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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
History of Changes
  Purpose

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


Condition Intervention Phase
Anal Fistula
 Procedure: Collagen Plug Placement
Procedure: Seton placement
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Fistula healing
  • Treatment failure

Secondary Outcome Measures:
  • Time to fistula healing
  • Time to treatment failure
  • Rates of postoperative fecal continence

Estimated Enrollment: 300
Study Start Date: February 2007
Estimated Study Completion Date: February 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450671

Contacts
Contact: Andreas M Kaiser, MD (323) 865-3690 akaiser@usc.edu
Contact: Daniel Klaristenfeld, MD (323) 865-3690

Locations
United States, California
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Glenn Ault, MD     323-226-7792     ault@usc.edu    
Principal Investigator: Andreas M Kaiser, MD            
Sub-Investigator: Abier Abdelnaby, MD            
Sub-Investigator: Joseph Frankhouse, MD            
Sub-Investigator: Daniel Klaristenfeld, MD            
USC Norris Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Andreas Kaiser, MD     323-865-3690     akaiser@usc.edu    
Sub-Investigator: Daniel Klaristenfeld, MD            
Sub-Investigator: Joseph Frankhouse, MD            
Sub-Investigator: Abier Abdelnaby, MD            
Sub-Investigator: Gina Avenido, MD            
Sub-Investigator: Ester Sie, MD            
Sub-Investigator: Robert W Beart, MD            
USC/University Hospital Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Andreas M Kaiser, MD     323-865-3690     akaiser@usc.edu    
Sub-Investigator: Glenn Ault, MD            
Sub-Investigator: Daniel Klaristenfeld, MD            
Sub-Investigator: Abier Abdelnaby, MD            
Sub-Investigator: Joseph Frankhouse, MD            
Sub-Investigator: Robert W Beart, MD            
H.Claude Hudson Comprehensive Health Center Recruiting
Los Angeles, California, United States, 90007
Contact: Glenn Ault, MD     323-226-7792     ault@usc.edu    
Principal Investigator: Andreas M Kaiser, MD            
Sub-Investigator: Daniel Klaristenfeld, MD            
Sub-Investigator: Abier Abdelnaby, MD            
Sub-Investigator: Joseph Frankhouse, MD            
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Andreas M Kaiser, MD University of Southern California Department of Colorectal Surgery
  More Information

Additional Information:
Am Soc Colon Rectal Surgeons - Patient information about fistula  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00450671     History of Changes
Other Study ID Numbers: Seton vs. Surgisis
Study First Received: March 20, 2007
Last Updated: November 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Fistula-in-ano
Anal fistula
Perirectal fistula
 Collagen plug
Surgisis
Seton

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013