User login
Calcium, PTH predict permanent hypoparathyroidism
BOSTON – Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.
“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.
To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.
Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.
Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.
Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).
Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.
Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.
Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.
Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.
“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”
Dr. Brown reported no relevant financial disclosures.
SOURCE: Brown S et al. AACE 2018, Abstract 720.
BOSTON – Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.
“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.
To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.
Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.
Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.
Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).
Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.
Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.
Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.
Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.
“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”
Dr. Brown reported no relevant financial disclosures.
SOURCE: Brown S et al. AACE 2018, Abstract 720.
BOSTON – Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.
With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.
“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.
To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.
Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.
Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.
Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).
Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.
Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.
Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.
Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.
“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”
Dr. Brown reported no relevant financial disclosures.
SOURCE: Brown S et al. AACE 2018, Abstract 720.
REPORTING FROM AACE 18
Key clinical point:
Major finding: Patients with low calcium and low PTH were 4.3 times as likely as those without to develop permanent hypoparathyroidism after total thyroidectomy.
Study details: Retrospective, single center study of 176 total thyroidectomy patients during 1999-2013.
Disclosures: The presenter reported no relevant financial disclosures.
Source: Brown S et al. AACE 2018, Abstract 720.
Study supports observation for select cases of porcelain gallbladder
Some adults with porcelain gallbladder may be eligible to forgo prophylactic cholecystectomy, suggest the results of a single-center retrospective study.
Over 1.7 years of median follow-up (range, 0 to 12.7 years), the observational group had no detected gallbladder malignancies and 4% developed adverse events versus 13% in the prophylactic cholecystectomy group (P = .15), wrote Haley DesJardins and her associates at Tufts University, Boston. The report was published in the Journal of the American College of Surgery.
The findings “still raise concern about an association between gallbladder wall calcifications and gallbladder malignancies, and therefore still suggest the need for cholecystectomy in the young, healthy, or symptomatic patient,” the researchers wrote. Nonetheless, surveillance for patients “who are poor surgical candidates is a reasonable approach, with a low risk of malignancy over a limited time frame.”
The investigators suggest that surgeons consider intervention when symptoms and workup points to gallbladder malignancy. But consider avoiding prophylactic cholecystectomy in patients with “limited life expectancy and significant comorbidities,” they emphasized. “Based on the results of this study, the act of prophylactic cholecystectomy for every single patient with gallbladder wall calcifications seems obsolete.”
The study comprised 113 patients with porcelain gallbladder diagnosed between 2004 and 2016. Radiographic reviews identified 70 definite cases and 43 “highly probable” cases. In all, 90 patients started out with observation only, of whom 26% with abdominal pain did not have cholecystectomy because of “significant comorbidities.” Four patients (4.4%) in the observational group subsequently underwent cholecystectomy for biliary colic, as part of liver transplantation, or for prophylactic reasons. None developed complications. In all, 11% developed new gallstones on follow-up imaging and 8% showed progression from focal to diffuse porcelain bladder, the researchers said. None developed gallbladder malignancy during 1.7 years of median follow-up.
Histopathologies of the operative group identified two cases of gallbladder malignancy, of which one was detected on initial imaging. “This patient had a mass at the gallbladder infundibulum extending into the hepatic duct bifurcation,” the researchers explained. “It was not entirely evident whether the resected adenocarcinoma was originating from the gallbladder or from the bile duct. For the purpose of this study, this patient was listed as [having] gallbladder cancer.” The second case consisted of metastatic squamous cell gallbladder carcinoma.
The investigators concluded that “while it is seemingly very reasonable to observe asymptomatic patients with limited life expectancy and significant comorbidities, the decision to proceed with prophylactic cholecystectomy versus observation remains in the hands of the treating physician and patient; especially since absolute criteria or cut-offs cannot be defined at this point.”
No external funding sources were reported. The researchers reported having no conflicts of interest.
SOURCE: DesJardins H et al. J Am Coll Surg. 2018 Apr 22. doi: 10.1016/j.jamcollsurg.2017.11.026.
Some adults with porcelain gallbladder may be eligible to forgo prophylactic cholecystectomy, suggest the results of a single-center retrospective study.
Over 1.7 years of median follow-up (range, 0 to 12.7 years), the observational group had no detected gallbladder malignancies and 4% developed adverse events versus 13% in the prophylactic cholecystectomy group (P = .15), wrote Haley DesJardins and her associates at Tufts University, Boston. The report was published in the Journal of the American College of Surgery.
The findings “still raise concern about an association between gallbladder wall calcifications and gallbladder malignancies, and therefore still suggest the need for cholecystectomy in the young, healthy, or symptomatic patient,” the researchers wrote. Nonetheless, surveillance for patients “who are poor surgical candidates is a reasonable approach, with a low risk of malignancy over a limited time frame.”
The investigators suggest that surgeons consider intervention when symptoms and workup points to gallbladder malignancy. But consider avoiding prophylactic cholecystectomy in patients with “limited life expectancy and significant comorbidities,” they emphasized. “Based on the results of this study, the act of prophylactic cholecystectomy for every single patient with gallbladder wall calcifications seems obsolete.”
The study comprised 113 patients with porcelain gallbladder diagnosed between 2004 and 2016. Radiographic reviews identified 70 definite cases and 43 “highly probable” cases. In all, 90 patients started out with observation only, of whom 26% with abdominal pain did not have cholecystectomy because of “significant comorbidities.” Four patients (4.4%) in the observational group subsequently underwent cholecystectomy for biliary colic, as part of liver transplantation, or for prophylactic reasons. None developed complications. In all, 11% developed new gallstones on follow-up imaging and 8% showed progression from focal to diffuse porcelain bladder, the researchers said. None developed gallbladder malignancy during 1.7 years of median follow-up.
Histopathologies of the operative group identified two cases of gallbladder malignancy, of which one was detected on initial imaging. “This patient had a mass at the gallbladder infundibulum extending into the hepatic duct bifurcation,” the researchers explained. “It was not entirely evident whether the resected adenocarcinoma was originating from the gallbladder or from the bile duct. For the purpose of this study, this patient was listed as [having] gallbladder cancer.” The second case consisted of metastatic squamous cell gallbladder carcinoma.
The investigators concluded that “while it is seemingly very reasonable to observe asymptomatic patients with limited life expectancy and significant comorbidities, the decision to proceed with prophylactic cholecystectomy versus observation remains in the hands of the treating physician and patient; especially since absolute criteria or cut-offs cannot be defined at this point.”
No external funding sources were reported. The researchers reported having no conflicts of interest.
SOURCE: DesJardins H et al. J Am Coll Surg. 2018 Apr 22. doi: 10.1016/j.jamcollsurg.2017.11.026.
Some adults with porcelain gallbladder may be eligible to forgo prophylactic cholecystectomy, suggest the results of a single-center retrospective study.
Over 1.7 years of median follow-up (range, 0 to 12.7 years), the observational group had no detected gallbladder malignancies and 4% developed adverse events versus 13% in the prophylactic cholecystectomy group (P = .15), wrote Haley DesJardins and her associates at Tufts University, Boston. The report was published in the Journal of the American College of Surgery.
