Actively Recruiting
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter 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
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
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
AI-Powered 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
CONTACT
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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