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临床试验/CTRI/2025/03/082533
CTRI/2025/03/082533尚未招募不适用

Comparative study of Endoscopic vs Open Spinal Decompression For Single Level Lumbar Spinal Canal Stenosis based on clinical and surgical outcomes - A randomized control study

Sri Venkateswara Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
试验地点
1
主要终点
To investigate the safety of fully endoscopic decompression methods compared to open laminectomy for the treatment of degenerative lumbar spinal stenosis.

研究概览

简要总结

Endoscopic and open spinal decompression are two surgical approaches for managing single-level lumbar spinal canal stenosis, each with distinct advantages and limitations. Open laminectomy, a traditional approach, provides direct visualization and effective decompression but is associated with increased muscle disruption, longer hospital stays, and delayed recovery. In contrast, fully endoscopic decompression offers a minimally invasive alternative with reduced tissue trauma, shorter recovery times, and quicker return to daily activities, though it requires specialized expertise and equipment. This study aims to compare both techniques in terms of clinical and surgical outcomes, focusing on safety, efficacy, complications, functional recovery, and long-term sustainability of results in a randomized control setting.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients between age 20-80 years with symptomatic single-level lumbar canal stenosis not relieved by conservative treatment.
  • Lumbar stenosis confirmed by MRI or CT requiring decompression Symptoms of claudication and/or radiculopathy.
  • Competent and understands study protocol Written informed consent to participate.

排除标准

  • 未提供

结局指标

主要结局

To investigate the safety of fully endoscopic decompression methods compared to open laminectomy for the treatment of degenerative lumbar spinal stenosis.

时间窗: Baseline, 3 months, 6 months

次要结局

  • proportion of complications, operation length, length of stay, days of return to normal activities, all-cause mortality, readmission, reoperation rates, Visual Analogue Scale (VAS) for pain, and Oswestry Disability Index (ODI)(3 months and 6 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Papasani Anil Kumar Reddy

SVIMS Tirupati

研究点 (1)

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