©2024 Stanford Medicine
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