Clinical trial NCT00450671: Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
Official title: Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anal Fistula
Keywords: Fistula-in-ano
Anal fistula
Perirectal fistula
Collagen plug
Surgisis
Seton
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fistula healing
measure: Treatment failure
Secondary outcomes:
measure: Time to fistula healing
measure: Time to treatment failure
measure: Rates of postoperative fecal continence
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: H.Claude Hudson Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/University Hospital
state: California
Study officials:
affiliation: University of Southern California Department of Colorectal Surgery
name: Andreas M Kaiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s10350-005-0199-1.
citation: 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. doi: 10.1007/s10350-006-0755-3.
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. doi: 10.1007/s10350-005-0288-1.