Platelet-Rich Plasma (PRP) versus Fibrin Glue in Cryptogenic Fistula-in-ano: a Phase HI Single-Center, Randomized, Double-Blind Trial

摘要

Purpose: To compare the clinical outcome of auto-logous 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 auto-logously prepared PRP vs. 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.