Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Unilateral Approach for Bilateral Lumbar Decompression: A Blinded Non-randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 80
- Primary Endpoint
- oswestry disability index
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
irrigation endoscopic 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
Intervention: open lumbar decompression (Procedure)
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)
Investigators
hesham magdi soliman
doctor
Cairo University