Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass (SLEEVE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Obesity

Treatments: Procedure: Gastric Bypass; Procedure: Sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00722995

K060213

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

280 participants in 2 patient groups

1

Active Comparator group

Description:

Sleeve gastrectomy

Treatment:

Procedure: Sleeve gastrectomy

2

Active Comparator group

Description:

Gastric Bypass

Treatment:

Procedure: Gastric Bypass