Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450671
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):
University of Southern California

March 20, 2007
March 22, 2007
March 17, 2017
February 2007
Not Provided
  • Fistula healing
  • Treatment failure
Same as current
Complete list of historical versions of study NCT00450671 on Archive Site
  • Time to fistula healing
  • Time to treatment failure
  • Rates of postoperative fecal continence
Same as current
Not Provided
Not Provided
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anal Fistula
  • Procedure: Collagen Plug Placement
  • Procedure: Seton placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 9, 2013
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Seton vs. Surgisis
HS-06-00342 ( Other Identifier: USC IRB )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of Southern California
University of Southern California
Not Provided
Principal Investigator: Andreas M Kaiser, MD University of Southern California Department of Colorectal Surgery
University of Southern California
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP