Irrigation Endoscopic Decompressive Laminotomy

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbosacral Spinal Stenosis
• Intervention / Treatment: Procedure: open lumbar 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
oswestry disability index	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
postoperative hospital stay	30 days
time required following surgery before return to work	30 days
vas for back pain	30 days

Other Outcome Measures

Outcome Measure	Time Frame
complications	24 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: hesham m soliman, MD, Cairo university

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: minimally invasive surgery; spinal stenosis; irrigation endoscopic decompression
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: IEDL