Image

Collagen Paste vs Mucosal Advancement Flap for FIA

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Description

Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.

Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.

Eligibility

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.

Study details

Fistula-in-ano

NCT06386835

Chinese University of Hong Kong

29 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.