Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434525
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 15, 2009
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Metabolic outcomes [ Time Frame: 5 years ]
  2. Diabetes resolution [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434525

United States, Texas
VA North Texas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Principal Investigator: Esteban Varela, MD, MPH VA North Texas

Responsible Party: Esteban Varela MD, MPH, VA North Texas Identifier: NCT00434525     History of Changes
Other Study ID Numbers: 07-011
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: August 2009

Keywords provided by North Texas Veterans Healthcare System:
Morbid obesity
Bariatric Surgery
Obesity Surgery
Sleeve gastrectomy

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms