Anal Fistula, Quality of Life
Conditions
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.
Interventions
DEVICEAlpha type
Tips of the seton will be tied as alpha-shaped.
DEVICEBeta type
Tips of the seton in this group will be overlapped and tied
DEVICEComfort type
Knotless seton will be applied
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* -Primary perianal fistula
Exclusion criteria
* Suprasphincteric fistula * Patient who had previous perianal fistula surgery * Crohn * Radiotherapy * Patient with pre-existing anal incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactKerem MD OZGU, MD
Outcome results
None listed