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

April 29, 2022 updated by: Cihangir Akyol, Ankara University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara University School of Medicine Department of General Surgery
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Utku S Celik, MD
        • Sub-Investigator:
          • Kerem Ozgu, MD
        • Sub-Investigator:
          • Mehmet A Koc, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • -Primary perianal fistula

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: alpha group
In this group, tips of the seton will be tied as alpha-shaped
Device: Alpha type
Tips of the seton will be tied as alpha-shaped.
Sham Comparator: Beta group
The tips of the seton in this group will be overlapped and tied. There is no palpable free ends.
Device: Beta type
Tips of the seton in this group will be overlapped and tied
Experimental: Comfort group
Knotless seton will be applied
Device: Comfort type
Knotless seton will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life on 14th day
Time Frame: 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
Quality of life on 30th day
Time Frame: 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
Quality of life on 90th day
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Mehmet A Koç, MD, Ankara Üniversitesi Tıp Fakültesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

December 12, 2022

Study Completion (Anticipated)

March 12, 2023

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUG-2021-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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