Irrigation Endoscopic Decompressive Laminotomy

Study Overview
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Brief Summary
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The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity .This is further magnified by the disease being more common in elderly with associated medical comorbidities and being usually global involving multiple levels.The purpose of this study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.

Detailed Description
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In the IEDL group,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 and bilateral decompression under endoscopic vision is performed. In the microsurgical group, bilateral fenestration is performed in the usual manner

Official Title
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Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Unilateral Approach for Bilateral Lumbar Decompression: A Blinded Non-randomized Controlled Trial.

Conditions
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Lumbosacral Spinal Stenosis

Intervention / Treatment
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* Procedure: open lumbar decompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neurogenic claudication,that correlated with moderate to severe spinal canal stenosis as shown on MRI and resistant to 3 months of conservative management . Exclusion Criteria: predominant back pain or instability

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irrigation endoscopic decompression<br>endoscopic decompression is performed for cases of lumbar spinal stenosis.Portals 0.5cm in size are used for the introduction of the instruments and the endoscope. Saline under pump pressure is used to open a potential working space. This is followed by performing an ipsilateral hemilaminotomy and contralateral decompression under the midline structure | Procedure: open lumbar decompression<br>* A posterior midline incision is performed over the affected levels. Bilateral subperiosteal dissection of the paraspinal muscles is performed. Bilateral hemilaminotomies, foraminotomies and lateral recess decompression is performed followed by wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oswestry disability index |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hospital stay |  | 30 days | 
| time required following surgery before return to work |  | 30 days | 
| vas for back pain |  | 30 days | 

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