Final results of a European, multicentre, prospective, observational study of Permacol™ collagen paste injection for the treatment of anal fistula. (1st March 2018)

• Record Type: Journal Article
• Authors: Giordano, P.; Sileri, P.; Buntzen, S.; Nunoo‐Mensah, J.; Lenisa, L.; Singh, B.; Thorlacius‐Ussing, O.; Griffiths, B.; Vujovic, Z.; Stuto, A.
• Is Part Of: Colorectal disease. Volume 20:Number 3(2018)
• Page Start: 243
• Page End: 251
• Publication Date: 2018-03-01
• Subjects: Anal fistula -- Permacol™ collagen paste -- faecal continence -- sphincter‐preserving technique; Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; 616.34
• DOI: 10.1111/codi.13715
• Languages: English
• ISSNs: 1462-8910

Abstract

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.