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痔切除术期间括约肌内注射肉毒杆菌毒素的术后结果:一项双盲临床试验。

Postoperative outcomes of intrasphincteric botox injection during hemorrhoidectomy: A double-blind clinical trial.

作者信息

Alvandipour Mina, Tavallaei Mehdi, Rezaei Fatemeh, Khodabakhsh Hamed

机构信息

Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran.

Department of Surgery, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Med Sci. 2021 Aug 30;26:53. doi: 10.4103/jrms.JRMS_612_18. eCollection 2021.

Abstract

BACKGROUND

Pain is the most common postoperative complication of hemorrhoidectomy. We evaluated the effectiveness of intrasphincteric Botox injection on posthemorrhoidectomy complications including pain reduction and wound healing.

MATERIALS AND METHODS

In this randomized, double-blind clinical trial, patients with Grades 3 or 4 symptomatic hemorrhoids who underwent open (Milligan-Morgan) hemorrhoidectomy were enrolled. The experimental group received intrasphincteric Botox injection during hemorrhoidectomy, while the controls received normal saline injection. Hemorrhoid grades, constipation status, history of hemorrhoidectomy, duration of operation, pain at rest and after defecation in six follow-up periods (6, 12, 24, and 48 h and 7 and 14 days after operation), wound healing (during follow-up after discharge with a 2-week period), analgesic use, and Botox side effects were evaluated and compared in the two experimental and control groups.

RESULTS

In this trial, 34 and 33 patients were randomly allocated in the experimental and control groups, respectively. Operation time was significantly higher in Botox group ( = 0.009). Mean dose of analgesics use in Botox was significantly lower ( < 0.001). Rate of wound healing during follow-ups was significantly higher in Botox group in the fifth follow-up ( = 0.009). Frequency of urinary retention ( = 0.02) and moderate itching ( = 0.01) was significantly higher in placebo than Botox group. Mean of postoperative pain at rest in Botox group was significantly lower at 12, 24, and 48 h and 7 and 14 days after operation ( < 0.01). Mean of postoperative pain in Botox group was significantly lower at 3 to 5 defecation ( < 0.01).

CONCLUSION

Our findings indicated that a single-dose injection of Botox during Milligan-Morgan hemorrhoidectomy is associated with less postsurgical pain at rest and during defecation and improved wound healing. It is suggested that it is a safe and effective procedure during hemorrhoidectomy regarding the procedure-related complications.

摘要

背景

疼痛是痔切除术最常见的术后并发症。我们评估了括约肌内注射肉毒杆菌毒素对痔切除术后并发症的有效性,包括减轻疼痛和促进伤口愈合。

材料与方法

在这项随机、双盲临床试验中,纳入了接受开放式(Milligan-Morgan)痔切除术的3或4级有症状痔患者。实验组在痔切除术中接受括约肌内肉毒杆菌毒素注射,而对照组接受生理盐水注射。对两组患者的痔分级、便秘状况、痔切除病史、手术时间、六个随访期(术后6、12、24和48小时以及7和14天)的静息痛和排便后疼痛、伤口愈合情况(出院后随访2周期间)、镇痛药物使用情况以及肉毒杆菌毒素副作用进行评估和比较。

结果

在本试验中,分别有34例和33例患者被随机分配到实验组和对照组。肉毒杆菌毒素组的手术时间明显更长(P = 0.009)。肉毒杆菌毒素组的平均镇痛药物使用剂量明显更低(P < 0.001)。在第五次随访时,肉毒杆菌毒素组的伤口愈合率明显更高(P = 0.009)。安慰剂组的尿潴留发生率(P = 0.02)和中度瘙痒发生率(P = 0.01)明显高于肉毒杆菌毒素组。肉毒杆菌毒素组术后静息痛的平均值在术后12、24和48小时以及7和14天明显更低(P < 0.01)。肉毒杆菌毒素组术后排便3至5次时的疼痛平均值明显更低(P < 0.01)。

结论

我们的研究结果表明,在Milligan-Morgan痔切除术中单次注射肉毒杆菌毒素与术后静息和排便时疼痛减轻以及伤口愈合改善有关。就与手术相关的并发症而言,建议其在痔切除术中是一种安全有效的方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9145/8506240/a199dbae4de2/JRMS-26-53-g001.jpg

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