566) were more than double that of HOPDs ($20,468) and ASCs ($19,110; P less than .001). Moreover, multivariate adjustment showed that postsurgical costs accrued 30 days after surgery for HOPDs and ASCs were 14% and 27% lower than IPs (P less than .001), respectively.
Additionally, each group exhibited similar evidence of opioid use in the 12-month period prior to undergoing surgery, ranging from 63% to 65%. Postsurgical opioid use among opioid-naive patients was the highest in the HOPD group at 96% prevalence, with IPs and ASCs trailing with 91% and 90% (P less than .001), respectively. However, the postsurgical prevalence of opioid use in patients who had used opioids before surgery was 95% for IPs and HOPDs and 82% for ASCs (P less than .001).
SOURCE: Waterman F et al. AMCP NEXUS 2019, Abstract U12.
REPORTING FROM AMCP NEXUS 2019
Head & neck cancers: What you’ll see, how to proceed
The statistics reveal a serious problem: This year, an estimated 63,030 Americans will be given a diagnosis of head and neck cancer (which includes laryngeal, oropharyngeal, sinonasal, nasopharyngeal, and salivary gland cancer1); approximately 13,360 of them will die. Furthermore, thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an estimated 56,870 cases in 2017.1,2 Major risk factors for head and neck cancer are tobacco and alcohol exposure and infection with Epstein-Barr virus and human papillomavirus (HPV).3
In this article, we review the background for each of the principal types of head and neck cancer with which you should be familiar. We also discuss how to evaluate signs and symptoms that raise suspicion of these neoplasms; outline the diagnostic strategy in the face of such suspicion; and summarize accepted therapeutic approaches. Last, we describe the important role that you, the family physician, play in providing posttreatment care for these patients, especially prevention and management of late adverse effects of radiation therapy.
General characterizationsof these cancers
Approximately one-half of patients with head and neck cancer present initially with a nonspecific, persistent neck mass that should be deemed malignant until proven otherwise, because a delay in diagnosis is associated with a worse outcome.4 In a series of 100 patients with head and neck cancer, for example, delay in diagnosis occurred in nearly 25%—most often because of time spent providing inappropriate antibiotic treatment.5 Guidelines for management of neck masses recommend against the use of antibiotics in patients who do not have evidence of infection.6
Patients with a neck mass that has been present for longer than 2 weeks or that is ulcerated, fixed to underlying tissues, of firm consistency, or > 1.5 cm should have a physical examination that includes visualization of the base of tongue, pharynx, and larynx. The mass should be evaluated with fine-needle aspiration (FNA) biopsy, which has a positive predictive value of 96% and negative predictive value of 90% for the diagnosis of a head and neck mass. (Note: Anticoagulation therapy is not an absolute contraindication to FNA, which is not associated with an increased risk of bleeding.6)
Laryngeal cancer
What you need to know. More than 90% of laryngeal cancers are squamous cell carcinoma (SCC). Smoking or heavy drinking (> 8 drinks/d), compared to neither behavior, is associated with an increased risk of laryngeal cancer (odds ratio, 9.4 and 2.5, respectively).7 The risk of cancer is directly proportional to the degree of tobacco exposure.
Laryngeal cancer occurs in the supraglottic region in one-third of patients; in the glottic region in one-half; and in the subglottic region in a very few.8 Glottic cancer presents earlier than supraglottic cancer with hoarseness, whereas supraglottic cancer presents with more advanced disease, causing stridor, dysphagia, and throat pain. (Note: Guidelines recommend against prescribing acid suppressants in patients with hoarseness who do not have symptoms of reflux.9)
Stage 1 and Stage 2 laryngeal cancers are localized; Stages 3-4B are locally advanced or involve lymph nodes, or both; Stage 4C is metastatic disease. Overall, 60% of patients have Stage 3 or Stage 4 disease at diagnosis.10
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Laryngoscopy should be performed before computed tomography (CT) or magnetic resonance imaging is considered in a patient with hoarseness that does not resolve after 3 months—or sooner, if there is suspicion of malignancy.
How is it treated? Most patients presenting with Stage 1 or Stage 2 cancer can be treated with local radiation or, less commonly, larynx-preserving surgery. Patients with Stage 3 or Stage 4 disease can be treated with a combination of radiation and chemotherapy, which, compared to radiation alone, confers a decreased risk of local recurrence and increased laryngectomy-free survival.11 Patients whose vocal cords are destroyed or who have recurrence following radiation and chemotherapy might need total laryngectomy and formation of a tracheostomy and prosthetic for voice creation.
Five-year overall survival for Stage 1 and Stage 2 supraglottic and glottic cancers is 80%—lower, however, for later-presenting subglottic cancers.12
Oropharyngeal cancer
What you need to know. The lifetime risk for cancer of the oropharynx is approximately 1%.13 SCC is responsible for approximately 90% of these cancers. Early detection is important: The 5-year survival rate is more than twice as high for localized disease (83%) than it is for metastatic disease (39%) at detection.13
At any given time, 7% of the US population has HPV infection of the oropharynx. Most of these cases clear spontaneously, but persistent high-risk HPV infection led to a 225% increase in HPV-positive oropharyngeal SCC from 1988 to 2004.14 The representative case of HPV-positive oropharyngeal SCC is a middle-aged (40- to 59-year-old) white male with a history of multiple sexual partners and with little or no tobacco exposure and low alcohol consumption.
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Oral cancers present with a lesion, often ulcerative, that should be examined by palpation with a gloved finger to describe the presence, color, and number of lesions; any tenderness; tissue consistency (soft, firm, hard); and fixation to underlying structures.15 The oropharynx should be examined without protrusion of the tongue, which obscures the oropharynx and can make it harder to depress the posterior part of the tongue.
A finding of leukoplakia (white plaques) and erythroplakia (red plaques) of the oropharynx might reflect benign hyperkeratosis or premalignant lesions; the plaques do not wipe off on examination. Referral to a dentist or otorhinolaryngologist for biopsy is indicated for all erythroplakia and leukoplakia, and for ulcers that persist longer than 2 weeks.16
(Note: Evidence is insufficient to support screening asymptomatic patients for oral and oropharyngeal cancers by physical examination. There is no US Food and Drug Administration-approved screening test for oral HPV infection.17)
How is it treated? A diagnosis of moderate dysplasia or carcinoma in situ should be treated with surgical excision to clear margins followed by routine monitoring every 3 to 6 months, for life.18 Topical medication, electrocautery, laser ablation, and cryosurgery are management options for less severe dysplasia.
Sinonasal cancer
What you need to know. Worldwide, sinonasal cancer accounts for approximately 0.7% of all new cancers but demonstrates strong genetic and regional associations, particularly among the Cantonese population of southern China.19 One-half of new sinonasal malignancies are SCC; the rest are adenocarcinoma, lymphoepithelial carcinoma, and rare subtypes.20
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Presentation tends to mimic common, nonmalignant conditions, such as sinusitis, until invasion into adjacent structures. When sinonasal passages are involved, the history might include epistaxis or nasal discharge; facial or dental pain; unilateral nasal obstruction with unexplained onset later in life; and failure to respond to treatment of presumed rhinosinusitis. Physical examination should include assessment of cranial nerves, palpation of the sinuses, and anterior rhinoscopy.
Thin-cut CT of the paranasal sinuses is the first-line imaging study. Sinonasal endoscopy, with targeted biopsy of suspicious lesions, is the evaluation of choice when malignancy is suspected.
How is it treated? Surgery is the treatment of choice, with postoperative radiation for patients at higher risk of recurrence because of more extensive disase.12 Five-year survival for advanced disease is poor (35%); only 15% of cases are diagnosed at a localized stage because presenting symptoms are nonspecific.21
Nasopharyngeal cancer
What you need to know. Nasopharyngeal cancer is rare in the United States and Europe, compared with China, where it is endemic (and where a variety of risk factors, including intake of salt-preserved fish, have been proposed22). Epstein-Barr virus infection and a history of smoking increase the risk.
Patients with nasopharyngeal cancer can present with epistaxis, nasal obstruction, and auditory symptoms, such as serous otitis media. Direct extension of the tumor can lead to cranial-nerve palsy, most commonly III, V, VI, and XII.23
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Three-quarters of patients present with a neck mass from lymph-node metastases. Patients with the risk factors for nasopharyngeal cancer noted above who present with concerning symptoms should have nasoendoscopy with biopsy.
How is it treated? Radiation is the primary treatment, which is combined with chemotherapy for more advanced disease.23 Screening high-risk populations for antibodies to Epstein-Barr virus and performing nasopharyngeal endoscopy on patients who screen positive increases the detection rate of nasopharyngeal cancer; however, this strategy has not been shown to improve survival.9
Salivary gland tumors
What you need to know. Salivary gland neoplasms are a rare and heterogeneous entity, comprising 6% to 8% of head and neck cancers.24 More than 70% of these tumors are located in the parotid gland; 8%, in the submandibular glands; 1%, in the sublingual glands; and the rest, in the minor salivary glands. Most salivary gland tumors are benign; the most prevalent malignant tumors are mucoepidermoid carcinoma (30%) and adenoid cystic carcinoma (10%).25 Additional identified risk factors for a salivary gland tumor include irradiation, prior head and neck cancer, and environmental exposures, including hairdressing, rubber manufacturing, and exposure to nickel compounds.26
What is the diagnostic strategy? The history and physical exam are essential to distinguish a salivary gland tumor from an infectious cause and sialolithiasis. Parotid tumors most commonly present as asymptomatic parotid swelling, although pain can be present in as many as 40% of malignant parotid tumors.25 Facial nerve weakness is found in 25% of parotid tumors; although the differential diagnosis of facial nerve palsy is broad, suspicion of malignancy should be raised in the presence of a parotid mass, progressive unilateral symptoms, hemifacial spasm progressing to weakness, and a history of skin cancer on the face or scalp. Additional characteristics that favor a neoplastic cause are trismus and nontender lymphadenopathy.25
In contrast, sialolithiasis is associated with intermittent pain caused by eating and is more common in the settings of dehydration and poor dental hygiene. Sialadenitis should be suspected when the presentation is fever, increased pain and swelling, erythema, and expression of pus from the salivary gland.
Continue to: If malignancy is suspected...
If malignancy is suspected, the initial diagnostic evaluation should include ultrasonography (US); concurrent FNA biopsy should be performed if a mass is detected.27 US-guided FNA has a sensitivity of 73% to 86% for salivary neoplasm.7 CT and magnetic resonance imaging are useful for further characterization of tumors and can be advantageous for surgical planning.
How is it treated? Treatment of a salivary gland tumor involves surgical resection, followed by radiotherapy for patients in whom disease is more extensive or who exhibit high-risk pathology. Primary radiotherapy can be used in patients with an unresectable tumor. Typically, chemotherapy is used only for palliative purposes in relapsing disease, when a tumor is not amenable to radiotherapy, and in metastatic disease.25
Prognosis varies by histotype but is generally favorable. The survival rates for a malignant salivary gland tumor are 83% at 1 year, 69% at 3 years, and 65% at 5 years.28 Distant metastases are the most common cause of death, occurring primarily in the lungs (80%), bone (15%), and liver.27 Factors that indicate poor prognosis include facial nerve involvement, trismus, a tumor > 4 cm, bone involvement, nodal spread, and recurrence.25
Thyroid cancer
What you need to know. Thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an annual incidence of 4.5%.1 In the United States, most thyroid cancers are differentiated thyroid cancer (DTC), which includes papillary and follicular cancers. Less-differentiated medullary thyroid cancer (MTC), typically associated with multiple endocrine neoplasia (MEN) 2A or 2B, and undifferentiated or anaplastic thyroid cancer are less common. The increasing incidence of thyroid cancer is primarily the result of an increase in nonclinically relevant DTC.
What is the diagnostic strategy? Thyroid cancer usually presents as a thyroid nodule found by the patient or incidentally on physical examination or imaging. Other presenting signs and symptoms include hoarseness, voice changes, and dysphagia.
Continue to: Thyroid US is the study of...
Thyroid US is the study of choice for initial evaluation of the size and features of a nodule; findings are used to make recommendations for further workup. If further evaluation is indicated, FNA biopsy is the test of choice.29
In 2016, the American Thyroid Association released updated guidelines for evaluating thyroid nodules (TABLE).30 The US Preventive Services Task Force recommends against screening for thyroid cancer by neck palpation or US in asymptomatic patients because evidence of significant mortality benefit is lacking.31
How is it treated? Treatment of thyroid cancer focuses on local excision of the nodule by partial or total thyroidectomy (depending on the size and type of cancer) and surgical removal of involved lymph nodes. Differentiated thyroid cancer is categorized as high-, medium-, or low-risk, depending on tumor extension, incomplete tumor resection, size of lymph nodes > 3 cm, and distant metastases. Adjuvant treatment with radioactive iodine can be considered for intermediate-risk DTC and is recommended for high-risk DTC.32
Following surgical treatment, thyroid-stimulating hormone suppression is recommended using levothyroxine.33 Patients at higher risk of recurrence should have longer and more intense suppression of thyroid-stimulating hormone.30 Levels of serum thyroglobulin and anti-thyroglobulin antibody should be followed postoperatively; rising values can indicate recurrent disease. The calcitonin level should be followed in patients with a history of MTC. Thyroid US should be performed 6 to 12 months postoperatively, then periodically, depending on determination of recurrence risk and any change in the thyroglobulin level.30
(Note: Glucagon-like peptide-1 [GLP-1] receptor agonists, used to treat type 2 diabetes mellitus, carry a black-box warning for their risk of MTC and are contraindicated in patients who have a personal or family history of MTC, MEN2A, or MEN2B.34)
Continue to: Anaplastic thyroid cancer...
Anaplastic thyroid cancer, a rare form of thyroid cancer, carries a high mortality rate, with a median survival of 5 months from diagnosis and 1-year survival of 20%. Patients require expeditious total thyroidectomy and neck dissection, followed by external-beam radiation with or without chemotherapy. If this strategy is not feasible, tracheostomy might be necessary to maintain a patent airway.2 Family physicians treating a patient who has anaplastic thyroid cancer can fulfill a crucial role by ensuring that an advance directive is established, a surrogate decision-maker is appointed, and goals of care are well defined.
Follow-up care for head and neck Ca
The risk of adverse effects after radiation therapy for head and neck cancer calls for close monitoring, appropriate treatment, and referral and counseling as needed. See “Follow-up care after treatment of head and neck cancer.” 35-39
SIDEBAR
Follow-up care after treatment of head and neck cancer35-39
Challenge: After radiation to the head and neck, as many as 53% of patients develop subclinical hypothyroidism and 33% develop clinical hypothyroidism.35Strategy: Measure the thyroid-stimulating hormone level within 1 year of the completion of radiotherapy and every 6 to 12 months thereafter.36
Challenge: Radiation to the head and neck can decrease the function of salivary glands, causing xerostomia in as many as 40% of patients. This condition can lead to problems with oral hygiene and difficulty with speech, eating, and swallowing.37Strategy:
- Treat xerostomia with artificial saliva, sugar-free candy and gum, or muscarinic cholinergic agonists, such as pilocarpine and cevimeline.
- Consider treatment with pilocarpine or cevimeline. Pilocarpine alleviates xerostomia in approximately 50% of patients who develop the condition, although its use can be limited by adverse cholinergic effects.3,7 Cevimeline causes fewer and less pronounced adverse effects than pilocarpine because it acts more specifically on receptors in the salivary glands.38
- Mention the possibility of acupuncture to your patients. There is evidence that it can stimulate salivary flow.39
Challenge: Patients who have had radiation to the head and neck have an increased risk of dental caries from xerostomia and the direct effect of radiation, which causes demineralization of teeth.
Strategy: Following radiation, instruct the patient about appropriate oral hygiene:
- regular flossing
- brushing and application of daily fluoride
- regular visits for dental care.39
Challenge: Trismus occurs in 5% to 25% of patients, depending on the type of radiation.36Strategy: Recommend exercise-based treatment, the treatment of choice. Surgery is indicated for severe cases.
Challenge: Dysphagia occurs in approximately 25% of patients treated with radiation.36Strategy: Provide a referral for swallowing exercises, which might be helpful. Some cases are severe enough to warrant placement of a feeding tube.37
Last, counsel all patients who have been treated for cancer of the head or neck, with any modality, about cessation of smoking and alcohol.
CORRESPONDENCE
Anne Mounsey, MD, Family Medicine Residency, The University of North Carolina at Chapel Hill, 590 Manning Dr., Chapel Hill, NC 27599; [email protected]
1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30.
2. Smallridge RC, Ain KB, Asa SL, et al; American Thyroid Association Anaplastic Thyroid Cancer Guidelines Taskforce. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012;22:1104-1139.
3. Marur S, Forastiere AA. Head and neck cancer: changing epidemiology, diagnosis, and treatment. Mayo Clin Proc. 2008;83:489-501.
4. Seoane J, Alvarez-Novoa P, Gomez I, et al. Early oral cancer diagnosis: The Aarhus statement perspective. A systematic review and meta-analysis. Head Neck. 2016;38(suppl 1):E2182-E2189.
