Trial reportTechniques in coloproctology2026
Efficacy of micronized purified flavonoid fraction in reducing pain after anal fistula surgery: a randomized controlled trial.
Trial report in Techniques in coloproctology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06184438 (Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery), which is not on this map. Not yet cited in PubMed.
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Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
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3 authors.
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Abstract
backgroundThis 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.
methodsA 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.
resultsAmong 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.
conclusionThis 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 registrationThis study was registered with ClinicalTrials.gov, and its registration number is NCT06184438.
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