BACKGROUND:This prospective randomized controlled trial investigated the efficacy of micronized purified flavonoid fraction (MPFF) in managing postoperative pain and complications following anal fistula surgery. MPFF, a phlebotropic agent with anti-inflammatory and microcirculatory benefits, has demonstrated efficacy in hemorrhoidectomy recovery but remains unexplored in fistula surgery.
METHODS:A total of 106 patients undergoing fistulotomy or fistulectomy were allocated to receive either MPFF at a dose of 1 g twice daily or serve as controls. The primary endpoints were daily pain scores measured by visual analog scale (VAS) and the frequency of dressing changes. Secondary outcomes included analgesic consumption, postoperative complications, and wound healing at 3 months.
RESULTS:Among the enrolled patients, 104 completed the study, comprising 52 patients in the MPFF group and 52 in the control group. VAS scores were significantly lower in the MPFF group compared to the control group at multiple time points from 8 h post-surgery to day 7, with statistically significant differences observed on days 2 (3.02 ± 2.37 vs. 3.92 ± 2.16; P = 0.045), 4 (2.54 ± 2.29 vs. 3.40 ± 1.89; P = 0.038), and 5 (2.34 ± 2.09 vs. 3.25 ± 1.88; P = 0.022). Additionally, the frequency of dressing changes was reduced in the MPFF group relative to the control group from day 1 to day 7 post-surgery, with statistically significant differences observed from day 4 onward (day 4, P = 0.036; day 5, P = 0.012; day 6, P = 0.012; day 7, P = 0.012). Secondary outcomes, including analgesic use, wound healing, and postoperative complications such as infection, bleeding, urinary retention, delayed healing, and recurrence, showed no significant differences between groups. No patient required re-intervention for hemorrhage.
CONCLUSION:This study demonstrates that MPFF not only decreases postoperative pain but also lowers the frequency of dressing changes, supporting its role as a valuable therapeutic option for improving recovery after anal fistula surgery.
CLINICAL TRIAL REGISTRATION:This study was registered with ClinicalTrials.gov, and its registration number is NCT06184438.