Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

Obesity Clinical Trial

— SLEEVE  

Official title:

Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722995
• Other study ID #: K060213
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: April 2015

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Sleeve gastrectomy
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
• Gastric Bypass
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Locations

Country	Name	City	State
France	Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criteria of morbid/mortality		during 18 months and 36 months
Secondary	Frequency of morbid events		during the follow up
Secondary	Percentage of excess weight loss		during 18 and 36 months
Secondary	Frequency of patients having a excess weight loss superior than 50%		during 36 months
Secondary	Regression of morbidities		during 36 months
Secondary	Rate serum ghrelin		at inclusion visit, 6, 12, 18 and 36 months
Secondary	Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score		at inclusion visit, 6, 12, 18 and 36 months
Secondary	Frequency of morbid/mortality events		during 36 months
Secondary	Frequency of patients having excess weight loss superior than 50%		during 18 month