NCT03137485

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

April 19, 2017

Last Update Submit

December 17, 2018

Conditions

Lumbar Disc Herniation

Keywords

lumbar disc herniationendoscopic discectomyopen discectomycomparative studyTranslaminarsurgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Hospital stay.

    up to one week.

  • Periprocedural complication.

    Up to two weeks.

  • Blood loss

    intraoperative.

  • lumbo-sacral MRI

    Up to six months

  • Operative time

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

Procedure: Conventional open lumbar discectomy

Endoscopic

ACTIVE COMPARATOR

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

Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy.Device: Easy Go system Endoscopy

Interventions

Conventional open lumbar discectomyPROCEDURE

Removal of single level lumbar disc herniation through conventional discectomy.

Conventional
Percutaneous Endoscopic Translaminar lumbar discectomy.PROCEDURE

Removal of single level Lumbar disc herniation using endoscope.

Endoscopic
Easy Go system EndoscopyDEVICE

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

Endoscopic

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17443505BACKGROUND

  • 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.

    PMID: 18500517BACKGROUND

  • 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.

    PMID: 25485257BACKGROUND

  • 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.

    PMID: 25695066BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad T Ahmed, Professor

    Head of Neurosurgery Department, Assiut University Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, Neurosurgery Department, Assiut Universiy Hosipitals

Study Record Dates

First Submitted

April 19, 2017

First Posted

May 2, 2017

Study Start

December 1, 2016

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12