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

Ankara University

Status: Unknown

Conditions: Quality of Life; Anal Fistula

Treatments: Device: Comfort type; Device: Beta type; Device: Alpha type

Study type: Interventional

Funder types: Other

Identifiers

NCT05348473

AUG-2021-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• -Primary perianal fistula

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

alpha group

Active Comparator group

Description:

In this group, tips of the seton will be tied as alpha-shaped

Treatment:

Device: Alpha type

Beta group

Sham Comparator group

Description:

The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.

Treatment:

Device: Beta type

Comfort group

Experimental group

Description:

Knotless seton will be applied

Treatment:

Device: Comfort type