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

Tracking Information

First Received Date ^ICMJE

November 1, 2007

Last Updated Date

November 1, 2007

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

diabetic indices [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

interleukin and cytokine levels, weight loss [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetes
Interleukins
Cytokines

Intervention ^ICMJE

Procedure: laparoscopic gastric bypass plus omentectomy

Study Arms / Comparison Groups

Experimental: surgery plus omentectomy
No Intervention: standard gastric bypass

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

undergoing laparoscopic gastric bypass, >18 yo, understands english

Exclusion Criteria:

previous lower pelvic surgery, self-pay patients, previous weight loss surgery,

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dennis Hong, MD, MS.c, FRCSC

503-227-5050

dennishong70@gmail.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00552942

Responsible Party

Study ID Numbers ^ICMJE

1234

Study Sponsor ^ICMJE

Legacy Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dennis Hong, MD., MS.c, FRCSC

Oregon Weight Loss Surgery LLC

Information Provided By

Legacy Health System

Verification Date

November 2007

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