#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Innovative Bariatric Procedures and Ethics in Bariatric Surgery: the IFSO Position Statement


Authors: Ashraf Haddad 1;  Lilian Kow 2;  Miguel F. Herrera 3;  Ricardo V. Cohen 4;  Jacques Himpens 5;  Jan Willem Greve 6;  Scott Shikora 7
Authors‘ workplace: Minimally Invasive & Bariatric Surgery, Gastrointestinal Bariatric and Metabolic Center (GBMC), Jordan Hospital, Ammán, Jordánsko 1;  Flinders University, Bedford Park, Austrálie 2;  Endocrine and Bariatric Surgery, UNAM at INCMNSZ, Mexico City, Mexiko 3;  The Centre for the Treatment of Obesity and Diabetes Hospital Oswaldo Cruz, Sao Paulo, Brazílie 4;  Delta CHIREC Hospital, Brusel, Belgie 5;  Research School NUTRIM and Department of Surgery Zuyderland Medical Center, Maastricht University Medical Center, Heerlen, Nizozemsko 6;  Center for Metabolic and Bariatric Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA 7
Published in: Čas. Lék. čes. 2022; 161: 285-295
Category: Guidelines

Overview

With the rise in obesity and bariatric procedures worldwide, there has been a surge in new and innovative procedures that has been increasingly offered to patients. In this position statement, IFSO highlights the importance of surgical ethics in innovation and when offering new procedures. Furthermore, the task force reviewed the current literature to describe which procedures can be offered as mainstream outside research protocols versus those that are still investigational and need further data.


