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Platelet-rich plasma (PRP) versus fibrin glue in cryptogenic fistula-in-ano: a phase III single-center, randomized, double-blind trial

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

To compare the clinical outcome of autologous platelet-rich growth factor (PRP) with commercial fibrin glue in the management of high cryptogenic fistulae-in-ano.

Method

The study was conducted at a single center between July 2012 and July 2015 and performed as a phase III, randomized, double-blind comparison of autologously prepared PRP versus fibrin glue for cryptoglandular anal fistulae without active sepsis. Patients were assessed with clinical and endosonographic follow-up. Patients were followed up at 1 week and then at 3, 6, and 12 postoperative months. The primary outcome measure was the fistula healing rate (complete, partial, and non-healing) with secondary outcome measures assessing fistula recurrence, continence status, quality of life, and visual analog pain scores.

Results

Of the 56 enrolled patients, 32 were PRP-treated and 24 were fibrin-treated. The groups were well matched for fistula type with an improved overall healing rate for PRP-treated over fibrin-treated cases (71% vs. 58.3%, respectively; P = 0.608); a complete healing rate of 48.4% vs. 41.7%, respectively; and a partial healing rate of 22.6% vs. 16.7%, respectively. The median pain scores of PRP-treated patients were lower at the first visit with a greater initial pain decrease early during follow-up. Improvements in pain reduction impacted the quality of life measures (P = 0.035). All adverse events were minor and no patient experienced a negative impact on continence.

Conclusion

Treatment of complex cryptoglandular anal fistula with autologous PRP is as effective as fibrin glue with less cost and no adverse effect on continence.

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Acknowledgments

The authors thank Andrew Zbar for the critical review of the manuscript.

Funding

A Grant for this work was provided by the Fundación Española de Coloproctología.

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Authors and Affiliations

  1. Coloproctology Unit Clinical Management Unit of General and Gastrointestinal Surgery Division Seville, Biomedical Research Institute (BIS), University Hospital Virgen del Rocio / CSIC University of Seville, Avenida Manuel Siurot s/n, 41013, Seville, Spain

    Fernando de la Portilla, Maria Virginia Durán Muñoz-Cruzado, Maria Victoria Maestre, Ana María García-Cabrera, María Luisa Reyes, Jorge Manuel Vázquez-Monchul, Rosa María Jimenez-Rodríguez, José Manuel Díaz-Pavón & Francisco Javier Padillo

Authors
  1. Fernando de la Portilla
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  2. Maria Virginia Durán Muñoz-Cruzado
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  3. Maria Victoria Maestre
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  4. Ana María García-Cabrera
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  5. María Luisa Reyes
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  6. Jorge Manuel Vázquez-Monchul
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  7. Rosa María Jimenez-Rodríguez
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  8. José Manuel Díaz-Pavón
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  9. Francisco Javier Padillo
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Contributions

FDP and VDMC: Study design, interpreting results, drafting of the manuscript.

MVM: Data acquisition.

JMVM, ANGC, MLR, JMDP, and RMJR: Surgical protocol, study design, interpreting results.

FJP: Critical review of the manuscript.

Corresponding author

Correspondence to Fernando de la Portilla.

Ethics declarations

The study was conducted as a phase III, randomized, double-blind parallel group design which was approved by the local University Ethics Committee, with each patient included providing written informed consent for participation.

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de la Portilla, F., Muñoz-Cruzado, M.V.D., Maestre, M.V. et al. Platelet-rich plasma (PRP) versus fibrin glue in cryptogenic fistula-in-ano: a phase III single-center, randomized, double-blind trial. Int J Colorectal Dis 34, 1113–1119 (2019). https://doi.org/10.1007/s00384-019-03290-6

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  • DOI: https://doi.org/10.1007/s00384-019-03290-6

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