PCORnet® Bariatric Shared Decision-making (PBS)
PI(s):
PaTH Protocol PI(s):
Study Summary: The main goal of the proposed study is to provide accurate estimates of the one-, three-, and five-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. These include, (a) changes in weight; (b) remission and relapse of diabetes; and (c) risk of major adverse events. The main goal of this study is to provide accurate estimates of the one-, three-, and five-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. These include, (a) changes in weight; (b) remission and relapse of diabetes; and (c) risk of major adverse events.
The study will involve 10 of PCORnet®’s Clinical Research Networks (CDRNs) including 53 healthcare organizations and more than 60,000 bariatric patients, with 50% gastric bypass, 10% gastric banding, and 40% sleeve gastrectomy procedures. This study will also include more than 900 adolescent bariatric patients (the largest adolescent cohort ever) and more than 17,000 patients with diabetes.
Study Design: Obesity Observational Research Initiative
PaTH Partners:
PCORnet Partners /CDRN Participating Sites:
Sponsor: PCORI®
Coordinating Center: Group Health Cooperative