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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00722995
First received: July 25, 2008
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Obesity
Procedure: Sleeve gastrectomy
Procedure: Gastric Bypass

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Composite criteria of morbid/mortality [ Time Frame: during 18 months and 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of morbid events [ Time Frame: during the follow up ] [ Designated as safety issue: Yes ]
  • Percentage of excess weight loss [ Time Frame: during 18 and 36 months ] [ Designated as safety issue: Yes ]
  • Frequency of patients having a excess weight loss superior than 50% [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
  • Regression of morbidities [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
  • Rate serum ghrelin [ Time Frame: at inclusion visit, 6, 12, 18 and 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Frequency of morbid/mortality events [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
  • Frequency of patients having excess weight loss superior than 50% [ Time Frame: during 18 month ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: January 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722995

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00722995     History of Changes
Other Study ID Numbers: K060213
Study First Received: July 25, 2008
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 15, 2014