Proper Approach to New Bariatric Procedures

  • Kara J. Kallies
  • Shanu N. Kothari


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.


Bariatric surgery Novel procedures Surgical devices Treatment outcome 


  1. 1.
    Mason EE, Ito C. Gastric bypass. Ann Surg. 1969;170(3):329–39.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Ponce J, DeMaria EJ, Nguyen NT, Hutter M, Sudan R, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in 2015 and surgeon workforce in the United States. Surg Obes Relat Dis. 2016;12(9):1637–9.CrossRefPubMedGoogle Scholar
  3. 3.
    ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy, Ginsberg GG, Chand B, CotEe GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011;74(5):943–53.CrossRefGoogle Scholar
  4. 4.
    Stain SC, Pryor AD, Shadduck PP, editors. The SAGES manual ethics of surgical innovation. New York: Springer; 2016.Google Scholar
  5. 5.
    U.S. Food & Drug Administration. Device approvals, denials and clearances. Available at: Last accessed 7 Apr 2017.
  6. 6.
    U.S. Food & Drug Administration. Device classification panels. Available at: Last accessed 7 Apr 2017.
  7. 7.
  8. 8.
    Courcoulas A, Abu Dayyeh BK, Eaton L, Robinson J, Woodman G, Fusco M, Shayani V, Billy H, Pambianco D, Gostout C. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes. 2017;41(3):427–33.CrossRefGoogle Scholar
  9. 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. 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
  11. 11.
    Morton JM, Shah SN, Wolfe BM, Apovian CM, Miller CJ, Tweden KS, Billington CJ, Shikora SA. Effect of vagal nerve blockade on moderate obesity with an obesity-related comorbid condition: the ReCharge study. Obes Surg. 2016;26(5):983–9.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 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. 13.
    American Society for Metabolic and Bariatric Surgery. Pathway for approval for new devices and procedures. Available at: Last accessed 29 Mar 2017.
  14. 14.
    Stirrat GM, Farrow SC, Farndon J, Dwyer N. The challenge of evaluating surgical procedures. Ann R Coll Surg Engl. 1992;74(2):80–4.PubMedPubMedCentralGoogle Scholar
  15. 15.
    Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, Balliol Collaboration. Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097–104.CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Brethauer SA, Kim J, el Chaar M, Papasavas P, Eisenberg D, Rogers A, Ballem N, Kligman M, Kothari S, ASMBS Clinical Issues Committee. Standardized outcomes reporting in metabolic and bariatric surgery. Surg Obes Relat Dis. 2015;11(3):489–506.CrossRefPubMedGoogle Scholar
  17. 17.
    Baker MT. The history and evolution of bariatric surgical procedures. Surg Clin N Am. 2011;91(6):1181–201.CrossRefPubMedGoogle Scholar
  18. 18.
    Scopinaro N, Adami G, Marinari G, et al. Biliopancreatic diversion. World J Surg. 1998;22(9):936–46.CrossRefPubMedGoogle Scholar
  19. 19.
    Clinical Issues Committee of American Society for Metabolic and Bariatric Surgery. Sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2007;3(6):573–6.CrossRefGoogle Scholar
  20. 20.
    Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis. 2009;5(4):469–75.CrossRefPubMedGoogle Scholar
  21. 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. 22.
    Collaborative Institutional Training Initiative (CITI) Program. Good Clinical Practice (GCP). Available at: Last accessed 4 Apr 2017.
  23. 23.
    National Institute of Health (NIH) Office of Extramural Research. Protecting human subject research participants. Available at: Last accessed 4 Apr 2017.
  24. 24.
    Sachdeva AK, Russell TR. Safe introduction of new procedures and emerging technologies in surgery: education, credentialing, and privileging. Surg Clin N Am. 2007;87(4):853–66.CrossRefPubMedGoogle Scholar
  25. 25.
    Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Available at: Last accessed 7 Apr 2017.
  26. 26.
    U.S. Food and Drug Administration. Medical Device Reporting (MDR). Available at: Last accessed 1 Apr 2017.

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Medical ResearchGundersen Medical FoundationLa CrosseUSA
  2. 2.Department of General SurgeryGundersen Health SystemLa CrosseUSA

Personalised recommendations