Comparing the Benefits and Harms of Three Types of Weight Loss Surgery -- The PCORnet® Bariatric Study

Summary

The main goal of this research project is to conduct a comparative effectiveness research study involving existing data in the PCORnet Common Data Model to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures - Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus on outcomes that are important to adults and adolescents with severe obesity: 1) changes in weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.

Conditions

• Obesity
• Bariatrics
• Body Weight
• Diabetes Mellitus
• Weight Loss
• Roux-en-Y Gastric Bypass
• Gastric Bypass

Interventions

PROCEDURE

Roux-en-y gastric bypass (RYGB) - historical

Participant has had RYGB, as identified using existing data

PROCEDURE

Adjustable gastric banding (AGB) - historical

Participant has had AGB, as identified using existing data

PROCEDURE

Sleeve gastrectomy (SG) - historical

Participant has had SG, as identified using existing data

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• National Patient-Centered Clinical Research Network

  collaborator OTHER

• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)

  collaborator OTHER

• Greater Plains Collaborative Clinical Data Research Network

  collaborator OTHER

• Research Action for Health Network (REACHnet)

  collaborator OTHER

• Mid-South Clinical Data Research Network

  collaborator OTHER

• PEDSnet: A Pediatric Learning Health System CDRN

  collaborator UNKNOWN

• New York City Clinical Data Research Network

  collaborator OTHER

• OneFlorida Clinical Research Consortium

  collaborator OTHER

• The Patient-Oriented Scalable National Network for Effectiveness Research

  collaborator OTHER

• PaTH: Towards a Learning Health System Clinical Data Research Network

  collaborator UNKNOWN

• Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)

  collaborator UNKNOWN

• COPD Patient-Powered Research Network

  collaborator UNKNOWN

• Obesity Action Coalition

  collaborator UNKNOWN

• Harvard Pilgrim Health Care

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• David E. Arterburn, MD, MPH · Kaiser Permanente

• Kathleen M. McTigue, MD, MS, MPH · University of Pittsburgh

• Neely A. Williams, M.Div · Mid-South CDRN

Eligibility

Min Age

12 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-04-30

Completion

2018-04-30