Comparación De La Ligadura Con Banda Elástica Y La Hemorroidectomía En Pacientes Con Hemorroides Sintomáticas De Grado Iii (Holland): Ensayo Multicéntrico, Abierto, Aleatorizado, Controlado Y De No Inferioridad

BACKGROUND: The optimal management strategy for grade III hemorrhoids remains a subject of ongoing debate. Hemorrhoidectomy is the criterion standard, but rubber band ligation offers a less invasive outpatient alternative. Treatment variability persists due to a lack of consensus on the preferred strategy. OBJECTIVE: To directly compare the effectiveness of rubber band ligation and hemorrhoidectomy in the treatment of grade III hemorrhoids. DESIGN: Open-label, parallel-group, randomized controlled noninferiority trial. SETTINGS: Multicenter study across 10 Dutch hospitals from October 2019 to September 2022. PATIENTS: Patients (aged 18 years or older) with symptomatic grade III (Goligher) hemorrhoids were included in this study. Exclusion criteria included prior rectal/anal surgery, more than 1 rubber band ligation/injection within the preceding 3 years, rectal radiation, preexisting sphincter injury, IBD, medical unfitness for surgery (ASA higher than 3), pregnancy, or hypercoagulability disorders. INTERVENTIONS: Randomized 1:1 to rubber band ligation or hemorrhoidectomy, with up to 2 banding sessions allowed. MAIN OUTCOME MEASURES: Primary outcomes included 12-month health-related quality of life and recurrence rate. Secondary outcomes included complications, pain, work resumption, and patient-reported outcome measures. RESULTS: Eighty-seven patients were randomly assigned (47 rubber band ligation vs 40 hemorrhoidectomy). Rubber band ligation was not noninferior to hemorrhoidectomy in quality-adjusted life years (–0.045; 95% CI, –0.087 to –0.004). Recurrence rate was worse in the rubber band ligation group (47.5% vs 6.1%), with an absolute risk difference of 41% (95% CI, 24%–59%). Complication rates were comparable. Pain scores after hemorrhoidectomy were higher during the first week (visual analogue scale 4 vs 1; p = 0.002). Rubber band ligation group returned to work sooner (1 vs 9 days; p = 0.021). Patient-reported hemorrhoidal symptom scores favored hemorrhoidectomy. LIMITATIONS: The primary limitation of the study was its early termination due to funding constraints, resulting in a relatively small sample size and limited statistical power. Patient recruitment was hindered by significant treatment preferences and the COVID-19 pandemic. CONCLUSIONS: Hemorrhoidectomy may benefit patients with grade III hemorrhoids in terms of quality of life, recurrence risk, and symptom burden, whereas rubber band ligation allows faster recovery with less pain. These findings can guide clinical decision-making.