5. Franco J, Elghouche AN, Harris MS, et al Diagnostic delays and errors in head and neck cancer patients: opportunities for improvement. Am J Med Qual. 2017;32:330-335.
6. Pynnonen MA, Gillespie MB, Roman B, et al. Clinical practice guideline: evaluation of the neck mass in adults. Otolaryngol Head Neck Surg. 2017;157(suppl 2):S1-S30.
7. Bosetti C, Gallus S, Franceschi S, et al. Cancer of the larynx in non-smoking alcohol drinkers and in non-drinking tobacco smokers. Br J Cancer. 2002;87:516-518.
8. Hoffman HT, Porter K, Karnell LH, et al. Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope. 2006;116(9 pt 2 suppl 111):1-13.
9. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009;141(3 suppl 2):S1-S31.
10. Steuer CE, El-Deiry M, Parks JR, et al. An update on larynx cancer. CA Cancer J Clin. 2017;67:31-50.
11. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091-2098.
12. Mendenhall WM, Werning JW, Hinerman RW, et al. Management of T1-T2 glottic carcinomas. Cancer. 2004;100:1786-1792.
13. Surveillance, Epidemiology, and End Results Unit. National Cancer Institute. Cancer stat facts: oral cavity and pharynx. https://seer.cancer.gov/statfacts/html/oralcav.html. Accessed October 18, 2019.
14. Pytynia KB, Dahlstrom KR, Sturgis EM. Epidemiology of HPV-associated oropharyngeal cancer. Oral Oncol. 2014;50:380-386.
15. Tarakji B, Gazal G, Al-Maweri SA, et al. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015;7:74-80.
16. Siu A, Landon K, Ramos DM. Differential diagnosis and management of oral ulcers. Semin Cutan Med Surg. 2015;34:171-177.
17. US Preventive Services Task Force. Final recommendation statement: oral cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/oral-cancer-screening1. Updated November 2013. Accessed October 18, 2019.
18. Villa A, Woo SB. Leukoplakia—a diagnostic and management algorithm. J Oral Maxillofac Surg. 2017;75:723-734.
19. Yang S, Wu S, Zhou J, et al. Screening for nasopharyngeal cancer. Cochrane Database Syst Rev. 2015;(11):CD008423.
20. Turner JH, Reh DD. Incidence and survival in patients with sinonasal cancer: a historical analysis of population-based data. Head Neck. 2012;34:877-885.
21. Ou SH, Zell JA, Ziogas A, et al. Epidemiology of nasopharyngeal carcinoma in the United States: improved survival of Chinese patients within the keratinizing squamous cell carcinoma histology. Ann Oncol. 2007;18:29-35.
22. Chang ET, Adami H-O. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006;15:1765-1777.
23. Chua MLK, Wee JTS, Hui EP, et al. Nasopharyngeal carcinoma. Lancet. 2016;387:1012-1024.
24. Spiro RH. Salivary neoplasms: overview of a 35-year experience with 2,807 patients. Head Neck Surg. 1986;8:177-184.
25. Lewis JS. Sinonasal squamous cell carcinoma: a review with emphasis on emerging histologic subtypes and the role of human papillomavirus. Head Neck Pathol. 2016;10:60-67.
26. Horn-Ross PL, Ljung BM, Morrow M. Environmental factors and the risk of salivary gland cancer. Epidemiology. 1997;8:414-419.
27. Colella G, Cannavale R, Flamminio F, et al. Fine-needle aspiration cytology of salivary gland lesions: a systematic review. J Oral Maxillofac Surg. 2010;68:2146-2153.
28. Berrino F, De Angelis R, Sant M, et al; EUROCARE Working Group. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995-99: results of the EUROCARE-4 study. Lancet Oncol. 2007;8:773-783.
29. Baloch ZW, LiVolsi VA, Asa SL, et al. Diagnostic terminology and morphologic criteria for cytologic diagnosis of thyroid lesions: a synopsis of the National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference. Diagn Cytopathol. 2008;36:425-437.
30. Haugen BR, Alexander EK, Bible KC, et al; The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26:1-133.
31. US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for thyroid Cancer: US Preventive Services Task Force recommendation statement. JAMA. 2017;317:1882-1887.
32. Jonklaas J, Cooper DS, Ain KB, et al; National Thyroid Cancer Treatment Cooperative Study Group. Radioiodine therapy in patients with stage I differentiated thyroid cancer. Thyroid. 2010;20:1423-1424.
33. Cooper DS, Specker B, Ho M, et al. Thyrotropin suppression and disease progression in patients with differentiated thyroid cancer: results from the National Thyroid Cancer Treatment Cooperative Registry. Thyroid. 1998;8:737-744.
34. US Food and Drug Administration. Highlight of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf. Updated December 2017. Accessed October 30, 1019.
35. Boomsma MJ, Bijl HP, Langendijk JA. Radiation-induced hypothyroidism in head and neck cancer patients: a systematic review. Radiother Oncol. 2011;99:1-5.
36. The development of quality of care measures for oral cavity cancer. Arch Otolaryngol Head Neck Surg. 2008;134:672.
37. Strojan P, Hutcheson KA, Eisbruch A, et al. Treatment of late sequelae after radiotherapy for head and neck cancer. Cancer Treat Rev. 2017;59:79-92.
38. Chambers MS, Posner M, Jones CU, et al. Cevimeline for the treatment of postirradiation xerostomia in patients with head and neck cancer. Int J Radiat Oncol Biol Phys. 2007;68:1102-1109.
39. Gupta N, Pal M, Rawat S, et al. Radiation-induced dental caries, prevention and treatment - a systematic review. Natl J Maxillofac Surg. 2015;6:160-166.
The statistics reveal a serious problem: This year, an estimated 63,030 Americans will be given a diagnosis of head and neck cancer (which includes laryngeal, oropharyngeal, sinonasal, nasopharyngeal, and salivary gland cancer1); approximately 13,360 of them will die. Furthermore, thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an estimated 56,870 cases in 2017.1,2 Major risk factors for head and neck cancer are tobacco and alcohol exposure and infection with Epstein-Barr virus and human papillomavirus (HPV).3
In this article, we review the background for each of the principal types of head and neck cancer with which you should be familiar. We also discuss how to evaluate signs and symptoms that raise suspicion of these neoplasms; outline the diagnostic strategy in the face of such suspicion; and summarize accepted therapeutic approaches. Last, we describe the important role that you, the family physician, play in providing posttreatment care for these patients, especially prevention and management of late adverse effects of radiation therapy.
General characterizationsof these cancers
Approximately one-half of patients with head and neck cancer present initially with a nonspecific, persistent neck mass that should be deemed malignant until proven otherwise, because a delay in diagnosis is associated with a worse outcome.4 In a series of 100 patients with head and neck cancer, for example, delay in diagnosis occurred in nearly 25%—most often because of time spent providing inappropriate antibiotic treatment.5 Guidelines for management of neck masses recommend against the use of antibiotics in patients who do not have evidence of infection.6
Patients with a neck mass that has been present for longer than 2 weeks or that is ulcerated, fixed to underlying tissues, of firm consistency, or > 1.5 cm should have a physical examination that includes visualization of the base of tongue, pharynx, and larynx. The mass should be evaluated with fine-needle aspiration (FNA) biopsy, which has a positive predictive value of 96% and negative predictive value of 90% for the diagnosis of a head and neck mass. (Note: Anticoagulation therapy is not an absolute contraindication to FNA, which is not associated with an increased risk of bleeding.6)
Laryngeal cancer
What you need to know. More than 90% of laryngeal cancers are squamous cell carcinoma (SCC). Smoking or heavy drinking (> 8 drinks/d), compared to neither behavior, is associated with an increased risk of laryngeal cancer (odds ratio, 9.4 and 2.5, respectively).7 The risk of cancer is directly proportional to the degree of tobacco exposure.
Laryngeal cancer occurs in the supraglottic region in one-third of patients; in the glottic region in one-half; and in the subglottic region in a very few.8 Glottic cancer presents earlier than supraglottic cancer with hoarseness, whereas supraglottic cancer presents with more advanced disease, causing stridor, dysphagia, and throat pain. (Note: Guidelines recommend against prescribing acid suppressants in patients with hoarseness who do not have symptoms of reflux.9)
Stage 1 and Stage 2 laryngeal cancers are localized; Stages 3-4B are locally advanced or involve lymph nodes, or both; Stage 4C is metastatic disease. Overall, 60% of patients have Stage 3 or Stage 4 disease at diagnosis.10
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Laryngoscopy should be performed before computed tomography (CT) or magnetic resonance imaging is considered in a patient with hoarseness that does not resolve after 3 months—or sooner, if there is suspicion of malignancy.
How is it treated? Most patients presenting with Stage 1 or Stage 2 cancer can be treated with local radiation or, less commonly, larynx-preserving surgery. Patients with Stage 3 or Stage 4 disease can be treated with a combination of radiation and chemotherapy, which, compared to radiation alone, confers a decreased risk of local recurrence and increased laryngectomy-free survival.11 Patients whose vocal cords are destroyed or who have recurrence following radiation and chemotherapy might need total laryngectomy and formation of a tracheostomy and prosthetic for voice creation.
Five-year overall survival for Stage 1 and Stage 2 supraglottic and glottic cancers is 80%—lower, however, for later-presenting subglottic cancers.12
Oropharyngeal cancer
What you need to know. The lifetime risk for cancer of the oropharynx is approximately 1%.13 SCC is responsible for approximately 90% of these cancers. Early detection is important: The 5-year survival rate is more than twice as high for localized disease (83%) than it is for metastatic disease (39%) at detection.13
At any given time, 7% of the US population has HPV infection of the oropharynx. Most of these cases clear spontaneously, but persistent high-risk HPV infection led to a 225% increase in HPV-positive oropharyngeal SCC from 1988 to 2004.14 The representative case of HPV-positive oropharyngeal SCC is a middle-aged (40- to 59-year-old) white male with a history of multiple sexual partners and with little or no tobacco exposure and low alcohol consumption.
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Oral cancers present with a lesion, often ulcerative, that should be examined by palpation with a gloved finger to describe the presence, color, and number of lesions; any tenderness; tissue consistency (soft, firm, hard); and fixation to underlying structures.15 The oropharynx should be examined without protrusion of the tongue, which obscures the oropharynx and can make it harder to depress the posterior part of the tongue.
A finding of leukoplakia (white plaques) and erythroplakia (red plaques) of the oropharynx might reflect benign hyperkeratosis or premalignant lesions; the plaques do not wipe off on examination. Referral to a dentist or otorhinolaryngologist for biopsy is indicated for all erythroplakia and leukoplakia, and for ulcers that persist longer than 2 weeks.16
(Note: Evidence is insufficient to support screening asymptomatic patients for oral and oropharyngeal cancers by physical examination. There is no US Food and Drug Administration-approved screening test for oral HPV infection.17)
How is it treated? A diagnosis of moderate dysplasia or carcinoma in situ should be treated with surgical excision to clear margins followed by routine monitoring every 3 to 6 months, for life.18 Topical medication, electrocautery, laser ablation, and cryosurgery are management options for less severe dysplasia.
Sinonasal cancer
What you need to know. Worldwide, sinonasal cancer accounts for approximately 0.7% of all new cancers but demonstrates strong genetic and regional associations, particularly among the Cantonese population of southern China.19 One-half of new sinonasal malignancies are SCC; the rest are adenocarcinoma, lymphoepithelial carcinoma, and rare subtypes.20
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Presentation tends to mimic common, nonmalignant conditions, such as sinusitis, until invasion into adjacent structures. When sinonasal passages are involved, the history might include epistaxis or nasal discharge; facial or dental pain; unilateral nasal obstruction with unexplained onset later in life; and failure to respond to treatment of presumed rhinosinusitis. Physical examination should include assessment of cranial nerves, palpation of the sinuses, and anterior rhinoscopy.
Thin-cut CT of the paranasal sinuses is the first-line imaging study. Sinonasal endoscopy, with targeted biopsy of suspicious lesions, is the evaluation of choice when malignancy is suspected.
How is it treated? Surgery is the treatment of choice, with postoperative radiation for patients at higher risk of recurrence because of more extensive disase.12 Five-year survival for advanced disease is poor (35%); only 15% of cases are diagnosed at a localized stage because presenting symptoms are nonspecific.21
Nasopharyngeal cancer
What you need to know. Nasopharyngeal cancer is rare in the United States and Europe, compared with China, where it is endemic (and where a variety of risk factors, including intake of salt-preserved fish, have been proposed22). Epstein-Barr virus infection and a history of smoking increase the risk.
Patients with nasopharyngeal cancer can present with epistaxis, nasal obstruction, and auditory symptoms, such as serous otitis media. Direct extension of the tumor can lead to cranial-nerve palsy, most commonly III, V, VI, and XII.23
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Three-quarters of patients present with a neck mass from lymph-node metastases. Patients with the risk factors for nasopharyngeal cancer noted above who present with concerning symptoms should have nasoendoscopy with biopsy.
How is it treated? Radiation is the primary treatment, which is combined with chemotherapy for more advanced disease.23 Screening high-risk populations for antibodies to Epstein-Barr virus and performing nasopharyngeal endoscopy on patients who screen positive increases the detection rate of nasopharyngeal cancer; however, this strategy has not been shown to improve survival.9
Salivary gland tumors
What you need to know. Salivary gland neoplasms are a rare and heterogeneous entity, comprising 6% to 8% of head and neck cancers.24 More than 70% of these tumors are located in the parotid gland; 8%, in the submandibular glands; 1%, in the sublingual glands; and the rest, in the minor salivary glands. Most salivary gland tumors are benign; the most prevalent malignant tumors are mucoepidermoid carcinoma (30%) and adenoid cystic carcinoma (10%).25 Additional identified risk factors for a salivary gland tumor include irradiation, prior head and neck cancer, and environmental exposures, including hairdressing, rubber manufacturing, and exposure to nickel compounds.26
What is the diagnostic strategy? The history and physical exam are essential to distinguish a salivary gland tumor from an infectious cause and sialolithiasis. Parotid tumors most commonly present as asymptomatic parotid swelling, although pain can be present in as many as 40% of malignant parotid tumors.25 Facial nerve weakness is found in 25% of parotid tumors; although the differential diagnosis of facial nerve palsy is broad, suspicion of malignancy should be raised in the presence of a parotid mass, progressive unilateral symptoms, hemifacial spasm progressing to weakness, and a history of skin cancer on the face or scalp. Additional characteristics that favor a neoplastic cause are trismus and nontender lymphadenopathy.25
In contrast, sialolithiasis is associated with intermittent pain caused by eating and is more common in the settings of dehydration and poor dental hygiene. Sialadenitis should be suspected when the presentation is fever, increased pain and swelling, erythema, and expression of pus from the salivary gland.
Continue to: If malignancy is suspected...
If malignancy is suspected, the initial diagnostic evaluation should include ultrasonography (US); concurrent FNA biopsy should be performed if a mass is detected.27 US-guided FNA has a sensitivity of 73% to 86% for salivary neoplasm.7 CT and magnetic resonance imaging are useful for further characterization of tumors and can be advantageous for surgical planning.
How is it treated? Treatment of a salivary gland tumor involves surgical resection, followed by radiotherapy for patients in whom disease is more extensive or who exhibit high-risk pathology. Primary radiotherapy can be used in patients with an unresectable tumor. Typically, chemotherapy is used only for palliative purposes in relapsing disease, when a tumor is not amenable to radiotherapy, and in metastatic disease.25
Prognosis varies by histotype but is generally favorable. The survival rates for a malignant salivary gland tumor are 83% at 1 year, 69% at 3 years, and 65% at 5 years.28 Distant metastases are the most common cause of death, occurring primarily in the lungs (80%), bone (15%), and liver.27 Factors that indicate poor prognosis include facial nerve involvement, trismus, a tumor > 4 cm, bone involvement, nodal spread, and recurrence.25
Thyroid cancer
What you need to know. Thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an annual incidence of 4.5%.1 In the United States, most thyroid cancers are differentiated thyroid cancer (DTC), which includes papillary and follicular cancers. Less-differentiated medullary thyroid cancer (MTC), typically associated with multiple endocrine neoplasia (MEN) 2A or 2B, and undifferentiated or anaplastic thyroid cancer are less common. The increasing incidence of thyroid cancer is primarily the result of an increase in nonclinically relevant DTC.
What is the diagnostic strategy? Thyroid cancer usually presents as a thyroid nodule found by the patient or incidentally on physical examination or imaging. Other presenting signs and symptoms include hoarseness, voice changes, and dysphagia.
Continue to: Thyroid US is the study of...
