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Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional open lumbar discectomy
Percutaneous Endoscopic Translaminar lumbar discectomy.
Easy Go system Endoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring lumbar disc herniation, endoscopic discectomy, open discectomy, comparative study, Translaminar, surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Conventional

    Endoscopic

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    Functional Improvement
    Functional Improvement using modified MacNab's criteria

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 19, 2017
    Last Updated
    December 17, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03137485
    Brief Title
    Comparison Between Conventional vs. Endoscopic Lumbar Discectomy
    Official Title
    Management of Lumbar Postero-lateral Single Level Disc Herniation: Comparative Study Between Conventional and Endoscopic Lumbar Discectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    May 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation
    Keywords
    lumbar disc herniation, endoscopic discectomy, open discectomy, comparative study, Translaminar, surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will have conventional open lumbar discectomy operation.
    Arm Title
    Endoscopic
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional open lumbar discectomy
    Intervention Description
    Removal of single level lumbar disc herniation through conventional discectomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous Endoscopic Translaminar lumbar discectomy.
    Intervention Description
    Removal of single level Lumbar disc herniation using endoscope.
    Intervention Type
    Device
    Intervention Name(s)
    Easy Go system Endoscopy
    Intervention Description
    This system will be used to remove herniated disc in endoscopic group
    Primary Outcome Measure Information:
    Title
    Improvement of Preoperative low back pain and radicular pain.
    Description
    Improvement of preoperative low back pain and radicular pain.Clinical outcomes will be measured using Visual Analogue Scale.
    Time Frame
    Up to ten months post operative.
    Title
    Functional Improvement
    Description
    Functional Improvement using modified MacNab's criteria
    Time Frame
    Up to ten months post operative.
    Secondary Outcome Measure Information:
    Title
    Hospital stay.
    Description
    Time spent in hospital post operative.
    Time Frame
    up to one week.
    Title
    Periprocedural complication.
    Description
    Such as neurological deficit, Cerebro-Spinal fluid (CSF) leak, wound infection...etc.
    Time Frame
    Up to two weeks.
    Title
    Blood loss
    Description
    Amount of blood loss intraoperative.
    Time Frame
    intraoperative.
    Title
    lumbo-sacral MRI
    Description
    Demonstration of any disc herniation recurrence.
    Time Frame
    Up to six months
    Title
    Operative time
    Description
    duration of operation
    Time Frame
    Intraoperative
    Title
    Wound length
    Description
    Length of incision needed by surgeon to complete each approach
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad T Ahmed, Professor
    Organizational Affiliation
    Head of Neurosurgery Department, Assiut University Hospitals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17443505
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18500517
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25485257
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25695066
    Citation
    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.
    Results Reference
    background

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    Comparison Between Conventional vs. Endoscopic Lumbar Discectomy

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