Early Experience with the Incisionless Operating Platform™ (IOP) for the Treatment of Obesity
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We report our initial experience and 6-month outcomes in a single center using the per-oral Incisionless Operating Platform™ (IOP) (USGI Medical) to place transmural plications in the gastric fundus and distal body using specialized suture anchors (the Primary Obesity Surgery Endolumenal [POSE] procedure).
A prospective observational study was undertaken with institutional Ethics Board approval in a private hospital in Barcelona, Spain. Indicated patients were WHO obesity class I–II, or III, where patients refused a surgical approach.
Between February 28, 2011 and March 23, 2012, the POSE procedure was successfully performed in 45 patients: 75.6 % female; mean age 43.4 ± 9.2 SD (range 21.0–64.0). At baseline: mean absolute weight (AW, kg), 100.8 ± 12.9 (75.5–132.5); body mass index (BMI, kg/m2), 36.7 ± 3.8 (28.1–46.6). A mean 8.2 suture-anchor plications were placed in the fundus, 3.0 along the distal body wall. Mean operative time, 69.2 ± 26.6 min (32.0–126.0); patients were discharged in <24 h. Six-month mean AW was 87.0 ± 10.3 (68.0–111.5); BMI decreased 5.8 to 31.3 ± 3.3 (25.1–38.6) (p < 0.001); EWL was 49.4 %; TBWL, 15.5 %. No mortality or operative morbidity. Minor postoperative side effects resolved with treatment by discharge. Patients reported less hunger and earlier satiety post procedure. Liquid intake began 12 h post procedure with full solids by 6 weeks.
At 6-month follow-up of a prospective case series, the POSE procedure appeared to provide safe and effective weight loss without the scarring, pain, and recovery issues of open and laparoscopic bariatric surgery. Long-term follow-up and further study are required.
- Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567–76. CrossRef
- Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366(17):1577–85. CrossRef
- Kissane NA, Pratt JS. Medical and surgical treatment of obesity. Best Pract Res Clin Anaesthesiol. 2011;25(1):11–25. CrossRef
- Karlsson J, Taft C, Ryden A, et al. Ten-year trends in health related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes. 2007;31:1248–61. CrossRef
- Dixon JB, Strauss BJ, Laurie C, et al. Changes in body composition with weight loss: obese subjects randomized to surgical and medical programs. Obesity (Silver Spring, MD). 2007;15:1187–98. CrossRef
- World Health Organization. Obesity and overweight—fact sheet No. 311. 2006. Accessible at: http://www.who.int/mediacentre/factsheets/fs311/en/index.html. Accessed September 25, 2012.
- Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–37. CrossRef
- Nguyen NT, Silver M, Robinson M, et al. Result of a national audit of bariatric surgery performed at academic centers: a 2004 University Health System Consortium Benchmarking Project. Arch Surg. 2006;141:445–9. CrossRef
- Gastrointestinal Surgery for Severe Obesity. NIH Consensus Statement. 1991;9(1):1–20.
- Martin M, Beekley A, Kjorstad R, et al. Socioeconomic disparities in eligibility and access to bariatric surgery: a national population-based analysis. Surg Obes Relat Dis. 2010;6(1):8–15. CrossRef
- Rattner D, Kalloo A, SAGES/ASGE Working Group on Natural Orifice Translumenal Endoscopic Surgery. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery: 2005. Surg Endosc. 2006;20:329–33. CrossRef
- Swanstrom LL, Kozarek R, Pasricha PJ, et al. Development of a new access device for transgastric surgery. J Gastrointest Surg. 2005;9:1129–36. discussion 1136–7. CrossRef
- Bardaro SJ, Swanström L. Development of advanced endoscopes for Natural Orifice Transluminal Endoscopic Surgery (NOTES). Minim Invasive Ther Allied Technol. 2006;15(6):378–83. CrossRef
- Mellinger JD, MacFadyen BV, Kozarek RA, et al. Initial experience with a novel endoscopic device allowing intragastric manipulation and plication. Surg Endosc. 2007;21(6):1002–5. CrossRef
- Horgan S, Thompson K, Talamini M, et al. Clinical experience with a multifunctional, flexible surgery system for endolumenal, single port and NOTES procedures. Surg Endosc. 2011;25(2):586–92. CrossRef
- Swanstrom LL, Dunst C, Whiteford M, Hungness E, Soper NJ. Initial experience with NOTES transgastric cholecystectomy. Surg Endosc. 2008;Apr Suppl:S034.
- Sclabas G, Swain P, Swanstrom LL. Endolumenal therapy for gastrotomy closure in natural orifice transenteric surgery (NOTES). Surg Innovation. 2006;13(1):23–30. CrossRef
- Raman SR, Holover S, Garber S. Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula. Surg Obes Relat Dis. 2011;7:304–8. CrossRef
- Ryou M, Swanstrom L, Mullady D, et al. Gastric pouch and stoma reduction using a novel endosurgical operating platform. Surg Obes Relat Dis. 2008;6:358–62. CrossRef
- Ryou M, Mullady DK, Lautz DB, et al. Pilot study evaluating technical feasibility and early outcomes of second-generation endosurgical platform for treatment of weight regain after gastric bypass surgery. Surg Obes Relat Dis. 2009;5(4):450–4. CrossRef
- Herron DM, Birkett DH, Thompson CC, et al. Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc. 2008;22(4):1093–9. CrossRef
- Horgan S, Jacobsen G, Weiss GD, et al. Incisionless revision of post Roux-en-Y bypass stomal and pouch dilatation: multi-center registry results. Surg Obes Relat Dis. 2010;6(3):290–5. CrossRef
- Borao F, Gorcey S, Capuano A. Prospective single-site case series utilizing an endolumenal tissue anchoring system for revision of post-RYGB stomal and pouch dilatation. Surg Endosc. 2010;29(9):2308–13. CrossRef
- Mearin F, Malagelada J-R. upper gut motility and perception in functional dyspepsia. Eur J Gastroentero Hepatol. 1992;4:615–21.
- Geliebter A, Schachter S, Lohmann-Walter C, et al. Reduced stomach capacity in obese subjects after dieting. Am J Clin Nutr. 1996;63:170–3.
- Schwizer W, Steingötter A, Fox M, et al. Non-invasive measurement of gastric accommodation in humans. Gut. 2002;51(Suppl I):i59–62. CrossRef
- Jones KL et al. Relation between postprandial satiation and antral area in normal subjects. Am J Clin Nutr. 1997;66(1):127–32.
- Gleysteen JJ. Gastric emptying of liquids after different vagotomies and pyloroplasty. Surg Gynecol Obstet. 1976;142(1):41–8.
- Clinical investigation of medical devices for human subjects – Part 1. General requirements. International Standard Ref. ISO 14155–1:2003(E).
- Clinical investigation of medical devices for human subjects – Part 1. Clinical investigation plans. International Standard Ref. ISO 14155–2:2003(E). 1st edition 2003-05-15.
- World Medical Association (WMA). Declaration of Helsinki—ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, amended by the 59th WMA General Assembly, Seoul, October 2008. World Med J. 2008;54(4):122–5.
- WHO. Obesity: preventing and managing the global epidemic. Report of a WHO Consultation on Obesity, Geneva, June 1997. Geneva, Switzerland: WHO; 1998.
- Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastroint Endosc. 2010;71(3):446–54. CrossRef
- Buchwald H, Buchwald JN. Evolution of surgery for morbid obesity. In: Pitombo C, Jones KB, Higa KD, Pareja JC, editors. Obesity surgery: principles and practice. New York: McGraw-Hill Medical; 2007. p. 3–14.
- Buchwald H, Estok R, Fahrbach K, et al. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. 632. 2007;142(4):621. discussion 632–5.
- Nguyen N, Nguyen B, Nguyen VQ, Ziogas A, Hohmann S, Stamos MJ. Outcomes of bariatric surgery performed at accredited vs nonaccredited centers. J AM Coll Surg. 2012. Published online June 25. In press.
- Dixon JB, McPhail T, O’Brien PE. Minimal reporting requirements for weight loss: current methods not ideal. Obes Surg. 2005;15(7):1034–9. CrossRef
- Metropolitan Height and Weight Tables, 1993. Metropolitan Life Foundation. Stat Bull. 1983;64(1):2–9.
- American Society for Bariatric Surgery Standards Committee, 2004–2005. Guidelines for weight calculations and follow-up in bariatric surgery. Surg Obes Rel Dis. 2005;1:67–8. CrossRef
- American Society for Gastrointestinal Endoscopy and the American Society for Metabolic and Bariatric Surgery Task Force on Endoscopic Therapy. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011;74(5):943–53. CrossRef
- Sharma M. Behavioural interventions for preventing and treating obesity in adults. Obes Rev. 2007;8:441–9. CrossRef
- Tsai AG, Wadden TA. Treatment of obesity in primary care practice in the United States: a systematic review. J Gen Intern Med. 2009;24(9):1073–9. CrossRef
- Garb J, Welch G, Zagarins S, et al. Bariatric surgery for the treatment of morbid obesity: a meta-analysis of weight loss outcomes for laparoscopic adjustable gastric banding and laparoscopic gastric bypass. Obes Surg. 2009;19(10):1447–55. CrossRef
- Abu Dayyeh BK, Thompson CC. Obesity and bariatrics for the endoscopist: new techniques. Ther Adv Gastroenterol. 2011;4(6):433–42. CrossRef
- De Jong K, Mathus-Vliegen EM, Veldhuyzen EA, et al. Short-term safety and efficacy of the trans-oral endoscopic restrictive implant system for the treatment of obesity. Gastrointest Endosc. 2010;72:497–504. CrossRef
- Gersin KS, Rothstein RI, Rosenthal RJ, et al. Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointest Endosc. 2010;71:976–82. CrossRef
- Schouten R, Rijs CS, Bouvy ND, et al. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010;251(2):236–43. CrossRef
- Thompson SK, Chang EY, Jobe BA. Clinical review: healing in gastrointestinal anastomoses, part I. Microsurgery. 2006;26:131–6. CrossRef
- Thorton FJ, Barbul A. Healing in the gastrointestinal tract. Surg Clin North Am. 1997;77:549–73. CrossRef
- Schroder W, Stippel D, Gutschow C, et al. Post-operative recovery of microcirculation after gastric tube formation. Langenbecks Arch Surg. 2004;389:267–71. CrossRef
- Seaman DL, Gostout CJ, de la Mora Levy JG, et al. Tissue anchors for transmural gut-wall apposition. Gastrointest Endosc. 2006;64:577–81. CrossRef
- Early Experience with the Incisionless Operating Platform™ (IOP) for the Treatment of Obesity
Volume 23, Issue 9 , pp 1375-1383
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
- Additional Links
- Primary Obesity Surgery Endolumenal (POSE)
- Incisionless Operating Platform (IOP)
- Weight loss
- Industry Sectors
- Author Affiliations
- 1. Unidad de Endoscopia, Centro Médico Teknon, Vilana, 12, 08022, Barcelona, Spain
- 2. Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA