Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00722995

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

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass Randomised Study Comparing Complications, Efficacy and Quality of Life

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 ]

Estimated Enrollment:	280
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Sleeve gastrectomy	Procedure: Sleeve gastrectomy Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
2: Active Comparator Gastric Bypass	Procedure: Gastric Bypass Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Detailed Description:

In the obese patient population, the frequency of patients presenting a severe morbid obesity (45 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese patients (BMI>40) 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> 45
- A super obesity BMI> 50
- A super super obesity BMI> 60
- Obese patient in failure following the installation of a gastric banding with BMI> 40
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

Contacts

Contact: Jean-Marc CATHELINE, MD, PhD

+ 33 (0) 1 48 95 52 95

jean-marc.catheline@avc.aphp.fr

Locations

France
Hopital Avicenne "AP-HP"	Recruiting
Bobigny, France, 93009
Contact: Jean Marc CATHELINE, MD, PhD 33 (0) 1 48 95 52 95 jean-marc.catheline@avc.aphp.fr
Contact: Regis COHEN, MD, PhD 33 (0) 1 48 95 51 51 regis.cohen@avc.aphp.fr
Principal Investigator: Jean Marc CATHELINE, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Jean-Marc CATHELINE, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Cécile JOURDAIN )
Study ID Numbers:	K060213, IDRCB2007-A00373-50
Study First Received:	July 25, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00722995
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Morbid obesity
Sleeve gastrectomy
Gastric bypass
Complications

Efficacity
Safety
Compare

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Quality of Life

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 16, 2009