Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

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

Primary outcome measure(s)

• Change in Disease-Specific Quality of Life Measured by the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q) — 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.

Trial sites (1)