Long-term Effects of Bariatric Surgery

Completed

• Conditions: Obesity

• Registration Number: NCT00465829
• Lead Sponsor: University of Pittsburgh

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-operative status

2. examining risks and benefits of surgery.

LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status.

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

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 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-04-24
• Study First Submitted QC: 2007-04-24
• Study First Posted: 2007-04-25
• Primary Completion: 2015-01
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2458

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (9)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Legacy Good Samaritan Hospital; 🇺🇸 Portland, Oregon, United States

Cornell University Medical Center; 🇺🇸 New York, New York, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Neuropsychiatric Research Institute; 🇺🇸 Fargo, North Dakota, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Washington; 🇺🇸 Seattle, Washington, United States