Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Completed · Phase 3

Conditions studied: Anal Fistula

In brief

The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

Key facts

Study ID

NCT00450671

Run by

University of Southern California

People needed

300

Starts

2007-02-01

Expected to finish

2013-05-09

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• H.Claude Hudson Comprehensive Health Center — Los Angeles, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• USC/University Hospital — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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