Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
NCT ID: NCT00450671
Last Updated: 2017-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2007-02-28
2013-05-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Collagen Plug Placement
Seton placement
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Andreas M Kaiser, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California Department of Colorectal Surgery
Locations
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H.Claude Hudson Comprehensive Health Center
Los Angeles, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
USC/University Hospital
Los Angeles, California, United States
Countries
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References
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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. doi: 10.1007/s10350-005-0199-1.
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. doi: 10.1007/s10350-006-0755-3.
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. doi: 10.1007/s10350-005-0288-1.
Other Identifiers
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HS-06-00342
Identifier Type: OTHER
Identifier Source: secondary_id
Seton vs. Surgisis
Identifier Type: -
Identifier Source: org_study_id
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