Proper Approach to New Bariatric Procedures
The field of bariatric surgery has advanced significantly from the days of Mason’s original gastric bypass operation. Advancement in minimally invasive surgical techniques has allowed for widespread acceptance of several bariatric procedures. Currently, the most commonly performed bariatric procedures worldwide include the laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, laparoscopic adjustable gastric banding, and biliopancreatic diversion with or without duodenal switch. As our understanding of the metabolic impact of each of these operations increases, innovators are driven to develop novel and even less invasive methods to reproduce the same results as the more traditional procedures. While innovation and development of new surgical devices and procedures are important to advance the field of bariatric surgery, a rigorous pathway of evaluation and transparent reporting is critical to obtain approval and increase its acceptance by surgeons and patients.
KeywordsBariatric surgery Novel procedures Surgical devices Treatment outcome
- 4.Stain SC, Pryor AD, Shadduck PP, editors. The SAGES manual ethics of surgical innovation. New York: Springer; 2016.Google Scholar
- 5.U.S. Food & Drug Administration. Device approvals, denials and clearances. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/. Last accessed 7 Apr 2017.
- 6.U.S. Food & Drug Administration. Device classification panels. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm. Last accessed 7 Apr 2017.
- 7.U.S. FDA. Device approvals. 2015. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm430692.htm. Last accessed 1 Apr 2017.
- 9.Ponce J, Woodman G, Swain J, Wilson E, English W, Ikramuddin S, Bour E, Edmundowicz S, Snyder B, Soto F, Sullivan S, Holcomb R, Lehmann J, REDUCE Pivotal Trial Investigators. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874–81.CrossRefPubMedGoogle Scholar
- 10.Shikora S, Toouli J, Herrera MF, Kulseng B, Zulewski H, Brancatisano R, Kow L, Pantoja JP, Johnsen G, Brancatisano A, Tweden KS, Knudson MB, Billington CJ. Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus. J Obes. 2013;2013:245683.CrossRefPubMedPubMedCentralGoogle Scholar
- 12.Ikramuddin S, Blackstone RP, Brancatisano A, Toouli J, Shah SN, Wolfe BM, Fujioka K, Maher JW, Swain J, Que FG, Morton JM, Leslie DB, Brancatisano R, Kow L, O’Rourke RW, Deveney C, Takata M, Miller CJ, Knudson MB, Tweden KS, Shikora SA, Sarr MG, Billington CJ. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA. 2014;312(9):915–22.CrossRefPubMedGoogle Scholar
- 13.American Society for Metabolic and Bariatric Surgery. Pathway for approval for new devices and procedures. Available at: https://asmbs.org/pathway-for-approval-for-new-devices-and-procedures. Last accessed 29 Mar 2017.
- 21.Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011;254(3):410–20.CrossRefPubMedPubMedCentralGoogle Scholar
- 22.Collaborative Institutional Training Initiative (CITI) Program. Good Clinical Practice (GCP). Available at: https://about.citiprogram.org/en/series/good-clinical-practice-gcp/. Last accessed 4 Apr 2017.
- 23.National Institute of Health (NIH) Office of Extramural Research. Protecting human subject research participants. Available at: https://phrp.nihtraining.com/users/login.php. Last accessed 4 Apr 2017.
- 25.Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Available at: https://www.facs.org/quality-programs/mbsaqip. Last accessed 7 Apr 2017.
- 26.U.S. Food and Drug Administration. Medical Device Reporting (MDR). Available at: https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. Last accessed 1 Apr 2017.