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Magnetic LES augmentation for Barrett’s regression debated
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
REPORTING FROM WCE 2018
Key clinical point: Magnetic lower esophageal sphincter augmentation might offer an easier and more effective fix for gastroesophageal reflux than the current standard, Nissen fundoplication.
Major finding: The overall regression rate of Barrett’s esophagus topped 70%.
Study details: Review of 67 patients
Disclosures: There was no industry funding, and the presenter had no disclosures. Two authors are consultants for Torax Medical, the company that makes the device.
Source: Alicuben E et al. WCE 2018, Abstract S095
Bismuth subgallate cuts stool smell after duodenal switch
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
SEATTLE – Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.
Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.
“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.
Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.
Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.
Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.
“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.
Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.
Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.
The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.
The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.
The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.
SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.
REPORTING FROM SAGES 2018
Key clinical point: Bismuth subgallate (Devrom) is a big help for an embarrassing and underappreciated problem after loop duodenal switch: stool odor.
Major finding: Patients reported about a 1.5-point improvement on 4-point scales rating stool and flatulence odor and their concerns about them.
Study details: Randomized, placebo-controlled trial with 36 patients
Disclosures: The investigators reported an unrestricted educational grant from Parthenon, the makers of the tested product.
Source: Zaveri H et al. SAGES 2018, Abstract S028.
Figure-of-eight overstitch keeps endoscopic stents in place
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
SEATTLE – Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.
Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.
Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).
The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,
The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.
“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.
Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.
Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.
Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.
Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.
Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.
In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.
The investigators did not report any relevant disclosures, and there was no outside funding.
REPORTING FROM SAGES 2018
Key clinical point: Consider fixation when endoscopic stents are used for bariatric surgery leaks.
Major finding: Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.
Study details: A review of 37 leak cases
Disclosures: The investigators did not report any relevant disclosures, and there was no outside funding.
VTE risk after bariatric surgery should be assessed
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
SEATTLE – Preop thromboelastometry can identify patients who need extra according to a prospective investigation of 40 patients at Conemaugh Memorial Medical Center in Johnstown, Pa.
Enoxaparin 40 mg twice daily just wasn’t enough for people who were hypercoagulable before surgery. The goal of the study was to find the best way to prevent venous thromboembolism (VTE) after weight loss surgery. At present, there’s no consensus on prophylaxis dosing, timing, duration, or even what agent to use for these patients. Conemaugh uses postop enoxaparin, a low-molecular-weight heparin. Among many other options, some hospitals opt for preop dosing with traditional heparin, which is less expensive.
The Conemaugh team turned to thromboelastometry (TEM) to look at the question of VTE risk in bariatric surgery patients. The test gauges coagulation status by measuring elasticity as a small blood sample clots over a few minutes. The investigators found that patients who were hypercoagulable before surgery were likely to be hypercoagulable afterwards. The finding argues for baseline TEM testing to guide postop anticoagulation.
The problem is that bariatric services don’t often have access to TEM equipment, and insurance doesn’t cover the $60 test. In this instance, the Lake Erie College of Osteopathic Medicine in Erie, Pa., had the equipment and covered the testing for the study.
The patients had TEM at baseline and then received 40 mg of enoxaparin about 4 hours after surgery – mostly laparoscopic gastric bypasses – and a second dose about 12 hours after the first. TEM was repeated about 2 hours after the second dose.
At baseline, 2 (5%) of the patients were hypocoagulable, 15 (37.5%) were normal, and 23 (57.5%) were hypercoagulable. On postop TEM, 17 patients (42.5%) were normal and 23 (57.5%) were hypercoagulable: “These 23 were inadequately anticoagulated,” said lead investigator Daniel Urias, MD, a general surgery resident at the medical center.
“There was an association between being normal at baseline and being normal postop, and being hypercoagulable at baseline and hypercoagulable postop. We didn’t anticipate finding such similarity between the numbers. Our suspicion that baseline status plays a major role is holding true,” Dr. Urias said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
When patients test hypercoagulable at baseline, “we are [now] leaning towards [enoxaparin] 60 mg twice daily,” he said.
