Final results of a European, multicentre, prospective, observational study of Permacol (TM) collagen paste injection for the treatment of anal fistula

TY - JOUR

T1 - Final results of a European, multicentre, prospective, observational study of Permacol (TM) collagen paste injection for the treatment of anal fistula

AU - Giordano, Pasquale

AU - Sileri, Pierpaolo

AU - Buntzen, Steen

AU - Stuto, Angelo

AU - Nunoo-Mensah, Joseph

AU - Lenisa, Leonardo

AU - Singh, Baljit

AU - Thorlacius-Ussing, Ole

AU - Griffiths, Ben

AU - Ziyaie, Dorin

N1 - The study was sponsored and funded by Medtronic (Mansfield, MA, USA)

PY - 2018/3

Y1 - 2018/3

N2 - Aim: Permacol(™) collagen paste (Permacol(™) paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft tissue repair. The use of Permacol(™) paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol(™) collagen paste for anal fistula repair in 100 patients.Method: Patients (N=100) with anal fistula were treated at ten European surgical sites with a sphincter-preserving technique using Permacol(™) paste. Fistula healing was assessed at 1, 3, 6, and 12 months post-treatment, with the primary endpoint being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up.Results: At 6 months post-surgery, 56.7% of patients were healed, and the percentage healed was largely maintained, with 53.5% healed at 12 months. 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure.Conclusion: Permacol(™) paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects.

AB - Aim: Permacol(™) collagen paste (Permacol(™) paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft tissue repair. The use of Permacol(™) paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol(™) collagen paste for anal fistula repair in 100 patients.Method: Patients (N=100) with anal fistula were treated at ten European surgical sites with a sphincter-preserving technique using Permacol(™) paste. Fistula healing was assessed at 1, 3, 6, and 12 months post-treatment, with the primary endpoint being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up.Results: At 6 months post-surgery, 56.7% of patients were healed, and the percentage healed was largely maintained, with 53.5% healed at 12 months. 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure.Conclusion: Permacol(™) paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects.

KW - Anal fistula

KW - Permacol™ collagen paste

KW - faecal continence

KW - sphincter-preserving technique

UR - https://www.scopus.com/pages/publications/85042663481

U2 - 10.1111/codi.13715

DO - 10.1111/codi.13715

M3 - Article

C2 - 28493393

SN - 1462-8910

VL - 20

SP - 243

EP - 251

JO - Colorectal Disease

JF - Colorectal Disease

IS - 3

ER -