๐ฌIn plain words
What the trial is, and whether it could suit you
The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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 โฅ 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.
๐
What it tests
- Collagen Paste
- Mucosal advancement
Department of Surgery, Chinese University of Hong Kong
Shatin, Hong Kong
Prince of Wlaes Hospital
Shatin, Hong Kong
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.