Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

NCT ID: NCT03137485

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-08-31

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.

Conditions

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Lumbar Disc Herniation

Keywords

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lumbar disc herniation endoscopic discectomy open discectomy comparative study Translaminar surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional

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

Group Type ACTIVE_COMPARATOR

Conventional open lumbar discectomy

Intervention Type PROCEDURE

Removal of single level lumbar disc herniation through conventional discectomy.

Endoscopic

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

Group Type ACTIVE_COMPARATOR

Percutaneous Endoscopic Translaminar lumbar discectomy.

Intervention Type PROCEDURE

Removal of single level Lumbar disc herniation using endoscope.

Easy Go system Endoscopy

Intervention Type DEVICE

This system will be used to remove herniated disc in endoscopic group

Interventions

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Conventional open lumbar discectomy

Removal of single level lumbar disc herniation through conventional discectomy.

Intervention Type PROCEDURE

Percutaneous Endoscopic Translaminar lumbar discectomy.

Removal of single level Lumbar disc herniation using endoscope.

Intervention Type PROCEDURE

Easy Go system Endoscopy

This system will be used to remove herniated disc in endoscopic group

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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H A Othman

Resident Doctor, Neurosurgery Department, Assiut Universiy Hosipitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad T Ahmed, Professor

Role: STUDY_CHAIR

Head of Neurosurgery Department, Assiut University Hospitals

References

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Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001350. doi: 10.1002/14651858.CD001350.pub4.

Reference Type BACKGROUND
PMID: 17443505 (View on PubMed)

Gotfryd A, Avanzi O. A systematic review of randomised clinical trials using posterior discectomy to treat lumbar disc herniations. Int Orthop. 2009 Feb;33(1):11-7. doi: 10.1007/s00264-008-0559-2. Epub 2008 May 24.

Reference Type BACKGROUND
PMID: 18500517 (View on PubMed)

Evaniew N, Khan M, Drew B, Kwok D, Bhandari M, Ghert M. Minimally invasive versus open surgery for cervical and lumbar discectomy: a systematic review and meta-analysis. CMAJ Open. 2014 Oct 1;2(4):E295-305. doi: 10.9778/cmajo.20140048. eCollection 2014 Oct.

Reference Type BACKGROUND
PMID: 25485257 (View on PubMed)

Jiang W, Sun B, Sheng Q, Song X, Zheng Y, Wang L. Feasibility and efficacy of percutaneous lateral lumbar discectomy in the treatment of patients with lumbar disc herniation: a preliminary experience. Biomed Res Int. 2015;2015:378612. doi: 10.1155/2015/378612. Epub 2015 Jan 28.

Reference Type BACKGROUND
PMID: 25695066 (View on PubMed)

Other Identifiers

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ENDODISC

Identifier Type: -

Identifier Source: org_study_id