By Reza Abbasi and Isfahan University of Medical Sciences
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The volume of bleeding was measured in milliliter
研究概览
简要总结
Now a days, due to the change in lifestyle, the extended lifespan and the increase in the rate of the road accidents, the need for surgical operation of spinal instrumentation has been increased. And these surgeries are the most crucial part of neurological surgery wards. The everyday improvements in the quality of equipment used and advancements in surgical methods lead to best performance of these procedures and finally the higher quality of patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to pain relief and better performance and developments in the quality of patients' lives.
In addition to the above mentioned improvements, you must consider the fact that these activities are still accompanied by complications during and after surgical operation.
Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate sagittal balance are the most significant side effects during spinal surgery.
One of the most important complications during and after these surgeries is perioperative bleeding that causes problems both for the patients and the surgeon.
详细描述
The individuals evaluated in this study were those who have been admitted and undergone spiral surgery (Fusion and Instrumentation) with pedicular screw because of spinal column instability and canal stenosis.
This study has been started and performed since Feb.2013 to June 2015 at the neurosurgery ward of Al.zahra hospital of Isfahan.
The candidates chosen for the study were those who undergone the surgery procedure due to degenerative change of Lumbar spinal canal.
The necessity of operation for each patient is diagnosed based on clinical finding, Imaging data and guidelines according to neurosurgery reference sources.(Richards Winn,Youmans Neurological Survey, Sixth Edition, Vol 3,Ch.303) During this prospective study, patients are randomly divided into two groups of Case and Control. The individuals attended these two groups are matched regarding age, sex and general medical condition. The age ranges in this study are 33 to 82 years old.
Other than general surgery consent taken from both groups, patients in Case group are informed about the procedure of the program and probable side effects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 33 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who suffer from lumbar spine degenerative disease and need spine fusion surgery.
排除标准
- •History of Trauma,
- •History of Malignancy,
- •previous spinal surgery,
- •History of coagulation disorder,
- •active infectious disease,
- •gastrointestinal problems,
- •severe movement disorders.
研究组 & 干预措施
PEG & Cefazolin
patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, cefazolin 1gram, every 6hours for 2 days
干预措施: PEG (Drug)
PEG & Cefazolin
patients firstly get liquid diet for 24 hours. After that they get PEG solution (80gr/1Litr) each 8 hours for 24 hours. After 48 hours, cefazolin 1gram, every 6hours for 2 days
干预措施: Cefazolin (Drug)
placebo & cefazolin
placebo for PEG and cefazolin 1gram, every 6hours for 2 days
干预措施: placebo (Drug)
placebo & cefazolin
placebo for PEG and cefazolin 1gram, every 6hours for 2 days
干预措施: Cefazolin (Drug)
结局指标
主要结局
The volume of bleeding was measured in milliliter
时间窗: up to 3 days
次要结局
未报告次要终点
研究者
Abbasi
Dr. Abbasi
Isfahan University of Medical Sciences