Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Degree of low back pain
研究概览
简要总结
This study aims to compare the endoscopic versus open lumbar discectomy in diabetic patients.
详细描述
Diabetes mellitus (DM) is a highly prevalent disease with the capacity to adversely affect nearly every major organ system. DM has been demonstrated as a risk factor for a variety of complications within medical and surgical spheres Open lumbar discectomy is the most common surgical discectomy technique and is considered by many to be the gold standard.
Endoscopic lumbar discectomy allowed spinal surgeons to decompress a symptomatic lumbar nerve root by using an endoscopic minimally invasive surgical approach.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years.
- •Both sexes.
- •Patients suffering from prolapsed lumbar disc postero-lateral, single level disc herniation at L4-5 or L5-S1 level with low back pain and unilateral radiculopathy and failure of conservative treatment for 12 weeks
排除标准
- •Extraforaminal disc herniation.
- •Recurrent and/or multiple level discs prolapses.
- •Spondylolisthesis.
- •Prior lumbar surgery at the same spinal level.
结局指标
主要结局
Degree of low back pain
时间窗: 48 hours postoperatively
The patients will be evaluated clinically using Visual Analogue Score (VAS) for low back pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
次要结局
- Degree of radicular pain(48 hours postoperatively)
- Length of hospital stay(1 week postoperatively)
- Intraoperative blood loss(Intraoperatively)
- Operative time(Intraoperatively)
- Wound length(Intraoperatively)
研究者
Awad Mohamed Hegab
Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
Al-Azhar University