Over 15 million Americans now have severe obesity, i.e. a body-mass index (BMI) ?35 kg/m2. Patients with severe obesity have 5-times higher prevalence of type 2 diabetes, and twice the annual medical costs of those with normal body weights. Bariatric surgery is the most effective treatment for severe obesity, but is invasive, costly, and associated with short and longer-term complications. The vertical sleeve gastrectomy (VSG) is a newer bariatric procedure that has substantially increased in use recently, now accounting for approximately half of procedures worldwide. However, very little is known about longer-term outcomes after VSG, including the durability of its impact on diabetes, and its potential for reducing cardiovascular morbidity and mortality. Of particular importance for patients considering surgery, the risks and benefits of VSG compared to the ?gold standard? gastric bypass (RYGB) procedure are not well understood. The proposed study will use a nationwide commercial insurance claims dataset to evaluate clinical and health care use outcomes among over 10,000 patients undergoing VSG, compared to 10,000 patients undergoing RYGB, between 2005 and 2017, with up to 8 years of post-operative follow-up. Rigorous observational study designs with propensity-score matching will be used to compare the effect of VSG and RYGB on: clinical outcomes, including diabetes remission and relapse, myocardial infarction, stroke and death; health care use outcomes including emergency department visits, hospital days, and reoperation or revisional surgery; and health care costs including standardized total, prescription and out-of-pocket costs. Furthermore, to assist with procedure selection, exploratory analyses will investigate the optimal surgical type for patients with certain key characteristics (e.g. by age group, diabetes severity). To minimize risk of confounding by indication, cutting-edge propensity-score matching algorithms will be employed and rigorous longitudinal designs such as interrupted time series and survival analysis will be constructed. This will be the largest claims-based comparative study of these two procedures, with potential to significantly impact clinical practice in bariatric surgery. Findings could inform more evidence-based practice and facilitate shared clinical decision-making by improving the ability of patients and surgeons to select a surgical approach that is optimized to patients? preferred health outcomes and personal characteristics.

Public Health Relevance

Bariatric surgery is the most effective available treatment for severe obesity and diabetes, but it is invasive and can result in complications. Severe obesity is becoming more common in the United States, so a rising number of patients may be considering these procedures. The proposed study will compare health outcomes after two types of bariatric surgery: gastric bypass and sleeve gastrectomy. The results of this study will help patients and their surgeons make more informed and personalized decisions between these two surgeries.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
1R01DK112750-01
Application #
9275700
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Unalp-Arida, Aynur
Project Start
2017-09-01
Project End
2022-06-30
Budget Start
2017-09-01
Budget End
2018-06-30
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Harvard Pilgrim Health Care, Inc.
Department
Type
DUNS #
071721088
City
Boston
State
MA
Country
United States
Zip Code
02215