Sources
  1. Angrisani L, Santonicola A, Iovino P et al. Bariatric surgery survey 2018: similarities and disparities among the 5 IFSO chapters. Obes Surg 2021; 31: 1937–1948.
  2. Cardenas D. Surgical ethics: a framework for surgeons, patients, and society. Rev Col Bras Cir 2020; 15: e20202519.
  3. Angelos P. Ethics and surgical innovation: challenges to the professionalism of surgeons. Int J Surg 2013; 11 (Suppl. 1): S2–5.
  4. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human subjects or Research. Dostupné na: www.hhs.gov/ohrp/regulations-and-policy
  5. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191–2194.
  6. Levine RJ. New international ethical guidelines for research involving human subjects. Ann Intern Med 1993; 119: 340–351.
  7. Health & Medicine, Technology, Business, Oct 25, 2011.
  8. Enfield KB, Truwit JD. The purpose, composition, and function of an institutional review board: balancing priorities. Respir Care 2008; 53: 1330–1336.
  9. Lapid MI, Clarke BL, Wright RS. Institutional Review Boards: what clinician researchers need to know. Mayo Clin Proc 2019; 94: 515–525.
  10. Blenkinsopp A. From compliance to concordance: how are we doing? Int J Pharm Pract 2001; 9: 65–66.
  11. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999; 49: 651–661.
  12. Raper SE, Sarwer DB. Informed consent issues in the conduct of bariatric surgery. Surg Obes Relat Dis 2008; 4: 60–68.
  13. Wee Ch C, Pratt JS. Fanelli R et al. Best practice updates for informed consent and patient education in weight loss surgery. Obesity 2012; 17: 885–888.
  14. Kaufman AS, McNelis J, Slevin M, La Marca C. Bariatric surgery claims—a medico-legal perspective. Obes Surg 2006; 16: 1555–1558.
  15. Heerman WJ, White RO, Barkin SL. Advancing informed consent for vulnerable populations. Pediatrics 2015; 135: e562–e564.
  16. Weithorn LA, Campbell SB. The competency of children and adolescents to make informed treatment decisions. Child Dev 1982; 53: 1589–1598.
  17. Kuther TL, Posada M. Children and adolescents' capacity to provide informed consent for participation in research. Adv Psychol Res 2004; 32: 163–173.
  18. Maddern G. The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) assesses new surgeries. Aust Health Rev 2004; 28: 143–144.
  19. The Practice Committee of the American Society for Reproductive Medicine. Definition of "experimental procedures". Fertil Steril 2009; 92(5): 1517.
  20. Ashton CM, Wray NP, Jarman AF et al. Ethics and methods in surgical trials. J Med Ethics 2009; 35: 579–583.
  21. McCambridge J, Sorhaindo A, Quirk A, Nanchahal K. Patient preferences and performance bias in a weight-loss trial with a usual care arm. Patient Educ Couns 2014; 95: 243–247.
  22. Broekman ML, Carrière ME, Bredenoord AL. Surgical innovation: the ethical agenda: a systematic review. Medicine (Baltimore) 2016; 95: e3790.
  23. Halverson JD, Wise L, Wazna MF, Ballinger WF. Jejunoileal bypass for morbid obesity. A critical appraisal. Am J Med 1978; 64: 461–475.
  24. Griffen WO Jr, Young VL, Stevenson CC. A prospective comparison of gastric and jejunoileal bypass procedures for morbid obesity. Ann Surg 1977; 186: 500–509.
  25. Mason EE, Ito C. Gastric bypass in obesity. Surg Clin North Am 1967; 47: 1345–1351.
  26. Abu Dayyeh BK, Edmundowicz S, Thompson CC. Clinical Practice Update: Expert Review on Endoscopic Bariatric Therapies. Gastroenterology 2017; 152: 716–729.
  27. Brown WA, Ponce de Leon-Ballesteros G, Ooi G et al. Single anastomosis duodenal-ileal bypass with sleeve gastrectomy/one anastomosis duodenal switch (SADI-S/OADS). IFSO Position Statement – update 2020. Obes Surg 2021; 31: 3–25.
  28. Robert M, Espalieu P, Pelascini E et al. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet 2019; 393: 1299–1309
  29. De Luca M, Tie T, Ooi G et al. Mini gastric bypass-one anastomosis gastric bypass (MGB-OAGB)-IFSO position statement. Obes Surg 2018; 28: 1188–1206.
  30. De Luca M, Piatto G, Merola G et al. IFSO update position statement on one anastomosis gastric bypass (OAGB). Obes Surg 2021; 31: 3251–3278.
  31. Aleman R, Lo Menzo E, Szomstein S, Rosenthal RJ. Efficiency and risks of one-anastomosis gastric bypass. Ann Transl Med 2020; 8 (Suppl. 1): S7.
  32. da Silva LE, Alves MM, El-Ajouz TK et al. Laparoscopic Sleeve-Collis-Nissen gastroplasty: a safe alternative for morbidly obese patients with gastroesophageal reflux disease. Obes Surg 2015; 25: 1217–1222.
  33. Del Genio G, Tolone S, Gambardella C et al. Sleeve gastrectomy and anterior fundoplication (D-SLEEVE) prevents gastroesophageal reflux in symptomatic GERD. Obes Surg 2020; 30: 1642–1652.
  34. Crawford C, Gibbens K, Lomelin D et al. Sleeve gastrectomy and anti-reflux procedures. Surg Endosc 2017; 31: 1012–1021.
  35. Aiolfi A, Micheletto G, Marin J et al. Laparoscopic sleeve-fundoplication for morbidly obese patients with gastroesophageal reflux: systematic review and meta-analysis. Obes Surg 2021; 31: 1714–1721.
  36. Carandina S, Zulian V, Nedelcu A et al. Is it safe to combine a fundoplication to sleeve gastrectomy? Medicina (Kaunas) 2021; 57: 392.
  37. Khazzaka A, Sarkis R. Fundoplication combined with mediogastric plication. Surg Obes Relat Dis 2013; 9: 398–403.
  38. Lee WJ, Han ML, Ser KH et al. Laparoscopic Nissen fundoplication with gastric plication as a potential treatment of morbidly obese patients with GERD, first experience and results. Obes Surg 2014; 24: 1447–1452.
  39. Talha A, Ibrahim M. Laparoscopic Nissen fundoplication plus mid-gastric plication for treatment of obese patients with gastroesophageal reflux disease. Obes Surg 2018; 28: 437–443.
