Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

March 15, 2017 updated by: University of Southern California

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fistula healing
Treatment failure

Secondary Outcome Measures

Outcome Measure
Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Andreas M Kaiser, MD, University of Southern California Department of Colorectal Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion

December 7, 2022

Study Completion (Actual)

May 9, 2013

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seton vs. Surgisis
  • HS-06-00342 (Other Identifier: USC IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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