Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Anal Fistula Clinical Trial

Official title:

Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450671
• Other study ID #: Seton vs. Surgisis
• Secondary ID: HS-06-00342
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: March 15, 2017
• Start date: February 2007
• Est. completion date: May 9, 2013

Study information

• Verified date: March 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue).

Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method.

The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 9, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group

2. Patients that are older than 18 years of age and are able to understand and sign consent

3. Patients that are suitable candidates for either seton or collagen plug placement

Exclusion Criteria:

1. 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

2. 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)

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Collagen Plug Placement

• Seton placement

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

Champagne BJ, O'Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum. 2006 Dec;49(12):1817-21. — View Citation

Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. — View Citation

Zmora O, Neufeld D, Ziv Y, Tulchinsky H, Scott D, Khaikin M, Stepansky A, Rabau M, Koller M. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum. 2005 Dec;48(12):2167-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula healing
Primary	Treatment failure
Secondary	Time to fistula healing
Secondary	Time to treatment failure
Secondary	Rates of postoperative fecal continence

External Links

•   Am Soc Colon Rectal Surgeons - Patient information about fistula