Study of Bariatric Surgery

Bariatric Surgery Clinical Trial

— BARIASURG  

Official title:

Prospective Cohort Study Monitoring Patients Undergoing Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857179
• Other study ID #: 69HCL16_0504
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2016
• Last updated: August 2, 2016
• Start date: November 2007
• Est. completion date: November 2032

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: Maud ROBERT, Pr
• Phone: (0)4 72 11 62 63
• Email: maud.robert[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 2032
• Est. primary completion date: November 2032
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• History of bariatric surgery procedure

Exclusion Criteria:

• Patients < 16 years

• Patients > 80 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Procedure:
• bariatric surgery
gastric bypass Or gastric banding Or Biliopancreatic diversion with duodenal switch Or sleeve gastrectomy Or endoscopic procedure (Endobarrier,…)

Locations

Country	Name	City	State
France	Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss in kg		Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)	No
Primary	Weight loss in kg/m²		Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)	No
Primary	Excess Weight Loss		Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)	No
Primary	% weight loss		Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)	No
Secondary	type of surgical procedure	gastric bypass, sleeve gastrectomy, gastric banding, biliopancreatic diversion, redo surgery, endoscopic procedure…	at the time of surgery (Day 1)	No
Secondary	age	demographic data: age	before surgery (Day 0)	No
Secondary	gender	demographic data: gender	before surgery (Day 0)	No
Secondary	Type of comorbidities	demographic data: comorbidities (diabetes, arterial hypertension, sleep apnea, dyslipidemia)	before surgery (Day 0)	No
Secondary	surgical complications	leaks, hemorrhage, phlebitis, pulmonary embolism, nutritional deficiencies, occlusions,…	per and postoperative (up to 25 years or loss to follow-up)	No
Secondary	dose of insulin	evolution of comorbidities: evolution of medical treatment	after surgery (up to 25 years or loss to follow-up)	No
Secondary	number of oral medications	evolution of comorbidities: evolution of medical treatment	after surgery (up to 25 years or loss to follow-up)	No