The findings “still raise concern about an association between gallbladder wall calcifications and gallbladder malignancies, and therefore still suggest the need for cholecystectomy in the young, healthy, or symptomatic patient,” the researchers wrote. Nonetheless, surveillance for patients “who are poor surgical candidates is a reasonable approach, with a low risk of malignancy over a limited time frame.”
The investigators suggest that surgeons consider intervention when symptoms and workup points to gallbladder malignancy. But consider avoiding prophylactic cholecystectomy in patients with “limited life expectancy and significant comorbidities,” they emphasized. “Based on the results of this study, the act of prophylactic cholecystectomy for every single patient with gallbladder wall calcifications seems obsolete.”
The study comprised 113 patients with porcelain gallbladder diagnosed between 2004 and 2016. Radiographic reviews identified 70 definite cases and 43 “highly probable” cases. In all, 90 patients started out with observation only, of whom 26% with abdominal pain did not have cholecystectomy because of “significant comorbidities.” Four patients (4.4%) in the observational group subsequently underwent cholecystectomy for biliary colic, as part of liver transplantation, or for prophylactic reasons. None developed complications. In all, 11% developed new gallstones on follow-up imaging and 8% showed progression from focal to diffuse porcelain bladder, the researchers said. None developed gallbladder malignancy during 1.7 years of median follow-up.
Histopathologies of the operative group identified two cases of gallbladder malignancy, of which one was detected on initial imaging. “This patient had a mass at the gallbladder infundibulum extending into the hepatic duct bifurcation,” the researchers explained. “It was not entirely evident whether the resected adenocarcinoma was originating from the gallbladder or from the bile duct. For the purpose of this study, this patient was listed as [having] gallbladder cancer.” The second case consisted of metastatic squamous cell gallbladder carcinoma.
The investigators concluded that “while it is seemingly very reasonable to observe asymptomatic patients with limited life expectancy and significant comorbidities, the decision to proceed with prophylactic cholecystectomy versus observation remains in the hands of the treating physician and patient; especially since absolute criteria or cut-offs cannot be defined at this point.”
No external funding sources were reported. The researchers reported having no conflicts of interest.
SOURCE: DesJardins H et al. J Am Coll Surg. 2018 Apr 22. doi: 10.1016/j.jamcollsurg.2017.11.026.
FROM JOURNAL OF THE AMERICAN COLLEGE OF SURGERY
Key clinical point: Observation is an option for select patients with porcelain gallbladder .
Major finding: Rates of adverse events were 4% with observation and 13% with surgery (P = .15).
Study details: Single-center retrospective cohort study of 113 patients.
Disclosures: No external funding sources were reported. The researchers reported having no conflicts of interest.
Source: DesJardins H et al. J Am Coll Surg. 2018 Apr 22. doi: 10.1016/j.jamcollsurg.2017.11.026.
ESBL-resistant bacteria spread in hospital despite strict contact precautions
MADRID – even when staff employed an active surveillance screening protocol to identify every carrier at admission.
The failure of precautions may have root in two thorny issues, said Friederike Maechler, MD, who presented the data at the the European Society of Clinical Microbiology and Infectious Diseases annual congress.
“Adherence to strict contact isolation and hand hygiene is never 100% in a real-life scenario,” said Dr. Maechler, of Charite University Hospital, Berlin. Also, she said, contact isolation can only be effective in a ward if all, or at least most, of the ESBL-E carriers are identified. “Even with an extensive surveillance screening program established, many carriers remained unknown to the health care staff.”
The 25-month study, dubbed R-Gnosis, was conducted in 20 Western European hospitals in Madrid, Berlin, Utrecht, and Geneva. It compared 12 months of contact precaution with standard precaution infection control strategies in medical and surgical non-ICUs.
The entire study hinged on a strict protocol to identify as many ESBL-E carriers as possible. This was done by screening upon admission to the unit, screening once per week during the hospital stay, and screening on discharge. Each patient underwent deep rectal swabs that were cultured on agar and screened for resistance.
The crossover design trial randomized each unit to either contact precautions or standard precautions for 12 months, followed by a 1-month washout period, after which they began the other protocol.
In all, 50,870 patients were entered into the study. By the end, Dr. Maechler had data on 11,367 patients with full screening and follow-up.
Standard precautions did not require a private bedroom, with gloves, gowns, and apron needed for direct contact to body fluids or wounds only, and consistent hand hygiene. Contact precautions required a private bedroom and strict hand hygiene, with gloves, gowns, and aprons used for any patient contact. Study staff monitored compliance with these procedures monthly.
The primary outcome was the ESBL-E acquisition rate per 1,000 patient days. This was defined as a new ESBL-E detection after the patient had a prior negative screen. Dr. Maechler noted that by epidemiological definition, acquisition does not necessarily imply cross-transmission from other patients.
Adherence to the study protocols was good, she said. Adherence to both contact and standard precautions was about 85%, while adherence to hand hygiene was less at around 62%.
Admission ESBL-E screenings revealed that about 12% of the study population was colonized with the strain at admission. The proportion was nearly identical in the contact and standard precaution groups (11.6%, 12.2%).
The incidence density of ward-acquired ESBL-E per 1,000 patient-days at risk was 4.6 in both intervention periods, regardless of the type of precaution taken. Contact precautions appeared to be slightly less effective for Escherichia coli (3.6 per 1,000 patient-days in contact precautions vs. 3.5 in standard), compared with Klebsiella pneumoniae (1.8 vs. 2.2).
A multivariate analysis controlled for screening compliance, colonization pressure, and length of stay, study site, and season of year. It showed that strict contact precautions did not reduce the risk of ward-acquired ESBL-E carriage.
Dr. Maechler had no financial disclosures. The R-Gnosis study was funded by the European Community’s Seventh Framework Programme.
SOURCE: Maechler F et al. ECCMID 2018, Oral Abstract O1130.
MADRID – even when staff employed an active surveillance screening protocol to identify every carrier at admission.
The failure of precautions may have root in two thorny issues, said Friederike Maechler, MD, who presented the data at the the European Society of Clinical Microbiology and Infectious Diseases annual congress.
“Adherence to strict contact isolation and hand hygiene is never 100% in a real-life scenario,” said Dr. Maechler, of Charite University Hospital, Berlin. Also, she said, contact isolation can only be effective in a ward if all, or at least most, of the ESBL-E carriers are identified. “Even with an extensive surveillance screening program established, many carriers remained unknown to the health care staff.”
The 25-month study, dubbed R-Gnosis, was conducted in 20 Western European hospitals in Madrid, Berlin, Utrecht, and Geneva. It compared 12 months of contact precaution with standard precaution infection control strategies in medical and surgical non-ICUs.
The entire study hinged on a strict protocol to identify as many ESBL-E carriers as possible. This was done by screening upon admission to the unit, screening once per week during the hospital stay, and screening on discharge. Each patient underwent deep rectal swabs that were cultured on agar and screened for resistance.
The crossover design trial randomized each unit to either contact precautions or standard precautions for 12 months, followed by a 1-month washout period, after which they began the other protocol.
