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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434525
First Posted: February 13, 2007
Last Update Posted: December 15, 2009
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.
Information provided by:
North Texas Veterans Healthcare System
  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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00434525


Locations
United States, Texas
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
  More Information

Responsible Party: Esteban Varela MD, MPH, VA North Texas
ClinicalTrials.gov Identifier: NCT00434525     History of Changes
Other Study ID Numbers: 07-011
First Submitted: February 9, 2007
First Posted: February 13, 2007
Last Update Posted: December 15, 2009
Last Verified: August 2009

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

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