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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

This study has been completed.
Information provided by:
North Texas Veterans Healthcare System Identifier:
First received: February 9, 2007
Last updated: December 14, 2009
Last verified: August 2009
  • 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 3

Study Type: Interventional
Study Design: 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

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

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

Secondary Outcome Measures:
  • Metabolic outcomes [ Time Frame: 5 years ]
  • Diabetes resolution [ Time Frame: 5 years ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This is a phase 3 prospective randomized trial.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Esteban Varela MD, MPH, VA North Texas Identifier: NCT00434525     History of Changes
Other Study ID Numbers: 07-011
Study First Received: February 9, 2007
Last Updated: December 14, 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 processed this record on August 18, 2017