Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

• Sponsor: North Texas Veterans Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00434525
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Laparoscopic restrictive procedure; Procedure: Sleeve gastrectomy	Phase 3

Detailed Description

This is a phase 3 prospective randomized trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Sleeve gastrectomy with omentectomy	Procedure: Laparoscopic restrictive procedure; Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
Active Comparator: 2 Sleeve gastrectomy	Procedure: Sleeve gastrectomy; Sleeve gastrectomy

Outcome Measures

Primary Outcome Measures

1. Weight loss [5 years]

Secondary Outcome Measures

1. Metabolic outcomes [5 years]

2. Diabetes resolution [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA North Texas	Dallas	Texas	United States	75216

Sponsors and Collaborators

• North Texas Veterans Healthcare System

Investigators

• Principal Investigator: Esteban Varela, MD, MPH, VA North Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00434525
• Other Study ID Numbers: 07-011
• First Posted: Feb 13, 2007
• Last Update Posted: Dec 15, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Morbid obesity; Bariatric Surgery; Obesity Surgery; Omentectomy; Sleeve gastrectomy
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Dec 15, 2009