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Clinical Trials/NCT03137485
NCT03137485CompletedNot Applicable

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

Assiut University0 sites30 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Primary Endpoint
Functional Improvement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Conventional

Active Comparator

Patients in this arm will have conventional open lumbar discectomy operation.

Intervention: Conventional open lumbar discectomy (Procedure)

Endoscopic

Active Comparator

Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy

Intervention: Percutaneous Endoscopic Translaminar lumbar discectomy. (Procedure)

Endoscopic

Active Comparator

Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy

Intervention: Easy Go system Endoscopy (Device)

Outcomes

Primary Outcomes

Functional Improvement

Time Frame: Up to ten months post operative.

Functional Improvement using modified MacNab's criteria

Improvement of Preoperative low back pain and radicular pain.

Time Frame: 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 Outcomes

  • Hospital stay.(up to one week.)
  • Blood loss(intraoperative.)
  • lumbo-sacral MRI(Up to six months)
  • Wound length(Intraoperative)
  • Operative time(Intraoperative)
  • Periprocedural complication.(Up to two weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

H A Othman

Resident Doctor, Neurosurgery Department, Assiut Universiy Hosipitals

Assiut University

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