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
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
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
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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