Back to resultsChanges in Patients' Quality of Life With Differences in Seton Application
Primary Purpose
Quality of Life, Anal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Alpha type
Beta type
Comfort type
Sponsored by
About this trial
This is an interventional health services research trial for Quality of Life
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
Sites / Locations
- Ankara University School of Medicine Department of General SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Experimental
Arm Label
alpha group
Beta group
Comfort group
Arm Description
In this group, tips of the seton will be tied as alpha-shaped
The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.
Knotless seton will be applied
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05348473
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
December 12, 2022 (Anticipated)
Study Completion Date
March 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Anal Fistula
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
alpha group
Arm Type
Active Comparator
Arm Description
In this group, tips of the seton will be tied as alpha-shaped
Arm Title
Beta group
Arm Type
Sham Comparator
Arm Description
The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.
Arm Title
Comfort group
Arm Type
Experimental
Arm Description
Knotless seton will be applied
Intervention Type
Device
Intervention Name(s)
Alpha type
Intervention Description
Tips of the seton will be tied as alpha-shaped.
Intervention Type
Device
Intervention Name(s)
Beta type
Intervention Description
Tips of the seton in this group will be overlapped and tied
Intervention Type
Device
Intervention Name(s)
Comfort type
Intervention Description
Knotless seton will be applied
Primary Outcome Measure Information:
Title
Quality of life on 14th day
Description
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.
Time Frame
14th day
Title
Quality of life on 30th day
Description
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.
Time Frame
30th day
Title
Quality of life on 90th day
Description
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.
Time Frame
90th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerem MD OZGU, MD
Phone
+9005549886868
Email
drkeremozgu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet A Koç, MD
Organizational Affiliation
Ankara Üniversitesi Tıp Fakültesi
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University School of Medicine Department of General Surgery
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet A Koç, MD
Phone
+905333393608
Email
mali.koc@gmail.com
First Name & Middle Initial & Last Name & Degree
Cihangir A Akyol, MD
Phone
+905052653497
Email
cihangirakyol@gmail.com
First Name & Middle Initial & Last Name & Degree
Utku S Celik, MD
First Name & Middle Initial & Last Name & Degree
Kerem Ozgu, MD
First Name & Middle Initial & Last Name & Degree
Mehmet A Koc, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29452968
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.
Results Reference
background
PubMed Identifier
26999764
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.
Results Reference
background
PubMed Identifier
28891853
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.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.ciresp.2017.12.003
Description
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
Learn more about this trial
Changes in Patients' Quality of Life With Differences in Seton Application
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