Preliminary Results of Open Excisional Hemorrhoidectomy Combined with 3% Polidocanol Foam Sclerotherapy in Patients with IV-Degree Hemorrhoidal Disease: A Randomized Controlled Open-Label Single-Center Study

BACKGROUND: The Milligan-Morgan Hemorrhoidectomy remains the gold standard for IV-degree hemorrhoidal disease. However, postoperative pain, bleeding, and prolonged recovery persist as challenges. Sclerotherapy shows promise but lacks evidence in IV-degree hemorrhoidal disease management. OBJECTIVE: This study evaluated the efficacy and safety of open excisional hemorrhoidectomy (Milligan-Morgan hemorrhoidectomy) combined with 3% polidocanol foam sclerotherapy in patients with IV-degree hemorrhoidal disease. DESIGN: Randomized, open-label, single-center clinical trial, SETTINGS: Department of Anorectal Surgery, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China. PATIENTS: Thirty-six patients aged 18–75 years with IV-degree hemorrhoidal disease were enrolled and randomized equally to two groups. INTERVENTIONS: The experimental group received Milligan-Morgan hemorrhoidectomy combined with 3% polidocanol foam sclerotherapy; the control group received Milligan-Morgan hemorrhoidectomy. MAIN OUTCOME MEASURES: The primary outcome is the time to return to daily activities. Secondary outcomes: Hemorrhoidal Disease Symptom Score, Vaizey Incontinence scores, Visual Analogue Scale, Short Health Scale for Hemorrhoidal Disease scores, postoperative bleeding grade, usage of analgesics, and satisfaction. RESULTS: The experimental group demonstrated a mean 5.78-day earlier return to normal activities and work than the control group (mean ± SD: 19.28 ± 8.35 vs. 25.06 ± 7.85 days, 95% CI: -11.27 to -0.29 days, p = 0.04), reduced postoperative bleeding (0-3 scale, Estimate: -0.45, 95% CI: -0.72 to -0.16, p = 0.002), lower analgesic use (0-3 scale, Estimate: -0.38, 95% CI: -0.66 to -0.09, p = 0.009), and improved symptom scores at 1–2 months (Z -2.52 and -2.11, p < 0.05). Median satisfaction scores were 10 vs. 9.5 ( p = 0.12). No adverse events occurred. LIMITATIONS: Small sample size, non-blinded, single-center design, and short follow-up period. CONCLUSIONS: Milligan-Morgan hemorrhoidectomy combined with 3% polidocanol foam sclerotherapy significantly enhances postoperative recovery, reduces complications, and demonstrates comparable patient satisfaction. Long-term follow-up is warranted to validate sustained efficacy. Clinical trial registration number: Chinese Clinical Trial Registry: ChiCTR2400087552. See Video Abstract.