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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00722995 |
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
Condition | Intervention |
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Obesity |
Procedure: Sleeve gastrectomy Procedure: Gastric Bypass |
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 |
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 |
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1: Active Comparator
Sleeve gastrectomy
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Procedure: Sleeve gastrectomy
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
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2: Active Comparator
Gastric Bypass
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Procedure: Gastric Bypass
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patient presenting one of the following criteria:
Exclusion Criteria:
Contact: Jean-Marc CATHELINE, MD, PhD | + 33 (0) 1 48 95 52 95 | jean-marc.catheline@avc.aphp.fr |
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 |
Principal Investigator: | Jean-Marc CATHELINE, MD, PhD | Assistance Publique - Hôpitaux de Paris |
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 History of Changes |
Health Authority: | France: Ministry of Health |
Morbid obesity Sleeve gastrectomy Gastric bypass Complications |
Efficacity Safety Compare |
Body Weight Signs and Symptoms Obesity Quality of Life |
Nutrition Disorders Overweight Overnutrition Obesity, Morbid |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |