An interventional study of minimally invasive surgery and conventional open surgery in Lumbar Spinal Stenosis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Exclusion Criteria:
randomly allocated
Procedure: minimally invasive surgery
randomly allocated
Procedure: conventional open surgery
using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.
open interlaminar lumbar decompression
Functional outcome
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).
Time frame: Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
back pain and lower limb pain
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).
Time frame: using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
Intraoperative blood loss
amount of intraoperative blood loss
Time frame: intraoperative
Operative time
in minutes
Time frame: intraoperative
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Assiut University