Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of incisional hernia.
研究概览
简要总结
Aim of the work This randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia Study design and setting This is a double-blind prospective randomized controlled trial that will be conducted in the general surgery department and colorectal surgery unit of Mansoura University hospital in the period from June 2019 to June2020. The patient's recruitment process will be started and continued for one year after getting the approval from the local Institutional Review Board in Mansoura University in concordance with the Helsinki Declaration Principals. The data will be collected and analyzed prospectively. A signed informed consent will be obtained from every patient before enrollment highlighting the possible future publication. On request, patients can be excluded from the study at any time if they do not want to continue.
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
- 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
- 否
入选标准
- •Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
排除标准
- •pregnancy
- •patients with myopathies
- •motor polyneuropathies, impaired neuromuscular transmission (Myasthenia Gravis)
- •complicated Chronic Obstructive Pulmonary Disease (COPD),
- •necrotizing fasciitis of the trunk
- •unfit for general anesthesia
- •patients with psychiatric disorders
- •patients with drug abuse or history of opioid intake
- •chronic pain disorder
- •coagulopathy
研究组 & 干预措施
Patients with no botox injection
Patients with major abdominal surgery without botox injection
干预措施: surgery without botox injection (Procedure)
Patients with ultrasound-guided botox injection
Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
干预措施: Botox (Biological)
结局指标
主要结局
incidence of incisional hernia.
时间窗: one year
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
次要结局
未报告次要终点
