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临床试验/NCT05147064
NCT05147064Unknown不适用

Minimally Invasive Surgery Versus Conventional Open Interlaminar Decompression in Treatment of Degenerative Lumbar Canal Stenosis

Assiut University0 个研究点目标入组 40 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
back pain and lower limb pain

研究概览

简要总结

Conventional open surgery has been shown to be an effective procedure for LCS decompression. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

详细描述

Lumbar canal stenosis (LCS) is defined as narrowing of the spinal canal, the vertebral foramina, and/or the lateral recesses, causing compression on the nearby neurologic structures. Degenerative LCS is one of the most common reasons for old patients to undergo spinal surgery. Neurogenic claudication is the most common symptom for LCS patients. The patients complain of pain or discomfort that radiates to the buttock, thigh and lower limb after walking for a certain distance, therefore leading to functional disability and decreased walking capacity. Conservative management is the first line of treatment in the absence of progressive neurologic deficit or intractable pain, consisting of physical therapy, medications (analgesics, steroids) and pain management procedures. Surgical intervention is recommended if the symptoms are persistent or worsening.

Various techniques are currently used for direct decompression of LCS. Conventional open surgery involves laminectomy that has been shown to be an effective procedure for LCS decompression. However, wide laminectomies disturbs the stability of bony and ligamentous structures and may exacerbate preexisting spondylolisthesis. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS. This technique avoids detachment of the paraspinal muscles and may promote preservation of stabilizing ligamentous and bony spinal structures.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patient with lumbar canal stenosis From 18_70 years old

排除标准

  • instability Infection Tumours of vertebrae

结局指标

主要结局

back pain and lower limb pain

时间窗: using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

Change of visual analogue scale (VAS) is being assessed to compare the pre and post operative values. VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters in length. For pain intensity, "no pain" (score of 0) or "worst imaginable pain" (score of 10).

Functional outcome

时间窗: Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

Change of Oswestry disability index (ODI) is being assessed to compare the pre and post operative values. This outcome measure is designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).

次要结局

  • Intraoperative blood loss(intraoperative)
  • Operative time(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Garamoun Abd El Zaher

Assistant lecturer

Assiut University

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