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

Study Updated 03/05/2024

Study Website: The PCORnet Bariatric Study (PBS)
ClinicalTrials.gov#: NCT02741674
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: David Arterburn
Site Name: Kaiser Permanente Washington Health Research Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2016 – 2018
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Gastroenterology
Condition: Bariatrics, Body Weight, Diabetes, Gastric Bypass, Obesity
Population: up to 79 Years (Child,  Adult,  Older Adult)
Status: Completed

Research Question(s):
We don’t know much about the long-term effectiveness of bariatric interventions. Can we use PCORnet to compare compare weight loss and safety among three popular bariatric procedures?

Primary Publication(s):
Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study
Inge TH, Coley RY., Bazzano LA,. et al. Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study. SOARD, 2018, 14(9):1374-1386.

Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study
McTigue KM, Wellman R, Nauman E, et al. PCORnet Bariatric Study Collaborative. Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study. JAMA Surg. 2020;155(5):e200087. doi: 10.1001/jamasurg.2020.0087. Epub 2020 May 20. PMID: 32129809; PMCID: PMC7057171.

Gastrectomy has more favorable safety outcomes for Black and Hispanic patients—but that may not mean it’s the better weight loss surgery

The PCORnet® Bariatric Study has found that there are significant differences in safety and utilization outcomes for Black and Hispanic patients who had Roux-en-Y gastric bypass (bypass) compared with sleeve gastrectomy (gastrectomy). While weight loss and diabetes outcomes were similar across racial and ethnic groups for both bypass  and gastrectomy, Black and Hispanic patients had a greater risk of hospitalization and adverse events with bypass surgery, according to the findings published in JAMA Surgery.

However, patients and providers shouldn’t necessarily conclude that gastrectomy is a superior choice of surgery for Black and Hispanic patients, the researchers noted. In fact, previous research conducted by the PCORnet Bariatric Study team found that more patients of all races and ethnicities who had bypass kept weight off five years after surgery than those who underwent gastrectomy. Those who had bypass were also significantly less likely to see a return of obesity-related medical conditions like Type 2 diabetes. The PCORnet Bariatric Study team says that these latest findings point to disparities in pre- and post-operative care rather than differences in the procedures themselves.

“As with many health care options, no one weight-loss surgical procedure is the best choice for every patient because tradeoffs are associated with each,” said Kathleen McTigue, M.D., M.P.H., M.S. “Results of this latest research should serve as a wake-up call for the medical community to identify and eliminate the barriers to safe bariatric surgery so that Black and Hispanic patients have the same experience as others.”

A continuation of important work

The PCORnet Bariatric Study was originally launched in 2016 as a retrospective, observational comparative effectiveness study designed to capture accurate estimates of 1-, 3-, and 5-year benefits and risk of bariatric surgery. Using PCORnet resources, the study team collaborated with 25 health care systems across the U.S. for insights related to more than 60,000 patients.

Of the original 60,000, 36,871 patients who underwent a primary bypass or sleeve gastrectomy between 2005 and 2015 were included in the current study.

“PCORnet has established partnerships across the nation’s leading health systems that allowed us to conduct bariatric research at the largest scale to date with patient data that is secure and fully de-identified,” Kathleen McTigue, M.D., M.P.H., M.S. “Bariatric procedures are only continuing to rise, and patients deserve a complete picture of what to expect. This research is an important piece of that puzzle, and we are looking forward to unlocking more insights in the months to come.”

Results from PCORnet® Bariatric Study Published in JAMA Surgery

There were no differences in all-cause mortality between patients who had sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB), but operations, hospitalizations, and other longer-term problems were more often associated with RYGB than sleeve gastrectomy, according to a new JAMA Surgery paper reporting results from the PCORnet® Bariatric Study.

The paper describes how researchers used resources from PCORnet, the National Patient-Centered Clinical Research Network, to build a diverse cohort of over 33,000 patients who underwent one of these two different types of bariatric surgery. Researchers were able to investigate the rates of longer-term problems up to five years after patients had their bariatric surgeries.

In an audio interview, study author Anita Courcoulas, MD, MPH, FACS, said that this research was different from past studies in that, by using PCORnet, researchers were able to leverage real-world clinical data from electronic health records and link that data to insurance claims data and other sources.

This information will help guide patients and their doctors in making important decisions about bariatric surgery as they weigh the rates of potential risks associated with each procedure and the average amount of weight loss produced by each, she noted. Study findings on how much weight patients lost and kept off were published in an earlier paper in the Annals of Internal Medicine.

Courcoulas also discussed the important role that bariatric patients, including co-investigator Neely Williams helped in shaping and guiding the study at every step.