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

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ClinicalTrials.gov Identifier: NCT00552942
Recruitment Status : Unknown
Verified November 2007 by Legacy Health System.
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
Legacy Health System

Brief Summary:
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.

Condition or disease Intervention/treatment Phase
Diabetes Interleukins Cytokines Procedure: laparoscopic gastric bypass plus omentectomy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : July 2006
Estimated Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: 1
surgery plus omentectomy
Procedure: laparoscopic gastric bypass plus omentectomy
No Intervention: 2
standard gastric bypass



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

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


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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,

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

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

Keywords provided by Legacy Health System:
obesity
diabetes
cytokines