In all, 50,870 patients were entered into the study. By the end, Dr. Maechler had data on 11,367 patients with full screening and follow-up.
Standard precautions did not require a private bedroom, with gloves, gowns, and apron needed for direct contact to body fluids or wounds only, and consistent hand hygiene. Contact precautions required a private bedroom and strict hand hygiene, with gloves, gowns, and aprons used for any patient contact. Study staff monitored compliance with these procedures monthly.
The primary outcome was the ESBL-E acquisition rate per 1,000 patient days. This was defined as a new ESBL-E detection after the patient had a prior negative screen. Dr. Maechler noted that by epidemiological definition, acquisition does not necessarily imply cross-transmission from other patients.
Adherence to the study protocols was good, she said. Adherence to both contact and standard precautions was about 85%, while adherence to hand hygiene was less at around 62%.
Admission ESBL-E screenings revealed that about 12% of the study population was colonized with the strain at admission. The proportion was nearly identical in the contact and standard precaution groups (11.6%, 12.2%).
The incidence density of ward-acquired ESBL-E per 1,000 patient-days at risk was 4.6 in both intervention periods, regardless of the type of precaution taken. Contact precautions appeared to be slightly less effective for Escherichia coli (3.6 per 1,000 patient-days in contact precautions vs. 3.5 in standard), compared with Klebsiella pneumoniae (1.8 vs. 2.2).
A multivariate analysis controlled for screening compliance, colonization pressure, and length of stay, study site, and season of year. It showed that strict contact precautions did not reduce the risk of ward-acquired ESBL-E carriage.
Dr. Maechler had no financial disclosures. The R-Gnosis study was funded by the European Community’s Seventh Framework Programme.
SOURCE: Maechler F et al. ECCMID 2018, Oral Abstract O1130.
MADRID – even when staff employed an active surveillance screening protocol to identify every carrier at admission.
The failure of precautions may have root in two thorny issues, said Friederike Maechler, MD, who presented the data at the the European Society of Clinical Microbiology and Infectious Diseases annual congress.
“Adherence to strict contact isolation and hand hygiene is never 100% in a real-life scenario,” said Dr. Maechler, of Charite University Hospital, Berlin. Also, she said, contact isolation can only be effective in a ward if all, or at least most, of the ESBL-E carriers are identified. “Even with an extensive surveillance screening program established, many carriers remained unknown to the health care staff.”
The 25-month study, dubbed R-Gnosis, was conducted in 20 Western European hospitals in Madrid, Berlin, Utrecht, and Geneva. It compared 12 months of contact precaution with standard precaution infection control strategies in medical and surgical non-ICUs.
The entire study hinged on a strict protocol to identify as many ESBL-E carriers as possible. This was done by screening upon admission to the unit, screening once per week during the hospital stay, and screening on discharge. Each patient underwent deep rectal swabs that were cultured on agar and screened for resistance.
The crossover design trial randomized each unit to either contact precautions or standard precautions for 12 months, followed by a 1-month washout period, after which they began the other protocol.
In all, 50,870 patients were entered into the study. By the end, Dr. Maechler had data on 11,367 patients with full screening and follow-up.
Standard precautions did not require a private bedroom, with gloves, gowns, and apron needed for direct contact to body fluids or wounds only, and consistent hand hygiene. Contact precautions required a private bedroom and strict hand hygiene, with gloves, gowns, and aprons used for any patient contact. Study staff monitored compliance with these procedures monthly.
The primary outcome was the ESBL-E acquisition rate per 1,000 patient days. This was defined as a new ESBL-E detection after the patient had a prior negative screen. Dr. Maechler noted that by epidemiological definition, acquisition does not necessarily imply cross-transmission from other patients.
Adherence to the study protocols was good, she said. Adherence to both contact and standard precautions was about 85%, while adherence to hand hygiene was less at around 62%.
Admission ESBL-E screenings revealed that about 12% of the study population was colonized with the strain at admission. The proportion was nearly identical in the contact and standard precaution groups (11.6%, 12.2%).
The incidence density of ward-acquired ESBL-E per 1,000 patient-days at risk was 4.6 in both intervention periods, regardless of the type of precaution taken. Contact precautions appeared to be slightly less effective for Escherichia coli (3.6 per 1,000 patient-days in contact precautions vs. 3.5 in standard), compared with Klebsiella pneumoniae (1.8 vs. 2.2).
A multivariate analysis controlled for screening compliance, colonization pressure, and length of stay, study site, and season of year. It showed that strict contact precautions did not reduce the risk of ward-acquired ESBL-E carriage.
Dr. Maechler had no financial disclosures. The R-Gnosis study was funded by the European Community’s Seventh Framework Programme.
SOURCE: Maechler F et al. ECCMID 2018, Oral Abstract O1130.
REPORTING FROM ECCMID 2018
Key clinical point: A protocol of strict contact precautions and hand hygiene was no better than standard contact precautions at preventing the spread of extended-spectrum, beta-lactamase–resistant Enterobacteriaceae.
Major finding: The incidence density of ward-acquired ESBL-E per 1,000 patient-days at risk was 4.6, regardless of precaution.
Study details: The 25-month crossover trial comprised more than 11,000 patients.
Disclosures: Dr. Maechler had no financial disclosures. The R-Gnosis study was funded by the European Community’s Seventh Framework Programme.
Source: Maechler F et al. ECCMID 2018, Oral Abstract O1130.
Upping the game of surgical researchers
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Restrictive fluids tied to kidney injury after major abdominal surgery
among high-risk patients undergoing major abdominal surgery and led to a significantly increased risk of acute kidney injury, researchers reported.
In an international, randomized trial with 366 median days of follow-up, estimated 1-year rates of disability-free survival were 81.9% with the restrictive intravenous fluid regimen and 82.3% with the liberal regimen (hazard ratio for death or disability, 1.05; P = .61), according to Paul S. Myles, MPH, DSc, and his associates.
Rates of acute renal injury were 8.6% in the restrictive IV fluid group and 5.0% with the liberal fluid therapy (P less than .001), the researchers reported online May 10 in the New England Journal of Medicine.
Guidelines recommend a restrictive intravenous fluid strategy to promote early recovery after major abdominal surgery, noted Dr. Myles of Alfred Hospital in Melbourne and his colleagues. “However, the supporting evidence is limited, and there is concern about impaired organ perfusion.”
Therefore, they randomly assigned, 3,000 patients to receive either the restrictive fluid regimen or a liberal regimen during major abdominal surgery and up to 24 hours after. Median intravenous volume was 3.7 L (interquartile range, 2.9-4.9 L) in the restrictive group and 6.1 L (IQR, 5.0-7.4 L) in the liberal fluid group. All patients were deemed high risk based on their age (at least 70 years) or because they had heart disease, diabetes, kidney disease, or morbid obesity.
Patients who received the restrictive regimen had higher rates of surgical site infection (16.5% vs. 13.6% with liberal fluids; P = .02) and were more likely to receive renal replacement therapy (0.9% vs. 0.3%; P = .048). However, these trends were no longer significant after the researchers controlled for the effects of testing for multiple variables.
