Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Composite criteria of morbid/mortality
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Sleeve gastrectomy
Intervention: Sleeve gastrectomy (Procedure)
2
Gastric Bypass
Intervention: Gastric Bypass (Procedure)
Outcomes
Primary Outcomes
Composite criteria of morbid/mortality
Time Frame: during 18 months and 36 months
Secondary Outcomes
- 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)
- 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)
- Regression of morbidities(during 36 months)
- Rate serum ghrelin(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)