Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Phase 3

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopic restrictive procedure; Procedure: Sleeve gastrectomy

• Registration Number: NCT00434525
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

* The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity.

* The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

Detailed Description

This is a phase 3 prospective randomized trial.

Study Timeline

• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-13
• Study Start: 2008-01
• Status Verified: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI>40)
• Age > 18

Exclusion Criteria

• Pregnancy
• Uncontrolled medical or psychiatric conditions
• Previous bariatric procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Sleeve gastrectomy with omentectomy	Laparoscopic restrictive procedure	-
2 Sleeve gastrectomy	Sleeve gastrectomy	-

Primary Outcome Measures

Name	Time	Method
Weight loss	5 years

Secondary Outcome Measures

Name	Time	Method
Metabolic outcomes	5 years
Diabetes resolution	5 years

Trial Locations

Locations (1)

VA North Texas; 🇺🇸 Dallas, Texas, United States