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Clinical Trials in France / NCT06271317
Recruiting Observational

Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study

NCT06271317 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-03-01
Last updated
2026-06-24

Condition(s) studied

Obesity

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Subject unable to read or/and write * Planned longer stay outside the region that prevents compliance with the visit plan * Current pregnancy * Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass). * Previous reflux surgery * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU Nantes Nantes Nantes Recruiting

More Nantes University Hospital trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06271317 on ClinicalTrials.gov ↗ ← All trials in France