Laparoscopic Sleeve Gastrectomy With and Without Omentectomy - Full Text View

Purpose

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	Intervention	Phase
Morbid Obesity	Procedure: Laparoscopic restrictive procedure Procedure: Sleeve gastrectomy	Phase III

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by North Texas Veterans' Healthcare System:

Primary Outcome Measures:

Weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Metabolic outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Diabetes resolution [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Sleeve gastrectomy with omentectomy: Experimental	Procedure: Laparoscopic restrictive procedure Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
2 Sleeve gastrectomy: Active Comparator	Procedure: Sleeve gastrectomy Sleeve gastrectomy

Detailed Description:

This is a phase 3 prospective randomized trial.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434525

Contacts


Contact: Tammy Nguyen, MT	214-857-1521	tammy.nguyen@va.gov

Locations


United States, Texas
	VA North Texas	Recruiting
	Dallas, Texas, United States, 75216
	Contact: Tammy Nguyen, MT 214-857-1521 tammy.nguyen@va.gov
	Principal Investigator: Esteban Varela, MD

Sponsors and Collaborators

North Texas Veterans' Healthcare System

Investigators


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

More Information

American College of Surgeons Surgery News This link exits the ClinicalTrials.gov site

Responsible Party:	VA North Texas ( Esteban Varela MD, MPH )
Study ID Numbers:	07-011
First Received:	February 9, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00434525
Health Authority:	United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:

Morbid obesity

Bariatric Surgery

Obesity Surgery

Omentectomy

Sleeve gastrectomy

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Obesity, Morbid

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	North Texas Veterans' Healthcare System
Information provided by:	North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier:	NCT00434525