Complex Anal FistulaSETon PROMNCT07818642
Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula
An observational study of Complex Anal Fistula and Cryptoglandular Anal Fistula, run by Acibadem Kent Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Anal Fistula, Cryptoglandular Anal Fistula
- What is being tested?
- Loose Seton Biomaterial
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Feb 2028
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Acibadem Kent Hospital
Izmir, 35630
Semra Demirli Atici, MD, 9005363624585, smrdemirli@hotmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Complex Anal Fistula, Cryptoglandular Anal Fistula
- Being tested
- Loose Seton Biomaterial
- Keywords
- Cryptoglandular Anal Fistula, Complex Anal Fistula, Loose Seton, Seton Material, Patient-Reported Outcomes, Quality of Life, QoLAF-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loose Seton BiomaterialDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Loose Seton Biomaterial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease-Specific Quality of Life Measured by the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q)
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.
Measured: Baseline and 12 weeks after loose seton replacement
Secondary outcomes (8)
Change in Perianal Pain Assessed by the Visual Analogue Scale (VAS)
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.
Measured: Baseline and 4 and 12 weeks after loose seton replacement
Change in Anal Continence Assessed by the Wexner Fecal Incontinence Score
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 12 weeks after loose seton replacement
Cumulative Analgesic Consumption Assessed by a Participant-Reported Medication Diary
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.
Measured: Through 12 weeks after loose seton replacement
Incidence of Postoperative Complications
Number and proportion of participants experiencing postoperative complications during follow-up, including local infection and premature seton loss.
Measured: Through 12 weeks after loose seton replacement
Incidence of Unplanned Treatment-Related Healthcare Utilization or Reintervention Assessed by Medical Record Review and Participant Interview
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.
Measured: From loose seton replacement through 12 weeks after replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Acibadem Kent Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, semra demirli atici, Acibadem Kent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818642
- Sponsor's protocol ID
- SETon PROM
- Acronym
- SETon PROM
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula: Protocol for the SETon PROM Prospective Self-Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT07818642
- Acronym / sponsor ID
- SETon PROM / SETon PROM
- Conditions
- Complex Anal Fistula, Cryptoglandular Anal Fistula
- Keywords
- Cryptoglandular Anal Fistula, Complex Anal Fistula, Loose Seton, Seton Material, Patient-Reported Outcomes, Quality of Life, QoLAF-Q
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Acibadem Kent HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Loose Seton Replacement | – | Device: Loose Seton BiomaterialAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loose Seton BiomaterialParticipants 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. | Device | Patients Undergoing Loose Seton Replacement |
Primary outcome
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.
8 secondary outcomes
Change in Perianal Pain Assessed by the Visual Analogue Scale (VAS)
Time frame: 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
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
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
Patient Preference for Loose Seton Biomaterial Assessed Using an Investigator-Defined Single-Item Preference Questionnaire
Time frame: 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
Incidence of Postoperative Complications
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Anal Fistula and Cryptoglandular Anal Fistula, run by Acibadem Kent Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semra Demirli Atici, MD (9005363624585, smrdemirli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.