“Our findings should not be used to support excessive administration of intravenous fluid,” the researchers cautioned. “Rather, they show that a regimen that includes a modestly liberal administration of fluid is safer than a restrictive regimen.”
Funders included the Australian National Health and Medical Research Council (NHMRC), the Health Research Council of New Zealand, the Australian and New Zealand College of Anaesthetists, and Monash University, Melbourne. Dr. Myles reported receiving grant support from NHMRC. He had no other disclosures.
SOURCE: Myles PS et al. New Engl J Med. 2018 May 10. doi: 10.1056/NEJMoa1801601.
Effective blinding was impossible in this randomized study, wrote Birgitte Brandstrup, PhD, in an accompanying editorial. Differences in fluid volume cause symptoms that clinicians can easily identify, she noted.
She recalled the 1990s, when “surgical patients received so much intravenous saline on the day of surgery that they often gained 4 to 6 kg, and by postoperative day 2 or 3, [and] pulmonary congestion and cardiac arrhythmias were commonplace.” Subsequent trials changed this practice, and patients in the current study received much less fluid than they would have in the old days, she noted.
Nonetheless, the findings indicate “that physiologic principles remain valid: Both hypovolemia and oliguria must be recognized and treated with fluid.” While that does not justify excessive perioperative fluid therapy, “a modestly liberal fluid regimen is safer than a truly restrictive regimen.”
Dr. Brandstrup is with the department of surgery at Holbaek (Denmark) Hospital. She reported having no relevant conflicts of interest. These comments recap her editorial (New Engl J Med. 2018 May 10. doi: 10.1056/NEJMe1805615).
Effective blinding was impossible in this randomized study, wrote Birgitte Brandstrup, PhD, in an accompanying editorial. Differences in fluid volume cause symptoms that clinicians can easily identify, she noted.
She recalled the 1990s, when “surgical patients received so much intravenous saline on the day of surgery that they often gained 4 to 6 kg, and by postoperative day 2 or 3, [and] pulmonary congestion and cardiac arrhythmias were commonplace.” Subsequent trials changed this practice, and patients in the current study received much less fluid than they would have in the old days, she noted.
Nonetheless, the findings indicate “that physiologic principles remain valid: Both hypovolemia and oliguria must be recognized and treated with fluid.” While that does not justify excessive perioperative fluid therapy, “a modestly liberal fluid regimen is safer than a truly restrictive regimen.”
Dr. Brandstrup is with the department of surgery at Holbaek (Denmark) Hospital. She reported having no relevant conflicts of interest. These comments recap her editorial (New Engl J Med. 2018 May 10. doi: 10.1056/NEJMe1805615).
Effective blinding was impossible in this randomized study, wrote Birgitte Brandstrup, PhD, in an accompanying editorial. Differences in fluid volume cause symptoms that clinicians can easily identify, she noted.
She recalled the 1990s, when “surgical patients received so much intravenous saline on the day of surgery that they often gained 4 to 6 kg, and by postoperative day 2 or 3, [and] pulmonary congestion and cardiac arrhythmias were commonplace.” Subsequent trials changed this practice, and patients in the current study received much less fluid than they would have in the old days, she noted.
Nonetheless, the findings indicate “that physiologic principles remain valid: Both hypovolemia and oliguria must be recognized and treated with fluid.” While that does not justify excessive perioperative fluid therapy, “a modestly liberal fluid regimen is safer than a truly restrictive regimen.”
Dr. Brandstrup is with the department of surgery at Holbaek (Denmark) Hospital. She reported having no relevant conflicts of interest. These comments recap her editorial (New Engl J Med. 2018 May 10. doi: 10.1056/NEJMe1805615).
among high-risk patients undergoing major abdominal surgery and led to a significantly increased risk of acute kidney injury, researchers reported.
In an international, randomized trial with 366 median days of follow-up, estimated 1-year rates of disability-free survival were 81.9% with the restrictive intravenous fluid regimen and 82.3% with the liberal regimen (hazard ratio for death or disability, 1.05; P = .61), according to Paul S. Myles, MPH, DSc, and his associates.
Rates of acute renal injury were 8.6% in the restrictive IV fluid group and 5.0% with the liberal fluid therapy (P less than .001), the researchers reported online May 10 in the New England Journal of Medicine.
Guidelines recommend a restrictive intravenous fluid strategy to promote early recovery after major abdominal surgery, noted Dr. Myles of Alfred Hospital in Melbourne and his colleagues. “However, the supporting evidence is limited, and there is concern about impaired organ perfusion.”
Therefore, they randomly assigned, 3,000 patients to receive either the restrictive fluid regimen or a liberal regimen during major abdominal surgery and up to 24 hours after. Median intravenous volume was 3.7 L (interquartile range, 2.9-4.9 L) in the restrictive group and 6.1 L (IQR, 5.0-7.4 L) in the liberal fluid group. All patients were deemed high risk based on their age (at least 70 years) or because they had heart disease, diabetes, kidney disease, or morbid obesity.
Patients who received the restrictive regimen had higher rates of surgical site infection (16.5% vs. 13.6% with liberal fluids; P = .02) and were more likely to receive renal replacement therapy (0.9% vs. 0.3%; P = .048). However, these trends were no longer significant after the researchers controlled for the effects of testing for multiple variables.
“Our findings should not be used to support excessive administration of intravenous fluid,” the researchers cautioned. “Rather, they show that a regimen that includes a modestly liberal administration of fluid is safer than a restrictive regimen.”
Funders included the Australian National Health and Medical Research Council (NHMRC), the Health Research Council of New Zealand, the Australian and New Zealand College of Anaesthetists, and Monash University, Melbourne. Dr. Myles reported receiving grant support from NHMRC. He had no other disclosures.
SOURCE: Myles PS et al. New Engl J Med. 2018 May 10. doi: 10.1056/NEJMoa1801601.
among high-risk patients undergoing major abdominal surgery and led to a significantly increased risk of acute kidney injury, researchers reported.
In an international, randomized trial with 366 median days of follow-up, estimated 1-year rates of disability-free survival were 81.9% with the restrictive intravenous fluid regimen and 82.3% with the liberal regimen (hazard ratio for death or disability, 1.05; P = .61), according to Paul S. Myles, MPH, DSc, and his associates.
Rates of acute renal injury were 8.6% in the restrictive IV fluid group and 5.0% with the liberal fluid therapy (P less than .001), the researchers reported online May 10 in the New England Journal of Medicine.
Guidelines recommend a restrictive intravenous fluid strategy to promote early recovery after major abdominal surgery, noted Dr. Myles of Alfred Hospital in Melbourne and his colleagues. “However, the supporting evidence is limited, and there is concern about impaired organ perfusion.”
Therefore, they randomly assigned, 3,000 patients to receive either the restrictive fluid regimen or a liberal regimen during major abdominal surgery and up to 24 hours after. Median intravenous volume was 3.7 L (interquartile range, 2.9-4.9 L) in the restrictive group and 6.1 L (IQR, 5.0-7.4 L) in the liberal fluid group. All patients were deemed high risk based on their age (at least 70 years) or because they had heart disease, diabetes, kidney disease, or morbid obesity.
