Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

December 17, 2018 updated by: H A Othman, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohammad T Ahmed, Professor, Head of Neurosurgery Department, Assiut University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDODISC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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