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Longitudinal Assessment of Bariatric Surgery (LABS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00433810
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : December 24, 2010
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Pittsburgh

Study Description
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Brief Summary:
The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

Condition or disease
Morbid Obesity

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 5102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-1)
Study Start Date : March 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All eligible bariatric surgery candidates at the participating LABS clinical sites.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433810


Locations
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United States, California
Sacramento Bariatric
Sacramento, California, United States
United States, New York
Cornell University Medical Center
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58107
United States, Oregon
Legacy Good Samaritan Hospital
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: Bruce Wolfe, MD Oregon Health and Science University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Bruce Wolfe, LABS Steering Committee Chair, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00433810    
Other Study ID Numbers: DK66557 (completed)
U01DK066557 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010
Keywords provided by University of Pittsburgh:
obesity
bariatric surgery
30-day mortality
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight