Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled, Non-Inferiority Trial.

Abstract

Background: The optimal management strategy for grade III hemorrhoids remains a subject of ongoing debate. Hemorrhoidectomy is the gold 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 non-inferiority trial.

Settings: Multicenter study across 10 Dutch hospitals from October 2019 to September 2022.

Patients: Patients (≥18 years) with symptomatic grade III (Goligher) hemorrhoids. Exclusions: prior rectal/anal surgery, >1 rubber band ligation/injection within the preceding three years, rectal radiation, preexisting sphincter injury, inflammatory bowel disease, medical unfitness for surgery (ASA >3), pregnancy, or hypercoagulability disorders.

Interventions: Randomized 1:1 to rubber band ligation or hemorrhoidectomy, with up to two banding sessions allowed.

Main outcome measures: Primary: 12-month health-related quality of life and recurrence rate. Secondary: complications, pain, work resumption, and patient-reported outcome measures.

Results: Eighty-seven patients were randomized (47 rubber band ligation vs 40 hemorrhoidectomy). Rubber band ligation was not non-inferior to hemorrhoidectomy in quality adjusted life years (-0.045, 95% confidence interval -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% confidence interval 24%-59%). Complication rates were comparable. Post-hemorrhoidectomy pain scores 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 study's primary limitation 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, while Rubber Band Ligation allows faster recovery with less pain. These findings can guide clinical decision-making. See Video Abstract.

Clinical trial registration number: NCT04621695.