Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients - Full Text View

Purpose

Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).

Condition

Obesity

MedlinePlus related topics:

Obesity Weight Loss Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients

Further study details as provided by Ohio State University:

Primary Outcome Measures:

Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery. [ Time Frame: 10 or more years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery. [ Time Frame: 10 or more years after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adults who participated in the bariatric program at OSUMC ten or more years ago, including bariatric surgery.

Criteria

Inclusion Criteria:

Adult
Treated by OSUMC physicians for obesity
Informed Consent

Exclusion Criteria:

Informed consent not given

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700843

Contacts


Contact: Rebecca R Dettorre, BA	614-293-8549	becky.dettorre@osumc.edu

Locations


United States, Ohio
	The Ohio State University Medical Center	Recruiting
	Columbus, Ohio, United States, 43210
	Contact: Rebecca R Dettorre, BA 614-293-8549 becky.dettorre@osumc.edu
	Sub-Investigator: Dean J Mikami, MD

Sponsors and Collaborators

Ohio State University

Investigators


Principal Investigator:	Bradley J Needleman, MD	The Ohio State University Medical Center

More Information

Responsible Party:	The Ohio State University Medical Center ( Bradley J. Needleman, MD )
Study ID Numbers:	2008H0008
First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00700843
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

bariatric surgery

long term follow up

gastric partitioning surgery

Roux-en-Y gastric bypass surgery

obesity

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00700843