Determinants of the Long-Term Success of Bariatric Surgery

Morbid Obesity Clinical Trial

— PRECOS  

Official title:

Determinants of the Long-Term Success of Bariatric Surgery "- Multicenter Regional Observational Study: Regional Multicentre Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517072
• Other study ID #: 2016_24
• Secondary ID: 2016-A02058-43
• Status: Recruiting
• Start date: July 31, 2018
• Est. completion date: January 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: François PATTOU, MD,PhD
• Phone: 3 20 44 42 73
• Email: françois.pattou[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
France	CH ARRAS	Arras
France	Ch Boulogne-Sur-Mer	Boulogne-sur-Mer
France	Hôpital Claude Huriez, CHU	Lille
France	Ch de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate in terms of weight loss	Rate of patients who lost at least 20 of their initial body weight	at 5 years after bariatric surgery
Secondary	Success rate in terms of weight loss according to type of bariatric surgery	Rate of patients who lost at least 20 of their initial body weight at 1 year according to type of bariatric surgery (Gastric by-pass in Y or Omega, sleeve gastrectomy, and gastric band)	at 1 year after bariatric surgery
Secondary	Success rate in terms of weight loss according to type of 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)	at 5 years after bariatric surgery
Secondary	Rate of re- interventions related to bariatric surgery	Evaluation of re-interventions following bariatric surgery	5 years
Secondary	Lost rate seen	Evaluation of lost to follow-up	at 5 years after bariatric surgery