Irrigation Endoscopic Decompressive Laminotomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991912

Enrollment

Registered

2013-11-25

Start date

2009-06-30

Completion date

2012-11-30

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbosacral Spinal Stenosis

Keywords

irrigation endoscopic decompression, minimally invasive surgery, spinal stenosis

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

Interventions

PROCEDUREopen 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
oswestry disability index	24 months

Secondary

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

Measure	Time frame
complications	24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026