Pilot Study Evaluating the Efficacy of AlloMEM(tm) in Prevention of Intraperitoneal Adhesions and Peritoneal Regeneration after Loop Ileostomy

Deborah S Keller, MD, Brad J Champagne, MD, Sharon L Stein, MD, Bridget O Ermlich, RN, MSN, Conor P Delaney, MD, MCh, PhD

University Hospitals-Case Medical Center

Objective: 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, 10 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 grading scale.

Results: The mean BMI was 31 (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 minutes (SD 12.0). The adhesion score was a mean 2 (SD 1.01) at the subcutaneous level and 1.7 (SD 1.29) at the fascial level. At the intra-abdominal points, the mean score was .54 (SD .44). The mean adhesive score for the points surrounding the ileostomy were .36 (SD .35). The areas with the most pronounced adhesions were the medial (1.7) and inferior (1.6) subcutaneous locations, and the inferior fascia (1.7). The median hospital length of stay was 2.6 days (range, 2-3). A single adverse event related to product packaging led to re-design 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 and easy to use in this pilot study. Comparative research is needed to assess the outcomes with this novel product.

Session: Poster Presentation

Program Number: P038

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