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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Sleeve gastrectomy; Procedure: 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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Denis, France, 93205
    • Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jean-Marc CATHELINE, MD, PhD, Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Complications; Sleeve gastrectomy; Morbid obesity; Gastric bypass; Compare; Efficacity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: K060213