Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management of Lumbar Postero-lateral Single Level Disc Herniation: Comparative Study Between Conventional and Endoscopic Lumbar Discectomy

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Procedure: Conventional open lumbar discectomy
* Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy.
* Device: Easy Go system Endoscopy


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: central, far lateral, recurrent and/or multiple level disc herniation. Lateral recess stenosis or spondylolisthesis. presence of neurological deficit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Patients in this arm will have conventional open lumbar discectomy operation. | Procedure: Conventional open lumbar discectomy<br>* Removal of single level lumbar disc herniation through conventional discectomy.<br>|
| Active Comparator: Endoscopic<br>Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy | Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy.<br>* Removal of single level Lumbar disc herniation using endoscope.<br>Device: Easy Go system Endoscopy<br>* This system will be used to remove herniated disc in endoscopic group<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar disc herniation, endoscopic discectomy, open discectomy, comparative study, Translaminar, surgery