Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, No.300 of Guangzhou Road, Nanjing, 210029, China.
Surg Endosc. 2023 Aug;37(8):6235-6245. doi: 10.1007/s00464-023-10108-8. Epub 2023 May 15.
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.
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.
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.
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.
内镜橡皮圈结扎术（ERBL）被认为是治疗有症状的 I 至 III 度痔的有效非手术治疗方法；然而，对于结扎痔还是同时结扎痔和近端正常黏膜（联合结扎）哪种方法更安全、更有效尚不清楚。本项对照、开放标签、前瞻性研究旨在评估这两种方法治疗有症状的 I 至 III 度痔的疗效和安全性。
70 例有症状的 I 至 III 度痔患者被随机分配到痔结扎组和联合结扎组（每组 35 例）。患者在 3、6 和 12 个月时进行随访，以评估症状改善、并发症和复发情况。主要结局是总体治疗成功率（完全缓解率和部分缓解率）。次要结局包括复发率和每个症状的疗效。还评估了并发症和患者满意度。
62 例患者（每组 31 例）完成了 12 个月的随访；42 例（67.8%）完全缓解，17 例（27.4%）部分缓解，3 例（4.8%）总体疗效无变化。痔结扎组和联合结扎组的完全缓解率、部分缓解率和无变化率分别为 71.0%和 64.5%、22.6%和 32.3%、6.5%和 3.2%。两组间总体疗效、复发率或每个症状（包括出血、脱垂、疼痛、肛门肿胀、瘙痒、污染和便秘）的疗效无显著差异。未发生需要手术干预的危及生命的事件。联合结扎组术后疼痛发生率较高（74.2% vs. 45.2%，P=0.02）。两组间其他并发症发生率或患者满意度无显著差异。
两种方法均获得了满意的治疗效果。两种结扎方法的疗效和安全性无显著差异；然而，联合结扎后疼痛发生率较高。
