Actively Recruiting
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy A French Multicenter Observational Study
Led by Nantes University Hospital · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obesity is a significant health problem, with 2% of the French adult population classified as morbidly obese. Bariatric surgery is the only effective treatment for severe obesity, with Sleeve Gastrectomy (SG) being the most common procedure in France. However, SG can lead to postoperative complications such as gastric fistula, bleeding, gastric stenosis, and a high rate of gastroesophageal reflux disease (GERD), which may reduce quality of life and require further treatment. The Nissen-Sleeve Gastrectomy (Nissen-SG) is an innovative technique combining a total anti-reflux fundoplication with SG, aiming to reduce GERD and related complications. The study compares the postoperative complications between conventional SG and Nissen-SG by collecting data from patients undergoing Nissen-SG across 18 French hospitals between 2022 and 2024. Nissen-SG involves creating a total anti-reflux wrap before performing the sleeve gastrectomy, potentially reducing reflux symptoms and the risk of gastric fistula by altering the gastric section site. Prior studies indicate that Nissen-SG may lower GERD symptoms long-term while maintaining effective weight loss. Participants will be monitored for postoperative complications and GERD presence up to 30 days after surgery. Researchers will assess morbidity related to both procedures using clinical evaluations and compare findings with published data on SG. The study aims to confirm whether Nissen-SG reduces GERD and complications without increasing risks. Total participation includes preoperative evaluation and postoperative follow-up focusing on safety and symptom monitoring.
CONDITIONS
Official Title
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Ability to attend all scheduled visits and comply with trial procedures
- Covered by public health insurance
- Use of effective contraception
- Eligible for sleeve gastrectomy after multidisciplinary evaluation per HAS 2009 criteria: BMI ≥ 40 kg/m² with failed diet for at least 1 year, or BMI ≥ 35 kg/m² with at least one comorbidity (hypertension, sleep apnea, severe respiratory disorders, type 2 diabetes, debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis)
You will not qualify if you...
- Unable to read or write
- Planned long stay outside the region preventing visit compliance
- Current pregnancy
- Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy, or gastric bypass)
- Previous reflux surgery
- BMI > 50 kg/m² for women or > 45 kg/m² for men
- Barrett's esophagus and esophagitis stage III or IV
- Funditis
- Not affiliated with French social security
- Legally protected adult
- Deprivation of liberty by judicial or administrative decision
- Participation in another clinical research program
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, France, 44000
Actively Recruiting
Research Team
C
Claire Louis, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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