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Recruiting NCT06271317

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

Conditions: Obesity

Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Nantes University Hospital

Location: CHU Nantes Nantes Nantes

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06271317). StuddyBuddy aggregates publicly available trial information.