Efficacy of MicrOnized Purified Flavonoid Fraction in PoST-Hemorrhoidectomy Period (MOST Trial): Open-Label Randomized Controlled Trial.

BACKGROUND: Frequent early postoperative complication of hemorrhoidectomy is thrombosis and edema of mucocutaneous "bridges."

OBJECTIVE: We investigated the efficacy of micronized purified flavonoid fraction in preventing complications following elective hemorrhoidectomy.

DESIGN: Prospective unicentral open-label randomized controlled trial.

SETTINGS: 2021-2022 Clinic of Colorectal and Minimally Invasive Surgery Sechenov University (Moscow, Russia).

PATIENTS: Patients after hemorrhoidectomy, which was done for grade III-IV hemorrhoids.

INTERVENTIONS: After hemorrhoidectomy, patients were randomly allocated either to standard treatment (peroral non-steroid anti-inflammatory drugs and local anesthetics, topical steroids, psyllium, warm sitz baths, nifedipine gel) - control group, or to standard treatment with micronized purified flavonoid fraction (study group) and followed for 60 days.

MAIN OUTCOME MEASURES: Thrombosis or edema of mucocutaneous bridges and pain intensity on a visual analogue scale оn 1st-7th, 14th , 21st and 30th postoperative day; quality of life and patient-assessed treatment effect оn 1st, 3rd, 7th, 21st and 30th postoperative day; perianal skin tags оn 60th postoperative day.

RESULTS: The data from 50 patients were analyzed (25 in each group). Visual analogue scale demonstrated nо differences between groups in each follow-up point. Compared to control group, the patients in study group had significantly higher patient-assessed treatment effect оn 1st, 3rd, 7th, 21st and 30th post operative days, significantly lower rate of thrombosis or edema of mucocutaneous bridges оn 1st-7th, and 14th days. Patients in the study group had significantly lower rates of perianal skin tags.

LIMITATIONS: Unicenter open-label design.

CONCLUSIONS: Micronized purified flavonoid fraction in the post-hemorrhoidectomy period is an effective adjunct to standard treatment that helps reduce the rate of thrombosis and edema of mucocutaneous bridges, improves patient-assessed treatment effect, and prevents postoperative perianal skin tags formation. Micronized purified flavonoid fraction in the post-hemorrhoidectomy period is not associated with additional pain relief in comparison with non-micronized purified flavonoid fraction standard treatment. See Video Abstract.