Studies complications after a sleeve gastrectomy with Nissen fundoplication
Compares complications of a Nissen sleeve gastrectomy with standard sleeve gastrectomy in adults with obesity.
Plain-language title generated from the registry record
Registry title: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Key facts
- Where
- Nantes, FranceSee the site
Where in France
- CHU NantesNantes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nantes University Hospital
- Trial code
- NCT06271317
- Record updated
- 24 June 2026
- Original description
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 techniqueRead full original descriptionShow less
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
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
Inclusion: Signed informed consent form; Subjects must be able to attend all scheduled visits and to comply with all trial procedures; Subjects must be covered by public health insurance; Contraception efficacy; Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH)).
Exclusion: Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass); Previous reflux surgery; Subject unable to read or/and write; Planned longer stay outside the region that prevents compliance with the visit plan; Current pregnancy; BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases); Barrett oesophagus and esophagitis stage III and IV; Funditis; No affiliation at the French social security scheme; Major protected by law; Deprivation of liberty by judicial or administrative decision. Participation to another clinical research program.