Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06271317

Recruiting nowNot applicableObservational

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot listed
ConditionObesity

Full registry criteria

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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Study postoperative morbidity after nissen sleeve gastrectomy in Nantes30 days post operation

Collection of complications at 30 days post-op (aphagia, valve necrosis, fistula, etc.) and classification according to Dindo-Clavien.

postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France30 days post operation

Comparison of Nissen Sleeve Gastrectomy data at 30d post-op (aphagia, valve necrosis, fistula...) with published PMSI sleeve gastrectomy data.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

CHU Nantes🇫🇷 Nantes, Nantes, France
Claire Blanchard, MD; PhDContact
Alexandra PoinasContact