Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Recruiting · NCT06271317 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nantes University Hospital
View the official record on ClinicalTrials.gov →What this trial 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- CHU Nantes - Nantes, Nantes, France