Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Morbid Obesity Clinical Trial

Official title:

Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434525
• Other study ID #: 07-011
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: December 14, 2009
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

This is a phase 3 prospective randomized trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic restrictive procedure
Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
• Sleeve gastrectomy
Sleeve gastrectomy

Locations

Country	Name	City	State
United States	VA North Texas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		5 years	No
Secondary	Metabolic outcomes		5 years	No
Secondary	Diabetes resolution		5 years	No