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Irrigation Endoscopic Decompression

Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02254590
Enrollment
104
Registered
2014-10-02
Start date
2009-09-30
Completion date
2014-03-31
Last updated
2014-10-02

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

Conditions

Lumbar Spinal Canal Stenosis

Keywords

IEDL, irrigation endoscopic decompressive laminotomy, irrigation endoscopic decompression, minimally invasive spine surgery, endoscopic decompression, spinal stenosis

Brief summary

To evaluate a new endoscopic technique for lumbar spinal canal decompression.

Detailed description

104 consecutive patients suffering of neurogenic claudication were included in the study. Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index \[19\] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Interventions

PROCEDUREIrrigation Endoscopic Decompressive Laminotomy

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/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit 2. Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included) 3. Failure of 3 months conservative treatment 4. Grade I degenerative spondylolisthesis and degenerative scoliosis

Exclusion criteria

1. Segmental Instability 2. Lytic Spondylolisthesis 2- Predominant low back pain

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index24 monthsMeasurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling
Modified Macnab criteria24 monthspatient satisfaction, the need for medications, ability to return to activity

Secondary

MeasureTime frameDescription
Time for ambulation72 hourspostoperative time required to start ambulation
Time for hospitalization72 hourspostoperative hospital stay till discharge
VAS for back pain72 hoursPain intensity on scale from 0-10

Outcome results

None listed

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