Last updated: April 24, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Mucosal advancement
Collagen Paste
Clinical Study ID
NCT06386835
CREC2021.724-T
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 fistulais suitable for treatment by insertion of a seton drain.
- Patients must have been treated with a draining seton for a minimum period of 6 weeksprior to randomisation.
- Patients must be aged ≥ 18 years and able to provide informed consent.
- Fistulas must be of cryptoglandular aetiology.
Exclusion
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 andrequiring concurrent insertion of more than one fistula plug.
- Clinical evidence of active perianal sepsis. In the event that there is disagreementbetween clinical and radiological assessment of active sepsis/collection, the clinicalopinion will prevail.
- Cultural or religious objection to the use of pig tissue.
- Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiacpacemaker).
- Patients with recurrent anal fistulas previously treated with a fistula plug.
Study Design
Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Mucosal advancement
Phase:
Study Start date:
January 26, 2024
Estimated Completion Date:
March 31, 2027
Study Description
Connect with a study center
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories
Hong KongActive - Recruiting
Prince of Wlaes Hospital
Sha Tin,
Hong KongActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.