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A Prospective, Multicenter, Randomized, Controlled Study of Non-cross-linked Porcine Acellular Dermal Matrix Fascial Sublay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

Fleshman, James W. M.D.1; Beck, David E. M.D.2; Hyman, Neil M.D.3; Wexner, Steven D. M.D.4; Bauer, Joel M.D.5; George, Virgilio M.D.6; the PRISM Study Group

Diseases of the Colon & Rectum: May 2014 - Volume 57 - Issue 5 - p 623–631
doi: 10.1097/DCR.0000000000000106
Original Contributions: Benign Colorectal Disease

BACKGROUND: A large proportion of patients with a colostomy or an ileostomy develop parastomal hernias. The placement of a reinforcing material at the stoma site may reduce parastomal hernia incidence.

OBJECTIVE: We aimed to assess the safety and efficacy of stoma reinforcement with sublay placement of non-cross-linked porcine-derived acellular dermal matrix at the time of stoma construction.

DESIGN: This is a randomized, patient- and third-party assessor-blind, controlled trial.

SETTINGS: This study took place in colorectal/general surgery institutions.

INTERVENTIONS: Patients were prospectively randomly assigned to undergo standard end-stoma construction with or without porcine-derived acellular dermal matrix reinforcement.

PATIENTS: Patients undergoing construction of a permanent stoma were eligible. A total of 113 patients (59 men, 54 women; mean age, 60 years; mean BMI, 25.4 kg/m2) participated: 58 controls and 55 with reinforcement.

MAIN OUTCOMES MEASURES: The incidence of parastomal hernia, safety, and stoma-related quality of life were assessed.

RESULTS: Intraoperative complications and blood loss were similar between groups. Quality-of-life scores were similar through 24 months of follow-up. At 24 months of follow-up, the incidence of parastomal hernias was similar for both groups (12.2% of the porcine-derived acellular dermal matrix group and 13.2% of controls).

LIMITATIONS: Study limitations include the inclusion of ileostomy and colostomy patients, open and laparoscopic techniques, and small numbers of patients at follow-up.

CONCLUSIONS: Safety and quality-of-life data from this randomized control trial show similar outcomes in both groups. Prosthetic reinforcement of stomas was safe, but it did not significantly reduce the incidence of parastomal hernia formation.

Clinical Trial Registration: Identification no. NCT00771407.

1Department of Surgery, Baylor University Medical Center, Dallas, Texas

2Department of Colon and Rectal Surgery, Ochsner Clinic, New Orleans, Louisiana

3University of Vermont, College of Medicine, Burlington, Vermont

4Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, Florida

5Department of Surgery, Mt. Sinai Hospital, New York, New York

6Department of Surgery, Indiana University, Indianapolis, Indiana

* See alphabetical listing at end of article.

Funding/Support: This work was funded by LifeCell Corporation, Branchburg, NJ. Editorial assistance was provided by Peloton Advantage, LLC, Parsippany, NJ, and was funded by LifeCell Corporation.

Financial Disclosures: Dr Wexner has received honoraria and grants from LifeCell Corporation, Branchburg, NJ. Dr Beck has received an honorarium and a grant from LifeCell Corporation. Dr Fleshman has received research funding from LifeCell Corporation. The remaining authors report no financial disclosures.

Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Vancouver, BC, Canada, May 14 to 18, 2011. Podium presentation at the meeting of The American Society of Colon and Rectal Surgeons, Phoenix, AZ, April 27 to May 1, 2013.

Correspondence: David E. Beck, M.D., Ochsner Clinic Foundation, 1514 Jefferson Hwy, New Orleans, LA 70121. E-mail: dbeck@ochsner.org.

© 2014 The American Society of Colon and Rectal Surgeons