The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- one week after operation
研究概览
简要总结
This is a prospective, randomized study, which anticipatedly recruited 60 patients in the outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After obtaining those patients' consent in the clinic, they were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with age over 20 but under 80, who need to undergo hemorrhoidectomy
排除标准
- •patients under the age of 20
- •patients with nonsteroidal anti-inflammatory drugs (NSAIDs) allergy or sensitivity
- •patients with Botulinum toxin allergy or sensitivity
- •patients with dialysis or renal insufficiency
- •pregnant and breastfeeding women
- •vulnerable population
结局指标
主要结局
one week after operation
时间窗: 1 weel
The degree of postoperative pain is assessed by visual analog scale (VAS). After operation, we record patients' average VAS score and maximum VAS score every day until one week after surgery.
次要结局
未报告次要终点
研究者
Yi-Chiao Cheng
Attending surgeon, division of colon and rectal surgery
Tri-Service General Hospital