Overview

This trial is active, not recruiting.

Condition obesity
Treatments sleeve gastrectomy, gastric bypass
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2008
End date July 2015
Trial size 280 participants
Trial identifier NCT00722995, K060213

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Sleeve gastrectomy
sleeve gastrectomy SLEEVE
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
(Active Comparator)
Gastric Bypass
gastric bypass BYPASS
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Primary Outcomes

Measure
Composite criteria of morbid/mortality
time frame: during 18 months and 36 months

Secondary Outcomes

Measure
Frequency of morbid events
time frame: during the follow up
Percentage of excess weight loss
time frame: during 18 and 36 months
Frequency of patients having a excess weight loss superior than 50%
time frame: during 36 months
Regression of morbidities
time frame: during 36 months
Rate serum ghrelin
time frame: at inclusion visit, 6, 12, 18 and 36 months
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
Frequency of morbid/mortality events
time frame: during 36 months
Frequency of patients having excess weight loss superior than 50%
time frame: during 18 month

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Principal investigator Jean-Marc CATHELINE, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.