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NCT06271317Recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
14 Feb 2024
Start date
1 Mar 2024
Primary completion date
Mar 2027
Lead sponsor
Nantes University Hospital
Diseases
Obesity
NCT number
NCT06271317

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Mar 2024 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
  • Previous reflux surgery

Other

  • 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.

Who the study is looking for

  • 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))

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.