Thyroid US is the study of choice for initial evaluation of the size and features of a nodule; findings are used to make recommendations for further workup. If further evaluation is indicated, FNA biopsy is the test of choice.29
In 2016, the American Thyroid Association released updated guidelines for evaluating thyroid nodules (TABLE).30 The US Preventive Services Task Force recommends against screening for thyroid cancer by neck palpation or US in asymptomatic patients because evidence of significant mortality benefit is lacking.31
How is it treated? Treatment of thyroid cancer focuses on local excision of the nodule by partial or total thyroidectomy (depending on the size and type of cancer) and surgical removal of involved lymph nodes. Differentiated thyroid cancer is categorized as high-, medium-, or low-risk, depending on tumor extension, incomplete tumor resection, size of lymph nodes > 3 cm, and distant metastases. Adjuvant treatment with radioactive iodine can be considered for intermediate-risk DTC and is recommended for high-risk DTC.32
Following surgical treatment, thyroid-stimulating hormone suppression is recommended using levothyroxine.33 Patients at higher risk of recurrence should have longer and more intense suppression of thyroid-stimulating hormone.30 Levels of serum thyroglobulin and anti-thyroglobulin antibody should be followed postoperatively; rising values can indicate recurrent disease. The calcitonin level should be followed in patients with a history of MTC. Thyroid US should be performed 6 to 12 months postoperatively, then periodically, depending on determination of recurrence risk and any change in the thyroglobulin level.30
(Note: Glucagon-like peptide-1 [GLP-1] receptor agonists, used to treat type 2 diabetes mellitus, carry a black-box warning for their risk of MTC and are contraindicated in patients who have a personal or family history of MTC, MEN2A, or MEN2B.34)
Continue to: Anaplastic thyroid cancer...
Anaplastic thyroid cancer, a rare form of thyroid cancer, carries a high mortality rate, with a median survival of 5 months from diagnosis and 1-year survival of 20%. Patients require expeditious total thyroidectomy and neck dissection, followed by external-beam radiation with or without chemotherapy. If this strategy is not feasible, tracheostomy might be necessary to maintain a patent airway.2 Family physicians treating a patient who has anaplastic thyroid cancer can fulfill a crucial role by ensuring that an advance directive is established, a surrogate decision-maker is appointed, and goals of care are well defined.
Follow-up care for head and neck Ca
The risk of adverse effects after radiation therapy for head and neck cancer calls for close monitoring, appropriate treatment, and referral and counseling as needed. See “Follow-up care after treatment of head and neck cancer.” 35-39
SIDEBAR
Follow-up care after treatment of head and neck cancer35-39
Challenge: After radiation to the head and neck, as many as 53% of patients develop subclinical hypothyroidism and 33% develop clinical hypothyroidism.35Strategy: Measure the thyroid-stimulating hormone level within 1 year of the completion of radiotherapy and every 6 to 12 months thereafter.36
Challenge: Radiation to the head and neck can decrease the function of salivary glands, causing xerostomia in as many as 40% of patients. This condition can lead to problems with oral hygiene and difficulty with speech, eating, and swallowing.37Strategy:
- Treat xerostomia with artificial saliva, sugar-free candy and gum, or muscarinic cholinergic agonists, such as pilocarpine and cevimeline.
- Consider treatment with pilocarpine or cevimeline. Pilocarpine alleviates xerostomia in approximately 50% of patients who develop the condition, although its use can be limited by adverse cholinergic effects.3,7 Cevimeline causes fewer and less pronounced adverse effects than pilocarpine because it acts more specifically on receptors in the salivary glands.38
- Mention the possibility of acupuncture to your patients. There is evidence that it can stimulate salivary flow.39
Challenge: Patients who have had radiation to the head and neck have an increased risk of dental caries from xerostomia and the direct effect of radiation, which causes demineralization of teeth.
Strategy: Following radiation, instruct the patient about appropriate oral hygiene:
- regular flossing
- brushing and application of daily fluoride
- regular visits for dental care.39
Challenge: Trismus occurs in 5% to 25% of patients, depending on the type of radiation.36Strategy: Recommend exercise-based treatment, the treatment of choice. Surgery is indicated for severe cases.
Challenge: Dysphagia occurs in approximately 25% of patients treated with radiation.36Strategy: Provide a referral for swallowing exercises, which might be helpful. Some cases are severe enough to warrant placement of a feeding tube.37
Last, counsel all patients who have been treated for cancer of the head or neck, with any modality, about cessation of smoking and alcohol.
CORRESPONDENCE
Anne Mounsey, MD, Family Medicine Residency, The University of North Carolina at Chapel Hill, 590 Manning Dr., Chapel Hill, NC 27599; [email protected]
The statistics reveal a serious problem: This year, an estimated 63,030 Americans will be given a diagnosis of head and neck cancer (which includes laryngeal, oropharyngeal, sinonasal, nasopharyngeal, and salivary gland cancer1); approximately 13,360 of them will die. Furthermore, thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an estimated 56,870 cases in 2017.1,2 Major risk factors for head and neck cancer are tobacco and alcohol exposure and infection with Epstein-Barr virus and human papillomavirus (HPV).3
In this article, we review the background for each of the principal types of head and neck cancer with which you should be familiar. We also discuss how to evaluate signs and symptoms that raise suspicion of these neoplasms; outline the diagnostic strategy in the face of such suspicion; and summarize accepted therapeutic approaches. Last, we describe the important role that you, the family physician, play in providing posttreatment care for these patients, especially prevention and management of late adverse effects of radiation therapy.
General characterizationsof these cancers
Approximately one-half of patients with head and neck cancer present initially with a nonspecific, persistent neck mass that should be deemed malignant until proven otherwise, because a delay in diagnosis is associated with a worse outcome.4 In a series of 100 patients with head and neck cancer, for example, delay in diagnosis occurred in nearly 25%—most often because of time spent providing inappropriate antibiotic treatment.5 Guidelines for management of neck masses recommend against the use of antibiotics in patients who do not have evidence of infection.6
Patients with a neck mass that has been present for longer than 2 weeks or that is ulcerated, fixed to underlying tissues, of firm consistency, or > 1.5 cm should have a physical examination that includes visualization of the base of tongue, pharynx, and larynx. The mass should be evaluated with fine-needle aspiration (FNA) biopsy, which has a positive predictive value of 96% and negative predictive value of 90% for the diagnosis of a head and neck mass. (Note: Anticoagulation therapy is not an absolute contraindication to FNA, which is not associated with an increased risk of bleeding.6)
Laryngeal cancer
What you need to know. More than 90% of laryngeal cancers are squamous cell carcinoma (SCC). Smoking or heavy drinking (> 8 drinks/d), compared to neither behavior, is associated with an increased risk of laryngeal cancer (odds ratio, 9.4 and 2.5, respectively).7 The risk of cancer is directly proportional to the degree of tobacco exposure.
Laryngeal cancer occurs in the supraglottic region in one-third of patients; in the glottic region in one-half; and in the subglottic region in a very few.8 Glottic cancer presents earlier than supraglottic cancer with hoarseness, whereas supraglottic cancer presents with more advanced disease, causing stridor, dysphagia, and throat pain. (Note: Guidelines recommend against prescribing acid suppressants in patients with hoarseness who do not have symptoms of reflux.9)
Stage 1 and Stage 2 laryngeal cancers are localized; Stages 3-4B are locally advanced or involve lymph nodes, or both; Stage 4C is metastatic disease. Overall, 60% of patients have Stage 3 or Stage 4 disease at diagnosis.10
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Laryngoscopy should be performed before computed tomography (CT) or magnetic resonance imaging is considered in a patient with hoarseness that does not resolve after 3 months—or sooner, if there is suspicion of malignancy.
How is it treated? Most patients presenting with Stage 1 or Stage 2 cancer can be treated with local radiation or, less commonly, larynx-preserving surgery. Patients with Stage 3 or Stage 4 disease can be treated with a combination of radiation and chemotherapy, which, compared to radiation alone, confers a decreased risk of local recurrence and increased laryngectomy-free survival.11 Patients whose vocal cords are destroyed or who have recurrence following radiation and chemotherapy might need total laryngectomy and formation of a tracheostomy and prosthetic for voice creation.
Five-year overall survival for Stage 1 and Stage 2 supraglottic and glottic cancers is 80%—lower, however, for later-presenting subglottic cancers.12
Oropharyngeal cancer
What you need to know. The lifetime risk for cancer of the oropharynx is approximately 1%.13 SCC is responsible for approximately 90% of these cancers. Early detection is important: The 5-year survival rate is more than twice as high for localized disease (83%) than it is for metastatic disease (39%) at detection.13
At any given time, 7% of the US population has HPV infection of the oropharynx. Most of these cases clear spontaneously, but persistent high-risk HPV infection led to a 225% increase in HPV-positive oropharyngeal SCC from 1988 to 2004.14 The representative case of HPV-positive oropharyngeal SCC is a middle-aged (40- to 59-year-old) white male with a history of multiple sexual partners and with little or no tobacco exposure and low alcohol consumption.
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Oral cancers present with a lesion, often ulcerative, that should be examined by palpation with a gloved finger to describe the presence, color, and number of lesions; any tenderness; tissue consistency (soft, firm, hard); and fixation to underlying structures.15 The oropharynx should be examined without protrusion of the tongue, which obscures the oropharynx and can make it harder to depress the posterior part of the tongue.
A finding of leukoplakia (white plaques) and erythroplakia (red plaques) of the oropharynx might reflect benign hyperkeratosis or premalignant lesions; the plaques do not wipe off on examination. Referral to a dentist or otorhinolaryngologist for biopsy is indicated for all erythroplakia and leukoplakia, and for ulcers that persist longer than 2 weeks.16
(Note: Evidence is insufficient to support screening asymptomatic patients for oral and oropharyngeal cancers by physical examination. There is no US Food and Drug Administration-approved screening test for oral HPV infection.17)
How is it treated? A diagnosis of moderate dysplasia or carcinoma in situ should be treated with surgical excision to clear margins followed by routine monitoring every 3 to 6 months, for life.18 Topical medication, electrocautery, laser ablation, and cryosurgery are management options for less severe dysplasia.
Sinonasal cancer
What you need to know. Worldwide, sinonasal cancer accounts for approximately 0.7% of all new cancers but demonstrates strong genetic and regional associations, particularly among the Cantonese population of southern China.19 One-half of new sinonasal malignancies are SCC; the rest are adenocarcinoma, lymphoepithelial carcinoma, and rare subtypes.20
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Presentation tends to mimic common, nonmalignant conditions, such as sinusitis, until invasion into adjacent structures. When sinonasal passages are involved, the history might include epistaxis or nasal discharge; facial or dental pain; unilateral nasal obstruction with unexplained onset later in life; and failure to respond to treatment of presumed rhinosinusitis. Physical examination should include assessment of cranial nerves, palpation of the sinuses, and anterior rhinoscopy.
Thin-cut CT of the paranasal sinuses is the first-line imaging study. Sinonasal endoscopy, with targeted biopsy of suspicious lesions, is the evaluation of choice when malignancy is suspected.
How is it treated? Surgery is the treatment of choice, with postoperative radiation for patients at higher risk of recurrence because of more extensive disase.12 Five-year survival for advanced disease is poor (35%); only 15% of cases are diagnosed at a localized stage because presenting symptoms are nonspecific.21
Nasopharyngeal cancer
What you need to know. Nasopharyngeal cancer is rare in the United States and Europe, compared with China, where it is endemic (and where a variety of risk factors, including intake of salt-preserved fish, have been proposed22). Epstein-Barr virus infection and a history of smoking increase the risk.
Patients with nasopharyngeal cancer can present with epistaxis, nasal obstruction, and auditory symptoms, such as serous otitis media. Direct extension of the tumor can lead to cranial-nerve palsy, most commonly III, V, VI, and XII.23
Continue to: What is the diagnostic strategy?
What is the diagnostic strategy? Three-quarters of patients present with a neck mass from lymph-node metastases. Patients with the risk factors for nasopharyngeal cancer noted above who present with concerning symptoms should have nasoendoscopy with biopsy.
How is it treated? Radiation is the primary treatment, which is combined with chemotherapy for more advanced disease.23 Screening high-risk populations for antibodies to Epstein-Barr virus and performing nasopharyngeal endoscopy on patients who screen positive increases the detection rate of nasopharyngeal cancer; however, this strategy has not been shown to improve survival.9
Salivary gland tumors
What you need to know. Salivary gland neoplasms are a rare and heterogeneous entity, comprising 6% to 8% of head and neck cancers.24 More than 70% of these tumors are located in the parotid gland; 8%, in the submandibular glands; 1%, in the sublingual glands; and the rest, in the minor salivary glands. Most salivary gland tumors are benign; the most prevalent malignant tumors are mucoepidermoid carcinoma (30%) and adenoid cystic carcinoma (10%).25 Additional identified risk factors for a salivary gland tumor include irradiation, prior head and neck cancer, and environmental exposures, including hairdressing, rubber manufacturing, and exposure to nickel compounds.26
What is the diagnostic strategy? The history and physical exam are essential to distinguish a salivary gland tumor from an infectious cause and sialolithiasis. Parotid tumors most commonly present as asymptomatic parotid swelling, although pain can be present in as many as 40% of malignant parotid tumors.25 Facial nerve weakness is found in 25% of parotid tumors; although the differential diagnosis of facial nerve palsy is broad, suspicion of malignancy should be raised in the presence of a parotid mass, progressive unilateral symptoms, hemifacial spasm progressing to weakness, and a history of skin cancer on the face or scalp. Additional characteristics that favor a neoplastic cause are trismus and nontender lymphadenopathy.25
In contrast, sialolithiasis is associated with intermittent pain caused by eating and is more common in the settings of dehydration and poor dental hygiene. Sialadenitis should be suspected when the presentation is fever, increased pain and swelling, erythema, and expression of pus from the salivary gland.
Continue to: If malignancy is suspected...
If malignancy is suspected, the initial diagnostic evaluation should include ultrasonography (US); concurrent FNA biopsy should be performed if a mass is detected.27 US-guided FNA has a sensitivity of 73% to 86% for salivary neoplasm.7 CT and magnetic resonance imaging are useful for further characterization of tumors and can be advantageous for surgical planning.
How is it treated? Treatment of a salivary gland tumor involves surgical resection, followed by radiotherapy for patients in whom disease is more extensive or who exhibit high-risk pathology. Primary radiotherapy can be used in patients with an unresectable tumor. Typically, chemotherapy is used only for palliative purposes in relapsing disease, when a tumor is not amenable to radiotherapy, and in metastatic disease.25
Prognosis varies by histotype but is generally favorable. The survival rates for a malignant salivary gland tumor are 83% at 1 year, 69% at 3 years, and 65% at 5 years.28 Distant metastases are the most common cause of death, occurring primarily in the lungs (80%), bone (15%), and liver.27 Factors that indicate poor prognosis include facial nerve involvement, trismus, a tumor > 4 cm, bone involvement, nodal spread, and recurrence.25
Thyroid cancer
What you need to know. Thyroid cancer is the most rapidly increasing cancer diagnosis in the United States, with an annual incidence of 4.5%.1 In the United States, most thyroid cancers are differentiated thyroid cancer (DTC), which includes papillary and follicular cancers. Less-differentiated medullary thyroid cancer (MTC), typically associated with multiple endocrine neoplasia (MEN) 2A or 2B, and undifferentiated or anaplastic thyroid cancer are less common. The increasing incidence of thyroid cancer is primarily the result of an increase in nonclinically relevant DTC.
What is the diagnostic strategy? Thyroid cancer usually presents as a thyroid nodule found by the patient or incidentally on physical examination or imaging. Other presenting signs and symptoms include hoarseness, voice changes, and dysphagia.
Continue to: Thyroid US is the study of...
Thyroid US is the study of choice for initial evaluation of the size and features of a nodule; findings are used to make recommendations for further workup. If further evaluation is indicated, FNA biopsy is the test of choice.29
In 2016, the American Thyroid Association released updated guidelines for evaluating thyroid nodules (TABLE).30 The US Preventive Services Task Force recommends against screening for thyroid cancer by neck palpation or US in asymptomatic patients because evidence of significant mortality benefit is lacking.31
How is it treated? Treatment of thyroid cancer focuses on local excision of the nodule by partial or total thyroidectomy (depending on the size and type of cancer) and surgical removal of involved lymph nodes. Differentiated thyroid cancer is categorized as high-, medium-, or low-risk, depending on tumor extension, incomplete tumor resection, size of lymph nodes > 3 cm, and distant metastases. Adjuvant treatment with radioactive iodine can be considered for intermediate-risk DTC and is recommended for high-risk DTC.32
Following surgical treatment, thyroid-stimulating hormone suppression is recommended using levothyroxine.33 Patients at higher risk of recurrence should have longer and more intense suppression of thyroid-stimulating hormone.30 Levels of serum thyroglobulin and anti-thyroglobulin antibody should be followed postoperatively; rising values can indicate recurrent disease. The calcitonin level should be followed in patients with a history of MTC. Thyroid US should be performed 6 to 12 months postoperatively, then periodically, depending on determination of recurrence risk and any change in the thyroglobulin level.30
(Note: Glucagon-like peptide-1 [GLP-1] receptor agonists, used to treat type 2 diabetes mellitus, carry a black-box warning for their risk of MTC and are contraindicated in patients who have a personal or family history of MTC, MEN2A, or MEN2B.34)
Continue to: Anaplastic thyroid cancer...
