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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.
de la Portilla, Fernando; Muñoz-Cruzado, Maria Virginia Durán; Maestre, Maria Victoria; García-Cabrera, Ana María; Reyes, María Luisa; Vázquez-Monchul, Jorge Manuel; Jimenez-Rodríguez, Rosa María; Díaz-Pavón, José Manuel; Padillo, Francisco Javier.
Afiliación
  • de la Portilla F; 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. delaportilla@ucpsevilla.es.
  • Muñoz-Cruzado MVD; 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.
  • Maestre MV; 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.
  • García-Cabrera AM; 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.
  • Reyes ML; 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.
  • Vázquez-Monchul JM; 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.
  • Jimenez-Rodríguez RM; 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.
  • Díaz-Pavón JM; 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.
  • Padillo FJ; 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.
Int J Colorectal Dis ; 34(6): 1113-1119, 2019 Jun.
Article en En | MEDLINE | ID: mdl-31037566
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Adhesivo de Tejido de Fibrina / Fístula Rectal / Plasma Rico en Plaquetas Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Aspecto: Patient_preference Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Int J Colorectal Dis Asunto de la revista: GASTROENTEROLOGIA Año: 2019 Tipo del documento: Article País de afiliación: España Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Adhesivo de Tejido de Fibrina / Fístula Rectal / Plasma Rico en Plaquetas Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Aspecto: Patient_preference Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Int J Colorectal Dis Asunto de la revista: GASTROENTEROLOGIA Año: 2019 Tipo del documento: Article País de afiliación: España Pais de publicación: Alemania