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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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.
Diseases of the Colon and Rectum 2014 May
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/m) 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.
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/m) 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.
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