Efficacy of two endoscopic rubber band ligation methods for symptomatic hemorrhoids: a randomized controlled trial.

ABSTRACT

BACKGROUND: Endoscopic rubber band ligation (ERBL) is considered an effective nonsurgical treatment for symptomatic grade I to III hemorrhoids; however, it is unclear whether ligation of hemorrhoids or simultaneous ligation of hemorrhoids and proximal normal mucosa (combined ligation) is safer and more effective. This controlled, open-label, and prospective study aimed to evaluate the efficacy and safety of both methods for symptomatic grade I to III hemorrhoids. METHODS: Seventy patients with symptomatic grade I to III hemorrhoids were randomly assigned to the hemorrhoid and combined ligation groups (35 in each group). Patients were followed up at 3, 6, and 12 months to assess symptom improvement, complications, and recurrence. The primary outcome was overall therapeutic success rate (complete resolution and partial resolution rates). The secondary outcomes included recurrence rate and efficacy for each symptom. Complications and patient satisfaction were also assessed. RESULTS: Sixty-two patients (31 in each group) completed the 12-month follow-up; 42 (67.8%) experienced complete resolution, 17 (27.4%) experienced partial resolution, and 3 (4.8%) experienced no change in overall efficacy. The rates of complete resolution, partial resolution, and no change in the hemorrhoid ligation and combined ligation groups were 71.0 and 64.5%, 22.6 and 32.3%, and 6.5 and 3.2%, respectively. No significant differences in overall efficacy, recurrence rate, or efficacy for each symptom (including bleeding, prolapse, pain, anal swelling, itching, soiling, and constipation) were observed between groups. No life-threatening events requiring surgical intervention occurred. The incidence of postoperative pain was higher in the combined ligation group (74.2% vs. 45.2%, P = 0.02). No significant differences between groups in terms of incidences of other complications or patient satisfaction were observed. CONCLUSION: Both methods achieved satisfactory therapeutic effects. No significant differences in efficacy and safety of the two ligation methods were observed; however, combined ligation resulted in a higher incidence of postprocedural pain.