Evaluating complications after Nissen sleeve gastrectomy for obesity

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

This study is testing if a new type of weight loss surgery called Nissen sleeve gastrectomy causes fewer complications than the regular sleeve gastrectomy for people with obesity.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (other)
• Locations: 1 site (Nantes)
• Trial ID: NCT06271317 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a BMI of 40 kg/m² or higher, or 35 kg/m² with obesity-related comorbidities, who are eligible for sleeve gastrectomy.

Not a fit: Patients who have previously undergone bariatric surgery or are currently pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical techniques and reduced postoperative complications for patients undergoing bariatric surgery.

How similar studies have performed: While there have been studies on sleeve gastrectomy, the specific evaluation of the Nissen sleeve gastrectomy technique is relatively novel and has not been extensively tested.

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.

Where this trial is running

Nantes

• CHU Nantes — Nantes, France (RECRUITING)

Study contacts

• Study coordinator: Claire Louis, M.D

Conditions: Obesity, Nissen sleeve gastrectomy, Morbidity-Fistula-Bariatric surgery, Sleeve gastrectomy