Longitudinal Assessment of Bariatric Surgery (LABS-1)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00433810
First received: February 9, 2007
Last updated: December 23, 2010
Last verified: December 2010

February 9, 2007
December 23, 2010
March 2005
December 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00433810 on ClinicalTrials.gov Archive Site
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Longitudinal Assessment of Bariatric Surgery
Longitudinal Assessment of Bariatric Surgery (LABS-1)

The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

The primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care

Funds are not available to pay for the surgery for patients, only to address research questions.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All eligible bariatric surgery candidates at the participating LABS clinical sites.

Morbid Obesity
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Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5102
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.

Exclusion Criteria:

  • Patients who do not provide informed consent
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00433810
DK66557 (completed), U01DK066557
Yes
Dr. Bruce Wolfe, LABS Steering Committee Chair, Oregon Health & Science University
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: Bruce Wolfe, MD Oregon Health and Science University
University of Pittsburgh
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP