Longitudinal Assessment of Bariatric Surgery (LABS-1)

Longitudinal Assessment of Bariatric Surgery (LABS-1)

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 5102

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States
      • Sacramento Bariatric
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Cornell University Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • North Dakota
    • Fargo, North Dakota, United States, 58107
      • Neuropsychiatric Research Institute
  • Oregon
    • Portland, Oregon, United States
      • Oregon Health and Science University
    • Portland, Oregon, United States
      • Legacy Good Samaritan Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98195
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Chair: Bruce Wolfe, MD, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Study web site

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 9, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 23, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; 30-day mortality
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: DK66557 (completed); U01DK066557 (U.S. NIH Grant/Contract)