A prospective multicentre observational study of Permacol collagen paste for anorectal fistula: preliminary results.
OBJECTIVE
Permacol collagen paste (Permacol paste) is a new option for the treatment of anorectal fistula. It functions by filling the fistula tract with an acellular crosslinked porcine dermal collagen matrix suspension. The MASERATI 100 study group was set up to evaluate the clinical outcome of Permacol paste in the treatment of anorectal fistula. This paper reports the results from the initial 30 patients enrolled in the MASERATI 100 prospective, observational clinical trial.


METHODS
Patients (N = 30) with anal fistula presenting to 10 European academic surgical units were treated with a sphincter-preserving technique using Permacol paste. Fistula healing was assessed at 1, 3, 6 and 12 months after treatment, with the primary end-point of fistula healing at 6 months post-surgery. Faecal continence and patient satisfaction were recorded at each follow-up visit and adverse events were monitored throughout the follow-up.


RESULTS
Of the 28 patients with data at 6 months post-surgery, 15 (54%) were healed, and the healing rate was maintained at 12 months. Healing after treatment with Permacol paste was similar for intersphincteric to transsphincteric fistulae and primary or recurrent fistulae. Only one patient exhibited an adverse event (perianal abscess) that was possibly related to the treatment. At the last outpatient visit, over 60% of patients were satisfied or very satisfied with the operation.


CONCLUSIONS
Permacol paste is shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects.
Colorectal Department, Whipps Cross University Hospital, Barts Health, London, UK.
P
P
Giordano
University of Rome Tor Vergata, Rome, Italy.
P
P
Sileri
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
S
S
Buntzen
General Surgery Department, Ospedale Santa Maria degli Angeli, Pordenone, Italy.
A
A
Stuto
Department of Colorectal Surgery, King's College Hospital, London, UK.
J
J
Nunoo-Mensah
Surgery Unit, San Pio X Hospital, Milan, Italy.
L
L
Lenisa
Leicester General Hospital, Leicester, UK.
B
B
Singh
Department of Gastrointestinal Surgery, Aalborg University Hospital, Aalborg, Denmark.
O
O
Thorlacius-Ussing
NUTH Foundation Trust, Newcastle, UK.
B
B
Griffiths
Ninewells Hospital and Medical School, Dundee, Scotland, UK.
D
D
Ziyaie
D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000187:drug effects / Q000601:surgery; D003094:Collagen / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000009:adverse effects / Q000379:methods* / Q000523:psychology; D005060:Europe; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications; D011184:Postoperative Period; D011446:Prospective Studies; D012003:Rectal Fistula / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D012008:Recurrence; D016896:Treatment Outcome
C422414:Permacol; D003094:Collagen
Anorectal fistula; Permacol™ collagen paste; faecal continence; sphincter-preserving technique