Collagen Paste vs Mucosal Advancement Flap for FIA

Not Applicable

Recruiting

• Conditions: Fistula-in-ano
• Interventions: Procedure: Collagen Paste; Procedure: Mucosal advancement

• Registration Number: NCT06386835
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-26
• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Paste	Collagen Paste	Seton is removed, the fistula tract is de-epithelialised and collagen paste applied.
Mucosal Advancement Flap	Mucosal advancement	The internal opening is excised and is covered with a "U-shape" rectal mucosal flap

Primary Outcome Measures

Name	Time	Method
Clinical healing of Fistula-in-ano	1 year	Clinical healing of the fistula-in-ano

Secondary Outcome Measures

Name	Time	Method
Quality of life score	1 year	Assess effect on Quality of life post operatively using Short Form 36 Health Survey
30-day morbidity	30 days	30-day morbidity using Clavien-Dindo classification
Faecal incontinence rate	1 year	Assess postoperative effect on continence
Hospital readmission rate	1 year	Assess hospital re-admission rate
Postoperative pain score	1 week	assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain)

Trial Locations

Locations (2)

Prince of Wlaes Hospital; 🇭🇰 Sha Tin, Hong Kong

Department of Surgery, Chinese University of Hong Kong; 🇭🇰 Shatin, New Territories, Hong Kong