Changes in Patients' Quality of Life With Differences in Seton Application
NCT ID: NCT05348473
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
63 participants
INTERVENTIONAL
2021-07-12
2023-03-12
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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alpha group
In this group, tips of the seton will be tied as alpha-shaped
Alpha type
Tips of the seton will be tied as alpha-shaped.
Beta group
The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.
Beta type
Tips of the seton in this group will be overlapped and tied
Comfort group
Knotless seton will be applied
Comfort type
Knotless seton will be applied
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient who had previous perianal fistula surgery
* Crohn
* Radiotherapy
* Patient with pre-existing anal incontinence
18 Years
65 Years
ALL
Yes
Sponsors
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Ankara University
OTHER
Responsible Party
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Cihangir Akyol
Associate Professor
Principal Investigators
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Mehmet A Koç, MD
Role: STUDY_DIRECTOR
Ankara Üniversitesi Tıp Fakültesi
Locations
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Ankara University School of Medicine Department of General Surgery
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
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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
Other Identifiers
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AUG-2021-0001
Identifier Type: -
Identifier Source: org_study_id
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