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NCT00433810 Clinical Trial

Longitudinal Assessment of Bariatric Surgery

Morbid Obesity Clinical Trial

— LABS-1  

Official title:
Longitudinal Assessment of Bariatric Surgery (LABS-1)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00433810
Other study ID # DK66557 (completed)
Secondary ID U01DK066557
Status Completed
Phase N/A
First received February 9, 2007
Last updated December 23, 2010
Start date March 2005
Est. completion date December 2007

Study information
Verified date December 2010
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 5102
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Neuropsychiatric Research Institute Fargo North Dakota
United States East Carolina University Greenville North Carolina
United States Columbia University Medical Center New York New York
United States Cornell University Medical Center New York New York
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Legacy Good Samaritan Hospital Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Sacramento Bariatric Sacramento California
United States University of Washington Seattle Washington
United States Virginia Mason Medical Center Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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