NCT00433810

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,102

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

2.8 years

First QC Date

February 9, 2007

Last Update Submit

December 23, 2010

Conditions

Morbid Obesity

Keywords

obesitybariatric surgery30-day mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible bariatric surgery candidates at the participating LABS clinical sites.

You may qualify if:

  • All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.

You may not qualify if:

  • Patients who do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sacramento Bariatric

Sacramento, California, United States

Location

Cornell University Medical Center

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Neuropsychiatric Research Institute

Fargo, North Dakota, 58107, United States

Location

Legacy Good Samaritan Hospital

Portland, Oregon, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (4)

  • 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.

    PMID: 31562705DERIVED

  • 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.

    PMID: 29777230DERIVED

  • 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.

    PMID: 29428999DERIVED

  • 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.

    PMID: 19641201DERIVED

Related Links

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce Wolfe, MD

    Oregon Health and Science University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 12, 2007

Study Start

March 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 24, 2010

Record last verified: 2010-12

Locations

US(10)