Treatment of transsphincteric fistula-in-ano with growth factors from autologous platelets: results of a phase II clinical trial
- 184 Downloads
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.
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.
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).
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.
KeywordsFistula PRGF Cryptoglandular Fibrin plug
Compliance with ethical standards
The study was approved by the local ethics committee and was conducted according to Good Clinical Practice guidelines.
- 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
- 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.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.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
- 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