Evaluating complications after Nissen sleeve gastrectomy for obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the postoperative complications associated with the Nissen sleeve gastrectomy technique compared to the conventional sleeve gastrectomy method. It focuses on patients suffering from obesity, particularly those with a BMI of 40 kg/m² or higher, who have not succeeded with dietary treatments. The study will involve multiple centers in France and will track various complications such as gastric fistula, bleeding, and gastroesophageal reflux disease (GERD) following surgery. The findings will help determine the safety and efficacy of the N-Sleeve technique in managing obesity-related health issues.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Nantes
  Nantes, Nantes, France Recruiting

Study contacts

• Study coordinator: Claire Louis, M.D
• Email: Claire.BLANCHARD@chu-nantes.fr
• Phone: 0240083022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.