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Bariatric Surgery Registry

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ClinicalTrials.gov Identifier: NCT01055054
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2010
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date January 20, 2010
First Posted Date January 25, 2010
Last Update Posted Date August 7, 2018
Study Start Date July 1980
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2010)
weight loss [ Time Frame: 1 year, 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01055054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 21, 2010)
  • surgical mortality [ Time Frame: 90 day post-surgery ]
  • surgical morbidity [ Time Frame: 90 day post-surgery ]
  • resolution of co-morbidities [ Time Frame: 1 year, 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bariatric Surgery Registry
Official Title Analysis Bariatric Surgery Data
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have undergone bariatric surgical procedures at the Virginia Commonwealth University (VCU) Medical Center.
Condition Obesity, Morbid
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: August 25, 2017)
5042
Original Actual Enrollment
 (submitted: January 21, 2010)
4382
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of morbid obesity
  • Have undergone a bariatric surgical procedure at the VCU Medical Center
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01055054
Other Study ID Numbers HM1587
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators Not Provided
Investigators
Principal Investigator: Guilherme M Campos, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date August 2018