Anaplastic thyroid cancer, a rare form of thyroid cancer, carries a high mortality rate, with a median survival of 5 months from diagnosis and 1-year survival of 20%. Patients require expeditious total thyroidectomy and neck dissection, followed by external-beam radiation with or without chemotherapy. If this strategy is not feasible, tracheostomy might be necessary to maintain a patent airway.2 Family physicians treating a patient who has anaplastic thyroid cancer can fulfill a crucial role by ensuring that an advance directive is established, a surrogate decision-maker is appointed, and goals of care are well defined.
Follow-up care for head and neck Ca
The risk of adverse effects after radiation therapy for head and neck cancer calls for close monitoring, appropriate treatment, and referral and counseling as needed. See “Follow-up care after treatment of head and neck cancer.” 35-39
SIDEBAR
Follow-up care after treatment of head and neck cancer35-39
Challenge: After radiation to the head and neck, as many as 53% of patients develop subclinical hypothyroidism and 33% develop clinical hypothyroidism.35Strategy: Measure the thyroid-stimulating hormone level within 1 year of the completion of radiotherapy and every 6 to 12 months thereafter.36
Challenge: Radiation to the head and neck can decrease the function of salivary glands, causing xerostomia in as many as 40% of patients. This condition can lead to problems with oral hygiene and difficulty with speech, eating, and swallowing.37Strategy:
- Treat xerostomia with artificial saliva, sugar-free candy and gum, or muscarinic cholinergic agonists, such as pilocarpine and cevimeline.
- Consider treatment with pilocarpine or cevimeline. Pilocarpine alleviates xerostomia in approximately 50% of patients who develop the condition, although its use can be limited by adverse cholinergic effects.3,7 Cevimeline causes fewer and less pronounced adverse effects than pilocarpine because it acts more specifically on receptors in the salivary glands.38
- Mention the possibility of acupuncture to your patients. There is evidence that it can stimulate salivary flow.39
Challenge: Patients who have had radiation to the head and neck have an increased risk of dental caries from xerostomia and the direct effect of radiation, which causes demineralization of teeth.
Strategy: Following radiation, instruct the patient about appropriate oral hygiene:
- regular flossing
- brushing and application of daily fluoride
- regular visits for dental care.39
Challenge: Trismus occurs in 5% to 25% of patients, depending on the type of radiation.36Strategy: Recommend exercise-based treatment, the treatment of choice. Surgery is indicated for severe cases.
Challenge: Dysphagia occurs in approximately 25% of patients treated with radiation.36Strategy: Provide a referral for swallowing exercises, which might be helpful. Some cases are severe enough to warrant placement of a feeding tube.37
Last, counsel all patients who have been treated for cancer of the head or neck, with any modality, about cessation of smoking and alcohol.
CORRESPONDENCE
Anne Mounsey, MD, Family Medicine Residency, The University of North Carolina at Chapel Hill, 590 Manning Dr., Chapel Hill, NC 27599; [email protected]
1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30.
2. Smallridge RC, Ain KB, Asa SL, et al; American Thyroid Association Anaplastic Thyroid Cancer Guidelines Taskforce. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012;22:1104-1139.
3. Marur S, Forastiere AA. Head and neck cancer: changing epidemiology, diagnosis, and treatment. Mayo Clin Proc. 2008;83:489-501.
4. Seoane J, Alvarez-Novoa P, Gomez I, et al. Early oral cancer diagnosis: The Aarhus statement perspective. A systematic review and meta-analysis. Head Neck. 2016;38(suppl 1):E2182-E2189.
5. Franco J, Elghouche AN, Harris MS, et al Diagnostic delays and errors in head and neck cancer patients: opportunities for improvement. Am J Med Qual. 2017;32:330-335.
6. Pynnonen MA, Gillespie MB, Roman B, et al. Clinical practice guideline: evaluation of the neck mass in adults. Otolaryngol Head Neck Surg. 2017;157(suppl 2):S1-S30.
7. Bosetti C, Gallus S, Franceschi S, et al. Cancer of the larynx in non-smoking alcohol drinkers and in non-drinking tobacco smokers. Br J Cancer. 2002;87:516-518.
8. Hoffman HT, Porter K, Karnell LH, et al. Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope. 2006;116(9 pt 2 suppl 111):1-13.
9. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009;141(3 suppl 2):S1-S31.
10. Steuer CE, El-Deiry M, Parks JR, et al. An update on larynx cancer. CA Cancer J Clin. 2017;67:31-50.
11. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091-2098.
12. Mendenhall WM, Werning JW, Hinerman RW, et al. Management of T1-T2 glottic carcinomas. Cancer. 2004;100:1786-1792.
13. Surveillance, Epidemiology, and End Results Unit. National Cancer Institute. Cancer stat facts: oral cavity and pharynx. https://seer.cancer.gov/statfacts/html/oralcav.html. Accessed October 18, 2019.
14. Pytynia KB, Dahlstrom KR, Sturgis EM. Epidemiology of HPV-associated oropharyngeal cancer. Oral Oncol. 2014;50:380-386.
15. Tarakji B, Gazal G, Al-Maweri SA, et al. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015;7:74-80.
16. Siu A, Landon K, Ramos DM. Differential diagnosis and management of oral ulcers. Semin Cutan Med Surg. 2015;34:171-177.
17. US Preventive Services Task Force. Final recommendation statement: oral cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/oral-cancer-screening1. Updated November 2013. Accessed October 18, 2019.
18. Villa A, Woo SB. Leukoplakia—a diagnostic and management algorithm. J Oral Maxillofac Surg. 2017;75:723-734.
19. Yang S, Wu S, Zhou J, et al. Screening for nasopharyngeal cancer. Cochrane Database Syst Rev. 2015;(11):CD008423.
20. Turner JH, Reh DD. Incidence and survival in patients with sinonasal cancer: a historical analysis of population-based data. Head Neck. 2012;34:877-885.
21. Ou SH, Zell JA, Ziogas A, et al. Epidemiology of nasopharyngeal carcinoma in the United States: improved survival of Chinese patients within the keratinizing squamous cell carcinoma histology. Ann Oncol. 2007;18:29-35.
22. Chang ET, Adami H-O. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006;15:1765-1777.
23. Chua MLK, Wee JTS, Hui EP, et al. Nasopharyngeal carcinoma. Lancet. 2016;387:1012-1024.
24. Spiro RH. Salivary neoplasms: overview of a 35-year experience with 2,807 patients. Head Neck Surg. 1986;8:177-184.
25. Lewis JS. Sinonasal squamous cell carcinoma: a review with emphasis on emerging histologic subtypes and the role of human papillomavirus. Head Neck Pathol. 2016;10:60-67.
26. Horn-Ross PL, Ljung BM, Morrow M. Environmental factors and the risk of salivary gland cancer. Epidemiology. 1997;8:414-419.
27. Colella G, Cannavale R, Flamminio F, et al. Fine-needle aspiration cytology of salivary gland lesions: a systematic review. J Oral Maxillofac Surg. 2010;68:2146-2153.
28. Berrino F, De Angelis R, Sant M, et al; EUROCARE Working Group. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995-99: results of the EUROCARE-4 study. Lancet Oncol. 2007;8:773-783.
29. Baloch ZW, LiVolsi VA, Asa SL, et al. Diagnostic terminology and morphologic criteria for cytologic diagnosis of thyroid lesions: a synopsis of the National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference. Diagn Cytopathol. 2008;36:425-437.
30. Haugen BR, Alexander EK, Bible KC, et al; The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26:1-133.
31. US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for thyroid Cancer: US Preventive Services Task Force recommendation statement. JAMA. 2017;317:1882-1887.
32. Jonklaas J, Cooper DS, Ain KB, et al; National Thyroid Cancer Treatment Cooperative Study Group. Radioiodine therapy in patients with stage I differentiated thyroid cancer. Thyroid. 2010;20:1423-1424.
33. Cooper DS, Specker B, Ho M, et al. Thyrotropin suppression and disease progression in patients with differentiated thyroid cancer: results from the National Thyroid Cancer Treatment Cooperative Registry. Thyroid. 1998;8:737-744.
34. US Food and Drug Administration. Highlight of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf. Updated December 2017. Accessed October 30, 1019.
35. Boomsma MJ, Bijl HP, Langendijk JA. Radiation-induced hypothyroidism in head and neck cancer patients: a systematic review. Radiother Oncol. 2011;99:1-5.
36. The development of quality of care measures for oral cavity cancer. Arch Otolaryngol Head Neck Surg. 2008;134:672.
37. Strojan P, Hutcheson KA, Eisbruch A, et al. Treatment of late sequelae after radiotherapy for head and neck cancer. Cancer Treat Rev. 2017;59:79-92.
38. Chambers MS, Posner M, Jones CU, et al. Cevimeline for the treatment of postirradiation xerostomia in patients with head and neck cancer. Int J Radiat Oncol Biol Phys. 2007;68:1102-1109.
39. Gupta N, Pal M, Rawat S, et al. Radiation-induced dental caries, prevention and treatment - a systematic review. Natl J Maxillofac Surg. 2015;6:160-166.
1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30.
2. Smallridge RC, Ain KB, Asa SL, et al; American Thyroid Association Anaplastic Thyroid Cancer Guidelines Taskforce. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012;22:1104-1139.
3. Marur S, Forastiere AA. Head and neck cancer: changing epidemiology, diagnosis, and treatment. Mayo Clin Proc. 2008;83:489-501.
4. Seoane J, Alvarez-Novoa P, Gomez I, et al. Early oral cancer diagnosis: The Aarhus statement perspective. A systematic review and meta-analysis. Head Neck. 2016;38(suppl 1):E2182-E2189.
5. Franco J, Elghouche AN, Harris MS, et al Diagnostic delays and errors in head and neck cancer patients: opportunities for improvement. Am J Med Qual. 2017;32:330-335.
6. Pynnonen MA, Gillespie MB, Roman B, et al. Clinical practice guideline: evaluation of the neck mass in adults. Otolaryngol Head Neck Surg. 2017;157(suppl 2):S1-S30.
7. Bosetti C, Gallus S, Franceschi S, et al. Cancer of the larynx in non-smoking alcohol drinkers and in non-drinking tobacco smokers. Br J Cancer. 2002;87:516-518.
8. Hoffman HT, Porter K, Karnell LH, et al. Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope. 2006;116(9 pt 2 suppl 111):1-13.
9. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009;141(3 suppl 2):S1-S31.
10. Steuer CE, El-Deiry M, Parks JR, et al. An update on larynx cancer. CA Cancer J Clin. 2017;67:31-50.
11. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091-2098.
12. Mendenhall WM, Werning JW, Hinerman RW, et al. Management of T1-T2 glottic carcinomas. Cancer. 2004;100:1786-1792.
13. Surveillance, Epidemiology, and End Results Unit. National Cancer Institute. Cancer stat facts: oral cavity and pharynx. https://seer.cancer.gov/statfacts/html/oralcav.html. Accessed October 18, 2019.
14. Pytynia KB, Dahlstrom KR, Sturgis EM. Epidemiology of HPV-associated oropharyngeal cancer. Oral Oncol. 2014;50:380-386.
15. Tarakji B, Gazal G, Al-Maweri SA, et al. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015;7:74-80.
16. Siu A, Landon K, Ramos DM. Differential diagnosis and management of oral ulcers. Semin Cutan Med Surg. 2015;34:171-177.
17. US Preventive Services Task Force. Final recommendation statement: oral cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/oral-cancer-screening1. Updated November 2013. Accessed October 18, 2019.
18. Villa A, Woo SB. Leukoplakia—a diagnostic and management algorithm. J Oral Maxillofac Surg. 2017;75:723-734.
19. Yang S, Wu S, Zhou J, et al. Screening for nasopharyngeal cancer. Cochrane Database Syst Rev. 2015;(11):CD008423.
20. Turner JH, Reh DD. Incidence and survival in patients with sinonasal cancer: a historical analysis of population-based data. Head Neck. 2012;34:877-885.
21. Ou SH, Zell JA, Ziogas A, et al. Epidemiology of nasopharyngeal carcinoma in the United States: improved survival of Chinese patients within the keratinizing squamous cell carcinoma histology. Ann Oncol. 2007;18:29-35.
22. Chang ET, Adami H-O. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006;15:1765-1777.
23. Chua MLK, Wee JTS, Hui EP, et al. Nasopharyngeal carcinoma. Lancet. 2016;387:1012-1024.
24. Spiro RH. Salivary neoplasms: overview of a 35-year experience with 2,807 patients. Head Neck Surg. 1986;8:177-184.
25. Lewis JS. Sinonasal squamous cell carcinoma: a review with emphasis on emerging histologic subtypes and the role of human papillomavirus. Head Neck Pathol. 2016;10:60-67.
26. Horn-Ross PL, Ljung BM, Morrow M. Environmental factors and the risk of salivary gland cancer. Epidemiology. 1997;8:414-419.
27. Colella G, Cannavale R, Flamminio F, et al. Fine-needle aspiration cytology of salivary gland lesions: a systematic review. J Oral Maxillofac Surg. 2010;68:2146-2153.
28. Berrino F, De Angelis R, Sant M, et al; EUROCARE Working Group. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995-99: results of the EUROCARE-4 study. Lancet Oncol. 2007;8:773-783.
29. Baloch ZW, LiVolsi VA, Asa SL, et al. Diagnostic terminology and morphologic criteria for cytologic diagnosis of thyroid lesions: a synopsis of the National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference. Diagn Cytopathol. 2008;36:425-437.
30. Haugen BR, Alexander EK, Bible KC, et al; The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016;26:1-133.
31. US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for thyroid Cancer: US Preventive Services Task Force recommendation statement. JAMA. 2017;317:1882-1887.
32. Jonklaas J, Cooper DS, Ain KB, et al; National Thyroid Cancer Treatment Cooperative Study Group. Radioiodine therapy in patients with stage I differentiated thyroid cancer. Thyroid. 2010;20:1423-1424.
33. Cooper DS, Specker B, Ho M, et al. Thyrotropin suppression and disease progression in patients with differentiated thyroid cancer: results from the National Thyroid Cancer Treatment Cooperative Registry. Thyroid. 1998;8:737-744.
34. US Food and Drug Administration. Highlight of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf. Updated December 2017. Accessed October 30, 1019.
35. Boomsma MJ, Bijl HP, Langendijk JA. Radiation-induced hypothyroidism in head and neck cancer patients: a systematic review. Radiother Oncol. 2011;99:1-5.
36. The development of quality of care measures for oral cavity cancer. Arch Otolaryngol Head Neck Surg. 2008;134:672.
37. Strojan P, Hutcheson KA, Eisbruch A, et al. Treatment of late sequelae after radiotherapy for head and neck cancer. Cancer Treat Rev. 2017;59:79-92.
38. Chambers MS, Posner M, Jones CU, et al. Cevimeline for the treatment of postirradiation xerostomia in patients with head and neck cancer. Int J Radiat Oncol Biol Phys. 2007;68:1102-1109.
39. Gupta N, Pal M, Rawat S, et al. Radiation-induced dental caries, prevention and treatment - a systematic review. Natl J Maxillofac Surg. 2015;6:160-166.
PRACTICE RECOMMENDATIONS
› Do not treat a neck mass with antibiotics unless it has features consistent with infection. C
› Order laryngoscopy for all patients with hoarseness that does not resolve after 3 months—or sooner, if malignancy is suspected. C
› Order ultrasonography-guided fine-needle aspiration for diagnostic evaluation of salivary gland masses. B
› Manage a thyroid nodule based on its sonographic features, including size, consistency, and the presence of concerning features. B
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
New models predict post-op pain in TKA
two-thirds of the time. Major risk factors include pre-operative pain, sensory testing results, anxiety and anticipated pain.
“The results of this study provide some basis for the identification of patients at risk of PPP after TKA and highlight several modifiable factors that may be targeted by clinicians in an attempt to reduce the risk of developing PPP,” write the authors of the study, which appeared in the British Journal of Anaesthesia.
The authors, led by David Rice, PhD, of Auckland University of Technology, note that moderate to severe levels of PPP affect an estimated 10%-34% of patients at least 3 months after TKA surgery. “PPP adversely affects quality of life, is the most important predictor of patient dissatisfaction after TKA, and is a common reason for undergoing revision surgery.”
The researchers, who launched the study to gain insight into the risk factors that can predict PPP, recruited 300 New Zealand volunteers (average age = 69, 48% female, 92% white, average body mass index [BMI] = 31 kg/m2) to be surveyed before and after TKA surgery. They monitored pain and tracked a long list of possible risk factors including psychological traits (such as anxiety, pain catastrophizing and depression), physical traits (such as gender, BMI), and surgical traits (such as total surgery time).
At 6 months, 21% of 291 patients reported moderate to severe pain, and the percentage fell to 16% in 288 patients at 12 months.
The researchers developed two models that successfully predicted moderate-to-severe PPP.
