Histopathological Assessment of Staple Line Reinforcement Materials in a Porcine Model (original) (raw)

2016, Surgery for Obesity and Related Diseases

Background: 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 not been sufficiently large to examine differences in outcomes across important patient subgroups, including older adults (4¼65 years of age) and racial/ ethnic minorities. Bariatric surgery outcomes research is limited and consists of studies with limited follow-up duration. More studies are needed in larger, broadly representative samples to help inform patient and provider decisions about the optimal choice of bariatric surgical procedure in various populations. Methods: The study's main goal is to provide accurate estimates of the one-, three-, and five-year benefits and risks of the three most common bariatric procedures in the United States today-Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomywith 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 has two additional goals: 1) the identification of patient preferences and opinions about (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) the delivery of follow-up care after bariatric surgery to be studied through a series of focus groups involving adults and children with severe obesity, and 2) the development of infrastructure-in the form of study processes and procedures-to support future comparative effectiveness studies using the National Patient-Centered Clinical Research Network (PCORnet). The study will demonstrate the PCORnet distributed research network's capacity to efficiently use electronic health records data from across the country to answer clinically-relevant questions. Patients and other stakeholders have been engaged in the development of the research questions, the selection of outcomes and the design of the study protocol, and will be engaged in all stages of the research moving forward, including protocol development, monitoring study conduct, and designing and implementing dissemination plans. Results: This study involves 11 of PCORnet's Clinical Data Research Networks (CDRNs) including 56 healthcare organizations across the United States and more than 60,000 patients who have previously undergone bariatric surgery from 2005-2015, with approximately 50 percent gastric bypass, 10 percent gastric banding, and 40 percent sleeve gastrectomy procedures. There is also large geographic variation in the bariatric procedures performed, with some areas dominated by gastric bypass while others are dominated by sleeve gastrectomy. This study includes more than 900 adolescent bariatric patients (the largest adolescent cohort ever) and more than 17,000 adult patients with diabetes. The study will take place in 2016-2017, with final results of all study aims anticipated by January 2018. Conclusions: This study is particularly timely because the sleeve gastrectomy procedure has rapidly grown in popularity in the United States (introduced in the late 2000s as a stand-alone procedure, it currently represents more than 50 percent of all procedures in our 11 PCORnet CDRNs), yet it lacks long-term data comparing its outcomes to the more well-established procedures. Apart from its size and geographic diversity, another key feature of the study is the depth and diversity of its stakeholder involvement, which includes several patients as study team members and executive stakeholder advisors, multiple pediatric and adult bariatric surgeons from different institutions, primary care and specialty physicians, researchers, and leaders of patient-level policy and