  40. Ospanov O, Maleckas A, Orekeshova A. Gastric greater curvature plication combined with Nissen fundoplication in treating gastroesophageal reflux disease and obesity. Medicina (Kaunas) 2016; 52: 283–290.
  41. Ivano FH, Mesquita LP, Simamura CM et al. Pre and postoperative pH monitoring and weight loss analysis in patients undergoing gastric plication in association with fundoplication. Arq Bras Cir Dig 2017; 30: 244–247.
  42. Herron DM. Comment on: fundoplication combined to a medio-gastric plication. Surg Obes Relat Dis 2013; 9: 403–404.
  43. Santoro S, Castro LC, Velhote MCP et al. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg 2012; 256: 104–110.
  44. Bilecik T. Metabolic effects of sleeve gastrectomy with transit bipartition in obese females with type 2 diabetes mellitus: results after 1 year follow-up. Obes Surg 2019; 29: 805–810.
  45. Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: a novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep 2014; 5: 56–58.
  46. Mahdy T, Al Wahedi A, Schou C. Efficacy of single anastomosis sleeve ileal (SASI) bypass for type-2 diabetic morbid obese patients: gastric bipartition, a novel metabolic surgery procedure: a retrospective cohort study. Int J Surg 2016; 34: 28–34.
  47. Mahdy T, Gado W, Alwahidi A et al. Sleeve gastrectomy, one-anastomosis gastric bypass (OAGB), and single anastomosis sleeve ileal (SASI) bypass in treatment of morbid obesity: a retrospective cohort study. Obes Surg 2021; 31: 1579–1589.
  48. Emile SH, Mahdy T, Schou C et al. Systematic review of the outcome of single-anastomosis sleeve ileal (SASI) bypass in treatment of morbid obesity with proportion meta-analysis of improvement in diabetes mellitus. Int J Surg 2021; 92: 104–110.
  49. Kasama K, Tagaya N, Kanehira E et al. Laparoscopic sleeve gastrectomy with duodeno-jejunal bypass: technique and preliminary results. Obes Surg 2009; 19: 1341–1345.
  50. Seki Y, Kasama K, Umezawa A et al. Laparoscopic sleeve gastrectomy with duodenojejunal bypass for type 2 diabetes mellitus. Obes Surg 2016; 26: 2035–2044.
  51. Seki Y, Kasama K, Haruta H  et al. Five-year-results of laparoscopic sleeve gastrectomy with duodenojejunal bypass for weight loss and type 2 diabetes mellitus. Obes Surg 2017; 3: 795–801.
  52. Praveen Raj P, Kumaravel R, Chandramaliteeswaran C et al. Is laparoscopic duodenojejunal bypass with sleeve an effective alternative to Roux-en-Y gastric bypass in morbidly obese patients: preliminary results of a randomized trial. Obes Surgery 2012; 22: 422–426.
  53. Lee WJ, Almulaifi AM, Tsou J-J et al. Duodenal–jejunal bypass with sleeve gastrectomy versus the sleeve gastrectomy procedure alone: the role of duodenal exclusion. Surg Obes Relat Dis 2015; 11: 765–770.
  54. Naitoh T, Kasama K, Seki Y et al. Efficacy of sleeve gastrectomy with duodenal-jejunal bypass for treating obese severe diabetes patients in Japan: a retrospective multicenter study. Obes Surg 2018; 28: 497–505.
  55. Melissas J, Peppe A, Askoxilakis et al. Sleeve gastrectomy plus side-to-side jejunoileal anastomosis for the treatment of morbid obesity and metabolic diseases: a promising operation. Obes Surg 2012; 22: 1104–1109.
  56. Hassn A, Luhmann A, Rahmani S, Morris-Stiff G. Medium-term results of combined laparoscopic sleeve gastrectomy and modified jejuno-ileal bypass in bariatric surgery. Obes Surg 2016; 26: 2316–2323.
  57. Singh D, Laya AS, Clarkston WK, Allen MJ. Jejunoileal bypass: a surgery of the past and a review of its complications. World J Gastroenterol 2009; 15: 2277–2279.
  58. Cohen R, Caravatto PP, Petry T. Metabolic surgery for type 2 diabetes in patients with a BMI of <35 kg/m2: A Surgeon’s Perspective. Obes Surg 2013; 23: 809–818.
  59. DePaula AL, Macedo AL, Mota BR, Schraibman V. Laparoscopic ileal interposition associated to a diverted sleeve gastrectomy is an effective operation for the treatment of type 2 diabetes mellitus patients with BMI 21–29. Surg Endosc 2009; 23: 1313–1320.
  60. Celik A, Ugale S, Ofluoglu H et al. Technical feasibility and safety profile of laparoscopic diverted sleeve gastrectomy with ileal transposition (DSIT). Obes Surg 2015; 25: 1184–1190.
  61. Tinoco A, El-Kadre L, Aquiar L et al. Short-term and mid-term control of type 2 diabetes mellitus by laparoscopic sleeve gastrectomy with ileal interposition. World J Surg 2011; 35: 2238–2244.
  62. de Paula AL, Macedo AL, Prudente AS et al. Laparoscopic sleeve gastrectomy with ileal Interposition ("neuroendocrine brake") – pilot study of a new operation. Surg Obes Relat Dis 2006; 2: 464–467.
  63. Celik A, Cagiltay E, Ugale S et al. Diverted sleeve gastrectomy with ileal transposition in overweight, obese, and morbidly obese patients with type 2 diabetes: results of 1-year follow-up. Surg Obes Relat Dis 2016; 12: 541–549.
  64. Inabnet WB. Comment on: Prospective randomized controlled trial comparing 2 versions of laparoscopic ileal Interposition associated with sleeve gastrectomy for patients with type 2 diabetes with BMI 21–34 kg/m2. Surg Obes Relat Dis 2010; 6: 304–305.

Originální publikace

Haddad A, Kow L, Herrera MF et al. Innovative Bariatric Procedures and Ethics in Bariatric Surgery: the IFSO Position Statement. Obes Surg 2022 Oct; 32: 3217–3230, doi: 10.1007/s11695-022-06220-8.

Labels
Addictology Allergology and clinical immunology Angiology Audiology Clinical biochemistry Dermatology & STDs Paediatric gastroenterology Paediatric surgery Paediatric cardiology Paediatric neurology Paediatric ENT Paediatric psychiatry Paediatric rheumatology Diabetology Pharmacy Vascular surgery Pain management Dental Hygienist

Article was published in

Journal of Czech Physicians

Issue 7-8

2022 Issue 7-8

Most read in this issue
Topics Journals
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#