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临床试验/NCT04422197
NCT04422197Unknown不适用

Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月16日最近更新:
适应症
干预措施

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

Active Comparator

Patients with major abdominal surgery without botox injection

干预措施: surgery without botox injection (Procedure)

Patients with ultrasound-guided botox injection

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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