Actively Recruiting

Age: 18Years +
All Genders
NCT06271317

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

Led by Nantes University Hospital · Updated on 2024-12-27

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Ability to attend all scheduled visits and comply with trial procedures
  • Covered by public health insurance
  • Use of effective contraception
  • Eligible for sleeve gastrectomy after multidisciplinary evaluation per HAS 2009 criteria: BMI ≥ 40 kg/m² with failed diet for at least 1 year, or BMI ≥ 35 kg/m² with at least one comorbidity (hypertension, sleep apnea, severe respiratory disorders, type 2 diabetes, debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis)
Not Eligible

You will not qualify if you...

  • Unable to read or write
  • Planned long stay outside the region preventing visit compliance
  • Current pregnancy
  • Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy, or gastric bypass)
  • Previous reflux surgery
  • BMI > 50 kg/m² for women or > 45 kg/m² for men
  • Barrett's esophagus and esophagitis stage III or IV
  • Funditis
  • Not affiliated with French social security
  • Legally protected adult
  • Deprivation of liberty by judicial or administrative decision
  • Participation in another clinical research program

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Nantes

Nantes, France, 44000

Actively Recruiting

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Research Team

C

Claire Louis, M.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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