Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Neihu District, Section 2, Cheng-Kong Rd, No. 325, Taipei, 114, Taiwan, ROC.
National Defense Medical Center, Taipei, Taiwan.
Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27.
Hemorrhoidectomy is the standard procedure for treating high-grade hemorrhoids. However, postoperative pain usually causes patients to delay or refuse surgical treatment. Because maximal resting pressure in the internal anal sphincter plays a major role in post-hemorrhoidectomy pain, Botulinum toxin injections have been proposed to reduce it. However, the optimal timing of Botulinum toxin injections is still unclear. The aim of the present study was to compare the effectiveness of early and intraoperative Botulinum toxin injections for postoperative pain control.
In this pilot study, we enrolled patients who had grade III or IV hemorrhoids and underwent Ferguson hemorrhoidectomy at a single tertiary care center from October 1, 2018 to November 30, 2020. The experimental group received 50 U Botulinum toxin injections to the internal anal sphincter 1 week before the operation, and the control group received injections intraoperatively. The primary endpoint was the daily maximal and resting visual analogue scale (VAS) score recorded from postoperative days 0-6. The secondary endpoints were analgesia requirements, number of bowel movements per day, healing time, and postoperative length of stay. Power of the daily resting VAS score is at least 93%, but the power of the daily maximal VAS is a little lower (71%) (calculated by G*Power 3.1.9.2).
Sixty-two patients (male: female = 27:35; mean age = 47.6 ± 13.1 years) were randomized to the experimental group (n = 31) or control group (n = 31). The experimental group (n = 31) showed significantly shorter postoperative hospital stay than the controls (n = 31; p = 0.019). A generalized estimating equations model revealed that the group that received Botulinum toxin yielded a significantly lower maximal (OR 0.4, 95% CI 0.2-1.0, p = 0.041) and resting (OR 0.4, 95% CI 0.2-0.7, p < 0.001) VAS compared to controls at all time points. The Botulinum toxin group also had significantly less resting pain from postoperative days 1-5, and lower maximal subjective pain scores on postoperative days 1 (p = 0.024) and 4 (p = 0.044). Similar trends were observed on other days.
Early Botulinum toxin injection produced shorter hospital stays, and less reported pain after hemorrhoidectomy than intraoperative injections, especially for pain at rest.
Identifier: NCT04485780 on ClinicalTrials.gov (retrospectively registered).
痔切除术是治疗高位痔的标准方法。然而，术后疼痛通常会导致患者延迟或拒绝手术治疗。由于内括约肌的最大静息压力在痔切除术后疼痛中起主要作用，因此已提出注射肉毒杆菌毒素以降低其压力。然而，肉毒杆菌毒素注射的最佳时机仍不清楚。本研究旨在比较早期和术中注射肉毒杆菌毒素控制术后疼痛的效果。
在这项初步研究中，我们招募了 2018 年 10 月 1 日至 2020 年 11 月 30 日在一家三级保健中心接受 Ferguson 痔切除术的 III 级或 IV 级痔患者。实验组在手术前 1 周接受 50U 肉毒杆菌毒素注射至内括约肌，对照组在术中接受注射。主要终点是术后 0-6 天记录的每日最大和静息视觉模拟量表（VAS）评分。次要终点是镇痛需求、每日排便次数、愈合时间和术后住院时间。每日静息 VAS 评分的功率至少为 93%，但每日最大 VAS 评分的功率略低（71%）（由 G*Power 3.1.9.2 计算）。
62 名患者（男：女=27:35；平均年龄 47.6±13.1 岁）被随机分配到实验组（n=31）或对照组（n=31）。实验组（n=31）的术后住院时间明显短于对照组（n=31；p=0.019）。广义估计方程模型显示，接受肉毒杆菌毒素治疗的组在所有时间点的最大（OR 0.4，95%CI 0.2-1.0，p=0.041）和静息（OR 0.4，95%CI 0.2-0.7，p<0.001）VAS 均显著低于对照组。肉毒杆菌毒素组在术后第 1-5 天的静息疼痛也明显减少，在术后第 1 天（p=0.024）和第 4 天（p=0.044）的最大主观疼痛评分也较低。在其他日子也观察到类似的趋势。
早期注射肉毒杆菌毒素可缩短痔切除术的住院时间，并减少术后疼痛，尤其是静息时的疼痛。
标识符：NCT04485780 在 ClinicalTrials.gov 上（回顾性注册）。
