Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Conventional open lumbar discectomy; Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy.; Device: Easy Go system Endoscopy

• Registration Number: NCT03137485
• Lead Sponsor: Assiut University

Brief Summary

This study is aimed to compare between the results of conventional lumbar discectomy and the newly used technique in our department; endoscopic lumbar discectomy in neurosurgery department Assiut university hospitals, so that we can offer our patients the best service in an updated and minimally invasive way.

Detailed Description

Lumbar discectomy is one of the most common operation performed worldwide for lumbar-related symptoms. Lumbar disc herniation accounts for only 5% of all low back pain problems but is the most common cause of radiating nerve root pain, sciatica.

Mixter and Barr described the first surgical procedure to remove the herniated lumbar disc in 1934 through a laminectomy and durotomy, with later enhancement by Semmes, who described approaching the herniated disc through hemilaminectomy and retraction of the dural sac. This became popularized as the "classical discectomy technique.

During the latter half of the 19th century, more techniques were developed to remove the herniated disc with minimal invasiveness. The first herniated disc excision using a microscope (microdiscectomy) was performed by Yasargil in 1977, which was the standard surgical procedure at the time In 1993, Mayer and Brock and then in 1997, Smith and Foley described endoscopic discectomy techniques. With these minimally invasive techniques, authors demonstrated decreased soft tissue manipulation, operative time, blood loss, and hospital stay, allowing early recovery.

In this study we try to evaluate clinical and radiological outcomes of percutaneous endoscopic translaminar discectomy at our hospital.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-02
• Primary Completion: 2018-05
• Study Completion: 2018-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• single level, postero-lateral, denovo lumbar disc herniation including those with migrated and/or sequestrated discs.
• L4,5 &L5,S1 disc prolapse
• Failure of conservative management after 12 weeks.

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Exclusion Criteria

• central, far lateral, recurrent and/or multiple level disc herniation.
• Lateral recess stenosis or spondylolisthesis.
• presence of neurological deficit.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional open lumbar discectomy	Patients in this arm will have conventional open lumbar discectomy operation.
Endoscopic	Easy Go system Endoscopy	Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy
Endoscopic	Percutaneous Endoscopic Translaminar lumbar discectomy.	Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy

Primary Outcome Measures

Name	Time	Method
Functional Improvement	Up to ten months post operative.	Functional Improvement using modified MacNab's criteria
Improvement of Preoperative low back pain and radicular pain.	Up to ten months post operative.	Improvement of preoperative low back pain and radicular pain.Clinical outcomes will be measured using Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Hospital stay.	up to one week.	Time spent in hospital post operative.
Blood loss	intraoperative.	Amount of blood loss intraoperative.
lumbo-sacral MRI	Up to six months	Demonstration of any disc herniation recurrence.
Wound length	Intraoperative	Length of incision needed by surgeon to complete each approach
Operative time	Intraoperative	duration of operation
Periprocedural complication.	Up to two weeks.	Such as neurological deficit, Cerebro-Spinal fluid (CSF) leak, wound infection...etc.