Status:

COMPLETED

Long-term Effects of Bariatric Surgery

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Obesity

Eligibility:

All Genders

18+ years

Brief Summary

The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by: 1. comparing post-surgical outcomes to pre-operat...

Detailed Description

The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400...

Eligibility Criteria

Inclusion

  • Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon
  • Previous enrollment in LABS-1
  • Selected by algorithm to be included in LABS-2

Exclusion

  • Informed consent not obtained
  • Prior bariatric surgery
  • Unlikely to comply with follow-up protocol
  • Unable to communicate with local study staff

Key Trial Info

Start Date :

March 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2016

Estimated Enrollment :

2458 Patients enrolled

Trial Details

Trial ID

NCT00465829

Start Date

March 1 2006

End Date

June 1 2016

Last Update

September 21 2016

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Cornell University Medical Center

New York, New York, United States, 10021

2

Columbia University Medical Center

New York, New York, United States, 10032

3

East Carolina University

Greenville, North Carolina, United States, 27834

4

Neuropsychiatric Research Institute

Fargo, North Dakota, United States, 58107