The 6-month model relied on higher levels of preoperative pain intensity, temporal summation (a statistic that’s based on quantitative sensory testing), trait anxiety (a measure of individual anxiety level), and expected pain. It correctly predicted moderate to severe PPP 66% of the time (area under the curve [AUC] = 0.70, sensitivity = 0.72, specificity = 0.64).
The 12-month model relied on higher levels of all the risk factors except for temporal summation and correctly predicted moderate-to-severe PPP 66% of the time (AUC = 0.66, sensitivity = 0.61, specificity = 0.67).
The researchers noted that other research has linked trait anxiety and expected pain to PPP. In regard to anxiety, “cognitive behavioral interventions in the perioperative period aimed at reducing the threat value of surgery and of postoperative pain, improving patients’ coping strategies, and enhancing self-efficacy might help to reduce the risk of PPP after TKA,” the researchers write. “Furthermore, there is some evidence that anxiolytic medications can diminish perioperative anxiety and reduce APOP [acute postoperative pain] although its effects on PPP are unclear.”
Moving forward, the authors write, “strategies to minimize intraoperative nerve injury, reduce preoperative pain intensity, and address preoperative psychological factors such as expected pain and anxiety may lead to improved outcomes after TKA and should be explored.”
The Australia New Zealand College of Anesthetists and Auckland University of Technology funded the study. The study authors report no relevant disclosures.
SOURCE: Rice D et al. Br J Anaesth 2018;804-12. doi: https://doi.org/10.1016/j.bja.2018.05.070.
two-thirds of the time. Major risk factors include pre-operative pain, sensory testing results, anxiety and anticipated pain.
“The results of this study provide some basis for the identification of patients at risk of PPP after TKA and highlight several modifiable factors that may be targeted by clinicians in an attempt to reduce the risk of developing PPP,” write the authors of the study, which appeared in the British Journal of Anaesthesia.
The authors, led by David Rice, PhD, of Auckland University of Technology, note that moderate to severe levels of PPP affect an estimated 10%-34% of patients at least 3 months after TKA surgery. “PPP adversely affects quality of life, is the most important predictor of patient dissatisfaction after TKA, and is a common reason for undergoing revision surgery.”
The researchers, who launched the study to gain insight into the risk factors that can predict PPP, recruited 300 New Zealand volunteers (average age = 69, 48% female, 92% white, average body mass index [BMI] = 31 kg/m2) to be surveyed before and after TKA surgery. They monitored pain and tracked a long list of possible risk factors including psychological traits (such as anxiety, pain catastrophizing and depression), physical traits (such as gender, BMI), and surgical traits (such as total surgery time).
At 6 months, 21% of 291 patients reported moderate to severe pain, and the percentage fell to 16% in 288 patients at 12 months.
The researchers developed two models that successfully predicted moderate-to-severe PPP.
The 6-month model relied on higher levels of preoperative pain intensity, temporal summation (a statistic that’s based on quantitative sensory testing), trait anxiety (a measure of individual anxiety level), and expected pain. It correctly predicted moderate to severe PPP 66% of the time (area under the curve [AUC] = 0.70, sensitivity = 0.72, specificity = 0.64).
The 12-month model relied on higher levels of all the risk factors except for temporal summation and correctly predicted moderate-to-severe PPP 66% of the time (AUC = 0.66, sensitivity = 0.61, specificity = 0.67).
The researchers noted that other research has linked trait anxiety and expected pain to PPP. In regard to anxiety, “cognitive behavioral interventions in the perioperative period aimed at reducing the threat value of surgery and of postoperative pain, improving patients’ coping strategies, and enhancing self-efficacy might help to reduce the risk of PPP after TKA,” the researchers write. “Furthermore, there is some evidence that anxiolytic medications can diminish perioperative anxiety and reduce APOP [acute postoperative pain] although its effects on PPP are unclear.”
Moving forward, the authors write, “strategies to minimize intraoperative nerve injury, reduce preoperative pain intensity, and address preoperative psychological factors such as expected pain and anxiety may lead to improved outcomes after TKA and should be explored.”
The Australia New Zealand College of Anesthetists and Auckland University of Technology funded the study. The study authors report no relevant disclosures.
SOURCE: Rice D et al. Br J Anaesth 2018;804-12. doi: https://doi.org/10.1016/j.bja.2018.05.070.
two-thirds of the time. Major risk factors include pre-operative pain, sensory testing results, anxiety and anticipated pain.
“The results of this study provide some basis for the identification of patients at risk of PPP after TKA and highlight several modifiable factors that may be targeted by clinicians in an attempt to reduce the risk of developing PPP,” write the authors of the study, which appeared in the British Journal of Anaesthesia.
The authors, led by David Rice, PhD, of Auckland University of Technology, note that moderate to severe levels of PPP affect an estimated 10%-34% of patients at least 3 months after TKA surgery. “PPP adversely affects quality of life, is the most important predictor of patient dissatisfaction after TKA, and is a common reason for undergoing revision surgery.”
The researchers, who launched the study to gain insight into the risk factors that can predict PPP, recruited 300 New Zealand volunteers (average age = 69, 48% female, 92% white, average body mass index [BMI] = 31 kg/m2) to be surveyed before and after TKA surgery. They monitored pain and tracked a long list of possible risk factors including psychological traits (such as anxiety, pain catastrophizing and depression), physical traits (such as gender, BMI), and surgical traits (such as total surgery time).
At 6 months, 21% of 291 patients reported moderate to severe pain, and the percentage fell to 16% in 288 patients at 12 months.
The researchers developed two models that successfully predicted moderate-to-severe PPP.
The 6-month model relied on higher levels of preoperative pain intensity, temporal summation (a statistic that’s based on quantitative sensory testing), trait anxiety (a measure of individual anxiety level), and expected pain. It correctly predicted moderate to severe PPP 66% of the time (area under the curve [AUC] = 0.70, sensitivity = 0.72, specificity = 0.64).
The 12-month model relied on higher levels of all the risk factors except for temporal summation and correctly predicted moderate-to-severe PPP 66% of the time (AUC = 0.66, sensitivity = 0.61, specificity = 0.67).
The researchers noted that other research has linked trait anxiety and expected pain to PPP. In regard to anxiety, “cognitive behavioral interventions in the perioperative period aimed at reducing the threat value of surgery and of postoperative pain, improving patients’ coping strategies, and enhancing self-efficacy might help to reduce the risk of PPP after TKA,” the researchers write. “Furthermore, there is some evidence that anxiolytic medications can diminish perioperative anxiety and reduce APOP [acute postoperative pain] although its effects on PPP are unclear.”
Moving forward, the authors write, “strategies to minimize intraoperative nerve injury, reduce preoperative pain intensity, and address preoperative psychological factors such as expected pain and anxiety may lead to improved outcomes after TKA and should be explored.”
The Australia New Zealand College of Anesthetists and Auckland University of Technology funded the study. The study authors report no relevant disclosures.
SOURCE: Rice D et al. Br J Anaesth 2018;804-12. doi: https://doi.org/10.1016/j.bja.2018.05.070.
FROM BRITISH JOURNAL OF ANESTHESIA
Best practice alerts really can work
SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.
At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.
Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.
The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.
Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.
As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.
The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.
“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”
Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.
Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.
The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.
The study was internally funded. The authors reported having no conflicts of interest.
SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.
At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.
Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.
The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.
Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.
As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.
The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.
“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”
Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.
Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.
The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.
The study was internally funded. The authors reported having no conflicts of interest.
SAN ANTONIO – Clinicians don’t appear to mind too much when their red blood cell orders are flagged for review by a best practice alert system, and alert fatigue doesn’t seem to hamper patient blood management efforts, investigators in a single-center study reported.
At the Medical University of South Carolina, Charleston (MUSC), if clinicians order RBC transfusions for patients with hemoglobin levels over 7.0 g/dL or for patients who did not have a hemoglobin determination over the past 24 hours, they receive a best practice alert. They must acknowledge it and cancel the order, or override it and document a reason in the medical record.
Although approximately 70% of alerts were overridden, the reasons for the overrides “were consistent over time and appropriate,” reported Jerry E. Squires, MD, PhD, and colleagues from MUSC in a poster presentation at the annual meeting of AABB, the group formerly known as the American Association of Blood Banks.
The goal of the study was to find out if the effectiveness of the alert was wearing out after months of active use by clinicians. “Is it true that they’re clicking too much and they’re inundated with other [best practice alerts], and are they even paying attention?” said coauthor Heather Toeppner, RN, also from MUSC, in an interview. “All in all, we found that the alert is making a lasting impression in our institution,” she said.
Transfusion clinical decision support systems that produce automated alerts for clinicians can improve usage and reduce waste of RBCs, but whether the effect is sustained over time was unknown, Ms. Toeppner said, prompting the investigators to study the effect of the RBC best practice alert over 10 months.
As noted, the alert is triggered when providers order RBCs for patients with hemoglobin levels over 7.0 g/dL or when there is no record of a hemoglobin test in the chart within the past 24 hours. Before the alert is triggered, however, the system reviews the record and excludes alerts for patients with specific conditions, such as concurrent surgery or sickle cell disease.
The authors found that the alert was triggered an average of 195 times per month over the 10 months studied. On average, 16% of the alerts resulted in a cancellation of the RBC order, and 71% of alerts were overridden.
“Most importantly, there was no trend suggesting that either cancellation of the RBC order or overriding the alert became more frequent over time,” the investigators wrote. “Similarly, reasons for overriding the alert were consistent over time, with ‘preparation for an invasive procedure’ and ‘active bleeding’ being the most common reasons for overriding the alert (32% and 23% of all overrides, respectively).”
Other common reasons for overrides included tachycardia, shortness of breath, hypotension, onset of chest pain, and acute coronary syndrome.
Interestingly, but perhaps not surprisingly, they found that overrides dropped sharply and changed orders rose by the same magnitude in July, when new residents started their rotations.
The investigators wrote that the relatively small number of alerts may be attributable to their institution’s robust patient blood management program and the intentional exclusion of orders for patients with specific diagnostic codes, including intraoperative patients, those with sickle cell disease, and all patients aged younger than 18 years.
The study was internally funded. The authors reported having no conflicts of interest.
REPORTING FROM AABB 2019
Does BSO status affect health outcomes for women taking estrogen for menopause?
Do health effects of menopausal estrogen therapy differ between women with bilateral oophorectomy versus those with conserved ovaries? To answer this question a group of investigators performed a subanalysis of the Women’s Health Initiative (WHI) Estrogen-Alone Trial,1 which included 40 clinical centers across the United States. They examined estrogen therapy outcomes by bilateral salpingo-oophorectomy (BSO) status, with additional stratification by 10-year age groups in 9,939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status. In the WHI trial, women were randomly assigned to conjugated equine estrogens (CEE) 0.625 mg/d or placebo for a median of 7.2 years. Investigators assessed the incidence of coronary heart disease and invasive breast cancer (the trial’s 2 primary end points), all-cause mortality, and a “global index”—these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture—during the intervention phase and 18-year cumulative follow-up.
OBG Management caught up with lead author JoAnn E. Manson, MD, DrPH, NCMP, to discuss the study’s results.
OBG Management : How many women undergo BSO with their hysterectomy?
Dr. JoAnn E. Manson, MD, DrPH, NCMP: Of the 425,000 women who undergo hysterectomy in the United States for benign reasons each year,2,3 about 40% of them undergo BSO—so between 150,000 and 200,000 women per year undergo BSO with their hysterectomy.4,5
OBG Management : Although BSO is performed with hysterectomy to minimize patients’ future ovarian cancer risk, does BSO have health risks of its own, and how has estrogen been shown to affect these risks?
Dr. Manson: First, yes, BSO has been associated with health risks, especially when it is performed at a young age, such as before age 45. It has been linked to an increased risk of heart disease, osteoporosis, cognitive decline, and all-cause mortality. According to observational studies, estrogen therapy appears to offset many of these risks, particularly those related to heart disease and osteoporosis (the evidence is less clear on cognitive deficits).5
OBG Management : What did you find in your trial when you randomly assigned women in the age groups of 50 to 79 who underwent hysterectomy with and without BSO to estrogen therapy or placebo?
Dr. Manson: The WHI is the first study to be conducted in a randomized trial setting to analyze the health risks and benefits of estrogen therapy according to whether or not women had their ovaries removed. What we found was that the woman’s age had a strong influence on the effects of estrogen therapy among women who had BSO but only a negligible effect among women who had conserved ovaries. Overall, across the full age range, the effects of estrogen therapy did not differ substantially between women who had a BSO and those who had their ovaries conserved.
However, there were major differences by age group among the women who had BSO. A significant 32% reduction in all-cause mortality emerged during the 18-year follow-up period among the younger women (below age 60) who had BSO when they received estrogen therapy as compared with placebo. By contrast, the women who had conserved ovaries did not have this significant reduction in all-cause mortality, or in most of the other outcomes on estrogen compared with placebo. Overall, the effects of estrogen therapy tended to be relatively neutral in the women with conserved ovaries.
Now, the reduction in all-cause mortality with estrogen therapy was particularly pronounced among women who had BSO before age 45. They had a 40% statistically significant reduction in all-cause mortality with estrogen therapy compared with placebo. Also, among the women with BSO, there was a strong association between the timing of estrogen initiation and the magnitude of reduction in mortality. Women who started the estrogen therapy within 10 years of having the BSO had a 34% significant reduction in all-cause mortality, and those who started estrogen more than 20 years after having their ovaries removed had no reduction in mortality.
Continue to:
OBG Management : Do your data give support to the timing hypothesis?
Dr. Manson: Yes, our findings do support a timing hypothesis that was particularly pronounced for women who underwent BSO. It was the women who had early surgical menopause (before age 45) and those who started the estrogen therapy within 10 years of having their ovaries removed who had the greatest reduction in all-cause mortality and the most favorable benefit-risk profile from hormone therapy. So, the results do lend support to the timing hypothesis.
By contrast, women who had BSO at hysterectomy and began hormone therapy at age 70 or older had net adverse effects from hormone therapy. They posted a 40% increase in the global index—which is a summary measure of adverse effects on cardiovascular disease, cancer, and other major health outcomes. So, the women with BSO who were randomized in the trial at age 70 and older, had unfavorable results from estrogen therapy and an increase in the global index, in contrast to the women who were below age 60 or within 10 years of menopause.
OBG Management : Given your study findings, in which women would you recommend estrogen therapy? And are there groups of women in which you would advise avoiding estrogen therapy?
Dr. Manson: Current guidelines6,7 recommend estrogen therapy for women who have early menopause, particularly an early surgical menopause and BSO prior to the average age at natural menopause. Unless the woman has contraindications to estrogen therapy, the recommendations are to treat with estrogen until the average age of menopause—until about age 50 to 51.
Our study findings provide reassurance that, if a woman continues to have indications for estrogen (vasomotor symptoms, or other indications for estrogen therapy), there is relative safety of continuing estrogen-alone therapy through her 50s, until age 60. For example, a woman who, after the average age of menopause continues to have vasomotor symptoms, or if she has bone health problems, our study would suggest that estrogen therapy would continue to have a favorable benefit-risk profile until at least the age of 60. Decisions would have to be individualized, especially after age 60, with shared decision-making particularly important for those decisions. (Some women, depending on their risk profile, may continue to be candidates for estrogen therapy past age 60.)
So, this study provides reassurance regarding use of estrogen therapy for women in their 50s if they have had BSO. Actually, the women who had conserved ovaries also had relative safety with estrogen therapy until age 60. They just didn’t show the significant benefits for all-cause mortality. Overall, their pattern of health-related benefits and risks was neutral. Thus, if vasomotor symptom management, quality of life benefits, or bone health effects are sought, taking hormone therapy is a quite reasonable choice for these women.
By contrast, women who have had a BSO and are age 70 or older should really avoid initiating estrogen therapy because it would follow a prolonged period of estrogen deficiency, or very low estrogen levels, and these women appeared to have a net adverse effect from initiating hormone therapy (with increases in the global index found).
Continue to:
OBG Management : Did taking estrogen therapy prior to trial enrollment make a difference when it came to study outcomes?
Dr. Manson: We found minimal if any effect in our analyses. In fact, even the women who did not have prior (pre-randomization) use of estrogen therapy tended to do well on estrogen-alone therapy if they were younger than age 60. This was particularly true for the women who had BSO. Even if they had not used estrogen previously, and they were many years past the BSO, they still did well on estrogen therapy if they were below age 60.
1. Manson JE, Aragaki AK, Bassuk SS. Menopausal estrogen-alone therapy and health outcomes in women with and without bilateral oophorectomy: a randomized trial. Ann Intern Med. 2019 September 10. doi:10.7326/M19-0274.
2. Einarsson J. Are hysterectomy volumes in the US really falling? Contemporary OB/GYN. 1 September 2017. www.contemporaryobgyn.net/gynecology/are-hysterectomy-volumes-us-really-falling. November 4, 2019.
3. Temkin SM, Minasian L, Noone AM. The end of the hysterectomy epidemic and endometrial cancer incidence: what are the unintended consequences of declining hysterectomy rates? Front Oncol. 2016;6:89.
4. Doll KM, Dusetzina SB, Robinson W. Trends in inpatient and outpatient hysterectomy and oophorectomy rates among commercially insured women in the United States, 2000-2014. JAMA Surg. 2016;151:876-877.
