Skip to main content
SpringerLink
Log in

Permacol™ Collagen Paste Injection in Anal Fistula Treatment: A Retrospective Study with One-Year Follow-Up

  • Original Research
  • Published:
Advances in Therapy Aims and scope Submit manuscript

Abstract

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-one patients with anal fistula underwent Permacol™ collagen paste injection between February 2015 and February 2017. The patients were followed up for a total of 12 months with recovery conditions monitored at intervals of 3, 6, and 12 months. Preoperative insertion of seton was performed in 15 patients for a period of 6–8 weeks and 2 patients for a period of 12 weeks.

Results

A trans-sphincteric anal fistula was present in 20 patients and an intersphincteric fistula was present in 11 patients. There was a recurrence in 7 patients (22.5%): 1 patient (3.2%) after 1-month follow-up, 3 patients (9.7%) after 3-month follow-up, 2 patients (6.5%) after 6-month follow-up, and 1 patient (3.2%) after 12-month follow-up. A complete recovery was observed in 24 (77.5%) patients after a 12-month follow-up. The mean Fecal Incontinence Severity Index score was 0.29 ± 0.64 preoperatively and 0.55 ± 1.03 after 12 months.

Conclusion

In this study, we show that treatment of patients with an anal fistula by injection of Permacol™ is a safe and successful method that does not compromise continence.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Ommer A, Herold A, Berg E, et al. Cryptoglandular anal fistulas. Dtsch Arztebl Int. 2011;108(42):707–13.

    PubMed  PubMed Central  Google Scholar 

  2. Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser–FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014;16(2):110–5.

    Article  PubMed  CAS  Google Scholar 

  3. Haim N, Neufeld D, Ziv Y, et al. Long-term results of fibrin glue treatment for cryptogenic perianal fistulas: a multicenter study. Dis Colon Rectum. 2011;54(10):1279–83.

    Article  PubMed  Google Scholar 

  4. Mishra A, Shah S, Nar AS, Bawa A. The role of fibrin glue in the treatment of high and low fistulas in ano. J Clin Diagn Res. 2013;7(5):876–9.

    PubMed  PubMed Central  Google Scholar 

  5. Sileri P, Giarratano G, Franceschilli L, et al. Ligation of the intersphincteric fistula tract (LIFT): a minimally invasive procedure for complex anal fistula: two-year results of a prospective multicentric study. Surg Innov. 2014;21(5):476–80.

    Article  PubMed  Google Scholar 

  6. Cintron JR, Park JJ, Orsay CP, Pearl RK, Nelson RL, Abcarian H. Repair of fistulas-in-ano using autologous fibrin tissue adhesive. Dis Colon Rectum. 1999;42(5):607–13.

    Article  PubMed  CAS  Google Scholar 

  7. Cintron JR, Park JJ, Orsay CP, et al. Repair of fistulas-in-ano using fibrin adhesive: long-term follow-up. Dis Colon Rectum. 2000;43(7):944–9 (discussion 949–50).

    Article  PubMed  CAS  Google Scholar 

  8. Sentovich SM. Fibrin glue for all anal fistulas. J Gastrointest Surg. 2001;5(2):158–61.

    Article  PubMed  CAS  Google Scholar 

  9. Dietz DW. Role of fibrin glue in the management of simple and complex fistula in ano. J Gastrointest Surg. 2006;10(5):631–2.

    PubMed  Google Scholar 

  10. Gisbertz SS, Sosef MN, Festen S, Gerhards MF. Treatment of fistulas in ano with fibrin glue. Dig Surg. 2005;22(1–2):91–4.

    Article  PubMed  Google Scholar 

  11. Singer M, Cintron J, Nelson R, et al. Treatment of fistulas-in-ano with fibrin sealant in combination with intra-adhesive antibiotics and/or surgical closure of the internal fistula opening. Dis Colon Rectum. 2005;48(4):799–808.

    Article  PubMed  Google Scholar 

  12. Garcia-Olmo D, Herreros D, Pascual I, et al. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009;52(1):79–86.

    Article  PubMed  Google Scholar 

  13. Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D, Group FC. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: Fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012;55(7):762–72.

    Article  PubMed  CAS  Google Scholar 

  14. Fabiani B, Menconi C, Martellucci J, Giani I, Toniolo G, Naldini G. Permacol collagen paste injection for the treatment of complex anal fistula: 1-year follow-up. Tech Coloproctol. 2017;21(3):211–5.

    Article  PubMed  CAS  Google Scholar 

  15. Giordano P, Sileri P, Buntzen S, 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. https://doi.org/10.1111/codi.13715.

    Article  PubMed  Google Scholar 

  16. Whiteford MH, Kilkenny J 3rd, Hyman N, et al. Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised). Dis Colon Rectum. 2005;48(7):1337–42.

    Article  PubMed  Google Scholar 

  17. Rockwood TH, Church JM, Fleshman JW, et al. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum. 1999;42(12):1525–32.

    Article  PubMed  CAS  Google Scholar 

  18. Tozer P, Sala S, Cianci V, et al. Fistulotomy in the tertiary setting can achieve high rates of fistula cure with an acceptable risk of deterioration in continence. J Gastrointest Surg. 2013;17(11):1960–5.

    Article  PubMed  CAS  Google Scholar 

  19. Westerterp M, Volkers NA, Poolman RW, van Tets WF. Anal fistulotomy between Skylla and Charybdis. Colorectal Dis. 2003;5(6):549–51.

    Article  PubMed  CAS  Google Scholar 

  20. Ritchie RD, Sackier JM, Hodde JP. Incontinence rates after cutting seton treatment for anal fistula. Colorectal Dis. 2009;11(6):564–71.

    Article  PubMed  CAS  Google Scholar 

  21. Garg P, Song J, Bhatia A, Kalia H, Menon GR. The efficacy of anal fistula plug in fistula-in-ano: a systematic review. Colorectal Dis. 2010;12(10):965–70.

    Article  PubMed  CAS  Google Scholar 

  22. Lewis R, Lunniss PJ, Hammond TM. Novel biological strategies in the management of anal fistula. Colorectal Dis. 2012;14(12):1445–55.

    Article  PubMed  CAS  Google Scholar 

  23. Jarman-Smith ML, Bodamyali T, Stevens C, Howell JA, Horrocks M, Chaudhuri JB. Porcine collagen crosslinking, degradation and its capability for fibroblast adhesion and proliferation. J Mater Sci Mater Med. 2004;15(8):925–32.

    Article  PubMed  CAS  Google Scholar 

  24. Giordano P, Sileri P, Buntzen S, et al. A prospective multicentre observational study of Permacol collagen paste for anorectal fistula: preliminary results. Colorectal Dis. 2016;18(3):286–94.

    Article  PubMed  CAS  Google Scholar 

  25. Stamos MJ, Snyder M, Robb BW, et al. A prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015;58(3):344–51.

    Article  PubMed  Google Scholar 

  26. Hammond TM, Porrett TR, Scott SM, Williams NS, Lunniss PJ. Management of idiopathic anal fistula using cross-linked collagen: a prospective phase 1 study. Colorectal Dis. 2011;13(1):94–104.

    Article  PubMed  CAS  Google Scholar 

  27. Himpson RC, Cohen CR, Sibbons P, Phillips RK. An experimentally successful new sphincter-conserving treatment for anal fistula. Dis Colon Rectum. 2009;52(4):602–8.

    Article  PubMed  Google Scholar 

  28. Sileri P, Franceschilli L, Del Vecchio Blanco G, Stolfi VM, Angelucci GP, Gaspari AL. Porcine dermal collagen matrix injection may enhance flap repair surgery for complex anal fistula. Int J Colorectal Dis. 2011;26(3):345–9.

    Article  PubMed  Google Scholar 

  29. Ellis CN, Rostas JW, Greiner FG. Long-term outcomes with the use of bioprosthetic plugs for the management of complex anal fistulas. Dis Colon Rectum. 2010;53(5):798–802.

    Article  PubMed  Google Scholar 

  30. Panés J, García-Olmo D, Van Assche G, et al. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn’s disease. Gastroenterology. 2018;154(5):1334–42.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

We thank the participants of the study.

Funding

No funding or sponsorship was received for this study or publication of this article. The article processing charges were funded by the authors.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

Mehmet Bayrak and Yasemin Altıntas have nothing to disclose.

Compliance with Ethics Guidelines

Written approval was obtained from Cukurova University Faculty of Medicine Clinical Ethical Board. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Data Availability

All data generated or analyzed during this study are included in this article as supplementary information files.

Author information

Authors and Affiliations

  1. Adana Ozel Ortadogu Hospital, Adana, Turkey

    Mehmet Bayrak & Yasemin Altıntas

Authors
  1. Mehmet Bayrak
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yasemin Altıntas
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mehmet Bayrak.

Additional information

Enhanced digital features

To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.6552704.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (XLSX 11 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Bayrak, M., Altıntas, Y. Permacol™ Collagen Paste Injection in Anal Fistula Treatment: A Retrospective Study with One-Year Follow-Up. Adv Ther 35, 1232–1238 (2018). https://doi.org/10.1007/s12325-018-0743-8

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12325-018-0743-8

Keywords

Search

Navigation