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Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450671
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):
University of Southern California

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

Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: Collagen Plug Placement Procedure: Seton placement Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
Study Start Date : February 2007
Actual Study Completion Date : May 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Collagen

Primary Outcome Measures :
  1. Fistula healing
  2. Treatment failure

Secondary Outcome Measures :
  1. Time to fistula healing
  2. Time to treatment failure
  3. Rates of postoperative fecal continence

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450671

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United States, California
H.Claude Hudson Comprehensive Health Center
Los Angeles, California, United States, 90007
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
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
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Principal Investigator: Andreas M Kaiser, MD University of Southern California Department of Colorectal Surgery
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Responsible Party: University of Southern California Identifier: NCT00450671    
Other Study ID Numbers: Seton vs. Surgisis
HS-06-00342 ( Other Identifier: USC IRB )
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern California:
Anal fistula
Perirectal fistula
Collagen plug
Additional relevant MeSH terms:
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Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases