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Pilot study evaluating the efficacy of AlloMEM™ for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy

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Abstract

Objective This study was designed to evaluate the feasibility of AlloMEM™, a novel lyophililzed human peritoneal membrane, at peritoneal reconstitution, and decreasing adhesion formation after temporary loop ileostomy.

Methods In a pilot study, ten patients had AlloMEM™ used during elective formation of a temporary diverting loop ileostomy for benign or malignant colorectal disease. A blinded investigator and the operating surgeon analyzed the change in adhesion formation and peritoneal remodelling using ileostomy mobilization time and a 5-point adhesion scale grading intra-abdominally and at the subcutaneous and fascial levels.

Results The mean body mass index was 31 [standard deviation (SD) 5.6], and 40 % of patients had previous abdominal surgery. Ileostomies were reversed after a mean 14 weeks (SD 6.0). The mean ileostomy mobilization time was 27.2 min (SD 12.0). From baseline to ileostomy reversal, there were significant increases in adhesions at the subcutaneous (p = 0.0002) and fascial levels (p = 0.0024). The increased subcutaneous adhesions were associated with improved peritoneal remodeling. There was no significant increase in adhesions from baseline to ileostomy reversal at the intra-abdominal points (p = 0.9393) or around the ileostomy site (p = 0.6128). The median hospital length of stay was 2.6 days (range, 2–3). A single adverse event related to product packaging led to redesign of the packaging process.

Conclusions Use of AlloMEM™ in ileostomy closures suggested improvement in adhesions around the fascia and promotion of peritoneal remodeling. AlloMEM™ was safe, feasible, and easy to use in this pilot study. Comparative research is needed to assess the outcomes with this novel product.

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Acknowledgments

This IRB-approved clinical study (ClinicalTrials.gov Identifier: NCT01113736) was cosponsored by Proxy Biomedical Limited (exclusive distributor of AlloMEM™) and Community Tissue Services (tissue bank processor of AlloMEM™).

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The authors have no disclosure.

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Authors and Affiliations

  1. Division of Colorectal Surgery, Department of Surgery, Institute for Surgery and Innovation, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Avenue, 7 Lakeside, Cleveland, OH, 44106-5047, USA

    Deborah S. Keller, Bradley J. Champagne, Sharon L. Stein, Bridget O. Ermlich & Conor P. Delaney

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  1. Deborah S. Keller
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  2. Bradley J. Champagne
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  3. Sharon L. Stein
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  4. Bridget O. Ermlich
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  5. Conor P. Delaney
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Correspondence to Deborah S. Keller.

Additional information

Poster Presentation, SAGES 2013 Annual Conference, Baltimore, MD.

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Keller, D.S., Champagne, B.J., Stein, S.L. et al. Pilot study evaluating the efficacy of AlloMEM™ for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy. Surg Endosc 27, 3891–3896 (2013). https://doi.org/10.1007/s00464-013-3004-6

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  • DOI: https://doi.org/10.1007/s00464-013-3004-6

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