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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleeve gastrectomy
Gastric Bypass
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Morbid obesity, Sleeve gastrectomy, Gastric bypass, Complications, Efficacity, Safety, Compare

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Sleeve gastrectomy

Gastric Bypass

Outcomes

Primary Outcome Measures

Composite criteria of morbid/mortality

Secondary Outcome Measures

Frequency of morbid events
Percentage of excess weight loss
Frequency of patients having a excess weight loss superior than 50%
Regression of morbidities
Rate serum ghrelin
Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score
Frequency of morbid/mortality events
Frequency of patients having excess weight loss superior than 50%

Full Information

First Posted
July 25, 2008
Last Updated
June 14, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00722995
Brief Title
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
Acronym
SLEEVE
Official Title
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Morbid obesity, Sleeve gastrectomy, Gastric bypass, Complications, Efficacity, Safety, Compare

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Sleeve gastrectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Gastric Bypass
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Other Intervention Name(s)
SLEEVE
Intervention Description
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
Intervention Type
Procedure
Intervention Name(s)
Gastric Bypass
Other Intervention Name(s)
BYPASS
Intervention Description
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
Primary Outcome Measure Information:
Title
Composite criteria of morbid/mortality
Time Frame
during 18 months and 36 months
Secondary Outcome Measure Information:
Title
Frequency of morbid events
Time Frame
during the follow up
Title
Percentage of excess weight loss
Time Frame
during 18 and 36 months
Title
Frequency of patients having a excess weight loss superior than 50%
Time Frame
during 36 months
Title
Regression of morbidities
Time Frame
during 36 months
Title
Rate serum ghrelin
Time Frame
at inclusion visit, 6, 12, 18 and 36 months
Title
Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score
Time Frame
at inclusion visit, 6, 12, 18 and 36 months
Title
Frequency of morbid/mortality events
Time Frame
during 36 months
Title
Frequency of patients having excess weight loss superior than 50%
Time Frame
during 18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc CATHELINE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine
City
Saint-Denis
ZIP/Postal Code
93205
Country
France

12. IPD Sharing Statement

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Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

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