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The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated for a anorectal fistula | Patients who were treated for a anorectal fistula with a Biodesign Fistula plug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Biodesign® Fistula Plug | Device | The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fistula closure | Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.
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| Name | Affiliation | Role |
|---|---|---|
| Adal Saeed, MD | St Josef's Hospital, Wiesbaden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville School of Medicine | Louisville | Kentucky | 40202 | United States | ||
| Our Lady of the Lake Regional Medical Center |
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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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| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| University Surgical Associates | Providence | Rhode Island | 02904 | United States |
| St Josef's Hospital | Wiesbaden | 65189 | Germany |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |