Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula (SETon PROM)

September 10, 2026 updated by: semra demirli atici, Acibadem Kent Hospital

Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula: Protocol for the SETon PROM Prospective Self-Controlled Cohort Study

This prospective, single-center, self-controlled pilot cohort study evaluates whether loose seton biomaterial is associated with patient-reported outcomes in adults with recurrent or persistent complex cryptoglandular anal fistula.

Participants with an existing polypropylene loose seton who require seton replacement as part of routine clinical management will be prospectively enrolled. The decision to replace the seton will be made by the treating colorectal surgeon independently of study participation. No seton replacement or additional surgical procedure will be performed solely for research purposes.

Patient-reported outcomes will be assessed immediately before replacement while the polypropylene loose seton remains in place and will be reassessed at 4 and 12 weeks after replacement with a braided polyester loose seton. The primary outcome is the within-participant change in disease-specific quality of life measured using the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q). Secondary outcomes include perianal pain, anal continence, patient comfort, foreign-body awareness, hygiene burden, anal discharge, interference with daily activities, patient satisfaction, analgesic use, and treatment-related adverse events.

The study uses a within-participant design in which each participant serves as their own control. As a pilot study, it will also evaluate recruitment, retention, questionnaire completion, protocol adherence, and outcome variability to inform the design of a future multicenter prospective study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The SETon PROM Study is an investigator-initiated, prospective, single-center, self-controlled pilot cohort study designed to investigate the association between loose seton biomaterial and patient-reported outcomes during prolonged treatment of recurrent or persistent complex cryptoglandular anal fistula.

The study will enroll consecutive eligible adults who already have a polypropylene loose seton in situ and for whom replacement of the existing seton with a braided polyester loose seton has been determined to be clinically indicated as part of routine care. The clinical decision to replace the seton will be made before enrollment and independently of participation in the study. The study therefore does not assign participants to a treatment or require seton replacement for research purposes.

Each participant will serve as their own control. Baseline patient-reported outcomes will be collected immediately before seton replacement while the polypropylene seton remains in situ and will reflect the participant's experience during the preceding two weeks. The same outcome measures will subsequently be collected at 4 and 12 weeks after placement of the braided polyester loose seton.

Surgical technique, perioperative management, postoperative instructions, and follow-up procedures will be standardized to reduce variability unrelated to the seton biomaterial. Any additional intraoperative procedures, protocol deviations, complications, unplanned healthcare use, or changes in treatment strategy will be prospectively documented.

The study is intended to generate preliminary estimates of within-participant changes in patient-reported outcomes and to assess the feasibility of this prospective self-controlled design. The findings will be used to inform the methodology and sample-size planning of a future multicenter prospective comparative study.

Study Type

Observational

Enrollment (Estimated)

50

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients with recurrent or persistent complex cryptoglandular anal fistula who present to a tertiary referral colorectal surgery center with an existing polypropylene loose seton and for whom replacement with a braided polyester loose seton is clinically indicated as part of routine management will be screened for eligibility. Participants must have clinically stable disease without acute perianal sepsis requiring emergency intervention and must be able to complete patient-reported outcome questionnaires. Eligible patients providing written informed consent will be prospectively enrolled.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Recurrent or persistent complex cryptoglandular anal fistula
  • Existing polypropylene loose seton in situ
  • Clinically indicated replacement of the polypropylene loose seton with a braided polyester loose seton as part of routine clinical management
  • Sufficient previous experience with the polypropylene loose seton to permit baseline assessment of patient-reported outcomes
  • Ability to understand and complete the study questionnaires
  • Provision of written informed consent

Exclusion Criteria:

  • Anal fistula associated with Crohn's disease
  • Anal malignancy
  • Rectovaginal fistula
  • Acute perianal abscess or acute perianal sepsis requiring emergency surgical intervention
  • Cognitive impairment preventing completion of patient-reported outcome questionnaires
  • Inability to complete the study questionnaires
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Undergoing Loose Seton Replacement
Adults with recurrent or persistent complex cryptoglandular anal fistula who have an existing polypropylene loose seton and undergo clinically indicated replacement with a braided polyester loose seton as part of routine clinical care. Patient-reported outcomes are assessed immediately before replacement while the polypropylene seton remains in situ and at 4 and 12 weeks after replacement with the braided polyester seton. Each participant serves as their own control.
Device: Loose Seton Biomaterial
Participants are observed during sequential exposure to two loose seton biomaterials. Patient-reported outcomes are assessed while an existing polypropylene loose seton is in situ and again at 4 and 12 weeks after clinically indicated replacement with a braided polyester loose seton. The decision to replace the seton is made by the treating colorectal surgeon as part of routine clinical care and independently of study participation. No seton replacement is performed solely for research purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease-Specific Quality of Life Measured by the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q)
Time Frame: Baseline and 12 weeks after loose seton replacement
Within-participant change in disease-specific quality of life from baseline with the polypropylene loose seton in situ to 12 weeks after replacement with the braided polyester loose seton, assessed using the 14-item Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q). The total score ranges from 14 to 70, with higher scores indicating a greater negative impact of anal fistula on quality of life and therefore a worse outcome. The primary outcome will be calculated as the within-participant change in total QoLAF-Q score between baseline and 12 weeks after seton replacement.
Baseline and 12 weeks after loose seton replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perianal Pain Assessed by the Visual Analogue Scale (VAS)
Time Frame: Baseline and 4 and 12 weeks after loose seton replacement
Within-participant change in perianal pain from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using the 10-cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.
Baseline and 4 and 12 weeks after loose seton replacement
Change in Anal Continence Assessed by the Wexner Fecal Incontinence Score
Time Frame: Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in anal continence from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using the Wexner Fecal Incontinence Score. The total score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate more severe fecal incontinence and therefore a worse outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Change in Overall Patient Comfort Assessed Using an Investigator-Defined 5-Point Patient Comfort Rating Scale
Time Frame: Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in overall comfort associated with the loose seton from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using an investigator-defined 5-point Patient Comfort Rating Scale. Scores range from 1 to 5: 1, very uncomfortable; 2, uncomfortable; 3, neither uncomfortable nor comfortable; 4, comfortable; and 5, very comfortable. Higher scores indicate greater patient comfort and therefore a better outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Change in Patient Satisfaction With the Loose Seton Assessed Using an Investigator-Defined 5-Point Patient Satisfaction Rating Scale
Time Frame: Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in overall satisfaction with the loose seton from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using an investigator-defined 5-point Patient Satisfaction Rating Scale. Scores range from 1 to 5: 1, very dissatisfied; 2, dissatisfied; 3, neither dissatisfied nor satisfied; 4, satisfied; and 5, very satisfied. Higher scores indicate greater patient satisfaction and therefore a better outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Patient Preference for Loose Seton Biomaterial Assessed Using an Investigator-Defined Single-Item Preference Questionnaire
Time Frame: 12 weeks after loose seton replacement
Participant-reported preference after experiencing both the polypropylene and braided polyester loose setons will be assessed using an investigator-defined single-item questionnaire: "Considering your overall experience, which loose seton material would you prefer?" Response options will be: (1) polypropylene loose seton, (2) braided polyester loose seton, and (3) no preference. Results will be reported as the number and percentage of participants selecting each response category. This is a categorical outcome; therefore, no minimum or maximum score or direction of scoring applies.
12 weeks after loose seton replacement
Cumulative Analgesic Consumption Assessed by a Participant-Reported Medication Diary
Time Frame: Through 12 weeks after loose seton replacement
Cumulative analgesic consumption after replacement of the polypropylene loose seton with the braided polyester loose seton will be assessed using a participant-reported medication diary. Participants will record the name of each analgesic medication, the dose taken, and the date of administration. The outcome will be expressed as the total number of analgesic doses taken by each participant during the 12-week follow-up period. The minimum possible value is 0 doses, with no predefined maximum. Higher values indicate greater analgesic requirement and therefore a worse outcome.
Through 12 weeks after loose seton replacement
Incidence of Postoperative Complications
Time Frame: Through 12 weeks after loose seton replacement
Number and proportion of participants experiencing postoperative complications during follow-up, including local infection and premature seton loss.
Through 12 weeks after loose seton replacement
Incidence of Unplanned Treatment-Related Healthcare Utilization or Reintervention Assessed by Medical Record Review and Participant Interview
Time Frame: From loose seton replacement through 12 weeks after replacement
The occurrence of any unplanned treatment-related healthcare utilization or reintervention following loose seton replacement will be assessed through medical record review and structured participant interview. A participant will be classified as having experienced the outcome if at least one of the following occurs during follow-up: an unplanned outpatient visit, emergency department attendance, hospital readmission, or an additional medical, radiological, or surgical intervention related to the loose seton or anal fistula. The outcome will be reported as the number and percentage of participants experiencing at least one event. This is a binary outcome (0 = no event; 1 = one or more events), with a value of 1 indicating a worse outcome.
From loose seton replacement through 12 weeks after replacement

Collaborators and Investigators

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

Sponsor

Acibadem Kent Hospital

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 (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SETon PROM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared because of participant confidentiality and data protection considerations. Aggregated study results will be reported in scientific publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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