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
  Purpose

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


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-1)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Enrollment: 5102
Study Start Date: March 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433810

Locations
United States, California
Sacramento Bariatric
Sacramento, California, United States
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Cornell University Medical Center
New York, New York, United States, 10021
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
Oregon Health and Science University
Portland, Oregon, United States
Legacy Good Samaritan Hospital
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
Investigators
Study Chair: Bruce Wolfe, MD Oregon Health and Science University
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Bruce Wolfe, LABS Steering Committee Chair, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00433810     History of Changes
Other Study ID Numbers: DK66557 (completed), U01DK066557
Study First Received: February 9, 2007
Last Updated: December 23, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
obesity
bariatric surgery
30-day mortality

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014