5. Adelman MR, Sharp HT. Ovarian conservation vs removal at the time of benign hysterectomy. Am J Obstet Gynecol. 2018;218:269-279.
6. ACOG Practice Bulletin No. 141: management of menopausal symptoms [published corrections appear in: Obstet Gynecol. 2016;127(1):166. and Obstet Gynecol. 2018;131(3):604]. Obstet Gynecol. 2014;123:202-216.
7. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24:728-753.
Do health effects of menopausal estrogen therapy differ between women with bilateral oophorectomy versus those with conserved ovaries? To answer this question a group of investigators performed a subanalysis of the Women’s Health Initiative (WHI) Estrogen-Alone Trial,1 which included 40 clinical centers across the United States. They examined estrogen therapy outcomes by bilateral salpingo-oophorectomy (BSO) status, with additional stratification by 10-year age groups in 9,939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status. In the WHI trial, women were randomly assigned to conjugated equine estrogens (CEE) 0.625 mg/d or placebo for a median of 7.2 years. Investigators assessed the incidence of coronary heart disease and invasive breast cancer (the trial’s 2 primary end points), all-cause mortality, and a “global index”—these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture—during the intervention phase and 18-year cumulative follow-up.
OBG Management caught up with lead author JoAnn E. Manson, MD, DrPH, NCMP, to discuss the study’s results.
OBG Management : How many women undergo BSO with their hysterectomy?
Dr. JoAnn E. Manson, MD, DrPH, NCMP: Of the 425,000 women who undergo hysterectomy in the United States for benign reasons each year,2,3 about 40% of them undergo BSO—so between 150,000 and 200,000 women per year undergo BSO with their hysterectomy.4,5
OBG Management : Although BSO is performed with hysterectomy to minimize patients’ future ovarian cancer risk, does BSO have health risks of its own, and how has estrogen been shown to affect these risks?
Dr. Manson: First, yes, BSO has been associated with health risks, especially when it is performed at a young age, such as before age 45. It has been linked to an increased risk of heart disease, osteoporosis, cognitive decline, and all-cause mortality. According to observational studies, estrogen therapy appears to offset many of these risks, particularly those related to heart disease and osteoporosis (the evidence is less clear on cognitive deficits).5
OBG Management : What did you find in your trial when you randomly assigned women in the age groups of 50 to 79 who underwent hysterectomy with and without BSO to estrogen therapy or placebo?
Dr. Manson: The WHI is the first study to be conducted in a randomized trial setting to analyze the health risks and benefits of estrogen therapy according to whether or not women had their ovaries removed. What we found was that the woman’s age had a strong influence on the effects of estrogen therapy among women who had BSO but only a negligible effect among women who had conserved ovaries. Overall, across the full age range, the effects of estrogen therapy did not differ substantially between women who had a BSO and those who had their ovaries conserved.
However, there were major differences by age group among the women who had BSO. A significant 32% reduction in all-cause mortality emerged during the 18-year follow-up period among the younger women (below age 60) who had BSO when they received estrogen therapy as compared with placebo. By contrast, the women who had conserved ovaries did not have this significant reduction in all-cause mortality, or in most of the other outcomes on estrogen compared with placebo. Overall, the effects of estrogen therapy tended to be relatively neutral in the women with conserved ovaries.
Now, the reduction in all-cause mortality with estrogen therapy was particularly pronounced among women who had BSO before age 45. They had a 40% statistically significant reduction in all-cause mortality with estrogen therapy compared with placebo. Also, among the women with BSO, there was a strong association between the timing of estrogen initiation and the magnitude of reduction in mortality. Women who started the estrogen therapy within 10 years of having the BSO had a 34% significant reduction in all-cause mortality, and those who started estrogen more than 20 years after having their ovaries removed had no reduction in mortality.
Continue to:
OBG Management : Do your data give support to the timing hypothesis?
Dr. Manson: Yes, our findings do support a timing hypothesis that was particularly pronounced for women who underwent BSO. It was the women who had early surgical menopause (before age 45) and those who started the estrogen therapy within 10 years of having their ovaries removed who had the greatest reduction in all-cause mortality and the most favorable benefit-risk profile from hormone therapy. So, the results do lend support to the timing hypothesis.
By contrast, women who had BSO at hysterectomy and began hormone therapy at age 70 or older had net adverse effects from hormone therapy. They posted a 40% increase in the global index—which is a summary measure of adverse effects on cardiovascular disease, cancer, and other major health outcomes. So, the women with BSO who were randomized in the trial at age 70 and older, had unfavorable results from estrogen therapy and an increase in the global index, in contrast to the women who were below age 60 or within 10 years of menopause.
OBG Management : Given your study findings, in which women would you recommend estrogen therapy? And are there groups of women in which you would advise avoiding estrogen therapy?
Dr. Manson: Current guidelines6,7 recommend estrogen therapy for women who have early menopause, particularly an early surgical menopause and BSO prior to the average age at natural menopause. Unless the woman has contraindications to estrogen therapy, the recommendations are to treat with estrogen until the average age of menopause—until about age 50 to 51.
Our study findings provide reassurance that, if a woman continues to have indications for estrogen (vasomotor symptoms, or other indications for estrogen therapy), there is relative safety of continuing estrogen-alone therapy through her 50s, until age 60. For example, a woman who, after the average age of menopause continues to have vasomotor symptoms, or if she has bone health problems, our study would suggest that estrogen therapy would continue to have a favorable benefit-risk profile until at least the age of 60. Decisions would have to be individualized, especially after age 60, with shared decision-making particularly important for those decisions. (Some women, depending on their risk profile, may continue to be candidates for estrogen therapy past age 60.)
So, this study provides reassurance regarding use of estrogen therapy for women in their 50s if they have had BSO. Actually, the women who had conserved ovaries also had relative safety with estrogen therapy until age 60. They just didn’t show the significant benefits for all-cause mortality. Overall, their pattern of health-related benefits and risks was neutral. Thus, if vasomotor symptom management, quality of life benefits, or bone health effects are sought, taking hormone therapy is a quite reasonable choice for these women.
By contrast, women who have had a BSO and are age 70 or older should really avoid initiating estrogen therapy because it would follow a prolonged period of estrogen deficiency, or very low estrogen levels, and these women appeared to have a net adverse effect from initiating hormone therapy (with increases in the global index found).
Continue to:
OBG Management : Did taking estrogen therapy prior to trial enrollment make a difference when it came to study outcomes?
Dr. Manson: We found minimal if any effect in our analyses. In fact, even the women who did not have prior (pre-randomization) use of estrogen therapy tended to do well on estrogen-alone therapy if they were younger than age 60. This was particularly true for the women who had BSO. Even if they had not used estrogen previously, and they were many years past the BSO, they still did well on estrogen therapy if they were below age 60.
Do health effects of menopausal estrogen therapy differ between women with bilateral oophorectomy versus those with conserved ovaries? To answer this question a group of investigators performed a subanalysis of the Women’s Health Initiative (WHI) Estrogen-Alone Trial,1 which included 40 clinical centers across the United States. They examined estrogen therapy outcomes by bilateral salpingo-oophorectomy (BSO) status, with additional stratification by 10-year age groups in 9,939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status. In the WHI trial, women were randomly assigned to conjugated equine estrogens (CEE) 0.625 mg/d or placebo for a median of 7.2 years. Investigators assessed the incidence of coronary heart disease and invasive breast cancer (the trial’s 2 primary end points), all-cause mortality, and a “global index”—these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture—during the intervention phase and 18-year cumulative follow-up.
OBG Management caught up with lead author JoAnn E. Manson, MD, DrPH, NCMP, to discuss the study’s results.
OBG Management : How many women undergo BSO with their hysterectomy?
Dr. JoAnn E. Manson, MD, DrPH, NCMP: Of the 425,000 women who undergo hysterectomy in the United States for benign reasons each year,2,3 about 40% of them undergo BSO—so between 150,000 and 200,000 women per year undergo BSO with their hysterectomy.4,5
OBG Management : Although BSO is performed with hysterectomy to minimize patients’ future ovarian cancer risk, does BSO have health risks of its own, and how has estrogen been shown to affect these risks?
Dr. Manson: First, yes, BSO has been associated with health risks, especially when it is performed at a young age, such as before age 45. It has been linked to an increased risk of heart disease, osteoporosis, cognitive decline, and all-cause mortality. According to observational studies, estrogen therapy appears to offset many of these risks, particularly those related to heart disease and osteoporosis (the evidence is less clear on cognitive deficits).5
OBG Management : What did you find in your trial when you randomly assigned women in the age groups of 50 to 79 who underwent hysterectomy with and without BSO to estrogen therapy or placebo?
Dr. Manson: The WHI is the first study to be conducted in a randomized trial setting to analyze the health risks and benefits of estrogen therapy according to whether or not women had their ovaries removed. What we found was that the woman’s age had a strong influence on the effects of estrogen therapy among women who had BSO but only a negligible effect among women who had conserved ovaries. Overall, across the full age range, the effects of estrogen therapy did not differ substantially between women who had a BSO and those who had their ovaries conserved.
However, there were major differences by age group among the women who had BSO. A significant 32% reduction in all-cause mortality emerged during the 18-year follow-up period among the younger women (below age 60) who had BSO when they received estrogen therapy as compared with placebo. By contrast, the women who had conserved ovaries did not have this significant reduction in all-cause mortality, or in most of the other outcomes on estrogen compared with placebo. Overall, the effects of estrogen therapy tended to be relatively neutral in the women with conserved ovaries.
Now, the reduction in all-cause mortality with estrogen therapy was particularly pronounced among women who had BSO before age 45. They had a 40% statistically significant reduction in all-cause mortality with estrogen therapy compared with placebo. Also, among the women with BSO, there was a strong association between the timing of estrogen initiation and the magnitude of reduction in mortality. Women who started the estrogen therapy within 10 years of having the BSO had a 34% significant reduction in all-cause mortality, and those who started estrogen more than 20 years after having their ovaries removed had no reduction in mortality.
Continue to:
OBG Management : Do your data give support to the timing hypothesis?
Dr. Manson: Yes, our findings do support a timing hypothesis that was particularly pronounced for women who underwent BSO. It was the women who had early surgical menopause (before age 45) and those who started the estrogen therapy within 10 years of having their ovaries removed who had the greatest reduction in all-cause mortality and the most favorable benefit-risk profile from hormone therapy. So, the results do lend support to the timing hypothesis.
By contrast, women who had BSO at hysterectomy and began hormone therapy at age 70 or older had net adverse effects from hormone therapy. They posted a 40% increase in the global index—which is a summary measure of adverse effects on cardiovascular disease, cancer, and other major health outcomes. So, the women with BSO who were randomized in the trial at age 70 and older, had unfavorable results from estrogen therapy and an increase in the global index, in contrast to the women who were below age 60 or within 10 years of menopause.
OBG Management : Given your study findings, in which women would you recommend estrogen therapy? And are there groups of women in which you would advise avoiding estrogen therapy?
Dr. Manson: Current guidelines6,7 recommend estrogen therapy for women who have early menopause, particularly an early surgical menopause and BSO prior to the average age at natural menopause. Unless the woman has contraindications to estrogen therapy, the recommendations are to treat with estrogen until the average age of menopause—until about age 50 to 51.
Our study findings provide reassurance that, if a woman continues to have indications for estrogen (vasomotor symptoms, or other indications for estrogen therapy), there is relative safety of continuing estrogen-alone therapy through her 50s, until age 60. For example, a woman who, after the average age of menopause continues to have vasomotor symptoms, or if she has bone health problems, our study would suggest that estrogen therapy would continue to have a favorable benefit-risk profile until at least the age of 60. Decisions would have to be individualized, especially after age 60, with shared decision-making particularly important for those decisions. (Some women, depending on their risk profile, may continue to be candidates for estrogen therapy past age 60.)
So, this study provides reassurance regarding use of estrogen therapy for women in their 50s if they have had BSO. Actually, the women who had conserved ovaries also had relative safety with estrogen therapy until age 60. They just didn’t show the significant benefits for all-cause mortality. Overall, their pattern of health-related benefits and risks was neutral. Thus, if vasomotor symptom management, quality of life benefits, or bone health effects are sought, taking hormone therapy is a quite reasonable choice for these women.
By contrast, women who have had a BSO and are age 70 or older should really avoid initiating estrogen therapy because it would follow a prolonged period of estrogen deficiency, or very low estrogen levels, and these women appeared to have a net adverse effect from initiating hormone therapy (with increases in the global index found).
Continue to:
OBG Management : Did taking estrogen therapy prior to trial enrollment make a difference when it came to study outcomes?
Dr. Manson: We found minimal if any effect in our analyses. In fact, even the women who did not have prior (pre-randomization) use of estrogen therapy tended to do well on estrogen-alone therapy if they were younger than age 60. This was particularly true for the women who had BSO. Even if they had not used estrogen previously, and they were many years past the BSO, they still did well on estrogen therapy if they were below age 60.
1. Manson JE, Aragaki AK, Bassuk SS. Menopausal estrogen-alone therapy and health outcomes in women with and without bilateral oophorectomy: a randomized trial. Ann Intern Med. 2019 September 10. doi:10.7326/M19-0274.
2. Einarsson J. Are hysterectomy volumes in the US really falling? Contemporary OB/GYN. 1 September 2017. www.contemporaryobgyn.net/gynecology/are-hysterectomy-volumes-us-really-falling. November 4, 2019.
3. Temkin SM, Minasian L, Noone AM. The end of the hysterectomy epidemic and endometrial cancer incidence: what are the unintended consequences of declining hysterectomy rates? Front Oncol. 2016;6:89.
4. Doll KM, Dusetzina SB, Robinson W. Trends in inpatient and outpatient hysterectomy and oophorectomy rates among commercially insured women in the United States, 2000-2014. JAMA Surg. 2016;151:876-877.
5. Adelman MR, Sharp HT. Ovarian conservation vs removal at the time of benign hysterectomy. Am J Obstet Gynecol. 2018;218:269-279.
6. ACOG Practice Bulletin No. 141: management of menopausal symptoms [published corrections appear in: Obstet Gynecol. 2016;127(1):166. and Obstet Gynecol. 2018;131(3):604]. Obstet Gynecol. 2014;123:202-216.
7. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24:728-753.
1. Manson JE, Aragaki AK, Bassuk SS. Menopausal estrogen-alone therapy and health outcomes in women with and without bilateral oophorectomy: a randomized trial. Ann Intern Med. 2019 September 10. doi:10.7326/M19-0274.
2. Einarsson J. Are hysterectomy volumes in the US really falling? Contemporary OB/GYN. 1 September 2017. www.contemporaryobgyn.net/gynecology/are-hysterectomy-volumes-us-really-falling. November 4, 2019.
3. Temkin SM, Minasian L, Noone AM. The end of the hysterectomy epidemic and endometrial cancer incidence: what are the unintended consequences of declining hysterectomy rates? Front Oncol. 2016;6:89.
4. Doll KM, Dusetzina SB, Robinson W. Trends in inpatient and outpatient hysterectomy and oophorectomy rates among commercially insured women in the United States, 2000-2014. JAMA Surg. 2016;151:876-877.
5. Adelman MR, Sharp HT. Ovarian conservation vs removal at the time of benign hysterectomy. Am J Obstet Gynecol. 2018;218:269-279.
6. ACOG Practice Bulletin No. 141: management of menopausal symptoms [published corrections appear in: Obstet Gynecol. 2016;127(1):166. and Obstet Gynecol. 2018;131(3):604]. Obstet Gynecol. 2014;123:202-216.
7. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24:728-753.
2019 Update on minimally invasive gynecologic surgery
Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.
Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.4
Attempts to improve the application of vaginal hysterectomy have been made.5 These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.6 An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.
Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.9
At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.
—Arnold P. Advincula, MD
Continue to: Development and evolution of NOTES...
Development and evolution of NOTES
Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.10 Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery.
Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution.
NOTES application in gynecology
With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.13
Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.14
While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.15 Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.16,17
The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.18 However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route.
In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.19 Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.9 Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.27,28
Continue to: Operative time, post-op stay shorter in NAOC-treated patients...
Operative time, post-op stay shorter in NAOC-treated patients
Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.29 Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).29
How vNOTES hysterectomy stacked up against TLH
In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.8 Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.8
Clearly, vNOTES is the next exciting development in minimally invasive surgery, improving patient outcomes and satisfaction with truly scarless surgery. Compared with traditional transvaginal surgery, vNOTES has the advantage of improved visualization with laparoendoscopic guidance, and it may be beneficial even for patients previously thought to have relative contraindications to successful completion of transvaginal surgery, such as nulliparity or a narrow introitus.
Approach for performing vNOTES procedures
At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes:
- low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac
- no surgical history suggestive of severe adhesive disease, and
- adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity.
In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery.
Continue to: Overview of vNOTES steps...
Overview of vNOTES steps
Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery.
1. Vaginal entry
Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection.
We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat.
Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1).
2. Traditional vaginal hysterectomy
After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible.
