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Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

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ClinicalTrials.gov Identifier: NCT00434525
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
North Texas Veterans Healthcare System

February 9, 2007
February 13, 2007
December 15, 2009
January 2008
December 2009   (Final data collection date for primary outcome measure)
Weight loss [ Time Frame: 5 years ]
Short and long term clinical outcomes
Complete list of historical versions of study NCT00434525 on ClinicalTrials.gov Archive Site
  • Metabolic outcomes [ Time Frame: 5 years ]
  • Diabetes resolution [ Time Frame: 5 years ]
Metabolic outcomes
Not Provided
Not Provided
 
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy
Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial
  • 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.
This is a phase 3 prospective randomized trial.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Morbid Obesity
  • Procedure: Laparoscopic restrictive procedure
    Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy
  • Procedure: Sleeve gastrectomy
    Sleeve gastrectomy
  • Experimental: 1 Sleeve gastrectomy with omentectomy
    Intervention: Procedure: Laparoscopic restrictive procedure
  • Active Comparator: 2 Sleeve gastrectomy
    Intervention: Procedure: Sleeve gastrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00434525
07-011
No
Not Provided
Not Provided
Esteban Varela MD, MPH, VA North Texas
North Texas Veterans Healthcare System
Not Provided
Principal Investigator: Esteban Varela, MD, MPH VA North Texas
North Texas Veterans Healthcare System
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP