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Published in: Obesity Surgery 9/2013

01-09-2013 | Original Contributions

Early Experience with the Incisionless Operating Platform™ (IOP) for the Treatment of Obesity

The Primary Obesity Surgery Endolumenal (POSE) Procedure

Authors: J. C. Espinós, R. Turró, A. Mata, M. Cruz, M. da Costa, V. Villa, J. N. Buchwald, J. Turró

Published in: Obesity Surgery | Issue 9/2013

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Abstract

Background

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).

Methods

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.

Results

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.

Conclusions

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.
Literature
1.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
2.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
3.
go back to reference Kissane NA, Pratt JS. Medical and surgical treatment of obesity. Best Pract Res Clin Anaesthesiol. 2011;25(1):11–25.PubMedCrossRef Kissane NA, Pratt JS. Medical and surgical treatment of obesity. Best Pract Res Clin Anaesthesiol. 2011;25(1):11–25.PubMedCrossRef
4.
go back to reference 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 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
5.
go back to reference 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 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
7.
go back to reference Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–37.PubMedCrossRef Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–37.PubMedCrossRef
8.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
9.
go back to reference Gastrointestinal Surgery for Severe Obesity. NIH Consensus Statement. 1991;9(1):1–20. Gastrointestinal Surgery for Severe Obesity. NIH Consensus Statement. 1991;9(1):1–20.
10.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
11.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
12.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
13.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
14.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
15.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
16.
go back to reference Swanstrom LL, Dunst C, Whiteford M, Hungness E, Soper NJ. Initial experience with NOTES transgastric cholecystectomy. Surg Endosc. 2008;Apr Suppl:S034. Swanstrom LL, Dunst C, Whiteford M, Hungness E, Soper NJ. Initial experience with NOTES transgastric cholecystectomy. Surg Endosc. 2008;Apr Suppl:S034.
17.
go back to reference 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 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
18.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
19.
go back to reference 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, 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
20.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
21.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
22.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
23.
go back to reference 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 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
24.
go back to reference Mearin F, Malagelada J-R. upper gut motility and perception in functional dyspepsia. Eur J Gastroentero Hepatol. 1992;4:615–21. Mearin F, Malagelada J-R. upper gut motility and perception in functional dyspepsia. Eur J Gastroentero Hepatol. 1992;4:615–21.
25.
go back to reference 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.PubMed 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.PubMed
26.
go back to reference Schwizer W, Steingötter A, Fox M, et al. Non-invasive measurement of gastric accommodation in humans. Gut. 2002;51(Suppl I):i59–62.PubMedCrossRef Schwizer W, Steingötter A, Fox M, et al. Non-invasive measurement of gastric accommodation in humans. Gut. 2002;51(Suppl I):i59–62.PubMedCrossRef
27.
go back to reference Jones KL et al. Relation between postprandial satiation and antral area in normal subjects. Am J Clin Nutr. 1997;66(1):127–32.PubMed Jones KL et al. Relation between postprandial satiation and antral area in normal subjects. Am J Clin Nutr. 1997;66(1):127–32.PubMed
28.
go back to reference Gleysteen JJ. Gastric emptying of liquids after different vagotomies and pyloroplasty. Surg Gynecol Obstet. 1976;142(1):41–8.PubMed Gleysteen JJ. Gastric emptying of liquids after different vagotomies and pyloroplasty. Surg Gynecol Obstet. 1976;142(1):41–8.PubMed
29.
go back to reference 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. General requirements. International Standard Ref. ISO 14155–1:2003(E).
30.
go back to reference 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. 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.
31.
go back to reference 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. 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.
32.
go back to reference WHO. Obesity: preventing and managing the global epidemic. Report of a WHO Consultation on Obesity, Geneva, June 1997. Geneva, Switzerland: WHO; 1998. WHO. Obesity: preventing and managing the global epidemic. Report of a WHO Consultation on Obesity, Geneva, June 1997. Geneva, Switzerland: WHO; 1998.
33.
go back to reference 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 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
34.
go back to reference 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, 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.
35.
go back to reference 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. 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.
36.
go back to reference 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. 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.
37.
go back to reference Dixon JB, McPhail T, O’Brien PE. Minimal reporting requirements for weight loss: current methods not ideal. Obes Surg. 2005;15(7):1034–9.PubMedCrossRef Dixon JB, McPhail T, O’Brien PE. Minimal reporting requirements for weight loss: current methods not ideal. Obes Surg. 2005;15(7):1034–9.PubMedCrossRef
38.
go back to reference Metropolitan Height and Weight Tables, 1993. Metropolitan Life Foundation. Stat Bull. 1983;64(1):2–9. Metropolitan Height and Weight Tables, 1993. Metropolitan Life Foundation. Stat Bull. 1983;64(1):2–9.
39.
go back to reference 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 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
40.
go back to reference 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 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
41.
go back to reference Sharma M. Behavioural interventions for preventing and treating obesity in adults. Obes Rev. 2007;8:441–9.PubMedCrossRef Sharma M. Behavioural interventions for preventing and treating obesity in adults. Obes Rev. 2007;8:441–9.PubMedCrossRef
42.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
43.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
44.
go back to reference Abu Dayyeh BK, Thompson CC. Obesity and bariatrics for the endoscopist: new techniques. Ther Adv Gastroenterol. 2011;4(6):433–42.CrossRef Abu Dayyeh BK, Thompson CC. Obesity and bariatrics for the endoscopist: new techniques. Ther Adv Gastroenterol. 2011;4(6):433–42.CrossRef
45.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
46.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
47.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
48.
go back to reference Thompson SK, Chang EY, Jobe BA. Clinical review: healing in gastrointestinal anastomoses, part I. Microsurgery. 2006;26:131–6.PubMedCrossRef Thompson SK, Chang EY, Jobe BA. Clinical review: healing in gastrointestinal anastomoses, part I. Microsurgery. 2006;26:131–6.PubMedCrossRef
49.
go back to reference Thorton FJ, Barbul A. Healing in the gastrointestinal tract. Surg Clin North Am. 1997;77:549–73.CrossRef Thorton FJ, Barbul A. Healing in the gastrointestinal tract. Surg Clin North Am. 1997;77:549–73.CrossRef
50.
go back to reference Schroder W, Stippel D, Gutschow C, et al. Post-operative recovery of microcirculation after gastric tube formation. Langenbecks Arch Surg. 2004;389:267–71.PubMedCrossRef Schroder W, Stippel D, Gutschow C, et al. Post-operative recovery of microcirculation after gastric tube formation. Langenbecks Arch Surg. 2004;389:267–71.PubMedCrossRef
51.
go back to reference Seaman DL, Gostout CJ, de la Mora Levy JG, et al. Tissue anchors for transmural gut-wall apposition. Gastrointest Endosc. 2006;64:577–81.PubMedCrossRef Seaman DL, Gostout CJ, de la Mora Levy JG, et al. Tissue anchors for transmural gut-wall apposition. Gastrointest Endosc. 2006;64:577–81.PubMedCrossRef
Metadata
Title
Early Experience with the Incisionless Operating Platform™ (IOP) for the Treatment of Obesity
The Primary Obesity Surgery Endolumenal (POSE) Procedure
Authors
J. C. Espinós
R. Turró
A. Mata
M. Cruz
M. da Costa
V. Villa
J. N. Buchwald
J. Turró
Publication date
01-09-2013
Publisher
Springer US
Published in
Obesity Surgery / Issue 9/2013
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-013-0937-8

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