Study of Bariatric Surgery

Recruiting

• Conditions: Bariatric Surgery

• Registration Number: NCT02857179
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. The investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-05
• Last Update Posted: 2016-08-05
• Primary Completion: 2032-11
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• History of bariatric surgery procedure

Read More

Exclusion Criteria

• Patients < 16 years
• Patients > 80 years

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss in kg	Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
Excess Weight Loss	Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
% weight loss	Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
Weight loss in kg/m²	Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)

Secondary Outcome Measures

Name	Time	Method
gender	before surgery (Day 0)	demographic data: gender
type of surgical procedure	at the time of surgery (Day 1)	gastric bypass, sleeve gastrectomy, gastric banding, biliopancreatic diversion, redo surgery, endoscopic procedure...
age	before surgery (Day 0)	demographic data: age
Type of comorbidities	before surgery (Day 0)	demographic data: comorbidities (diabetes, arterial hypertension, sleep apnea, dyslipidemia)
dose of insulin	after surgery (up to 25 years or loss to follow-up)	evolution of comorbidities: evolution of medical treatment
number of oral medications	after surgery (up to 25 years or loss to follow-up)	evolution of comorbidities: evolution of medical treatment
surgical complications	per and postoperative (up to 25 years or loss to follow-up)	leaks, hemorrhage, phlebitis, pulmonary embolism, nutritional deficiencies, occlusions,...

Trial Locations

Locations (1)

Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon; 🇫🇷 Lyon, France