Longitudinal Assessment of Bariatric Surgery

NCT ID: NCT00433810

Last Updated: 2010-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Morbid Obesity

Keywords

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obesity bariatric surgery 30-day mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Oregon Health & Science University

Principal Investigators

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Bruce Wolfe, MD

Role: STUDY_CHAIR

Oregon Health and Science University

Locations

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Sacramento Bariatric

Sacramento, California, United States

Site Status

Cornell University Medical Center

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Neuropsychiatric Research Institute

Fargo, North Dakota, United States

Site Status

Legacy Good Samaritan Hospital

Portland, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Walker E, Elman M, Takemoto EE, Fennern E, Mitchell JE, Pories WJ, Ahmed B, Pomp A, Wolfe BM. Bariatric Surgery Among Medicare Subgroups: Short- and Long-Term Outcomes. Obesity (Silver Spring). 2019 Nov;27(11):1820-1827. doi: 10.1002/oby.22613. Epub 2019 Sep 27.

Reference Type DERIVED
PMID: 31562705 (View on PubMed)

O'Rourke RW, Johnson GS, Purnell JQ, Courcoulas AP, Dakin GF, Garcia L, Hinojosa M, Mitchell JE, Pomp A, Pories WJ, Spaniolas K, Flum DR, Wahed AS, Wolfe BM. Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes. Int J Obes (Lond). 2019 Feb;43(2):285-296. doi: 10.1038/s41366-018-0088-z. Epub 2018 May 17.

Reference Type DERIVED
PMID: 29777230 (View on PubMed)

Purnell JQ, Johnson GS, Wahed AS, Dalla Man C, Piccinini F, Cobelli C, Prigeon RL, Goodpaster BH, Kelley DE, Staten MA, Foster-Schubert KE, Cummings DE, Flum DR, Courcoulas AP, Havel PJ, Wolfe BM. Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass. Diabetologia. 2018 May;61(5):1142-1154. doi: 10.1007/s00125-018-4553-y. Epub 2018 Feb 10.

Reference Type DERIVED
PMID: 29428999 (View on PubMed)

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. doi: 10.1056/NEJMoa0901836.

Reference Type DERIVED
PMID: 19641201 (View on PubMed)

Related Links

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Other Identifiers

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U01DK066557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK66557 (completed)

Identifier Type: -

Identifier Source: org_study_id