Permacol Collagen Paste Injection for Treatment of Complex Cryptoglandular Anal Fistulas: An Observational Cohort Study With a 2-Year Follow-up.
BACKGROUND
Permacol paste injection is a novel treatment approach for complex cryptoglandular anal fistulas. This study was performed to evaluate the long-term clinical outcomes of treatment with Permacol paste for complex cryptoglandular fistulas.


METHODS
Patients with primary or recurrent complex cryptoglandular anal fistulas treated with Permacol paste from 2014 to 2016 were retrospectively analyzed.


RESULTS
A total of 46 patients (median age, 41.3 years; 21 female) underwent Permacol paste injection; 20 patients (43%) had previously undergone failed fistula surgery. The patients had experienced anal fistula-related symptoms for a median of 10 weeks (range, 3-50 weeks). All patients had a draining seton in situ for a median of 10 weeks (range, 4-46 weeks). The median follow-up time was 24 months (range, 1-25 months). At the 1-month follow-up, 2 patients had paste extrusion and 2 had anal abscesses. The mean preoperative Continence Grading Scale score was 1.10 ± 1.40, and that at 3 months postoperatively was 1.13 ± 1.39 ( P = .322). There was a significant difference in the preoperative and the 1- and 3-month postoperative pain scores ( P < .001). At the 24-month follow-up, the healing rate was 50% (n = 23). A total of 19 patients (41%) with a recurrent fistula after failed Permacol paste injection required additional operative procedures. The satisfaction rate at the 2-year follow-up was 65%.


CONCLUSION
Permacol paste injection is minimally invasive and technically easy to perform. It can be considered as a viable and reasonable option for the treatment of complex cryptoglandular anal fistulas in patients with fecal continence disorders.
['Schiano di Visconte|Michele|M|https://orcid.org/0000-0002-1137-4628', 'Braini|Andrea|A|', 'Moras|Luana|L|', 'Brusciano|Luigi|L|https://orcid.org/0000-0003-4112-1282', 'Docimo|Ludovico|L|', 'Bellio|Gabriele|G|https://orcid.org/0000-0002-0864-4420']
D000328:Adult D000368:Aged D001003:Anal Canal D003094:Collagen D005242:Fecal Incontinence D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D059351:Organ Sparing Treatments D017060:Patient Satisfaction D012003:Rectal Fistula D012189:Retrospective Studies D016896:Treatment Outcome D055815:Young Adult
permacol collagen paste fecal continence fistula-in-ano sphincter-preserving technique