Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

Study Overview
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Brief Summary
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The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass

Detailed Description
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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.

Official Title
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Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Sleeve gastrectomy
* Procedure: Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sleeve gastrectomy | Procedure: Sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity<br>* Other names: SLEEVE;|
| Active Comparator: 2<br>Gastric Bypass | Procedure: Gastric Bypass<br>* Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity<br>* Other names: BYPASS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criteria of morbid/mortality |  | during 18 months and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of morbid events |  | during the follow up | 
| 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 | 
| 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 | 
| Frequency of morbid/mortality events |  | during 36 months | 
| Frequency of patients having excess weight loss superior than 50% |  | during 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Morbid obesity, Sleeve gastrectomy, Gastric bypass, Complications, Efficacity, Compare