跳至主要内容
临床试验/CTRI/2025/08/093548
CTRI/2025/08/093548招募中3 期

Comparison of clinical outcomes of unilateral biportal endoscopic technique and open technique of discectomy in lumbar disc herniation

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
22
试验地点
1
主要终点
Visaual Analoque score between the 2 groups

研究概览

简要总结

Lumbar disc herniation (LDH) is a prevalent cause of lower back pain and sciatica, primarily occurring at the L4-L5 or L5-S1 levels. While most cases respond to conservative treatment, surgery is indicated for patients with persistent symptoms or neurological deficits. The standard surgical approach, open lumbar discectomy (OLD), is effective but associated with higher tissue damage, postoperative pain, and longer recovery. Minimally invasive techniques like Unilateral Biportal Endoscopic Discectomy (UBE) offer advantages such as reduced muscle trauma, shorter hospital stays, and faster recovery.

This randomized controlled study will be conducted at Maulana Azad Medical College, comparing clinical outcomes of UBE and OLD in patients aged 18–60 years with confirmed LDH unresponsive to conservative treatment. The primary outcome assessed is the change in Visual Analogue Score (VAS) at 2 weeks and 6 months. Secondary outcomes include Oswestry Disability Index (ODI), Macnab score, intraoperative blood loss, surgical duration, hospital stay, and biochemical markers of muscle injury (CPK, LDH, CRP, ESR). With a sample size of 11 patients per group, the study aims to evaluate the invasiveness and efficacy of both techniques. Follow-ups are scheduled at 2 weeks, 6 weeks, 3 months, and 6 months to monitor recovery and outcomes.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with compressive lumbar radiculopathy due to lumbar disc herniation not responding to at least 6 weeks trial of standard conservative management.

排除标准

  • Degenerative lumbar scoliosis, Spinal stenosis, Calcified ligamentum flavum, Segmental instability of lumbar spine, Psychosomatic pain syndromes, Previously operated patients for disc herniation.

结局指标

主要结局

Visaual Analoque score between the 2 groups

时间窗: The patients will be assessed at baseline, at postoperative 14 ± 2 days, 6 weeks, 3 months and 6 months

次要结局

  • To compare the extent of tissue damage caused by Unilateral Biportal Endoscopic discectomy and Open discectomy by measuring biochemical markers of tissue injury(Baseline, Postoperative Day 1, Postoperative Day 3)
  • To compare amount of blood loss during Unilateral Biportal Endoscopic discectomy and open discectomy(Baseline Haemoglobin, Postoperative day 1 and Postoperative Day 2)
  • To compare hospital stay after Unilateral Biportal Endoscopic discectomy and Open Discectomy(Number of days admitted after surgery)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Rupjyoti Dutta

Maulana Azad Medical College

研究点 (1)

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