Irrigation Endoscopic Decompression

Not Applicable

Completed

• Conditions: Lumbar Spinal Canal Stenosis
• Interventions: Procedure: Irrigation Endoscopic Decompressive Laminotomy

• Registration Number: NCT02254590
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Study First Posted: 2014-10-02
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IEDL	Irrigation Endoscopic Decompressive Laminotomy	Endoscopic decompression of spinal stenosis

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	24 months	Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling
Modified Macnab criteria	24 months	patient satisfaction, the need for medications, ability to return to activity

Secondary Outcome Measures

Name	Time	Method
Time for ambulation	72 hours	postoperative time required to start ambulation
Time for hospitalization	72 hours	postoperative hospital stay till discharge
VAS for back pain	72 hours	Pain intensity on scale from 0-10