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In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 4weeks | Active Comparator | Duration of placed seton 4 weeks |
|
| Group 12weeks | Active Comparator | Duration of placed seton 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placement of non-cutting seton (silicone) | Procedure | Treatment of Fistula in ano is conducted according to the institution's treatment guidelines. Silicon seton placement is conducted under general anesthesia. Identification of the FIA is secured by the insertion of a bulb-headed lacrimal probe, on which a silicon vessel loop is attached and pulled through the entire fistulous tract. In case of a perianal abscess, drainage and sphincter-sparing debridement is performed followed by secondary wound healing. The loop is ligated loosely outside the anus without any additional tension to the skin. Duration of placed seton is depending on group assignment and is set to either 4 or 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent fistula in ano | 6 months after initial surgery | |
| Recurrent perianal abscess | 6 months after initial surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Diez, MD | Contact | 004991318532923 | sonja.diez@uk-erlangen.de | |
| Manuel Besendörfer, MD | Contact | 004991318532923 | manuel.besendoerfer@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Diez, MD | Friedrich-Alexander-Universität Erlangen-Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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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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| ID | Term |
|---|---|
| D012828 | Silicones |
| ID | Term |
|---|---|
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
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Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks
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Masking is not possible due to study design.
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|
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046911 |
| Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |