International Journal of Colorectal Disease

, Volume 32, Issue 11, pp 1545–1550 | Cite as

Treatment of transsphincteric fistula-in-ano with growth factors from autologous platelets: results of a phase II clinical trial

  • F. de la Portilla
  • J. J. Segura-Sampedro
  • M. L. Reyes-Díaz
  • M. V. Maestre
  • A. M. Cabrera
  • R. M. Jimenez-Rodríguez
  • J. M. Vázquez-Monchul
  • J. M. Diaz-Pavón
  • F. J. Padillo-Ruiz
Original Article

Abstract

Purpose

The aim of this paper is to evaluate to the safety, feasibility and efficacy of a novel treatment for transsphincteric cryptoglandular fistula: injection of autologous plasma rich in growth factors (PRGF) into the fistula tract accompanied by sealing using a fibrin plug created from the activated platelet-poor fraction of the same plasma.

Method

This article is a prospective, phase II clinical trial. The procedure was externally audited. Thirty-six patients diagnosed with transsphincteric fistula-in-ano were included. All patients underwent follow-up examinations at 1 week and again at 3, 6 and 12 months after discharge. Main outcome measures safety (number of adverse events), feasibility and effectiveness of the treatment.

Results

A total of 36 patients received the study treatment, with the procedure found to be feasible in all patients. A total of seven adverse events (AE) related to the injected product or surgical procedure were identified in 4 of 36 patients. At the end of the follow-up period (12 months), 33.3% of patients (12/36) had achieved complete fistula healing and 11.1% of patients (4/36) had achieved partial healing. In total, this amounted to 44.4% of patients (16/36) being asymptomatic at final follow-up. In successfully healed patients, a gradual reduction in pain was observed, as measured using a Visual Analog Scale (VAS) (p = 0.0278). Compared to baseline, a significant improvement in Wexner score was seen in patients achieving total or partial healing of the fistula (p = 0.0195).

Conclusions

The study treatment was safe and feasible, with apparently modest efficacy rates. Continence and pain improvement following treatment may be considered predictive factors for healing.

Keywords

Fistula PRGF Cryptoglandular Fibrin plug 

References

  1. 1.
    Malik AI, Nelson RL (2008) Surgical management of anal fistulae: a systematic review. Color Dis 10:420–430. doi:10.1111/j.1463-1318.2008.01483.x CrossRefGoogle Scholar
  2. 2.
    Bokhari S, Lindsey I (2010) Incontinence following sphincter division for treatment of anal fistula. Color Dis 12:e135–e139. doi:10.1111/j.1463-1318.2009.01872.x CrossRefGoogle Scholar
  3. 3.
    Altomare DF, Greco VJ, Tricomi N, Arcanà F, Mancini S, Rinaldi M (2011) Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial. Color Dis 13:82–86. doi:10.1111/j.1463-1318.2009.02056.x CrossRefGoogle Scholar
  4. 4.
    Anitua E (2000) Plasma rich in growth factors: preliminary results of use in the preparation of future sites for implants. Int J Oral Maxillofac Implants 14:529–535Google Scholar
  5. 5.
    Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT (2004) Autologous platelets as a source of proteins for healing and tissue regeneration. Thromb Haemost 91:4–15. doi:10.1160/TH03-07-0440 PubMedGoogle Scholar
  6. 6.
    van der Hagen SJ, Baeten CG, Soeters PB, Van Gemert WG (2011) Autologous platelet-derived growth factors (platelet-rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular perianal fistulae: a pilot study. Color Dis 13:215–218. doi:10.1111/j.1463-1318.2009.01991.x CrossRefGoogle Scholar
  7. 7.
    Göttgens KW, Vening W, van der Hagen SJ, van Gemert WG, Smeets RR, Stassen LP (2014) Long-term results of mucosal advancement flap combined with platelet-rich plasma for high cryptoglandular perianal fistulas. Dis Colon rectum 57:223–227. doi:10.1097/DCR.0000000000000023
  8. 8.
    Fernández-Hurtado I, Espín-Bassany E, González-Argenté F (2011) Tratamiento de las fístulas perianales complejas con una fibrina rica en plaquetas. Estudio piloto. Dep. Cir. / Univ. AutònomaBarcelona, Barcelona http://ddd.uab.cat/pub/trerecpro/2011/hdl_2072_179036/TR_FernandezHurtado.pdf Google Scholar
  9. 9.
    Lara FJP, Serrano AM, Moreno JU, Carmona JH, Marquez MF, Pérez LR (2014) Platelet-rich fibrin sealant as a treatment for complex perianal fistulas: a multicentre study. J Gastrointest Surg 19:360–368. doi:10.1007/s11605-014-2698-7 CrossRefPubMedGoogle Scholar
  10. 10.
    Schwandner O (2011) Obesity is a negative predictor of success after surgery for complex anal fistula. BMC Gastroenterol 11:61. doi:10.1186/1471-230X-11-61 CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Ellis CN, Clark S (2007) Effect of tobacco smoking on advancement flap repair of complex anal fistulas. Dis Colon rectum 50:459–463. doi:10.1007/s10350-006-0829-2
  12. 12.
    Garcia-Olmo D, Guadalajara H, Rubio-Perez I, Herreros MD, de-la-Quintana P, Garcia-Arranz M (2015) Recurrent anal fistulae: limited surgery supported by stem cells. World J Gastroenterol 21:3330–3336. doi:10.3748/wjg.v21.i11.3330 CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany 2017

Authors and Affiliations

  • F. de la Portilla
    • 1
    • 2
  • J. J. Segura-Sampedro
    • 1
    • 3
  • M. L. Reyes-Díaz
    • 1
  • M. V. Maestre
    • 1
  • A. M. Cabrera
    • 1
  • R. M. Jimenez-Rodríguez
    • 1
  • J. M. Vázquez-Monchul
    • 1
  • J. M. Diaz-Pavón
    • 1
  • F. J. Padillo-Ruiz
    • 1
  1. 1.Department of General and Digestive Surgery, Colorectal Surgery Unit“Virgen del Rocío” University Hospital/IBiS/CSIC/University of SevilleSevillaSpain
  2. 2.Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd)Instituto de Salud Carlos IIIMadridSpain
  3. 3.Department of General and Digestive Surgery“Son Espases” University Hospital/IdISPaPalma de MallorcaSpain

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