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Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Legacy Health System.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552942
First Posted: November 2, 2007
Last Update Posted: November 2, 2007
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:
Legacy Health System
  Purpose
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.

Condition Intervention Phase
Diabetes Interleukins Cytokines Procedure: laparoscopic gastric bypass plus omentectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • diabetic indices [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • interleukin and cytokine levels, weight loss [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: July 2006
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
Experimental: 1
surgery plus omentectomy
Procedure: laparoscopic gastric bypass plus omentectomy
No Intervention: 2
standard gastric bypass

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing laparoscopic gastric bypass, >18 yo, understands english

Exclusion Criteria:

  • previous lower pelvic surgery, self-pay patients, previous weight loss surgery,
  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): NCT00552942


Contacts
Contact: Dennis Hong, MD, MS.c, FRCSC 503-227-5050 dennishong70@gmail.com

Locations
United States, Oregon
Oregon Weight Loss Surgery LLC Recruiting
Portland, Oregon, United States, 97210
Contact: Dennis Hong, MD, MS.,c, FRCSC    503-227-5050    dennishong70@gmail.com   
Sponsors and Collaborators
Legacy Health System
Investigators
Principal Investigator: Dennis Hong, MD., MS.c, FRCSC Oregon Weight Loss Surgery, LLC
  More Information

ClinicalTrials.gov Identifier: NCT00552942     History of Changes
Other Study ID Numbers: 1234
First Submitted: November 1, 2007
First Posted: November 2, 2007
Last Update Posted: November 2, 2007
Last Verified: November 2007

Keywords provided by Legacy Health System:
obesity
diabetes
cytokines


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