Patients who received the restrictive regimen had higher rates of surgical site infection (16.5% vs. 13.6% with liberal fluids; P = .02) and were more likely to receive renal replacement therapy (0.9% vs. 0.3%; P = .048). However, these trends were no longer significant after the researchers controlled for the effects of testing for multiple variables.
“Our findings should not be used to support excessive administration of intravenous fluid,” the researchers cautioned. “Rather, they show that a regimen that includes a modestly liberal administration of fluid is safer than a restrictive regimen.”
Funders included the Australian National Health and Medical Research Council (NHMRC), the Health Research Council of New Zealand, the Australian and New Zealand College of Anaesthetists, and Monash University, Melbourne. Dr. Myles reported receiving grant support from NHMRC. He had no other disclosures.
SOURCE: Myles PS et al. New Engl J Med. 2018 May 10. doi: 10.1056/NEJMoa1801601.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Compared with a liberal fluid regimen, restricting fluids did not improve disability-free survival and was tied to a significantly increased risk of acute kidney injury among high-risk patients undergoing major abdominal surgery.
Major finding: Rates of acute renal injury were 8.6% with restrictive fluids and 5.0% with liberal fluids.
Study details: International randomized trial of 3,000 patients undergoing major abdominal surgery.
Disclosures: Funders included the Australian National Health and Medical Research Council, the Health Research Council of New Zealand, the Australian and New Zealand College of Anaesthetists, and Monash University, Melbourne. Dr. Myles reported receiving grant support from NHMRC. He had no other disclosures.
Source: Myles PS et al. New Engl J Med. 2018 May 10. doi: 10.1056/NEJMoa1801601
Piperacillin-tazobactam tripled risk of death for patients with cephalosporin-resistant septicemia
MADRID – A study designed to test the benefit of piperacillin-tazobactam in cephalosporin-resistant bloodstream infections has showed just the opposite: The combination can be fatal for these patients, conferring a threefold increased risk of death compared with meropenem.
The piperacillin-tazobactam combination (PTZ) was associated with a significantly higher 30-day mortality than that of meropenem (12.3% vs. 3.7%; RR 3.4), Patrick Harris, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
The number needed to harm with PTZ treatment was 12, said Dr. Harris of the University of Queensland, Australia.
“This was really not the result we wanted. We were expecting to show noninferiority, but the answer we did get was quite compelling. We have to say that in patients with these kinds of bloodstream infections, the use of piperacillin-tazobactam is definitely not supported.”
The signal came on strongly and quickly in the 32-country MERINO trial, he said. An independent data safety monitoring board stopped the study at 75% recruitment after reviewing the alarming interim results last summer.
The trial was designed to test a seemingly sound hypothesis. PTZ is an effective weapon against increasingly extended spectrum beta-lactamase–producing (ESBL) Escherichia coli and Klebsiella infections. These have long been treated with carbapenems, including meropenem, but the widespread global use of that class is putting heavy environmental pressure on these bacteria and creating carbapenem resistance, Dr. Harris said.
“Carbapenems have for many years been the top therapy for these infections, but it may well be a strong selection driver for carbapenem resistance in Gram negative bacilli. We should be thinking about carbapenem-sparing therapy, and it seemed that piperacillin-tazobactam could be useful here.”
Some observational studies do suggest a use for it in this setting but the combination had never been formally investigated. MERINO was designed to do so; investigators hoped to show that PTZ would be noninferior to meropenem in patients with septicemias caused by ESBL E. coli and K. pneumoniae.
The enrollment target for MERINO was 454 patients. Between 2014 and 2017, the study enrolled 391, of whom 379 were included in the final analysis. Patients had to start treatment with the study drugs within 72 hours of confirmatory blood culture. Both arms underwent 4 days of treatment with either PTZ 4.5 g every 6 hours or meropenem 1 g every 8 hours.
The study’s primary outcome was 30-day all-cause mortality. Secondary outcomes were days to clinical and microbiological resolution, clinical and microbiological success at day 4, relapsing septicemia or secondary infection with a PTZ- or meropenem-resistant organism, or Clostridium difficile infection.
The mean age of the patients was 66 years. Most (86%) were infected with resistant strains of E. coli; the rest had K. pneumoniae. About 60% of the infections were acquired in a health care or hospital setting, and about 50% originated in the urinary tract. APACHE II scores were different between the meropenem and PTZ groups (21 vs. 17.9). More patients in PTZ arm had immune compromise (27% vs. 21%).
By 30 days, 23 of those randomized to the combination therapy (12.3%) and seven (3.7%) of those randomized to meropenem had died – a significant 8.6% difference. This translated to more than a threefold increase in the risk of death for those taking the combination (RR 3.4; P = .002). The number needed to harm was just 12.
All of the secondary endpoints also favored meropenem, although the differences were not statistically significant. Patients taking meropenem experienced clinical and microbiological improvement a mean of 1 day sooner (2 vs. 3 days). Microbiological relapse occurred in 2% of those taking meropenem compared with 4.8% of those taking PTZ. The meropenem group was also less likely to develop a multidrug resistant organism or C. difficile infection (4.2% vs. 8%).
The investigators performed several subgroup analyses looking for other trends in 30-day mortality. The difference remained significant no matter how the groups were analyzed.
“Patients with urinary tract infections had a slightly lower risk of mortality, but even after adjusting for risk in several multivariate regression models, the increased risk of 30-day mortality remained,” Dr. Harris said.
The Australasian Society for Antimicrobials and the International Society for Chemotherapy funded the work. Dr. Harris reported having no financial declarations.
MADRID – A study designed to test the benefit of piperacillin-tazobactam in cephalosporin-resistant bloodstream infections has showed just the opposite: The combination can be fatal for these patients, conferring a threefold increased risk of death compared with meropenem.
The piperacillin-tazobactam combination (PTZ) was associated with a significantly higher 30-day mortality than that of meropenem (12.3% vs. 3.7%; RR 3.4), Patrick Harris, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
The number needed to harm with PTZ treatment was 12, said Dr. Harris of the University of Queensland, Australia.
“This was really not the result we wanted. We were expecting to show noninferiority, but the answer we did get was quite compelling. We have to say that in patients with these kinds of bloodstream infections, the use of piperacillin-tazobactam is definitely not supported.”
The signal came on strongly and quickly in the 32-country MERINO trial, he said. An independent data safety monitoring board stopped the study at 75% recruitment after reviewing the alarming interim results last summer.
The trial was designed to test a seemingly sound hypothesis. PTZ is an effective weapon against increasingly extended spectrum beta-lactamase–producing (ESBL) Escherichia coli and Klebsiella infections. These have long been treated with carbapenems, including meropenem, but the widespread global use of that class is putting heavy environmental pressure on these bacteria and creating carbapenem resistance, Dr. Harris said.
“Carbapenems have for many years been the top therapy for these infections, but it may well be a strong selection driver for carbapenem resistance in Gram negative bacilli. We should be thinking about carbapenem-sparing therapy, and it seemed that piperacillin-tazobactam could be useful here.”
