Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

University of Southern California

Status and phase: Completed; Phase 3

Conditions: Anal Fistula

Treatments: Procedure: Collagen Plug Placement; Procedure: Seton placement

Study type: Interventional

Funder types: Other

Identifiers

NCT00450671

HS-06-00342 (Other Identifier)

Seton vs. Surgisis

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)