Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 7:46 AM
Study NCT ID:
NCT00722995
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEVE
Brief Summary:
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
Detailed Description:
In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 \>= BMI \<= 50), a super obesity (BMI \>50), a super super obesity (BMI\>60), and obese patients (BMI\>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.
This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.
This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: