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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348473
• Other study ID #: AUG-2021-0001
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: March 12, 2023

Study information

• Verified date: April 2022
• Source: Ankara University
• Contact: Kerem MD OZGU, MD
• Phone: +9005549886868
• Email: drkeremozgu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: March 12, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• -Primary perianal fistula

Exclusion Criteria:

• Suprasphincteric fistula

• Patient who had previous perianal fistula surgery

• Crohn

• Radiotherapy

• Patient with pre-existing anal incontinence

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Quality of Life
• Rectal Fistula

Intervention

Device:
• Alpha type
Tips of the seton will be tied as alpha-shaped.
• Beta type
Tips of the seton in this group will be overlapped and tied
• Comfort type
Knotless seton will be applied

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine Department of General Surgery	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ferrer-Márquez M, Espínola-Cortés N, Reina-Duarte Á, Granero-Molina J, Fernández-Sola C, Hernández-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. — View Citation

Ferrer-Márquez M, Espínola-Cortés N, Reina-Duarte A, Granero-Molina J, Fernández-Sola C, Hernández-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Análisis y descripción de la calidad de vida específica en pacientes con fístula analAnalysis and description of disease-specific quality of life in patients with anal fistula