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

• Sponsor: Legacy Health System (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00552942
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2006
• Anticipated Study Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. diabetic indices [6 months]

Secondary Outcome Measures

1. interleukin and cytokine levels, weight loss [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Oregon Weight Loss Surgery LLC	Portland	Oregon	United States	97210

Sponsors and Collaborators

• Legacy Health System

Investigators

• Principal Investigator: Dennis Hong, MD., MS.c, FRCSC, Oregon Weight Loss Surgery, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00552942
• Other Study ID Numbers: 1234
• First Posted: Nov 2, 2007
• Last Update Posted: Nov 2, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: obesity; diabetes; cytokines

Study Results

No Results Posted as of Nov 2, 2007