Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Gastric Bypass; Procedure: Sleeve gastrectomy

• Registration Number: NCT00722995
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Patient aged from 18 to 60 years old

• Patient having given his consent to the use of data from the project

• Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)

• Patient presenting one of the following criteria:

  • A morbid obesity strict with BMI> 40
  • A super obesity BMI> 50
  • A super super obesity BMI> 60
  • Obese patient in failure following the installation of a gastric banding with BMI> 35
  • obese patient 35>BMI>40 with a comorbidity

• Preliminary agreement during the consultation of a psychiatrist / psychologist

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Exclusion Criteria

• Patient with complications or co morbidities associated involving life to less 6 months
• Patient presenting no anaesthetic indication
• Patient presenting no psychiatric indication for obesity surgery
• Patient not affiliated with a social security scheme
• Pregnant Patient likely to breastfeed in the first year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Gastric Bypass	Gastric Bypass
1	Sleeve gastrectomy	Sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Composite criteria of morbid/mortality	during 18 months and 36 months

Secondary Outcome Measures

Name	Time	Method
Frequency of morbid events	during the follow up
Rate serum ghrelin	at inclusion visit, 6, 12, 18 and 36 months
Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score	at inclusion visit, 6, 12, 18 and 36 months
Percentage of excess weight loss	during 18 and 36 months
Frequency of patients having a excess weight loss superior than 50%	during 36 months
Regression of morbidities	during 36 months
Frequency of morbid/mortality events	during 36 months
Frequency of patients having excess weight loss superior than 50%	during 18 month

Trial Locations

Locations (1)

Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine; 🇫🇷 Saint-Denis, France