Comparing the Benefits and Harms of Three Types of Weight Loss Surgery: The PCORnet Bariatric Study
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Abstract
Study 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.
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The use of bariatric surgery as a treatment for severe obesity has increased dramatically over the past two decades, but there have been few high-quality, long-term studies comparing the outcomes of different procedures. Prior studies have also not been large enough to examine differences in outcomes across important patient subgroups, including older adults (>65 years of age) and racial/ethnic minorities. Research on the outcomes of adolescent bariatric surgery is even more limited and mostly consists of studies of short duration. More studies are needed in larger, more broadly representative samples to help inform patient and provider decisions about the optimal choice of bariatric surgical procedure in various populations.
The goal of the 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: 1) changes in weight, 2) rates of remission and relapse of diabetes, and 3) risk of major adverse events.
The study also had two additional goals: 1) the development of infrastructure - in the form of study processes and procedures - to support future comparative effectiveness studies using the PCORnet distributed research network, and 2) the identification of patient preferences and opinions about (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and © the delivery of follow-up care after bariatric surgery through a series of focus groups involving adults and children with severe obesity. Patients and other stakeholders have been fully engaged in the development of this proposal and engaged in all stages of the protocol development, including formulating the research questions, selecting outcomes that are of interest to the study population, identifying methods to address these outcomes, monitoring study conduct, and designing and implementing dissemination plans.
Cohort Description
Bariatric procedures were identified from over 100 million patient records in 41 health systems from the 11 clinical data research networks DRNs. For each patient, their first observed bariatric procedure in the data set was considered the index procedure; index procedures had to occur in inpatient or ambulatory care encounters. The following were excluded:
- Patients aged less than 12 years and those aged greater than or equal to 80 years at the index procedure.
- Individuals with different bariatric procedure codes on the same day.
- Individuals with any revision bariatric procedure code, gastrointestinal cancer diagnosis code, or fundoplasty procedure in the year before the index procedure.
- Individuals with any emergency department encounter on the day of the index procedure.
- Patients without BMI data and those without a BMI of greater than or equal to 35 in the year before their procedure.
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