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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| University of Ottawa | OTHER |
| Massachusetts General Hospital | OTHER |
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Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIFT | Active Comparator | those subjects receiving the Ligation of Intersphincteric Fistula Track procedure |
|
| Plug | Active Comparator | those subjects randomized to the receive the placement of the porcine anal fistula plug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligation of intersphincteric fistula track procedure | Procedure | Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of this study will be to compare the rate of fistula closure between the ligation of the intersphincteric fistula track (LIFT) procedure and the use of a porcine bioabsorbable anal fistula plug | 1month, 3 month, 6 month, 12 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation | 1 month, 3 month, 6 month, 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deb J Jones, BS | Contact | 651-225-7830 | djones@crsal.org | |
| Rachael Peterson, BS | Contact | 651-225-7817 | rpeterson@crsal.org |
| Name | Affiliation | Role |
|---|---|---|
| Heather L Rossi, MD | University of Minnesota/Colon and Rectal Surgery Associates, Ltd. | Principal Investigator |
| Husein Moloo, MD | University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
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| anal fistula plug | Procedure | placement of the porcine anal fistula plug as per the instructions for use in product packaging |
|
| Joshua Bleier, MD |
| University of Pennsylvania Health System |
| Principal Investigator |
| Liliana Bordeianou, MD | Massachusetts General Hospital | Principal Investigator |
| Colon and Rectal Surgery Associates, Ltd | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| University of Pennsylvania Health System | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Ottawa | Not yet recruiting | Ottawa | Ontario | K1N6N5 | Canada |
|
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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