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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014