Ultimately, anticoagulation TEM could be used to titrate patients into the normal range. For best outcomes, it’s likely that “obese patients require goal-directed therapy instead of weight-based or fixed dosing,” he said, but nothing is going to happen until insurance steps up.
The patients did not have underlying coagulopathies, and 33 (82.5%) were women; the average age was 44 years and average body mass index was 43.6 kg/m2. The mean preop Caprini score was 4, indicating moderate VTE risk. Surgery lasted about 200 minutes. Patients were out of bed and walking on postop day 0.
The investigators had no relevant disclosures.
SOURCE: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
REPORTING FROM SAGES 2018
Key clinical point: Preoperative thromboelastometry identifies patients who need extra anticoagulation against venous thromboembolism following bariatric surgery.
Major finding: Baseline and postop coagulation were similar: 37.5% vs. 42.5% were normal and 57.5% vs 57.5% were hypercoagulable.
Study details: Prospective study of 40 bariatric surgery patients.
Disclosures: The investigators did not have any relevant disclosures. The Lake Erie College of Osteopathic Medicine paid for the testing.
Source: Urias D et al. World Congress of Endoscopic Surgery hosted by SAGES & CAGS abstract S023.
Dexamethasone lowered risk of urinary retention in laparoscopic hernia repair
SEATTLE – Intraoperative in 955 men at the NorthShore University HealthSystem, Chicago.
Urinary retention occurs in up to a third of hernia repair patients. Men are at far higher risk than women; benign prostatic hypertrophy (BPH) and older age also increase the risk.
Intraoperative dexamethasone is a common antiemetic. The investigators had a hunch that it also reduces urinary retention by calming overstimulation of the bladder neck and prostate during the operation. “We believe this overstimulation” causes urinary retention, lead investigator Merritt Denham, BS, said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
She and her team went back in the records about 8 years to compare 617 laparoscopic inguinal hernia repair patients who received intraoperative dexamethasone with 338 who did not. They were all men: women were excluded from the review. The men voided before surgery. Those who received dexamethasone received more fluids during the operation than those who did not, a mean of 973 mL versus 878 mL (P = .0019).
Even so, urinary retention was far less likely in the dexamethasone group (3.7% vs. 9.8%; P = .0001). Controlling for age and BPH, the corticosteroid was highly protective (odds ratio, 0.48; 95% confidence interval, 0.26-0.87; P = .0147). The benefit was the same regardless of the intraoperative dexamethasone dosage, which ranged from 4 mg to 8 mg.
Dexamethasone patients had a shorter length of stay, and, counterintuitively, fewer surgical site infections (0.2% vs. 1.7%; P = .0109). They were also less likely to have BPH (16.7% vs. 22.5%; P = 0.026). The urinary retention odds ratio controlled for the difference in BPH.
The results are “interesting, but I don’t think the conclusion is there yet; there are a lot of variables to consider. We need more data,” said moderator Eduardo Parra-Davila, MD, FACS, director of minimally invasive and colorectal surgery at Florida Hospital Celebration Health in Celebration, Fla.
In both groups, mean body mass index was about 26 kg/m2, mean age about 57 years, and mean operative time about 40 minutes. Four general surgeons performed the repairs.
There was no external funding for the work, and the investigators had no disclosures.
SOURCE: Denham M. et al. SAGES 2018, Abstract S006.
SEATTLE – Intraoperative in 955 men at the NorthShore University HealthSystem, Chicago.
Urinary retention occurs in up to a third of hernia repair patients. Men are at far higher risk than women; benign prostatic hypertrophy (BPH) and older age also increase the risk.
Intraoperative dexamethasone is a common antiemetic. The investigators had a hunch that it also reduces urinary retention by calming overstimulation of the bladder neck and prostate during the operation. “We believe this overstimulation” causes urinary retention, lead investigator Merritt Denham, BS, said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
She and her team went back in the records about 8 years to compare 617 laparoscopic inguinal hernia repair patients who received intraoperative dexamethasone with 338 who did not. They were all men: women were excluded from the review. The men voided before surgery. Those who received dexamethasone received more fluids during the operation than those who did not, a mean of 973 mL versus 878 mL (P = .0019).
