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| ID | Type | Description | Link |
|---|---|---|---|
| KEK-ZH-Nr. 2013-XYZ | Other Identifier | Cantonal Ethical Committee Canton of Zurich |
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The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.
A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recurrent anal fistula | Active Comparator | Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap |
|
| No recurrence of anal fistula | Active Comparator | Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anal Fistula Plug | Procedure | Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anal fistula recurrence rate | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | In-hospital costs. Typically 1 to 3 days of hospitalization | 3 days |
| Complication rate | Classified according to the Clavien-Dindo Classification of Surgical Complications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver M Fisher, MD | University of Zurich | Principal Investigator |
| Antonio Nocito, MD | University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19733880 | Background | Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6. | |
| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| Endorectal Advancement Flap | Procedure | Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap |
|
|
| 3 days |
| Length of hospital stay | Typically 1 to 3 days of hospitalization. | 3 days |
| Independent factors predicting fistula recurrence | Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management. | One year |
| Independent factors predicting higher costs | Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management. | One year |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |