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Compares treatment options for Fistula-in-ano
Official title Collagen Paste vs Mucosal Advancement Flap for FIA
ClinicalTrials.gov ID: NCT06386835
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, New Territories, Hong Kong
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, New Territories, Hong Kong; Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.