Back to resultsIrrigation Endoscopic Decompressive Laminotomy
Primary Purpose
Lumbosacral Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open lumbar decompression
Sponsored by
About this trial
This is an interventional treatment trial for Lumbosacral Spinal Stenosis focused on measuring irrigation endoscopic decompression, minimally invasive surgery, spinal stenosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
irrigation endoscopic decompression
Arm Description
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
Outcomes
Primary Outcome Measures
oswestry disability index
Secondary Outcome Measures
postoperative hospital stay
time required following surgery before return to work
vas for back pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01991912
Brief Title
Irrigation Endoscopic Decompressive Laminotomy
Official Title
Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Unilateral Approach for Bilateral Lumbar Decompression: A Blinded Non-randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Spinal Stenosis
Keywords
irrigation endoscopic decompression, minimally invasive surgery, spinal stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
irrigation endoscopic decompression
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
open lumbar decompression
Intervention Description
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
Primary Outcome Measure Information:
Title
oswestry disability index
Time Frame
24 months
Secondary Outcome Measure Information:
Title
postoperative hospital stay
Time Frame
30 days
Title
time required following surgery before return to work
Time Frame
30 days
Title
vas for back pain
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
complications
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hesham m soliman, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Irrigation Endoscopic Decompressive Laminotomy
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