Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcibadem Kent Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Anal fistula associated with Crohn's disease
Anal malignancy
Rectovaginal fistula
Acute perianal abscess or acute perianal sepsis requiring emergency surgical intervention
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Loose Seton Biomaterial
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Loose Seton Replacement1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 12 weeks after loose seton replacementSecondary outcomes
1
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.
Time frame
Baseline and 4 and 12 weeks after loose seton replacement2
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.
Time frame
Baseline, 4 weeks, and 12 weeks after loose seton replacement3
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.
Time frame
Baseline, 4 weeks, and 12 weeks after loose seton replacement4
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.
Time frame
Baseline, 4 weeks, and 12 weeks after loose seton replacementSponsors and contacts
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Source ClinicalTrials.gov
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