Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00450671
First received: March 20, 2007
Last updated: November 25, 2008
Last verified: March 2007

March 20, 2007
November 25, 2008
February 2007
Not Provided
  • Fistula healing
  • Treatment failure
Same as current
Complete list of historical versions of study NCT00450671 on ClinicalTrials.gov 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2012
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)
Both
18 Years and older
No
Contact: Andreas M Kaiser, MD (323) 865-3690 akaiser@usc.edu
Contact: Daniel Klaristenfeld, MD (323) 865-3690
United States
 
NCT00450671
Seton vs. Surgisis
Yes
Not Provided
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 2007

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