Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Brief Title:
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy French Multicenter Study
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy French Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the impact about complications between the procedure sleeve gastrectomy technique with a Nissen fundoplication N-Sleeve and conventional sleeve gastrectomy technique
Detailed Description:
Obesity is currently a major health problem 2 of the French adult population is morbidly obese BMI40kgm² In this case the only effective treatment is bariatric surgery More than 50000 acts of bariatric surgery were performed in 2018 in France Three main operations are considered Sleeve Gastrectomy SG Roux en Y Gastric Bypass RYGB and Gastric Banding
SG was validated by the Haute Autorité de Santé HAS in 2008 and is the most widely used procedure in France 35580 operations in 2018 It consists of a 23 partial gastrectomy Long-term weight loss of 61 23 is expected with significant improvement in obesity-related comorbidities
However this technique is associated with postoperative complications Gastric fistula 2 most often located at the upper end of the stapling line bleeding from the gastric section 2 and gastric stenosis 1 are the most frequent early postoperative complications that may require reoperation In addition gastroesophageal reflux disease GERD is very common 30-57 and can have serious consequences for the esophageal mucosa esophagitis Barretts esophagus cancer Alarmingly high rates of Barretts esophagus 17-18 after SG have recently been described in the long term causing concern in the medical community This may be an exacerbation of preoperative GERD symptoms or de novo postoperative GERD Medical treatment is generally effective proton pump inhibitors PPIs However the long-term safety of PPIs has not been demonstrated Whats more these patients quality of life may be considerably reduced and re-intervention gastric Y-bypass may be necessary to treat refractory GERD
The classic surgical treatment for GERD independently of bariatric surgery is fundoplication which can be partial 180 Toupet technique or total 360 Nissen technique The gastric fundus is wrapped around the esophagus to reinforce the esophageal sphincter
Nissen-Sleeve Gastrectomy Nissen-SG is an innovative technique performed in expert centers in France It consists in creating a total anti-reflux fundoplicature Nissen before performing a SG
A prospective non-comparative pilot study of 25 patients who underwent Nissen-SG in 2014 at Montpellier University Hospital showed that while 92 of patients had symptoms of GERD preoperatively 24 were symptomatic at 3 months after Nissen and SG only 12 had clinical GERD at 6 months and 1 year postoperatively Excess weight loss at 1 year was 59 similar to the efficacy of conventional SG although a larger gastric residual volume was left after Nissen-SG but used as plication The 5-year results were presented at the SOFFCO 2020 congress and at the International Federation of Obesity Surgery IFSO congress Excess weight loss EWL was 7087 112 patients and 5832 31 patients at 2 and 5 years follow-up Less than 7 of patients had GERD symptoms at 5 years
Our hypothesis is that the creation of a total anti-reflux fundoplicature prior to performing SLEEVE could significantly reduce the rate of postoperative GERD observed with standard SLEEVE
Whats more the creation of a Nissen fundoplicature means that a gastric section is made away from the HIS angle the area most at risk of fistula 90 which could reduce this complication almost definitively no gastric fistula on the staple line in this pilot study
Quality of life and socio-economic impact could be significant if such hypotheses are confirmed However complications specific to the Nissen sleeve such as dilatation and perforation of the envelope were also reported in this prospective trial A 39 rate of perioperative complications after Nissen Sleeve was described after the learning curve of the procedure on 301 patients 2018-2020 Nocca 2016 Nocca 2020
Our aim in this study is to highlight that there are no more complications when performing Nissen-SG than SG taking published PMSI data and to show a decrease in post-operative GERD after Nissen-SG To achieve this data will be collected on patients undergoing Nissen-SG surgery in 2022 until 2024 in 18 French hospitals For these patients any post-operative complications and the presenceevolution of GERD will be collected and compared with SG data available in the literature
SG was validated by the Haute Autorité de Santé HAS in 2008 and is the most widely used procedure in France 35580 operations in 2018 It consists of a 23 partial gastrectomy Long-term weight loss of 61 23 is expected with significant improvement in obesity-related comorbidities
However this technique is associated with postoperative complications Gastric fistula 2 most often located at the upper end of the stapling line bleeding from the gastric section 2 and gastric stenosis 1 are the most frequent early postoperative complications that may require reoperation In addition gastroesophageal reflux disease GERD is very common 30-57 and can have serious consequences for the esophageal mucosa esophagitis Barretts esophagus cancer Alarmingly high rates of Barretts esophagus 17-18 after SG have recently been described in the long term causing concern in the medical community This may be an exacerbation of preoperative GERD symptoms or de novo postoperative GERD Medical treatment is generally effective proton pump inhibitors PPIs However the long-term safety of PPIs has not been demonstrated Whats more these patients quality of life may be considerably reduced and re-intervention gastric Y-bypass may be necessary to treat refractory GERD
The classic surgical treatment for GERD independently of bariatric surgery is fundoplication which can be partial 180 Toupet technique or total 360 Nissen technique The gastric fundus is wrapped around the esophagus to reinforce the esophageal sphincter
Nissen-Sleeve Gastrectomy Nissen-SG is an innovative technique performed in expert centers in France It consists in creating a total anti-reflux fundoplicature Nissen before performing a SG
A prospective non-comparative pilot study of 25 patients who underwent Nissen-SG in 2014 at Montpellier University Hospital showed that while 92 of patients had symptoms of GERD preoperatively 24 were symptomatic at 3 months after Nissen and SG only 12 had clinical GERD at 6 months and 1 year postoperatively Excess weight loss at 1 year was 59 similar to the efficacy of conventional SG although a larger gastric residual volume was left after Nissen-SG but used as plication The 5-year results were presented at the SOFFCO 2020 congress and at the International Federation of Obesity Surgery IFSO congress Excess weight loss EWL was 7087 112 patients and 5832 31 patients at 2 and 5 years follow-up Less than 7 of patients had GERD symptoms at 5 years
Our hypothesis is that the creation of a total anti-reflux fundoplicature prior to performing SLEEVE could significantly reduce the rate of postoperative GERD observed with standard SLEEVE
Whats more the creation of a Nissen fundoplicature means that a gastric section is made away from the HIS angle the area most at risk of fistula 90 which could reduce this complication almost definitively no gastric fistula on the staple line in this pilot study
Quality of life and socio-economic impact could be significant if such hypotheses are confirmed However complications specific to the Nissen sleeve such as dilatation and perforation of the envelope were also reported in this prospective trial A 39 rate of perioperative complications after Nissen Sleeve was described after the learning curve of the procedure on 301 patients 2018-2020 Nocca 2016 Nocca 2020
Our aim in this study is to highlight that there are no more complications when performing Nissen-SG than SG taking published PMSI data and to show a decrease in post-operative GERD after Nissen-SG To achieve this data will be collected on patients undergoing Nissen-SG surgery in 2022 until 2024 in 18 French hospitals For these patients any post-operative complications and the presenceevolution of GERD will be collected and compared with SG data available in the literature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None