Changes in Patients' Quality of Life With Differences in Seton Application

Study Overview
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Brief Summary
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Investigators aim to investigate the changes in patients' quality of life with different type of seton application.

Detailed Description
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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.

Official Title
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Comparison of the Effects of Different Seton Application Techniques on the Quality of Life in the Postoperative Period in Perianal Fistula Disease

Conditions
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Quality of Life, Anal Fistula

Intervention / Treatment
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* Device: Alpha type
* Device: Beta type
* Device: Comfort type


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Primary perianal fistula Exclusion Criteria: Suprasphincteric fistula Patient who had previous perianal fistula surgery Crohn Radiotherapy Patient with pre-existing anal incontinence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alpha group<br>In this group, tips of the seton will be tied as alpha-shaped | Device: Alpha type<br>* Tips of the seton will be tied as alpha-shaped.<br>|
| Sham Comparator: Beta group<br>The tips of the seton in this group will be overlapped and tied. There is no palpable free ends. | Device: Beta type<br>* Tips of the seton in this group will be overlapped and tied<br>|
| Experimental: Comfort group<br>Knotless seton will be applied | Device: Comfort type<br>* Knotless seton will be applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |