Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT06386835
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of high cryptoglandular fistula-in-ano.
* Patients must have undergone a prior EUA to characterise the nature of the fistula.
* The fistula tract should be ≥ 2 cm in length.
* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
* Patients must be aged ≥ 18 years and able to provide informed consent.
* Fistulas must be of cryptoglandular aetiology.
Exclusion Criteria:
* Unable/unwilling to provide informed consent.
* Contraindication to general anaesthesia or spinal anaesthesia.
* Low trans-sphincteric fistulas.
* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
* Cultural or religious objection to the use of pig tissue.
* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).
* Patients with recurrent anal fistulas previously treated with a fistula plug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06386835
Study Brief:
Protocol Section:
NCT06386835