Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

NCT ID: NCT00722995

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity

2

Gastric Bypass

Group Type: ACTIVE_COMPARATOR

Gastric Bypass

Intervention Type: PROCEDURE

Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Interventions

Sleeve gastrectomy

Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity

Intervention Type: PROCEDURE

Gastric Bypass

Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Intervention Type: PROCEDURE

Other Intervention Names

SLEEVE; BYPASS

Eligibility Criteria

Inclusion Criteria

• Patient aged from 18 to 60 years old
• Patient having given his consent to the use of data from the project
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc CATHELINE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)

Locations

Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine

Saint-Denis, , France

Countries

France

Other Identifiers

K060213

Identifier Type: -

Identifier Source: org_study_id