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Investigators aim to investigate the changes in patients' quality of life with different type of seton application.
Perianal fistula is a very common disease. Perianal fistula develops in the 50% of the anorectal abscess. Perianal fistulas are usually complications of recurrent anorectal abscesses. The management of the fistula is sometimes challenging and requires a long period of time. One of the treatment methods in perianal fistula is seton application. Seton is a rubber band made of various materials such as silicone, silk, latex, etc. It is passed through the fistula tract, and then the tips are tied to each other. Seton is usually kept there for 3 - 6 months depending on the condition of the fistula. Seton causes a foreign body reaction. After this process, there are various fistula management methods. Seton application is again one of the choices besides fistulotomy, fistulectomy, ablation methods, etc.
As seton is a frequently preferred method, patients should get used to living with seton. Severe irritation and a decrease in quality of life are observed in patients depending potentially on the seton binding methods.
Investigators aim to evaluate the seton application methods that will minimize the decrease in the quality of life in this difficult process for patients by comparing 3 different seton application methods that investigators apply in daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha group | Active Comparator | In this group, tips of the seton will be tied as alpha-shaped |
|
| Beta group | Sham Comparator | The tips of the seton in this group will be overlapped and tied. There is no palpable free ends. |
|
| Comfort group | Experimental | Knotless seton will be applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha type | Device | Tips of the seton will be tied as alpha-shaped. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life on 14th day | Quality of Life in patients with Anal Fistula Questionnaire (Qolaf-Q) will measure the quality of life in all groups. Minimum and maximum values are 17 and 85, respectively. Higher scores mean a worse outcome. | 14th day |
| Quality of life on 30th day | Quality of Life in patients with Anal Fistula Questionnaire (Qolaf-Q) will measure the quality of life in all groups. Minimum and maximum values are 17 and 85, respectively. Higher scores mean a worse outcome. | 30th day |
| Quality of life on 90th day | Quality of Life in patients with Anal Fistula Questionnaire (Qolaf-Q) will measure the quality of life in all groups. Minimum and maximum values are 17 and 85, respectively. Higher scores mean a worse outcome. | 90th day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerem MD OZGU, MD | Contact | +9005549886868 | drkeremozgu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mehmet A KoƧ, MD | Ankara Ćniversitesi Tıp Fakültesi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University School of Medicine Department of General Surgery | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29452968 | Background | Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-Padilla JM. Analysis and description of disease-specific quality of life in patients with anal fistula. Cir Esp (Engl Ed). 2018 Apr;96(4):213-220. doi: 10.1016/j.ciresp.2017.12.003. Epub 2018 Feb 13. English, Spanish. | |
| 26999764 | Background |
| Label | URL |
|---|---|
| AnĆ”lisis y descripción de la calidad de vida especĆfica en pacientes con fĆstula analAnalysis and description of disease-specific quality of life in patients with anal fistula | View source |
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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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| Beta type |
| Device |
Tips of the seton in this group will be overlapped and tied |
|
| Comfort type | Device | Knotless seton will be applied |
|
| Kristo I, Stift A, Staud C, Kainz A, Bachleitner-Hofmann T, Chitsabesan P, Riss S. The type of loose seton for complex anal fistula is essential to improve perianal comfort and quality of life. Colorectal Dis. 2016 Jun;18(6):O194-8. doi: 10.1111/codi.13335. |
| 28891853 | Background | Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-Padilla JM. Design and Psychometric Evaluation of the Quality of Life in Patients With Anal Fistula Questionnaire. Dis Colon Rectum. 2017 Oct;60(10):1083-1091. doi: 10.1097/DCR.0000000000000877. |
| 41612009 | Derived | Ozgu K, Kutlu B, Koc MA, Ersoz S, Gokmen D, Akyol C. Assessing quality of life in anal fistula patients after Seton placement using different knot types: Randomized controlled trial. Int J Colorectal Dis. 2026 Jan 29;41(1):52. doi: 10.1007/s00384-026-05099-6. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |