Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

This study has been completed.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00434525
First received: February 9, 2007
Last updated: December 14, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Laparoscopic Sleeve Gastrectomy With or Without Omentectomy: Prospective Randomized Trial

Resource links provided by NLM:


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
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

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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Esteban Varela MD, MPH, VA North Texas
ClinicalTrials.gov Identifier: NCT00434525     History of Changes
Other Study ID Numbers: 07-011
Study First Received: February 9, 2007
Last Updated: December 14, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014