3. Single-site port placement
The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3).
After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4).
Continue to: 4. Laparoendoscopic surgery...
4. Laparoendoscopic surgery
Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5).
vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills.
During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6).
This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device.
5. Specimen removal
For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina.
Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled.
6. Vaginal cuff closure
The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.
vNOTES is the most recent innovative development in the field of minimally invasive surgery, and it has demonstrated feasibility and safety in the fields of general surgery, urology, and gynecology. Adopting vNOTES in clinical practice can improve patient satisfaction and cosmesis as well as surgical outcomes. Gynecologic surgeons can think of vNOTES hysterectomy as "placing an eye" in the vagina while performing transvaginal hysterectomy. The surgical principle of "vaginal pull, laparoscopic push" facilitates the learning process.
1. ACOG Committee on Gynecologic Practice. Committee opinion no. 444. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
2. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1-3.
3. Whiteside JL, Kaeser CT, Ridgeway B. Achieving high value in the surgical approach to hysterectomy. Am J Obstet Gynecol. 2019;220:242-245.
4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
5. Moen M, Walter A, Harmanli O, et al. Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology. Obstet Gynecol. 2014;124:585-588.
6. Balgobin S, Owens DM, Florian-Rodriguez ME, et al. Vaginal hysterectomy suturing skills training model and curriculum. Obstet Gynecol. 2019;134:553-558.
7. Baekelandt J. Total vaginal NOTES hysterectomy: a new approach to hysterectomy. J Minim Invasive Gynecol. 2015;22:1088-1094.
8. Baekelandt JF, De Mulder PA, Le Roy I, et al. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019;126:105-113.
9. Guan X, Bardawil E, Liu J, et al. Transvaginal natural orifice transluminal endoscopic surgery as a rescue for total vaginal hysterectomy. J Minim Invasive Gynecol. 2018;25:1135-1136.
10. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;3:CD003677.
11. Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004;60:114-117.
12. Reddy N, Rao P. Per oral transgastric endoscopic appendectomy in human. Paper Presented at: 45th Annual Conference of the Society of Gastrointestinal Endoscopy of India; February 28-29, 2004; Jaipur, India.
13. Clark MP, Qayed ES, Kooby DA, et al. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;189296.
14. Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/ SAGES Working Group on natural orifice translumenal endoscopic surgery, October 2005. Surg Endosc. 2006;20:329-333.
15. Autorino R, Yakoubi R, White WM, et al. Natural orifice transluminal endoscopic surgery (NOTES): where are we going? A bibliometric assessment. BJU Int. 2013;111:11-16.
16. Santos BF, Hungness ES. Natural orifice transluminal endoscopic surgery: progress in humans since the white paper. World J Gastroenterol. 2011;17:1655-1665.
17. Tolcher MC, Kalogera E, Hopkins MR, et al. Safety of culdotomy as a surgical approach: implications for natural orifice transluminal endoscopic surgery. JSLS. 2012;16:413-420.
18. ACOG Committee on Gynecologic Practice. Committee opinion no. 701. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2017:129:e155-e159.
19. Ahn KH, Song JY, Kim SH, et al. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012;19:631-635.
20. Liu J, Kohn J, Sun B, et al. Transvaginal natural orifice transluminal endoscopic surgery sacrocolpopexy: tips and tricks. Minim Invasive Gynecol. 2019;26:38-39.
21. Liu J, Kohn J, Fu H, et al. Transvaginal natural orifice transluminal endoscopic surgery for sacrocolpopexy: a pilot study of 26 cases. J Minim Invasive Gynecol. 2019;26:748-753.
22. Su H, Yen CF, Wu KY, et al. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach. Taiwan J Obstet Gynecol. 2012;51:217-221.
23. Lee CL, Huang CY, Wu KY, et al. Natural orifice transvaginal endoscopic surgery myomectomy: an innovative approach to myomectomy. Gynecol Minim Invasive Ther. 2014;3:127-130.
24. Chen Y, Li J, Zhang Y, et al. Transvaginal single-port laparoscopy sacrocolpopexy. J Minim Invasive Gynecol. 2018;25:585- 588.
25. Lee CL, Wu KY, Tsao FY, et al. Natural orifice transvaginal endoscopic surgery for endometrial cancer. Gynecol Minim Invasive Ther. 2014;3:89-92.
26. Leblanc E, Narducci F, Bresson L, et al. Fluorescence-assisted sentinel (SND) and pelvic node dissections by single-port transvaginal laparoscopic surgery, for the management of an endometrial carcinoma (EC) in an elderly obese patient. Gynecol Oncol. 2016;143:686-687.
27. Lee CL, Wu KY, Su H, et al. Robot-assisted natural orifice transluminal endoscopic surgery for hysterectomy. Taiwan J Obstet Gynecol. 2015;54:761-765.
28. Rezai S, Giovane RA, Johnson SN, et al. Robotic natural orifice transluminal endoscopic surgery (R-NOTES) in gynecologic surgeries, a case report and review of literature. Obstet Gynecol Int J. 2019;10:287-289.
29. Wang CJ, Wu PY, Kuo HH, et al. Natural orifice transluminal endoscopic surgery-assisted versus laparoscopic ovarian cystectomy (NAOC vs. LOC): a case-matched study. Surg Endosc. 2016;30:1227-1234.
Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.
Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.4
Attempts to improve the application of vaginal hysterectomy have been made.5 These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.6 An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.
Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.9
At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.
—Arnold P. Advincula, MD
Continue to: Development and evolution of NOTES...
Development and evolution of NOTES
Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.10 Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery.
Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution.
NOTES application in gynecology
With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.13
Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.14
While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.15 Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.16,17
The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.18 However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route.
In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.19 Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.9 Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.27,28
Continue to: Operative time, post-op stay shorter in NAOC-treated patients...
Operative time, post-op stay shorter in NAOC-treated patients
Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.29 Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).29
How vNOTES hysterectomy stacked up against TLH
In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.8 Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.8
Clearly, vNOTES is the next exciting development in minimally invasive surgery, improving patient outcomes and satisfaction with truly scarless surgery. Compared with traditional transvaginal surgery, vNOTES has the advantage of improved visualization with laparoendoscopic guidance, and it may be beneficial even for patients previously thought to have relative contraindications to successful completion of transvaginal surgery, such as nulliparity or a narrow introitus.
Approach for performing vNOTES procedures
At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes:
- low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac
- no surgical history suggestive of severe adhesive disease, and
- adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity.
In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery.
Continue to: Overview of vNOTES steps...
Overview of vNOTES steps
Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery.
1. Vaginal entry
Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection.
We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat.
Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1).
2. Traditional vaginal hysterectomy
After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible.
3. Single-site port placement
The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3).
After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4).
Continue to: 4. Laparoendoscopic surgery...
4. Laparoendoscopic surgery
Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5).
vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills.
During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6).
This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device.
5. Specimen removal
For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina.
Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled.
6. Vaginal cuff closure
The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.
vNOTES is the most recent innovative development in the field of minimally invasive surgery, and it has demonstrated feasibility and safety in the fields of general surgery, urology, and gynecology. Adopting vNOTES in clinical practice can improve patient satisfaction and cosmesis as well as surgical outcomes. Gynecologic surgeons can think of vNOTES hysterectomy as "placing an eye" in the vagina while performing transvaginal hysterectomy. The surgical principle of "vaginal pull, laparoscopic push" facilitates the learning process.
Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.
Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.4
Attempts to improve the application of vaginal hysterectomy have been made.5 These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.6 An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.
Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.9
At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.
—Arnold P. Advincula, MD
Continue to: Development and evolution of NOTES...
Development and evolution of NOTES
Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.10 Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery.
Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution.
NOTES application in gynecology
With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.13
Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.14
While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.15 Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.16,17
The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.18 However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route.
In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.19 Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.9 Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.27,28
Continue to: Operative time, post-op stay shorter in NAOC-treated patients...
Operative time, post-op stay shorter in NAOC-treated patients
Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.29 Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).29
How vNOTES hysterectomy stacked up against TLH
In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.8 Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.8
Clearly, vNOTES is the next exciting development in minimally invasive surgery, improving patient outcomes and satisfaction with truly scarless surgery. Compared with traditional transvaginal surgery, vNOTES has the advantage of improved visualization with laparoendoscopic guidance, and it may be beneficial even for patients previously thought to have relative contraindications to successful completion of transvaginal surgery, such as nulliparity or a narrow introitus.
Approach for performing vNOTES procedures
At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes:
- low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac
- no surgical history suggestive of severe adhesive disease, and
- adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity.
In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery.
Continue to: Overview of vNOTES steps...
Overview of vNOTES steps
Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery.
1. Vaginal entry
Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection.
We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat.
Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1).
2. Traditional vaginal hysterectomy
After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible.
3. Single-site port placement
The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3).
After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4).
Continue to: 4. Laparoendoscopic surgery...
4. Laparoendoscopic surgery
Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5).
vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills.
During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6).
This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device.
5. Specimen removal
For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina.
Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled.
6. Vaginal cuff closure
The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.
vNOTES is the most recent innovative development in the field of minimally invasive surgery, and it has demonstrated feasibility and safety in the fields of general surgery, urology, and gynecology. Adopting vNOTES in clinical practice can improve patient satisfaction and cosmesis as well as surgical outcomes. Gynecologic surgeons can think of vNOTES hysterectomy as "placing an eye" in the vagina while performing transvaginal hysterectomy. The surgical principle of "vaginal pull, laparoscopic push" facilitates the learning process.
1. ACOG Committee on Gynecologic Practice. Committee opinion no. 444. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
2. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1-3.
3. Whiteside JL, Kaeser CT, Ridgeway B. Achieving high value in the surgical approach to hysterectomy. Am J Obstet Gynecol. 2019;220:242-245.
4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
5. Moen M, Walter A, Harmanli O, et al. Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology. Obstet Gynecol. 2014;124:585-588.
6. Balgobin S, Owens DM, Florian-Rodriguez ME, et al. Vaginal hysterectomy suturing skills training model and curriculum. Obstet Gynecol. 2019;134:553-558.
7. Baekelandt J. Total vaginal NOTES hysterectomy: a new approach to hysterectomy. J Minim Invasive Gynecol. 2015;22:1088-1094.
8. Baekelandt JF, De Mulder PA, Le Roy I, et al. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019;126:105-113.
9. Guan X, Bardawil E, Liu J, et al. Transvaginal natural orifice transluminal endoscopic surgery as a rescue for total vaginal hysterectomy. J Minim Invasive Gynecol. 2018;25:1135-1136.
10. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;3:CD003677.
11. Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004;60:114-117.
12. Reddy N, Rao P. Per oral transgastric endoscopic appendectomy in human. Paper Presented at: 45th Annual Conference of the Society of Gastrointestinal Endoscopy of India; February 28-29, 2004; Jaipur, India.
13. Clark MP, Qayed ES, Kooby DA, et al. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;189296.
14. Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/ SAGES Working Group on natural orifice translumenal endoscopic surgery, October 2005. Surg Endosc. 2006;20:329-333.
15. Autorino R, Yakoubi R, White WM, et al. Natural orifice transluminal endoscopic surgery (NOTES): where are we going? A bibliometric assessment. BJU Int. 2013;111:11-16.
16. Santos BF, Hungness ES. Natural orifice transluminal endoscopic surgery: progress in humans since the white paper. World J Gastroenterol. 2011;17:1655-1665.
17. Tolcher MC, Kalogera E, Hopkins MR, et al. Safety of culdotomy as a surgical approach: implications for natural orifice transluminal endoscopic surgery. JSLS. 2012;16:413-420.
18. ACOG Committee on Gynecologic Practice. Committee opinion no. 701. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2017:129:e155-e159.
19. Ahn KH, Song JY, Kim SH, et al. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012;19:631-635.
20. Liu J, Kohn J, Sun B, et al. Transvaginal natural orifice transluminal endoscopic surgery sacrocolpopexy: tips and tricks. Minim Invasive Gynecol. 2019;26:38-39.
21. Liu J, Kohn J, Fu H, et al. Transvaginal natural orifice transluminal endoscopic surgery for sacrocolpopexy: a pilot study of 26 cases. J Minim Invasive Gynecol. 2019;26:748-753.
22. Su H, Yen CF, Wu KY, et al. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach. Taiwan J Obstet Gynecol. 2012;51:217-221.
23. Lee CL, Huang CY, Wu KY, et al. Natural orifice transvaginal endoscopic surgery myomectomy: an innovative approach to myomectomy. Gynecol Minim Invasive Ther. 2014;3:127-130.
24. Chen Y, Li J, Zhang Y, et al. Transvaginal single-port laparoscopy sacrocolpopexy. J Minim Invasive Gynecol. 2018;25:585- 588.
25. Lee CL, Wu KY, Tsao FY, et al. Natural orifice transvaginal endoscopic surgery for endometrial cancer. Gynecol Minim Invasive Ther. 2014;3:89-92.
26. Leblanc E, Narducci F, Bresson L, et al. Fluorescence-assisted sentinel (SND) and pelvic node dissections by single-port transvaginal laparoscopic surgery, for the management of an endometrial carcinoma (EC) in an elderly obese patient. Gynecol Oncol. 2016;143:686-687.
27. Lee CL, Wu KY, Su H, et al. Robot-assisted natural orifice transluminal endoscopic surgery for hysterectomy. Taiwan J Obstet Gynecol. 2015;54:761-765.
28. Rezai S, Giovane RA, Johnson SN, et al. Robotic natural orifice transluminal endoscopic surgery (R-NOTES) in gynecologic surgeries, a case report and review of literature. Obstet Gynecol Int J. 2019;10:287-289.
29. Wang CJ, Wu PY, Kuo HH, et al. Natural orifice transluminal endoscopic surgery-assisted versus laparoscopic ovarian cystectomy (NAOC vs. LOC): a case-matched study. Surg Endosc. 2016;30:1227-1234.
1. ACOG Committee on Gynecologic Practice. Committee opinion no. 444. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
2. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1-3.
3. Whiteside JL, Kaeser CT, Ridgeway B. Achieving high value in the surgical approach to hysterectomy. Am J Obstet Gynecol. 2019;220:242-245.
4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
5. Moen M, Walter A, Harmanli O, et al. Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology. Obstet Gynecol. 2014;124:585-588.
6. Balgobin S, Owens DM, Florian-Rodriguez ME, et al. Vaginal hysterectomy suturing skills training model and curriculum. Obstet Gynecol. 2019;134:553-558.
7. Baekelandt J. Total vaginal NOTES hysterectomy: a new approach to hysterectomy. J Minim Invasive Gynecol. 2015;22:1088-1094.
8. Baekelandt JF, De Mulder PA, Le Roy I, et al. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019;126:105-113.
9. Guan X, Bardawil E, Liu J, et al. Transvaginal natural orifice transluminal endoscopic surgery as a rescue for total vaginal hysterectomy. J Minim Invasive Gynecol. 2018;25:1135-1136.
10. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;3:CD003677.
11. Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004;60:114-117.
12. Reddy N, Rao P. Per oral transgastric endoscopic appendectomy in human. Paper Presented at: 45th Annual Conference of the Society of Gastrointestinal Endoscopy of India; February 28-29, 2004; Jaipur, India.
13. Clark MP, Qayed ES, Kooby DA, et al. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;189296.
14. Rattner D, Kalloo A; ASGE/SAGES Working Group. ASGE/ SAGES Working Group on natural orifice translumenal endoscopic surgery, October 2005. Surg Endosc. 2006;20:329-333.
15. Autorino R, Yakoubi R, White WM, et al. Natural orifice transluminal endoscopic surgery (NOTES): where are we going? A bibliometric assessment. BJU Int. 2013;111:11-16.
16. Santos BF, Hungness ES. Natural orifice transluminal endoscopic surgery: progress in humans since the white paper. World J Gastroenterol. 2011;17:1655-1665.
17. Tolcher MC, Kalogera E, Hopkins MR, et al. Safety of culdotomy as a surgical approach: implications for natural orifice transluminal endoscopic surgery. JSLS. 2012;16:413-420.
18. ACOG Committee on Gynecologic Practice. Committee opinion no. 701. Choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2017:129:e155-e159.
19. Ahn KH, Song JY, Kim SH, et al. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012;19:631-635.
20. Liu J, Kohn J, Sun B, et al. Transvaginal natural orifice transluminal endoscopic surgery sacrocolpopexy: tips and tricks. Minim Invasive Gynecol. 2019;26:38-39.
21. Liu J, Kohn J, Fu H, et al. Transvaginal natural orifice transluminal endoscopic surgery for sacrocolpopexy: a pilot study of 26 cases. J Minim Invasive Gynecol. 2019;26:748-753.
22. Su H, Yen CF, Wu KY, et al. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach. Taiwan J Obstet Gynecol. 2012;51:217-221.
23. Lee CL, Huang CY, Wu KY, et al. Natural orifice transvaginal endoscopic surgery myomectomy: an innovative approach to myomectomy. Gynecol Minim Invasive Ther. 2014;3:127-130.
24. Chen Y, Li J, Zhang Y, et al. Transvaginal single-port laparoscopy sacrocolpopexy. J Minim Invasive Gynecol. 2018;25:585- 588.
25. Lee CL, Wu KY, Tsao FY, et al. Natural orifice transvaginal endoscopic surgery for endometrial cancer. Gynecol Minim Invasive Ther. 2014;3:89-92.
26. Leblanc E, Narducci F, Bresson L, et al. Fluorescence-assisted sentinel (SND) and pelvic node dissections by single-port transvaginal laparoscopic surgery, for the management of an endometrial carcinoma (EC) in an elderly obese patient. Gynecol Oncol. 2016;143:686-687.
27. Lee CL, Wu KY, Su H, et al. Robot-assisted natural orifice transluminal endoscopic surgery for hysterectomy. Taiwan J Obstet Gynecol. 2015;54:761-765.
28. Rezai S, Giovane RA, Johnson SN, et al. Robotic natural orifice transluminal endoscopic surgery (R-NOTES) in gynecologic surgeries, a case report and review of literature. Obstet Gynecol Int J. 2019;10:287-289.
29. Wang CJ, Wu PY, Kuo HH, et al. Natural orifice transluminal endoscopic surgery-assisted versus laparoscopic ovarian cystectomy (NAOC vs. LOC): a case-matched study. Surg Endosc. 2016;30:1227-1234.
Hysterectomy in patients with history of prior cesarean delivery: A reverse dissection technique for vesicouterine adhesions
Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.
In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.5-8
With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.9 These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.
In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space.
Steps in operative planning
Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.
Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.10 Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.
Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.10 Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.11 Any posterior uterine adhesions or endometriosis are treated appropriately.12
First step in the surgical technique: Lateral dissection
We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.
Continue to: Using the tip of the vessel sealing...
Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.
The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.
Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.11 (See the box below for links to videos that demonstrate the techniques described here.)
Creating the “new” space
In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space11 (FIGURE 1).
Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.
Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).
Using the reverse vesicouterine fold dissection technique
Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.
The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).
Once the bladder adhesions are well delineated and separated from the uterus by the reverse vesicouterine fold dissection technique, it is safe to proceed with complete bladder mobilization. Sharp dissection can be used to dissect the remaining scarred bladder at its most superior attachments. Avoid the use of thermal energy to prevent heat injury to the bladder. Carefully dissect the bladder adhesions from the cervicouterine junction. Additional inferior bladder mobilization should be performed up to 3 cm past the leading edge of the cervicovaginal junction to ensure sufficient vaginal tissue for cuff closure. Note that the bladder pillars occasionally may be trapped inside a CD scar. This surgical technique could make it easier to release the pillars from inside the adhesions and penetrating into the scar.15
Continue to: Completing the surgery...
Completing the surgery
Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.16 Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.17
From the Center for Special Minimally Invasive and Robotic Surgery
https://youtu.be/wgGssnd1JAo
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy
- Case 1: TLH with development of the "new space": The technique with prior C-section
- Case 2: A straightforward case: Dysmenorrhea and menorrhagia
- Case 3: History of multiple C-sections with adhesions and fibroids
https://youtu.be/6vHamfPZhdY
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy after prior cesarean delivery
An effective technique in challenging situations
Genitourinary injury is a common complication of hysterectomy.18 The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.6 This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.6 Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.18
The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.16
While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.
- Page B. Nezhat & the advent of advanced operative video-laparoscopy. In: Nezhat C. Nezhat's History of Endoscopy. Tuttlingen, Germany: Endo Press; 2011:159-179. https://laparoscopy.blogs.com/endoscopyhistory/chapter_22. Accessed October 23, 2019.
- Podratz KC. Degrees of freedom: advances in gynecological and obstetric surgery. In: American College of Surgeons. Remembering Milestones and Achievements in Surgery: Inspiring Quality for a Hundred Years, 1913-2012. Tampa, FL: Faircount Media Group; 2013:113-119. http://endometriosisspecialists.com/wp-content/uploads/pdfs/Degrees-of-Freedom-Advances-in-Gynecological-and-Obstetrical-Surgery.pdf. Accessed October 31, 2019.
- Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008;12:351-357.
- Tokunaga T. Video surgery expands its scope. Stanford Med. 1993/1994;11(2)12-16.
- Rooney CM, Crawford AT, Vassallo BJ, et al. Is previous cesarean section a risk for incidental cystotomy at the time of hysterectomy? A case-controlled study. Am J Obstet Gynecol. 2005;193:2041-2044.
- Tan-Kim J, Menefee SA, Reinsch CS, et al. Laparoscopic hysterectomy and urinary tract injury: experience in a health maintenance organization. J Minim Invasive Gynecol. 2015;22:1278-1286.
- Sinha R, Sundaram M, Lakhotia S, et al. Total laparoscopic hysterectomy in women with previous cesarean sections. J Minim Invasive Gynecol. 2010;17:513-517.
- O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009;16:195-197.
- Martin JA, Hamilton BE, Osterman MJ, et al. Births: final data for 2013. Natl Vital Stat Rep. 2015;64:1-65.
- Nezhat C, Nezhat F, Nezhat C, eds. Nezhat's Video-Assisted and Robotic-Assisted Laparoscopy and Hysteroscopy with DVD, 4th ed. New York, NY: Cambridge University Press; 2013.
- Nezhat C, Grace LA, Razavi GM, et al. Reverse vesicouterine fold dissection for laparoscopic hysterectomy after prior cesarean deliveries. Obstet Gynecol. 2016;128:629-633.
- Nezhat C, Xie J, Aldape D, et al. Use of laparoscopic modified nerve-sparing radical hysterectomy for the treatment of extensive endometriosis. Cureus. 2014;6:e159.
- Yabuki Y, Sasaki H, Hatakeyama N, et al. Discrepancies between classic anatomy and modern gynecologic surgery on pelvic connective tissue structure: harmonization of those concepts by collaborative cadaver dissection. Am J Obstet Gynecol. 2005;193:7-15.
- Uhlenhuth E. Problems in the Anatomy of the Pelvis: An Atlas. Philadelphia, PA: JB Lippincott Co; 1953.
- Nezhat C, Grace, L, Soliemannjad, et al. Cesarean scar defect: what is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38-39,53.
- Nezhat C, Kennedy Burns M, Wood M, et al. Vaginal cuff dehiscence and evisceration: a review. Obstet Gynecol. 2018;132:972-985.
- Nezhat C, Main J, Paka C, et al. Advanced gynecologic laparoscopy in a fast-track ambulatory surgery center. JSLS. 2014;18:pii:e2014.00291.
- Nezhat C, Falik R, McKinney S, et al. Pathophysiology and management of urinary tract endometriosis. Nat Rev Urol. 2017;14:359-372.
Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.
In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.5-8
With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.9 These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.
In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space.
Steps in operative planning
Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.
Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.10 Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.
Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.10 Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.11 Any posterior uterine adhesions or endometriosis are treated appropriately.12
First step in the surgical technique: Lateral dissection
We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.
Continue to: Using the tip of the vessel sealing...
Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.
The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.
Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.11 (See the box below for links to videos that demonstrate the techniques described here.)
Creating the “new” space
In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space11 (FIGURE 1).
Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.
Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).
Using the reverse vesicouterine fold dissection technique
Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.
The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).
Once the bladder adhesions are well delineated and separated from the uterus by the reverse vesicouterine fold dissection technique, it is safe to proceed with complete bladder mobilization. Sharp dissection can be used to dissect the remaining scarred bladder at its most superior attachments. Avoid the use of thermal energy to prevent heat injury to the bladder. Carefully dissect the bladder adhesions from the cervicouterine junction. Additional inferior bladder mobilization should be performed up to 3 cm past the leading edge of the cervicovaginal junction to ensure sufficient vaginal tissue for cuff closure. Note that the bladder pillars occasionally may be trapped inside a CD scar. This surgical technique could make it easier to release the pillars from inside the adhesions and penetrating into the scar.15
Continue to: Completing the surgery...
Completing the surgery
Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.16 Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.17
From the Center for Special Minimally Invasive and Robotic Surgery
https://youtu.be/wgGssnd1JAo
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy
- Case 1: TLH with development of the "new space": The technique with prior C-section
- Case 2: A straightforward case: Dysmenorrhea and menorrhagia
- Case 3: History of multiple C-sections with adhesions and fibroids
https://youtu.be/6vHamfPZhdY
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy after prior cesarean delivery
An effective technique in challenging situations
Genitourinary injury is a common complication of hysterectomy.18 The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.6 This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.6 Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.18
The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.16
While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.
Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.
In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.5-8
With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.9 These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.
In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space.
Steps in operative planning
Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.
Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.10 Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.
Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.10 Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.11 Any posterior uterine adhesions or endometriosis are treated appropriately.12
First step in the surgical technique: Lateral dissection
We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.
Continue to: Using the tip of the vessel sealing...
Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.
The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.
Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.11 (See the box below for links to videos that demonstrate the techniques described here.)
Creating the “new” space
In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space11 (FIGURE 1).
Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.
Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).
Using the reverse vesicouterine fold dissection technique
Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.
The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).
Once the bladder adhesions are well delineated and separated from the uterus by the reverse vesicouterine fold dissection technique, it is safe to proceed with complete bladder mobilization. Sharp dissection can be used to dissect the remaining scarred bladder at its most superior attachments. Avoid the use of thermal energy to prevent heat injury to the bladder. Carefully dissect the bladder adhesions from the cervicouterine junction. Additional inferior bladder mobilization should be performed up to 3 cm past the leading edge of the cervicovaginal junction to ensure sufficient vaginal tissue for cuff closure. Note that the bladder pillars occasionally may be trapped inside a CD scar. This surgical technique could make it easier to release the pillars from inside the adhesions and penetrating into the scar.15
Continue to: Completing the surgery...
Completing the surgery
Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.16 Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.17
From the Center for Special Minimally Invasive and Robotic Surgery
https://youtu.be/wgGssnd1JAo
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy
- Case 1: TLH with development of the "new space": The technique with prior C-section
- Case 2: A straightforward case: Dysmenorrhea and menorrhagia
- Case 3: History of multiple C-sections with adhesions and fibroids
https://youtu.be/6vHamfPZhdY
Reverse vesicouterine fold dissection for total laparoscopic hysterectomy after prior cesarean delivery
An effective technique in challenging situations
Genitourinary injury is a common complication of hysterectomy.18 The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.6 This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.6 Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.18
The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.16
While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.
- Page B. Nezhat & the advent of advanced operative video-laparoscopy. In: Nezhat C. Nezhat's History of Endoscopy. Tuttlingen, Germany: Endo Press; 2011:159-179. https://laparoscopy.blogs.com/endoscopyhistory/chapter_22. Accessed October 23, 2019.
- Podratz KC. Degrees of freedom: advances in gynecological and obstetric surgery. In: American College of Surgeons. Remembering Milestones and Achievements in Surgery: Inspiring Quality for a Hundred Years, 1913-2012. Tampa, FL: Faircount Media Group; 2013:113-119. http://endometriosisspecialists.com/wp-content/uploads/pdfs/Degrees-of-Freedom-Advances-in-Gynecological-and-Obstetrical-Surgery.pdf. Accessed October 31, 2019.
- Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008;12:351-357.
- Tokunaga T. Video surgery expands its scope. Stanford Med. 1993/1994;11(2)12-16.
- Rooney CM, Crawford AT, Vassallo BJ, et al. Is previous cesarean section a risk for incidental cystotomy at the time of hysterectomy? A case-controlled study. Am J Obstet Gynecol. 2005;193:2041-2044.
- Tan-Kim J, Menefee SA, Reinsch CS, et al. Laparoscopic hysterectomy and urinary tract injury: experience in a health maintenance organization. J Minim Invasive Gynecol. 2015;22:1278-1286.
- Sinha R, Sundaram M, Lakhotia S, et al. Total laparoscopic hysterectomy in women with previous cesarean sections. J Minim Invasive Gynecol. 2010;17:513-517.
- O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009;16:195-197.
- Martin JA, Hamilton BE, Osterman MJ, et al. Births: final data for 2013. Natl Vital Stat Rep. 2015;64:1-65.
- Nezhat C, Nezhat F, Nezhat C, eds. Nezhat's Video-Assisted and Robotic-Assisted Laparoscopy and Hysteroscopy with DVD, 4th ed. New York, NY: Cambridge University Press; 2013.
- Nezhat C, Grace LA, Razavi GM, et al. Reverse vesicouterine fold dissection for laparoscopic hysterectomy after prior cesarean deliveries. Obstet Gynecol. 2016;128:629-633.
- Nezhat C, Xie J, Aldape D, et al. Use of laparoscopic modified nerve-sparing radical hysterectomy for the treatment of extensive endometriosis. Cureus. 2014;6:e159.
- Yabuki Y, Sasaki H, Hatakeyama N, et al. Discrepancies between classic anatomy and modern gynecologic surgery on pelvic connective tissue structure: harmonization of those concepts by collaborative cadaver dissection. Am J Obstet Gynecol. 2005;193:7-15.
- Uhlenhuth E. Problems in the Anatomy of the Pelvis: An Atlas. Philadelphia, PA: JB Lippincott Co; 1953.
- Nezhat C, Grace, L, Soliemannjad, et al. Cesarean scar defect: what is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38-39,53.
- Nezhat C, Kennedy Burns M, Wood M, et al. Vaginal cuff dehiscence and evisceration: a review. Obstet Gynecol. 2018;132:972-985.
- Nezhat C, Main J, Paka C, et al. Advanced gynecologic laparoscopy in a fast-track ambulatory surgery center. JSLS. 2014;18:pii:e2014.00291.
- Nezhat C, Falik R, McKinney S, et al. Pathophysiology and management of urinary tract endometriosis. Nat Rev Urol. 2017;14:359-372.
- Page B. Nezhat & the advent of advanced operative video-laparoscopy. In: Nezhat C. Nezhat's History of Endoscopy. Tuttlingen, Germany: Endo Press; 2011:159-179. https://laparoscopy.blogs.com/endoscopyhistory/chapter_22. Accessed October 23, 2019.
- Podratz KC. Degrees of freedom: advances in gynecological and obstetric surgery. In: American College of Surgeons. Remembering Milestones and Achievements in Surgery: Inspiring Quality for a Hundred Years, 1913-2012. Tampa, FL: Faircount Media Group; 2013:113-119. http://endometriosisspecialists.com/wp-content/uploads/pdfs/Degrees-of-Freedom-Advances-in-Gynecological-and-Obstetrical-Surgery.pdf. Accessed October 31, 2019.
- Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008;12:351-357.
- Tokunaga T. Video surgery expands its scope. Stanford Med. 1993/1994;11(2)12-16.
- Rooney CM, Crawford AT, Vassallo BJ, et al. Is previous cesarean section a risk for incidental cystotomy at the time of hysterectomy? A case-controlled study. Am J Obstet Gynecol. 2005;193:2041-2044.
- Tan-Kim J, Menefee SA, Reinsch CS, et al. Laparoscopic hysterectomy and urinary tract injury: experience in a health maintenance organization. J Minim Invasive Gynecol. 2015;22:1278-1286.
- Sinha R, Sundaram M, Lakhotia S, et al. Total laparoscopic hysterectomy in women with previous cesarean sections. J Minim Invasive Gynecol. 2010;17:513-517.
- O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009;16:195-197.
- Martin JA, Hamilton BE, Osterman MJ, et al. Births: final data for 2013. Natl Vital Stat Rep. 2015;64:1-65.
- Nezhat C, Nezhat F, Nezhat C, eds. Nezhat's Video-Assisted and Robotic-Assisted Laparoscopy and Hysteroscopy with DVD, 4th ed. New York, NY: Cambridge University Press; 2013.
- Nezhat C, Grace LA, Razavi GM, et al. Reverse vesicouterine fold dissection for laparoscopic hysterectomy after prior cesarean deliveries. Obstet Gynecol. 2016;128:629-633.
- Nezhat C, Xie J, Aldape D, et al. Use of laparoscopic modified nerve-sparing radical hysterectomy for the treatment of extensive endometriosis. Cureus. 2014;6:e159.
- Yabuki Y, Sasaki H, Hatakeyama N, et al. Discrepancies between classic anatomy and modern gynecologic surgery on pelvic connective tissue structure: harmonization of those concepts by collaborative cadaver dissection. Am J Obstet Gynecol. 2005;193:7-15.
- Uhlenhuth E. Problems in the Anatomy of the Pelvis: An Atlas. Philadelphia, PA: JB Lippincott Co; 1953.
- Nezhat C, Grace, L, Soliemannjad, et al. Cesarean scar defect: what is it and how should it be treated? OBG Manag. 2016;28(4):32,34,36,38-39,53.
- Nezhat C, Kennedy Burns M, Wood M, et al. Vaginal cuff dehiscence and evisceration: a review. Obstet Gynecol. 2018;132:972-985.
- Nezhat C, Main J, Paka C, et al. Advanced gynecologic laparoscopy in a fast-track ambulatory surgery center. JSLS. 2014;18:pii:e2014.00291.
- Nezhat C, Falik R, McKinney S, et al. Pathophysiology and management of urinary tract endometriosis. Nat Rev Urol. 2017;14:359-372.