Some observational studies do suggest a use for it in this setting but the combination had never been formally investigated. MERINO was designed to do so; investigators hoped to show that PTZ would be noninferior to meropenem in patients with septicemias caused by ESBL E. coli and K. pneumoniae.
The enrollment target for MERINO was 454 patients. Between 2014 and 2017, the study enrolled 391, of whom 379 were included in the final analysis. Patients had to start treatment with the study drugs within 72 hours of confirmatory blood culture. Both arms underwent 4 days of treatment with either PTZ 4.5 g every 6 hours or meropenem 1 g every 8 hours.
The study’s primary outcome was 30-day all-cause mortality. Secondary outcomes were days to clinical and microbiological resolution, clinical and microbiological success at day 4, relapsing septicemia or secondary infection with a PTZ- or meropenem-resistant organism, or Clostridium difficile infection.
The mean age of the patients was 66 years. Most (86%) were infected with resistant strains of E. coli; the rest had K. pneumoniae. About 60% of the infections were acquired in a health care or hospital setting, and about 50% originated in the urinary tract. APACHE II scores were different between the meropenem and PTZ groups (21 vs. 17.9). More patients in PTZ arm had immune compromise (27% vs. 21%).
By 30 days, 23 of those randomized to the combination therapy (12.3%) and seven (3.7%) of those randomized to meropenem had died – a significant 8.6% difference. This translated to more than a threefold increase in the risk of death for those taking the combination (RR 3.4; P = .002). The number needed to harm was just 12.
All of the secondary endpoints also favored meropenem, although the differences were not statistically significant. Patients taking meropenem experienced clinical and microbiological improvement a mean of 1 day sooner (2 vs. 3 days). Microbiological relapse occurred in 2% of those taking meropenem compared with 4.8% of those taking PTZ. The meropenem group was also less likely to develop a multidrug resistant organism or C. difficile infection (4.2% vs. 8%).
The investigators performed several subgroup analyses looking for other trends in 30-day mortality. The difference remained significant no matter how the groups were analyzed.
“Patients with urinary tract infections had a slightly lower risk of mortality, but even after adjusting for risk in several multivariate regression models, the increased risk of 30-day mortality remained,” Dr. Harris said.
The Australasian Society for Antimicrobials and the International Society for Chemotherapy funded the work. Dr. Harris reported having no financial declarations.
MADRID – A study designed to test the benefit of piperacillin-tazobactam in cephalosporin-resistant bloodstream infections has showed just the opposite: The combination can be fatal for these patients, conferring a threefold increased risk of death compared with meropenem.
The piperacillin-tazobactam combination (PTZ) was associated with a significantly higher 30-day mortality than that of meropenem (12.3% vs. 3.7%; RR 3.4), Patrick Harris, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
The number needed to harm with PTZ treatment was 12, said Dr. Harris of the University of Queensland, Australia.
“This was really not the result we wanted. We were expecting to show noninferiority, but the answer we did get was quite compelling. We have to say that in patients with these kinds of bloodstream infections, the use of piperacillin-tazobactam is definitely not supported.”
The signal came on strongly and quickly in the 32-country MERINO trial, he said. An independent data safety monitoring board stopped the study at 75% recruitment after reviewing the alarming interim results last summer.
The trial was designed to test a seemingly sound hypothesis. PTZ is an effective weapon against increasingly extended spectrum beta-lactamase–producing (ESBL) Escherichia coli and Klebsiella infections. These have long been treated with carbapenems, including meropenem, but the widespread global use of that class is putting heavy environmental pressure on these bacteria and creating carbapenem resistance, Dr. Harris said.
“Carbapenems have for many years been the top therapy for these infections, but it may well be a strong selection driver for carbapenem resistance in Gram negative bacilli. We should be thinking about carbapenem-sparing therapy, and it seemed that piperacillin-tazobactam could be useful here.”
Some observational studies do suggest a use for it in this setting but the combination had never been formally investigated. MERINO was designed to do so; investigators hoped to show that PTZ would be noninferior to meropenem in patients with septicemias caused by ESBL E. coli and K. pneumoniae.
The enrollment target for MERINO was 454 patients. Between 2014 and 2017, the study enrolled 391, of whom 379 were included in the final analysis. Patients had to start treatment with the study drugs within 72 hours of confirmatory blood culture. Both arms underwent 4 days of treatment with either PTZ 4.5 g every 6 hours or meropenem 1 g every 8 hours.
The study’s primary outcome was 30-day all-cause mortality. Secondary outcomes were days to clinical and microbiological resolution, clinical and microbiological success at day 4, relapsing septicemia or secondary infection with a PTZ- or meropenem-resistant organism, or Clostridium difficile infection.
The mean age of the patients was 66 years. Most (86%) were infected with resistant strains of E. coli; the rest had K. pneumoniae. About 60% of the infections were acquired in a health care or hospital setting, and about 50% originated in the urinary tract. APACHE II scores were different between the meropenem and PTZ groups (21 vs. 17.9). More patients in PTZ arm had immune compromise (27% vs. 21%).
By 30 days, 23 of those randomized to the combination therapy (12.3%) and seven (3.7%) of those randomized to meropenem had died – a significant 8.6% difference. This translated to more than a threefold increase in the risk of death for those taking the combination (RR 3.4; P = .002). The number needed to harm was just 12.
All of the secondary endpoints also favored meropenem, although the differences were not statistically significant. Patients taking meropenem experienced clinical and microbiological improvement a mean of 1 day sooner (2 vs. 3 days). Microbiological relapse occurred in 2% of those taking meropenem compared with 4.8% of those taking PTZ. The meropenem group was also less likely to develop a multidrug resistant organism or C. difficile infection (4.2% vs. 8%).
The investigators performed several subgroup analyses looking for other trends in 30-day mortality. The difference remained significant no matter how the groups were analyzed.
“Patients with urinary tract infections had a slightly lower risk of mortality, but even after adjusting for risk in several multivariate regression models, the increased risk of 30-day mortality remained,” Dr. Harris said.
The Australasian Society for Antimicrobials and the International Society for Chemotherapy funded the work. Dr. Harris reported having no financial declarations.
REPORTING FROM ECCMID 2018
Key clinical point: PTZ more than tripled the risk of 30-day mortality in patients with cephalosporin-resistant bloodstream infections.
Major finding: Compared with meropenem, PZT increased the risk of death by 3.4, with a number needed to harm of 12.
Study details: The study randomized 391 patients.
Disclosures: The Australasian Society for Antimicrobials and the International Society for Chemotherapy funded the work. Dr. Harris has no financial declarations.
Source: Harris et al. ECCMID 2018, abstract O1121.
Can adhesive small bowel obstructions be addressed laparoscopically?
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM MISS
Empiric fluid restriction cuts transsphenoidal surgery readmissions
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
REPORTING FROM ENDO 2018
Key clinical point: A simple fluid restriction protocol cuts readmissions 70% following transsphenoidal surgery.
Major finding: The readmission rate among the transsphenoidal surgery patients was 7.6% before the fluid restriction protocol was implemented, compared with 2.4% (P = .044) afterward.
