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

The Primary Obesity Surgery Endolumenal (POSE) Procedure

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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.

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Acknowledgments

We thank Dror Rom, PhD, Prosoft Software, LLC (Wayne, PA), for performing the statistical analysis, and T.W. McGlennon, M3, LLC (Maiden Rock, WI) for statistical consultation. We also thank Maribel Sanchez for nutritional consultation during the study, Marta Lasaosa for administration, Sandra Andres for endoscopic nursing, Dr. Monica Prat for psychiatric consultation, and Sonia Oliva for psychological evaluation.

Disclosure

The clinical study at the Teknon site was not financially supported and was conducted independently by Teknon’s physicians. Manuscript development was supported by USGI Medical, USA. J.N. Buchwald is the director and chief scientific research writer at Medwrite LLC, a CRO under contract with USGI. Manuscript development was supported by USGI Medical, Inc.

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Authors and Affiliations

  1. Unidad de Endoscopia, Centro Médico Teknon, Vilana, 12, 08022, Barcelona, Spain

    J. C. Espinós, R. Turró, A. Mata, M. Cruz, M. da Costa, V. Villa & J. Turró

  2. Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA

    J. N. Buchwald

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  1. J. C. Espinós
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Correspondence to J. C. Espinós.

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Espinós, J.C., Turró, R., Mata, A. et al. Early Experience with the Incisionless Operating Platform™ (IOP) for the Treatment of Obesity. OBES SURG 23, 1375–1383 (2013). https://doi.org/10.1007/s11695-013-0937-8

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