Irrigation Endoscopic Decompressive Laminotomy

Not Applicable

Completed

• Conditions: Lumbosacral Spinal Stenosis
• Interventions: Procedure: open lumbar decompression

• Registration Number: NCT01991912
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-06
• Study Completion: 2012-11
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
irrigation endoscopic decompression	open lumbar decompression	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

Primary Outcome Measures

Name	Time	Method
oswestry disability index	24 months

Secondary Outcome Measures

Name	Time	Method
postoperative hospital stay	30 days
time required following surgery before return to work	30 days
vas for back pain	30 days