Study details: Review of 287 transsphenoidal surgery patients.
Disclosures: The National Institutes of Health supported the work. The investigators did not have any disclosures.
Source: Deaver KE et al. Abstract SUN-572
Think about breast cancer surveillance for transgender patients
CHICAGO – , said Christel de Blok, MD, sharing results of a Dutch national study.
The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.
Overall, there were 16 observed cases of breast cancer in transgender women and four in transgender men. After gender-affirming surgery, the transgender women were followed for a median of 146 months, and experienced a median of 193 months of HT. Transgender men who had mastectomies were followed for a median 93 months, and those who had a hysterectomy-oophorectomy were followed for a median 144 months. Transgender men received a median 176 months of HT.
“Breast cancer can still occur after mastectomy in [transgender] men,” Dr. de Blok said at the annual meeting of the Endocrine Society. “What is interesting is that three out of the four cases of breast cancer in [transgender] men happened after mastectomy.”
In the Netherlands, one in eight women and one in 1,000 men will develop cancer at some point during their lives. In patients who have had a subtotal mastectomy and who are BRCA-1/2 carriers, there is still an approximate 5% residual risk of breast cancer, said Dr. de Blok.
A literature review conducted by Dr. de Blok and her colleagues revealed 19 cases of breast cancer in transgender women and 13 in transgender men. However, a more general study of incidence and characteristics of breast cancer in transgender people receiving hormone treatment had not been done, said Dr. de Blok, of the VU University Medical Center, Amsterdam.
The investigators examined data for adult transgender people seen at their center from 1991 to 2017 and started on hormone treatment. This clinic, said Dr. de Blok, sees about 95% of the transgender individuals in the Netherlands.
The study was able to capitalize on comprehensive information from national databases and registries. Investigators drew from a national histopathology and cytopathology registry as well as from a national vital statistics database. A comprehensive cancer database was used to establish both reference incidence values for males and females and the number of expected cases within the study group.
In both transgender men and women, exactly 50% of cases were ductal carcinoma, compared to 85% in the group of reference women.
An additional 31% of the breast cancers in transgender women were lobular, 6% were ductal carcinoma in situ (DCIS), and the remainder were of other types. Of the cancers in transgender women, 82% were estrogen receptor positive, 64% were progesterone receptor positive, and 9% were Her2/neu positive.
For transgender men, there were no lobular carcinomas; 25% were DCIS, and 25% were of other types. Half of the cancers were estrogen receptor positive, and half were progesterone receptor positive; 25% were Her2/neu positive, and there was one case of androgen receptor positive breast cancer.
Dr. de Blok explained that their analysis compared the observed cases in both transgender men and women to the expected number of cases for the same number of males and females, yielding two standardized incidence ratios (SIRs) for each transgender group.
For transgender women, the SIR for breast cancer compared with males was 50.9 (95% confidence interval, 30.1-80.9). The SIR compared to females was 0.3 (95% CI, 0.2-0.4). This reflected the expected case number of 0.3 for males and the 58 expected cases for a matched group of females.
For transgender men, the SIR for breast cancer compared with males was 59.8 (95% CI, 19-144.3), while the SIR compared to females was 0.2 (95% CI, 0.1-0.5). The expected cases for a similar group of males would be 0.1, and for females, 18.
In many cases, whether a transgender person receives standardized screening mammogram reminders will depend on which sex is assigned to that individual in insurance and other administrative databases, Mr. de Blok noted. When electronic health records and other databases have a binary system, at-risk individuals may fall through the cracks.
Dr. de Blok reported no conflicts of interest.
SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.
CHICAGO – , said Christel de Blok, MD, sharing results of a Dutch national study.
The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.
Overall, there were 16 observed cases of breast cancer in transgender women and four in transgender men. After gender-affirming surgery, the transgender women were followed for a median of 146 months, and experienced a median of 193 months of HT. Transgender men who had mastectomies were followed for a median 93 months, and those who had a hysterectomy-oophorectomy were followed for a median 144 months. Transgender men received a median 176 months of HT.
“Breast cancer can still occur after mastectomy in [transgender] men,” Dr. de Blok said at the annual meeting of the Endocrine Society. “What is interesting is that three out of the four cases of breast cancer in [transgender] men happened after mastectomy.”
In the Netherlands, one in eight women and one in 1,000 men will develop cancer at some point during their lives. In patients who have had a subtotal mastectomy and who are BRCA-1/2 carriers, there is still an approximate 5% residual risk of breast cancer, said Dr. de Blok.
A literature review conducted by Dr. de Blok and her colleagues revealed 19 cases of breast cancer in transgender women and 13 in transgender men. However, a more general study of incidence and characteristics of breast cancer in transgender people receiving hormone treatment had not been done, said Dr. de Blok, of the VU University Medical Center, Amsterdam.
The investigators examined data for adult transgender people seen at their center from 1991 to 2017 and started on hormone treatment. This clinic, said Dr. de Blok, sees about 95% of the transgender individuals in the Netherlands.
The study was able to capitalize on comprehensive information from national databases and registries. Investigators drew from a national histopathology and cytopathology registry as well as from a national vital statistics database. A comprehensive cancer database was used to establish both reference incidence values for males and females and the number of expected cases within the study group.
In both transgender men and women, exactly 50% of cases were ductal carcinoma, compared to 85% in the group of reference women.
An additional 31% of the breast cancers in transgender women were lobular, 6% were ductal carcinoma in situ (DCIS), and the remainder were of other types. Of the cancers in transgender women, 82% were estrogen receptor positive, 64% were progesterone receptor positive, and 9% were Her2/neu positive.
For transgender men, there were no lobular carcinomas; 25% were DCIS, and 25% were of other types. Half of the cancers were estrogen receptor positive, and half were progesterone receptor positive; 25% were Her2/neu positive, and there was one case of androgen receptor positive breast cancer.
Dr. de Blok explained that their analysis compared the observed cases in both transgender men and women to the expected number of cases for the same number of males and females, yielding two standardized incidence ratios (SIRs) for each transgender group.
For transgender women, the SIR for breast cancer compared with males was 50.9 (95% confidence interval, 30.1-80.9). The SIR compared to females was 0.3 (95% CI, 0.2-0.4). This reflected the expected case number of 0.3 for males and the 58 expected cases for a matched group of females.
For transgender men, the SIR for breast cancer compared with males was 59.8 (95% CI, 19-144.3), while the SIR compared to females was 0.2 (95% CI, 0.1-0.5). The expected cases for a similar group of males would be 0.1, and for females, 18.
In many cases, whether a transgender person receives standardized screening mammogram reminders will depend on which sex is assigned to that individual in insurance and other administrative databases, Mr. de Blok noted. When electronic health records and other databases have a binary system, at-risk individuals may fall through the cracks.
Dr. de Blok reported no conflicts of interest.
SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.
CHICAGO – , said Christel de Blok, MD, sharing results of a Dutch national study.
The study included 3,078 transgender people (2,064 transgender women) who began hormone therapy (HT) at age 18 years or older. The mean age at which transgender women began HT was 33 years; for transgender men, the mean age was 25 years. In all, transgender women in the study had a total of 30,699 person-years of exposure to HT; for transgender men, the figure was 13,155 person-years.
