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Clinical Trials/NCT01991912
NCT01991912
Completed
Not Applicable

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

Cairo University0 sites80 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbosacral Spinal Stenosis
Sponsor
Cairo University
Enrollment
80
Primary Endpoint
oswestry disability index
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
November 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

hesham magdi soliman

doctor

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

oswestry disability index

Time Frame: 24 months

Secondary Outcomes

  • postoperative hospital stay(30 days)
  • time required following surgery before return to work(30 days)
  • vas for back pain(30 days)

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