Outcomes Evaluation of Interlaminar Endoscopic Uniportal Bilateral Lumbar Decompression Versus Open Laminectomy for Degenerative Lumbar Canal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Functional Disability (Oswestry Disability Index - ODI)
研究概览
简要总结
This is a randomized controlled trial comparing interlaminar uniportal endoscopic bilateral lumbar decompression with conventional open laminectomy in patients with degenerative lumbar canal stenosis. The study aims to evaluate and compare clinical outcomes including pain relief, functional improvement, operative parameters, and recovery profile between both surgical techniques. Patients will be followed postoperatively for one day outcomes, one month, and six months to assess effectiveness and safety of each procedure.
详细描述
This randomized controlled trial was designed to compare the clinical and surgical outcomes of interlaminar uniportal endoscopic bilateral lumbar decompression versus conventional open laminectomy in patients diagnosed with degenerative lumbar canal stenosis. Lumbar spinal stenosis is a common degenerative condition that results in neurogenic claudication, radicular pain, and functional disability due to compression of neural elements.
The study was conducted at Ain Shams University Hospitals and Damanhour Medical National Institute. Patients meeting inclusion criteria were diagnosed based on clinical evaluation and radiological confirmation using MRI. Eligible patients were randomized into two groups: one group underwent minimally invasive interlaminar uniportal endoscopic bilateral decompression, while the other group underwent conventional open laminectomy.
The primary objective of the study was to compare the effectiveness of both surgical techniques in terms of pain relief and functional improvement. Secondary objectives included comparison of operative time, intraoperative blood loss, postoperative hospital stay, complication rates, muscle injury markers, and time to return to normal activity.
Patients were evaluated preoperatively and postoperatively using standardized clinical assessment tools. Postoperative follow-up was conducted at one day postoperative period, one month, and six months to assess both early and mid-term outcomes.
The hypothesis of the study is that minimally invasive endoscopic decompression provides equivalent or superior clinical outcomes compared to conventional open laminectomy, with the advantage of reduced tissue trauma, less postoperative pain, faster recovery, and shorter hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with degenerative lumbar spinal stenosis based on clinical and radiological findings.
- •Patients presenting with neurogenic claudication and/or radicular leg pain. Patients indicated for surgical decompression after failure of conservative treatment.
- •Age 18 years and above. Patients able to provide informed consent.
排除标准
- •Patients with previous lumbar spine surgery at the same level. Patients with spinal instability requiring fusion. Presence of spinal infection, tumor, or traumatic pathology. Severe comorbid conditions contraindicating surgery. Patients with incomplete clinical or follow-up data.
研究组 & 干预措施
Endoscopic Decompression Group
Patients undergo interlaminar uniportal endoscopic bilateral lumbar decompression for treatment of degenerative lumbar spinal stenosis.
干预措施: Interlaminar Uniportal Endoscopic Lumbar Decompression (Procedure)
Open Laminectomy Group
Patients undergo conventional open laminectomy for treatment of degenerative lumbar spinal stenosis
干预措施: Open Lumbar Laminectomy (Procedure)
结局指标
主要结局
Functional Disability (Oswestry Disability Index - ODI)
时间窗: Preoperative, 1 month, and 6 months postoperative
The Oswestry Disability Index (ODI) will be used to evaluate functional disability related to lumbar spinal stenosis. The ODI is a validated questionnaire assessing limitations in activities of daily living, including pain intensity, personal care, walking, sitting, standing, and social function. Scores range from 0 to 100, with higher scores indicating greater disability. Outcomes will be compared between patients undergoing interlaminar endoscopic and conventional open lumbar decompression.
Postoperative Leg Pain (VAS-Leg Score)
时间窗: Preoperative, 1 day, 1 month, and 6 months postoperative
Radicular leg pain will be assessed using the Visual Analogue Scale (VAS), a validated 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will rate their leg pain intensity preoperatively and at follow-up intervals. This measure reflects the severity of nerve root compression symptoms and will be used to compare the effectiveness of interlaminar endoscopic versus conventional open lumbar decompression
Postoperative Back Pain (VAS-Back Score)
时间窗: Preoperative, 1 day, 1 month, and 6 months postoperative
Low back pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated patient-reported outcome measure ranging from 0 (no pain) to 10 (worst imaginable pain). This scale evaluates the severity of axial back pain associated with degenerative lumbar spinal stenosis. Measurements will be obtained preoperatively and at follow-up intervals to compare pain relief between interlaminar endoscopic and conventional open lumbar decompression techniques.
Claudication Distance
时间窗: Preoperative, 1 month, and 6 months postoperative
Claudication distance will be assessed as the maximum walking distance a patient can achieve before the onset of neurogenic claudication symptoms, such as leg pain, numbness, or weakness. This measure reflects functional limitation due to lumbar spinal stenosis and will be used to evaluate improvement after interlaminar endoscopic versus open lumbar decompression.
次要结局
- Operative Time(Intraoperative)
- Length of Hospital Stay(From surgery to hospital discharge (typically within 1-5 days postoperative))
- Postoperative Complications(Up to 6 months postoperative)
- Time to Return to Work(Up to 6 months postoperative)
- Creatine Phosphokinase (CPK) Level(1 day postoperative)
研究者
Mohammad Yousof Mohammad
Assistant Lecturer, Department of Neurosurgery
Ain Shams University