Under construction – not a live service
Sign in
Taking people in FranceNo phase

Studies complications after a sleeve gastrectomy with Nissen fundoplication

Compares complications of a Nissen sleeve gastrectomy with standard sleeve gastrectomy in adults with obesity.

Key facts

Who runs it
Nantes University Hospital
Where
Nantes, FranceSee the site
Trial code
Registry title
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Status
Recruiting
People taking part
100 people, planned
Started
1 Mar 2024
Expected to end
Mar 2027
Type of study
Observational, 2 groups
Record updated
24 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are going to have a sleeve gastrectomy for obesity. It compares two ways of doing the surgery and their complications.

Age
18 years or older
Sex
Men and women can join
Disease stage
Obesity with BMI ≥ 40 kg / m² after at least 1 year of failed diet treatment, or BMI ≥ 35kg / m² with at least one health problem that surgery could improve (such as high blood pressure, sleep apnea, type 2 diabetes, severe joint or muscle disease, or NASH). A team of doctors must agree on sleeve gastrectomy.
Earlier treatment
Diet treatment must have failed for at least 1 year if BMI is ≥ 40 kg / m². Previous weight-loss surgery or reflux surgery is not allowed.

Main reasons for not taking part

  • Current pregnancy
  • Previous weight-loss surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or gastric bypass)
  • Previous reflux surgery
  • BMI > 50 kg / m² for women or > 45kg / m² for men
  • Barrett oesophagus, or oesophagitis stage III and IV

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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))

Who cannot take part

  • Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass)
  • Previous reflux surgery
  • Subject unable to read or/and write
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Current pregnancy
  • 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 in France

  • CHU NantesNantes, FranceContact: Claire Blanchard, MD; PhDTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Nissen sleeve gastrectomy

    Nissen sleeve gastrectomy patients

  • Sleeve gastrectomy with the data of PMSI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
Plain-language title
Studies complications after a sleeve gastrectomy with Nissen fundoplicationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 June 2026