NCT05348473

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Quality of Life
• Anal Fistula

Interventions

Type	Name	Description
DEVICE	Alpha type	Tips of the seton will be tied as alpha-shaped.
DEVICE	Beta type	Tips of the seton in this group will be overlapped and tied
DEVICE	Comfort type	Knotless seton will be applied

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-12-12
• Completion: 2023-03-12
• First posted: 2022-04-27
• Last updated: 2022-05-05

Locations

1 site across 1 country: Turkey (Türkiye)