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Introduction: This study aimed to evaluate the applicability, safety, results, and functional performance of Permacol™ collagen
paste injection in patients with an anal fistula.
Methods: Thirty-nine patients with anal fistula underwent Permacol™ collagen paste injection between February 2015 and
February 2018. The patients were followed up for a total of 18months with intervals of 3, 6, 12 and 18 month recovery conditions
monitored. Fifteen patients for a period of 6-8 weeks and two patients for a period of 12 weeks underwent preoperative
insertion of seton.
Results: A transsphincteric anal fistula was present in 20 patients, and an intersphincteric fistula was present in 11 patients.
There was a recurrence in 7 patients (17.9%): 1 patient (2.5%) after 1-month follow-up, 3 patients (7.6%) after 3-month
follow-up, 2 patients (5.1%) after 6-month follow-up, and 1 patient (2.5%) after 18-month follow-up. A complete recovery
was observed in 32(82.0%) patients after a 18-month follow-up. The mean Fecal Incontinence Severity Index (FISI) score was
0.29 ±0.64 preoperatively and 0.55 ±1.03 after 12 months.
Conclusion: In this study, we show that Permacol™ is a safe and successful method that does not compromise continence
following injection and treatment of patients with an anal fistula.
Recent Publications
1. Panes J, Garcia-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M,
Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S;
ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex
Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.
2. Haim N, Neufeld D, Ziv Y, Tulchinsky H, Koller M, Khaikin M, et al., Long-term results of fibrin glue treatment for
cryptogenic perianal fistulas: a multicenter study. Dis Colon Rectum. 2011;54(10):1279-83.
3. Fabiani B, Menconi C, Martellucci J, Giani I, Toniolo G, and Naldini G, Permacol collagen paste injection for the treatment
of complex anal fistula: 1-year follow-up. Tech Coloproctol. 2017;21(3):211-215.
4. Giordano P, Sileri P, Buntzen S, Stuto A, Nunoo-Mensah J, Lenisa L, et al., Final results of a European, multi-centre,
prospective, observational Study of Permacol() collagen paste injection for the treatment of anal fistula. Colorectal Dis.
2017. May 11. doi: 10.1111/codi.13715. [Epub ahead of print] PubMed PMID: 28493393
5. Giordano P, Sileri P, Buntzen S, Stuto A, Nunoo-Mensah J, Lenisa L, et al., A prospective multicentre observational study
of Permacol collagen paste for anorectal fistula: preliminary results. Colorectal Dis. 2016;18(3):286-94.
Biography
Mehmet Bayrak and Yasemin Altıntas have expertise in evaluation and passion in improving the health and wellbeing. Their open and contextual evaluation model based on responsive constructivists creates new pathways for improving healthcare. They have built this treatment model after years of experience in research, evaluation, teaching and administration both in hospital and education institutions. This approach is responsive to all stakeholders and has a different way of focusing.