Status:
COMPLETED
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
Lead Sponsor:
University of Southern California
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
Detailed Description
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, t...
Eligibility Criteria
Inclusion
- Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
- Patients that are older than 18 years of age and are able to understand and sign consent
- Patients that are suitable candidates for either seton or collagen plug placement
Exclusion
- Preoperative patient exclusion factors:
- Pregnant patients
- Patients with a tumor-related fistula
- Patients with known allergies to porcine products
- Patients with known Crohn's disease
- Intraoperative patient exclusion factors:
- Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery
- Patients with a large diameter fistula (\>3mm)
- Patients with a superficial fistula
- Patients with a short fistula (\<1 cm in length)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 9 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00450671
Start Date
February 1 2007
End Date
May 9 2013
Last Update
March 17 2017
Active Locations (4)
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1
H.Claude Hudson Comprehensive Health Center
Los Angeles, California, United States, 90007
2
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
3
USC Norris Cancer Center
Los Angeles, California, United States, 90033
4
USC/University Hospital
Los Angeles, California, United States, 90033