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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722995
Recruitment Status : Unknown
Verified May 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2008
Last Update Posted : June 3, 2015
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Obesity Procedure: Sleeve gastrectomy Procedure: Gastric Bypass Not Applicable

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  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Study Start Date : January 2008
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

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 Name: 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 Name: BYPASS

Primary Outcome Measures :
  1. Composite criteria of morbid/mortality [ Time Frame: during 18 months and 36 months ]

Secondary Outcome Measures :
  1. Frequency of morbid events [ Time Frame: during the follow up ]
  2. Percentage of excess weight loss [ Time Frame: during 18 and 36 months ]
  3. Frequency of patients having a excess weight loss superior than 50% [ Time Frame: during 36 months ]
  4. Regression of morbidities [ Time Frame: during 36 months ]
  5. Rate serum ghrelin [ Time Frame: at inclusion visit, 6, 12, 18 and 36 months ]
  6. 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 ]
  7. Frequency of morbid/mortality events [ Time Frame: during 36 months ]
  8. Frequency of patients having excess weight loss superior than 50% [ Time Frame: during 18 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00722995

Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine
Saint-Denis, France, 93205
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean-Marc CATHELINE, MD, PhD Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00722995     History of Changes
Other Study ID Numbers: K060213
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Morbid obesity
Sleeve gastrectomy
Gastric bypass

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms