Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

NCT00722995 | Completed DMC

• 1 other identifier: K060213
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Morbid obesity; Sleeve gastrectomy; Gastric bypass; Complications; Efficacity; Safety; Compare

Outcome Measures

Primary Outcomes (1)

• Composite criteria of morbid/mortality

  during 18 months and 36 months

Secondary Outcomes (8)

• Frequency of morbid events

  during the follow up

• Percentage of excess weight loss

  during 18 and 36 months

• Frequency of patients having a excess weight loss superior than 50%

  during 36 months

• Regression of morbidities

  during 36 months

• Rate serum ghrelin

  at inclusion visit, 6, 12, 18 and 36 months

Study Arms (2)

1

ACTIVE COMPARATOR

Sleeve gastrectomy

Procedure: Sleeve gastrectomy

2

ACTIVE COMPARATOR

Gastric Bypass

Procedure: Gastric Bypass

Interventions

Sleeve gastrectomy PROCEDURE

Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity

Also known as: SLEEVE

1

Gastric Bypass PROCEDURE

Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity

Also known as: BYPASS

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged from 18 to 60 years old
• Patient having given his consent to the use of data from the project
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine

Saint-Denis, 93205, France

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Jean-Marc CATHELINE, MD, PhD

  Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 28, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

FR (1)