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Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

This study is currently recruiting participants.
Verified by University of Southern California, March 2007

Sponsored by: University of Southern California
Information provided by: University of Southern California
ClinicalTrials.gov Identifier: NCT00450671
  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 III

MedlinePlus related topics:   Fistulas   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study

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) 865-3677     akaiser@usc.edu    
Contact: Daniel Klaristenfeld, MD     (323) 865-3677     klariste@usc.edu    

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     323-865-3677     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     323-865-3677     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


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

Publications:
Zmora O, Neufeld D, Ziv Y, Tulchinsky H, Scott D, Khaikin M, Stepansky A, Rabau M, Koller M. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum. 2005 Dec;48(12):2167-72.
 
Champagne BJ, O'Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum. 2006 Dec;49(12):1817-21.
 
Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6.
 

Study ID Numbers:   Seton vs. Surgisis
First Received:   March 20, 2007
Last Updated:   March 20, 2007
ClinicalTrials.gov Identifier:   NCT00450671
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

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Fistula
Intestinal Diseases
Rectal Diseases
Fistula

Additional relevant MeSH terms:
Digestive System Fistula

ClinicalTrials.gov processed this record on September 19, 2008

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