Overall, there were 16 observed cases of breast cancer in transgender women and four in transgender men. After gender-affirming surgery, the transgender women were followed for a median of 146 months, and experienced a median of 193 months of HT. Transgender men who had mastectomies were followed for a median 93 months, and those who had a hysterectomy-oophorectomy were followed for a median 144 months. Transgender men received a median 176 months of HT.
“Breast cancer can still occur after mastectomy in [transgender] men,” Dr. de Blok said at the annual meeting of the Endocrine Society. “What is interesting is that three out of the four cases of breast cancer in [transgender] men happened after mastectomy.”
In the Netherlands, one in eight women and one in 1,000 men will develop cancer at some point during their lives. In patients who have had a subtotal mastectomy and who are BRCA-1/2 carriers, there is still an approximate 5% residual risk of breast cancer, said Dr. de Blok.
A literature review conducted by Dr. de Blok and her colleagues revealed 19 cases of breast cancer in transgender women and 13 in transgender men. However, a more general study of incidence and characteristics of breast cancer in transgender people receiving hormone treatment had not been done, said Dr. de Blok, of the VU University Medical Center, Amsterdam.
The investigators examined data for adult transgender people seen at their center from 1991 to 2017 and started on hormone treatment. This clinic, said Dr. de Blok, sees about 95% of the transgender individuals in the Netherlands.
The study was able to capitalize on comprehensive information from national databases and registries. Investigators drew from a national histopathology and cytopathology registry as well as from a national vital statistics database. A comprehensive cancer database was used to establish both reference incidence values for males and females and the number of expected cases within the study group.
In both transgender men and women, exactly 50% of cases were ductal carcinoma, compared to 85% in the group of reference women.
An additional 31% of the breast cancers in transgender women were lobular, 6% were ductal carcinoma in situ (DCIS), and the remainder were of other types. Of the cancers in transgender women, 82% were estrogen receptor positive, 64% were progesterone receptor positive, and 9% were Her2/neu positive.
For transgender men, there were no lobular carcinomas; 25% were DCIS, and 25% were of other types. Half of the cancers were estrogen receptor positive, and half were progesterone receptor positive; 25% were Her2/neu positive, and there was one case of androgen receptor positive breast cancer.
Dr. de Blok explained that their analysis compared the observed cases in both transgender men and women to the expected number of cases for the same number of males and females, yielding two standardized incidence ratios (SIRs) for each transgender group.
For transgender women, the SIR for breast cancer compared with males was 50.9 (95% confidence interval, 30.1-80.9). The SIR compared to females was 0.3 (95% CI, 0.2-0.4). This reflected the expected case number of 0.3 for males and the 58 expected cases for a matched group of females.
For transgender men, the SIR for breast cancer compared with males was 59.8 (95% CI, 19-144.3), while the SIR compared to females was 0.2 (95% CI, 0.1-0.5). The expected cases for a similar group of males would be 0.1, and for females, 18.
In many cases, whether a transgender person receives standardized screening mammogram reminders will depend on which sex is assigned to that individual in insurance and other administrative databases, Mr. de Blok noted. When electronic health records and other databases have a binary system, at-risk individuals may fall through the cracks.
Dr. de Blok reported no conflicts of interest.
SOURCE: de Blok C, et al. ENDO 2018, abstract OR 25-6.
REPORTING FROM ENDO 2018
Key clinical point: Transgender individuals had increased risk of breast cancer similar to a female reference population.
Major finding: Transgender men had a standardized incidence ratio of 59.8 compared to a male reference population.
Study details: Study of 3,078 transgender adults receiving hormone therapy.
Disclosures: Dr. de Blok reported no conflicts of interest.
Source: de Blok C, et al. ENDO 2018, abstract OR 25-6.
Bile spillage during lap cholecystectomy comes with a price
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
Bile spillage that happens during laparoscopic gallbladder removal is a known problem, but a large study has put some numbers to quantify the risks to patients.
A research team at Massachusetts General Hospital, Boston, conducted a prospective study of 1,001 such operations to look at the impact of bile spillage. They found that wound infection rates in cases involving bile spillage were almost three times higher than were those without spillage and resulting hospital stays were 50% longer, according to an article in the Journal of the American College of Surgeons.
The study involved adults who had laparoscopic and laparoscopic converted to open cholecystectomy at the academic hospital during May 2010-March 2017. The latter category accounted for 95 patients, a 9.5% conversion rate. Overall, bile was spilled in 591 patients (59%), with empyema in 86 (8.6%), hydrops in 62 (6.2%), and clear bile spillage in the remainder. Bile spillage along with gallstone spillage occurred in 202 patients (20.2%), with recovery of all spilled gallstones in 145 (71.8%) of those cases.
Overall, the surgical site infection (SSI) rate was 2.4% (n = 8) in patients with no bile spillage vs. 7.1% (n = 30) for those with bile spillage. Median hospital length of stay was 2 days for the nonspillage patients vs. 3 days for those with spillage. The 30-day readmission rates were 5.9% for the nonspillage group vs. 9.6% for the spillage group.
The bile spillage rate in this study was considerably higher than previous studies had reported, the researchers noted. A retrospective study of 1,127 patients reported a spillage rate of 11.6% (World J Surg. 1999;23:1186-90). “One needs to notice that a retrospective review of medical records almost certainly underappreciates the rate of bile spillage,” the investigators wrote. A Mayo Clinic study reported a bile spillage rate of 29% and an increased risk of intra-abdominal abscesses (J Gastrointest Surg. 1997;1:85-90). The complex and acute nature of the cases at Mass General may explain their higher spillage rates, the researchers suggested.
This study identifies bile spillage, along with conversion to open surgery and patient ASA class 2 or higher as the only independent predictors of SSI. The study also found no link between empyema and hydrops with SSI, although the small number of cases may preclude an representative sample.
Nonetheless, surgeons must face the question of how to decrease SSI in laparoscopic cholecystectomy with bile spillage, study authors wrote. “First, surgeons should acknowledge that gallbladder perforations and bile spillage come at a price,” they said, “and thus should be cautious and try to avoid them.”
When bile is spilled, liberal peritoneal irrigation may be futile; this study showed similar SSI rates after bile spillage, regardless of peritoneal irrigation. “We could consider modifying perioperative antibiotic coverage,” the investigators wrote, but they acknowledged a need for more research to validate its benefit.
The investigators reported having no financial disclosures.
SOURCE: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Bile spillage during laparoscopic cholecystectomy increases the patient’s risk for surgical site infection.
Major finding: Surgical site infection rates were 7.1% in cases in which bile spillage occurred vs. 2.4% in cases that had no bile spillage.
Data source: Prospective analysis of 1,001 laparoscopic or laparoscopic converted to open operations in adults during May 2010-March 2017.
Disclosures: Dr. Velmahos and coauthors reported having no financial disclosures.
Source: Peponis T et al. J Am Coll Surg. 2018 Mar 1. doi: 10.1016/j.jamcollsurg.2017.11.025.