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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
118
Collagen paste injection
Mucosal advancement flap
Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
RECRUITINGPrince of Wlaes Hospital
Shatin, Hong Kong
RECRUITINGClinical healing of Fistula-in-ano
Clinical healing of the fistula-in-ano
Time frame: 1 year
30-day morbidity
30-day morbidity using Clavien-Dindo classification
Time frame: 30 days
Quality of life score
Assess effect on Quality of life post operatively using Short Form 36 Health Survey
Time frame: 1 year
Postoperative pain score
assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain)
Time frame: 1 week
Faecal incontinence rate
Assess postoperative effect on continence
Time frame: 1 year
Hospital readmission rate
Assess hospital re-admission rate
Time frame: 1 year
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