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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| University Hospital, Linkoeping | OTHER |
| Region Örebro County | OTHER |
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The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.
Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advancement flap surgery | Active Comparator |
| |
| Collagen plug | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anal fistula treatment | Procedure | A comparison of collagen plug vs advancement flap surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anorectal fistula closing rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Oresland, M.D., Ph.D. | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lorenskog | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28489253 | Derived | Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10. |
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| ID | Term |
|---|---|
| D011167 | Portacaval Shunt, Surgical |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
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| D013504 | Cardiovascular Surgical Procedures |