Comparing collagen paste and mucosal advancement flap for treating fistula-in-ano

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of collagen paste injection versus mucosal advancement flap surgery for treating high anal fistulas. The study aims to determine which method provides better healing and lower complication rates while preserving anal sphincter function. Collagen paste is a novel treatment that promotes healing through a matrix that enhances tissue contact and neovascularization. The trial includes patients with specific criteria, such as having undergone prior evaluation and treatment with a draining seton. The outcomes will help establish a more effective first-line treatment for fistula-in-ano.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Surgery, Chinese University of Hong Kong
  Shatin, New Territories, Hong Kong Recruiting
• Prince of Wlaes Hospital
  Shatin, Hong Kong Recruiting

Study contacts

• Study coordinator: Kaori Futaba, FRCS
• Email: kfutaba@surgery.cuhk.edu.hk
• Phone: 35051495

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.