Irrigation Endoscopic Decompressive Laminotomy

Lumbosacral Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991912
• Other study ID #: IEDL
• Status: Completed
• Phase: N/A
• First received: June 7, 2013
• Last updated: January 28, 2014
• Start date: June 2009
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbosacral Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• open lumbar decompression
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complications		24 months	Yes
Primary	oswestry disability index		24 months	No
Secondary	postoperative hospital stay		30 days	No
Secondary	time required following surgery before return to work		30 days	No
Secondary	vas for back pain		30 days	No