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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Anal Fistula

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Fistula healing

Principal Investigator

Andreas M Kaiser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California Department of Colorectal Surgery

Authority:

United States: Institutional Review Board

Study ID:

Seton vs. Surgisis

NCT ID:

NCT00450671

Start Date:

February 2007

Completion Date:

February 2012

Related Keywords:

  • Anal Fistula
  • Fistula-in-ano
  • Anal fistula
  • Perirectal fistula
  • Collagen plug
  • Surgisis
  • Seton
  • Fistula
  • Rectal Fistula

Name

Location
USC Norris Cancer Center Los Angeles, California  90033
Los Angeles County-USC Medical Center Los Angeles, California  90033
USC/University Hospital Los Angeles, California  90033
H.Claude Hudson Comprehensive Health Center Los Angeles, California  90007