Clinical trial NCT05348473: Changes in Patients' Quality of Life With Differences in Seton Application
Official title: Comparison of the Effects of Different Seton Application Techniques on the Quality of Life in the Postoperative Period in Perianal Fistula Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Anal Fistula
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* -Primary perianal fistula

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of life on 14th day
timeFrame: 14th day
measure: Quality of life on 30th day
timeFrame: 30th day
measure: Quality of life on 90th day
timeFrame: 90th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department of General Surgery
Study officials:
affiliation: Ankara Üniversitesi Tıp Fakültesi
name: Mehmet A Koç, MD
role: STUDY_DIRECTOR
References:
citation: Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-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.
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.
citation: Ferrer-Marquez M, Espinola-Cortes N, Reina-Duarte A, Granero-Molina J, Fernandez-Sola C, Hernandez-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.