P Giordano1, P Sileri2, S Buntzen3, J Nunoo-Mensah4, L Lenisa5, B Singh6, O Thorlacius-Ussing7, B Griffiths8, Z Vujovic9, A Stuto10. 1. Colorectal Department, Whipps Cross University Hospital, Barts Health, London, UK. 2. Surgery, University of Rome Tor Vergata, Rome, Italy. 3. Colorectal Surgery, Department of Surgery, Aarhus University Hospital, Aarhus, Denmark. 4. Department of Colorectal Surgery, King's College Hospital, London, UK. 5. General Surgery Unit, Casa di Cura Humanitas San Pio X, Milan, Italy. 6. Leicester General Hospital, Leicester, UK. 7. Department of Gastrointestinal Surgery, Aalborg University Hospital, Aalborg, Denmark. 8. NUTH Foundation Trust, Newcastle, UK. 9. Ninewells Hospital & Medical School, Dundee, Scotland, UK. 10. Coloproctology and Pelvic Floor Surgery, Policlinico Abano Terme, Padova, Italy.
Abstract
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 10 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 end-point 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 postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12 months. Regarding AEs, 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 is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects. Colorectal Disease
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 10 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 end-point 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 postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12 months. Regarding AEs, 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 is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects. Colorectal Disease
Authors: A Amato; C Bottini; P De Nardi; P Giamundo; A Lauretta; A Realis Luc; V Piloni Journal: Tech Coloproctol Date: 2020-01-23 Impact factor: 3.781
Authors: F Litta; A Parello; L Ferri; N O Torrecilla; A A Marra; R Orefice; V De Simone; P Campennì; M Goglia; C Ratto Journal: Tech Coloproctol Date: 2021-01-02 Impact factor: 3.781
Authors: Paul F Vollebregt; Grietje J Vander Mijnsbrugge; Charlotte B H Molenaar; Richelle J F Felt-Bersma Journal: Colorectal Dis Date: 2021-05-16 Impact factor: 3.788