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

Not Applicable

• Conditions: Quality of Life; Anal Fistula
• Interventions: Device: Alpha type; Device: Beta type; Device: Comfort type

• Registration Number: NCT05348473
• Lead Sponsor: Ankara University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2022-03-20
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12-12
• Study Completion: 2023-03-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• -Primary perianal fistula

Exclusion Criteria

• Suprasphincteric fistula
• Patient who had previous perianal fistula surgery
• Crohn
• Radiotherapy
• Patient with pre-existing anal incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha group	Alpha type	In this group, tips of the seton will be tied as alpha-shaped
Beta group	Beta type	The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.
Comfort group	Comfort type	Knotless seton will be applied

Primary Outcome Measures

Name	Time	Method
Quality of life on 14th day	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.
Quality of life on 30th day	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.
Quality of life on 90th day	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.

Trial Locations

Locations (1)

Ankara University School of Medicine Department of General Surgery; 🇹🇷 Ankara, Turkey