Determinants of the Long-Term Success of Bariatric Surgery

Recruiting

• Conditions: Bariatric Surgery Candidate; Morbid Obesity

• Registration Number: NCT03517072
• Lead Sponsor: University Hospital, Lille

Brief Summary

The management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

Detailed Description

Currently, there is insufficient data to determine the persistence over time of the positive results of bariatric surgery on weight loss. Moreover, there is no consensus or criteria for choosing one surgical weight loss procedure over another. The best choice for one patient may not be the most appropriate for another.

The results of this project will allow to better select obese patients likely to benefit from bariatric surgery, and to further personalise the management of severe obesity.

Study Timeline

• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-07
• Study Start: 2018-07-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients who received bariatric surgery 5 years ago.

Exclusion Criteria

• Refusal to participate in the study,
• Unable to receive informed information,
• Unable to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate in terms of weight loss	at 5 years after bariatric surgery	Rate of patients who lost at least 20 of their initial body weight

Secondary Outcome Measures

Name	Time	Method
Lost rate seen	at 5 years after bariatric surgery	Evaluation of lost to follow-up
Success rate in terms of weight loss according to type of bariatric surgery	at 5 years after bariatric surgery	Rate of patients who lost at least 20 of their initial body weight at 5 years according to type of bariatric surgery (Gastric by-pass in Y or Omega, sleeve gastrectomy, and gastric band)
Rate of re- interventions related to bariatric surgery	5 years	Evaluation of re-interventions following bariatric surgery

Trial Locations

Locations (4)

CH ARRAS; 🇫🇷 Arras, France

Ch Boulogne-Sur-Mer; 🇫🇷 Boulogne-sur-Mer, France

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France

Ch de Valenciennes; 🇫🇷 Valenciennes, France