Even so, urinary retention was far less likely in the dexamethasone group (3.7% vs. 9.8%; P = .0001). Controlling for age and BPH, the corticosteroid was highly protective (odds ratio, 0.48; 95% confidence interval, 0.26-0.87; P = .0147). The benefit was the same regardless of the intraoperative dexamethasone dosage, which ranged from 4 mg to 8 mg.
Dexamethasone patients had a shorter length of stay, and, counterintuitively, fewer surgical site infections (0.2% vs. 1.7%; P = .0109). They were also less likely to have BPH (16.7% vs. 22.5%; P = 0.026). The urinary retention odds ratio controlled for the difference in BPH.
The results are “interesting, but I don’t think the conclusion is there yet; there are a lot of variables to consider. We need more data,” said moderator Eduardo Parra-Davila, MD, FACS, director of minimally invasive and colorectal surgery at Florida Hospital Celebration Health in Celebration, Fla.
In both groups, mean body mass index was about 26 kg/m2, mean age about 57 years, and mean operative time about 40 minutes. Four general surgeons performed the repairs.
There was no external funding for the work, and the investigators had no disclosures.
SOURCE: Denham M. et al. SAGES 2018, Abstract S006.
SEATTLE – Intraoperative in 955 men at the NorthShore University HealthSystem, Chicago.
Urinary retention occurs in up to a third of hernia repair patients. Men are at far higher risk than women; benign prostatic hypertrophy (BPH) and older age also increase the risk.
Intraoperative dexamethasone is a common antiemetic. The investigators had a hunch that it also reduces urinary retention by calming overstimulation of the bladder neck and prostate during the operation. “We believe this overstimulation” causes urinary retention, lead investigator Merritt Denham, BS, said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
She and her team went back in the records about 8 years to compare 617 laparoscopic inguinal hernia repair patients who received intraoperative dexamethasone with 338 who did not. They were all men: women were excluded from the review. The men voided before surgery. Those who received dexamethasone received more fluids during the operation than those who did not, a mean of 973 mL versus 878 mL (P = .0019).
Even so, urinary retention was far less likely in the dexamethasone group (3.7% vs. 9.8%; P = .0001). Controlling for age and BPH, the corticosteroid was highly protective (odds ratio, 0.48; 95% confidence interval, 0.26-0.87; P = .0147). The benefit was the same regardless of the intraoperative dexamethasone dosage, which ranged from 4 mg to 8 mg.
Dexamethasone patients had a shorter length of stay, and, counterintuitively, fewer surgical site infections (0.2% vs. 1.7%; P = .0109). They were also less likely to have BPH (16.7% vs. 22.5%; P = 0.026). The urinary retention odds ratio controlled for the difference in BPH.
The results are “interesting, but I don’t think the conclusion is there yet; there are a lot of variables to consider. We need more data,” said moderator Eduardo Parra-Davila, MD, FACS, director of minimally invasive and colorectal surgery at Florida Hospital Celebration Health in Celebration, Fla.
In both groups, mean body mass index was about 26 kg/m2, mean age about 57 years, and mean operative time about 40 minutes. Four general surgeons performed the repairs.
There was no external funding for the work, and the investigators had no disclosures.
SOURCE: Denham M. et al. SAGES 2018, Abstract S006.
REPORTING FROM SAGES 2018
Key clinical point: Patients given dexamethasone intraoperatively were less likely to have urinary retention.
Major finding: The dexamethasone group was less likely to have urinary retention, 3.7% versus 9.8% (P = 0.0001).
Study details: A review of 955 laparoscopic inguinal hernia repairs.
Disclosures: There was no external funding for the work, and the investigators had no disclosures.
Source: Denham M et al. SAGES 2018, Abstract S006.
Robotic approach falls short for sleeve gastrectomy
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
REPORTING FROM SAGES 2018
Key clinical point: Operative times are longer, and leaks and surgical site infections more common, when surgeons opt for robotic instead of laparoscopic sleeve gastrectomy.
Major finding: Anastomotic leaks were 3.4 times more likely with the robotic approach (95% CI 2.47-4.0; P less than .01).
Study details: Review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database
Disclosures: The was no external funding for the project, and the investigators had no relevant disclosures.
Source: Alizadeh RF et al. SAGES 2018, Abstract S024