Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Difficulty recruiting)
Sponsor:
Information provided by (Responsible Party):
Bradley Needleman, Ohio State University
ClinicalTrials.gov Identifier:
NCT00700843
First received: June 17, 2008
Last updated: May 13, 2015
Last verified: May 2015
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: April 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Bradley J Needleman, MD Ohio State University
  More Information

Responsible Party: Bradley Needleman, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00700843     History of Changes
Other Study ID Numbers: 2008H0008 
Study First Received: June 17, 2008
Last Updated: May 13, 2015
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

ClinicalTrials.gov processed this record on September 26, 2016