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| ID | Type | Description | Link |
|---|---|---|---|
| HS-06-00342 | Other Identifier | USC IRB |
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The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Plug Placement | Procedure | |||
| Seton placement | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula healing | ||
| Treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fistula healing | ||
| Time to treatment failure | ||
| Rates of postoperative fecal continence |
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Inclusion Criteria:
Exclusion Criteria:
Preoperative patient exclusion factors:
Intraoperative patient exclusion factors:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas M Kaiser, MD | University of Southern California Department of Colorectal Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H.Claude Hudson Comprehensive Health Center | Los Angeles | California | 90007 | United States | ||
| Los Angeles County-USC Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16258708 | Background | 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. | |
| 17082891 | Background |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Los Angeles |
| California |
| 90033 |
| United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| USC/University Hospital | Los Angeles | California | 90033 | United States |
| 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. |
| 16421664 | Background | 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. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |