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Bariatric Surgery Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01055054
First received: January 20, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

Periodic analyses of our extensive database with regards to different surgical procedures for severe obesity and different obesity co-morbidities will be of benefit to our severely obese patients as well as to others world-wide.


Condition
Obesity, Morbid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis Bariatric Surgery Data

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surgical mortality [ Time Frame: 90 day post-surgery ] [ Designated as safety issue: Yes ]
  • surgical morbidity [ Time Frame: 90 day post-surgery ] [ Designated as safety issue: Yes ]
  • resolution of co-morbidities [ Time Frame: 1 year, 5 years ] [ Designated as safety issue: No ]

Enrollment: 4595
Study Start Date: July 1980
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone bariatric surgical procedures at the VCU Medical Center.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of morbid obesity
  • Have undergone a bariatric surgical procedure at the VCU Medical Center
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055054

Locations
United States, Virginia
VCU Health Systems
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: James W Maher, MD Virginia Commonwealth University
  More Information

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01055054     History of Changes
Other Study ID Numbers: VCU-IRB-1587
Study First Received: January 20, 2010
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
bariatrics

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013