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Parastomal Reinforcement With Strattice
Not Recruiting
Trial ID: NCT00771407
Purpose
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Official Title
A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies
Stanford Investigator(s)
Andrew A. Shelton, MD, FACS, FACRS
Clinical Professor, Surgery - General Surgery
Eligibility
Inclusion Criteria:
* adults
* need for permanent ileostomy or colostomy
Exclusion Criteria:
* history of hernia at new ostomy site
* has previously implanted surgical mesh at site of planned ostomy
* requires a temporary ostomy
* has need for multiple ostomies
* is receiving chronic immunosuppression therapy, has MELD score of \> 17, has severe COPD, systemic infection, or known collagen disorder
* is bedridden or otherwise non-ambulatory
Intervention(s):
other: Standard ostomy creation
device: Strattice Reconstructive Matrix
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Moe Jalali
6507244023