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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: December 19, 2013
Last verified: December 2013
  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:


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: July 2014
Estimated Primary Completion Date: July 2014 (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
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: NCT01055054

Locations
United States, Virginia
VCU Health Systems
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: James G Bittner, IV, 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: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
bariatrics

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

ClinicalTrials.gov processed this record on November 25, 2014