Actively Recruiting
Collagen Paste vs Mucosal Advancement Flap for FIA
Led by Chinese University of Hong Kong · Updated on 2024-04-26
118
Participants Needed
2
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Collagen Paste vs Mucosal Advancement Flap for FIA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Actively Recruiting
2
Prince of Wlaes Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
K
Kaori Futaba, FRCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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