Irrigation Endoscopic Decompression

Study Overview
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Brief Summary
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To evaluate a new endoscopic technique for lumbar spinal canal decompression.

Detailed Description
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104 consecutive patients suffering of neurogenic claudication were included in the study. Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index [19] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Official Title
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Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression

Conditions
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Lumbar Spinal Canal Stenosis

Intervention / Treatment
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* Procedure: Irrigation Endoscopic Decompressive Laminotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included) Failure of 3 months conservative treatment Grade I degenerative spondylolisthesis and degenerative scoliosis Exclusion Criteria: Segmental Instability Lytic Spondylolisthesis 2- Predominant low back pain

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IEDL<br>Endoscopic decompression of spinal stenosis | Procedure: Irrigation Endoscopic Decompressive Laminotomy<br>* 2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling | 24 months | 
| Modified Macnab criteria | patient satisfaction, the need for medications, ability to return to activity | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for ambulation | postoperative time required to start ambulation | 72 hours | 
| Time for hospitalization | postoperative hospital stay till discharge | 72 hours | 
| VAS for back pain | Pain intensity on scale from 0-10 | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irrigation endoscopic decompressive laminotomy, IEDL, minimally invasive spine surgery, spinal stenosis, irrigation endoscopic decompression, endoscopic decompression