A Comparative Study of The Outcomes of Lumbar Disc Herniation Treated by Percutaneous Endoscopic Discectomy And Microdiscectomy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Assessment & Functional Assessment
研究概览
简要总结
Lumbar disc herniation is a common spinal disorder causing pain,disability and significant health care burden. The gold standard surgical procedure for treating lumbar disc herniations is microdiscectomy (MD).
In addition to the potential for surgical site infection, there is still worry about the risks of injury to muscles, including the multifidus, and excessive articular facet resection during laminectomy, which can result in instability, the development of widespread epidural fibrosis, and the persistence of radiated pain. An approach that is less intrusive is endoscopic discectomy (ED). There were no appreciable changes in post-operative pain and function between the groups in a few prospective randomised clinical trials comparing standard MD with ED. On the other hand, ED led to decreased rates of pain and complications, shorter hospital stays, less bleeding, and fewer inflammatory serum markers. We felt that this type of study was required because there weren’t many published prospective randomised clinical trials. Comparing standard MD and ED in terms of symptom alleviation over a 06-month follow-up is the primary goal of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Surgical indication and MRI in concordance with clinical symptoms Presence of single symptomatic disc herniation Failure of atleast 6 weeks of non operative treatment.
排除标准
- •In subjects where endoscopic resection and microdiscectomy is not possible which includes subjects who require foraminotomy or bone resection or with bone stenosis of the canal or with foraminal stenosis or with previous surgery on the lumbar spine or with cauda equina syndrome or who are unfit for surgery.
结局指标
主要结局
Pain Assessment & Functional Assessment
时间窗: POD1, POD1week, POD1, 3, 6 Months
次要结局
未报告次要终点
研究者
Dakuri Satvik Reddy
AIIMS Bibinagar
