跳至主要内容
临床试验/CTRI/2026/01/102156
CTRI/2026/01/102156尚未招募不适用

A Comparative Study of The Outcomes of Lumbar Disc Herniation Treated by Percutaneous Endoscopic Discectomy And Microdiscectomy: A Randomised Controlled Trial

Aiims bibinagar1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年2月5日最近更新:

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

发起方
Aiims bibinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dakuri Satvik Reddy

AIIMS Bibinagar

研究点 (1)

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