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

Launched by NANTES UNIVERSITY HOSPITAL · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the possible complications that may occur after a specific type of weight loss surgery called the Nissen Sleeve Gastrectomy, which combines two techniques: sleeve gastrectomy and Nissen fundoplication. The goal is to find out how this new approach compares to the standard sleeve gastrectomy procedure in terms of complications. The study is currently looking for participants, and it includes both men and women aged 65 to 74 who meet certain health criteria.

To be eligible for this trial, participants need to sign a consent form and be able to attend all scheduled appointments. They should have a body mass index (BMI) of 40 or higher, or a BMI of 35 or higher with related health issues like high blood pressure or diabetes. It’s important that participants do not have any previous surgeries for weight loss or reflux problems, and they should not be pregnant or unable to read and write. Those who join the study will be monitored closely throughout the process, and they will help researchers understand how safe and effective this new surgical method is for treating obesity.

Gender

ALL

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.