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临床试验/NCT05891314
NCT05891314已完成不适用

The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control: a Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Post-operative pain

研究概览

简要总结

Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment.

Conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. On the other hand, a few patients require surgical intervention. Surgery is indicated for those not responding to conservative management, those with grade III, and grade IV hemorrhoids.

Surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. The most radical operations with the best results are the Milligan-Morgan and Ferguson hemorrhoidectomy .

However, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. The cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (IAS) that becomes exposed after hemorrhoidectomy. The spasm of the IAS is considered the target to relieve pain post operatively. Lateral internal sphincterotomy (LIS) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. However, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial.

On the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing.

Our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.

详细描述

many procedures have been described to decrease the pain post hemorridectomy. Internal sphincterotomy Botox Injection giving strong analgesics

We aim to evaluate the efficacy of Botox and internal sphincterotomy in pain relief after hemorridectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes,
  • aged between 18 and 70 years old.
  • Grade III and IV hemorrhoids.
  • Those with failed conservative treatment.

排除标准

  • surgically unfit patients due to multiple comorbidities,
  • patients who need emergency operation for complicated hemorrhoids,
  • patients with partial rectal prolapse
  • patients with rectal varices due to portal hypertension

结局指标

主要结局

Post-operative pain

时间窗: 2weeks

according to the visual analogue scale (VAS), which contain 10 degrees, the lower the degree , the lower the score this means less pain.

次要结局

  • Time taken to return to daily activities in days.(4-6weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Sakr

consultant and lecturer of general surgery

Mansoura University

研究点 (1)

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