Lumbar Disc HerniationNCT03137485
Comparison Between Conventional vs. Endoscopic Lumbar Discectomy
A study testing Conventional open lumbar discectomy, Percutaneous Endoscopic Translaminar lumbar discectomy. and Easy Go system Endoscopy in people with Lumbar Disc Herniation, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Conventional open lumbar discectomy, Percutaneous Endoscopic Translaminar lumbar discectomy. and Easy Go system Endoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- central, far lateral, recurrent and/or multiple level disc herniation.
- Lateral recess stenosis or spondylolisthesis.
- presence of neurological deficit.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Conventional open lumbar discectomy, Percutaneous Endoscopic Translaminar lumbar discectomy., Easy Go system Endoscopy
- Keywords
- lumbar disc herniation, endoscopic discectomy, open discectomy, comparative study, Translaminar, surgery
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional open lumbar discectomyProcedure or surgery
Removal of single level lumbar disc herniation through conventional discectomy.
Percutaneous Endoscopic Translaminar lumbar discectomy.Procedure or surgery
Removal of single level Lumbar disc herniation using endoscope.
Easy Go system EndoscopyDevice
This system will be used to remove herniated disc in endoscopic group
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Patients in this arm will have conventional open lumbar discectomy operation. Receives: 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 Receives: Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy.; Device: Easy Go system Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to ten months post operative.
Functional Improvement
Functional Improvement using modified MacNab's criteria
Measured: Up to ten months post operative.
Secondary outcomes (6)
Hospital stay.
Time spent in hospital post operative.
Measured: up to one week.
Periprocedural complication.
Such as neurological deficit, Cerebro-Spinal fluid (CSF) leak, wound infection...etc.
Measured: Up to two weeks.
Blood loss
Amount of blood loss intraoperative.
Measured: intraoperative.
lumbo-sacral MRI
Demonstration of any disc herniation recurrence.
Measured: Up to six months
Operative time
duration of operation
Measured: Intraoperative
Wound length
Length of incision needed by surgeon to complete each approach
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startDec 2016
- Primary completionMay 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H A Othman, Assiut University
- Investigators
- Mohammad T Ahmed, Professor, Study chair, Head of Neurosurgery Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137485
- Sponsor's protocol ID
- ENDODISC
- Status last verified
- Dec 2018
- First submitted
- 19 Apr 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17443505Gotfryd 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.
PubMed 18500517Evaniew 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.
PubMed 25485257Jiang 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.
PubMed 25695066
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Lumbar Postero-lateral Single Level Disc Herniation: Comparative Study Between Conventional and Endoscopic Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT03137485
- Acronym / sponsor ID
- ENDODISC
- Conditions
- Lumbar Disc Herniation
- Keywords
- lumbar disc herniation, endoscopic discectomy, open discectomy, comparative study, Translaminar, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Conventional open lumbar discectomyPatients in this arm will have conventional open lumbar discectomy operation. |
| Endoscopic | Active comparator | Procedure: Percutaneous Endoscopic Translaminar lumbar discectomy., Device: Easy Go system EndoscopyPatients in this arm will have Percutaneous Endoscopic Translaminar lumbar discectomy operation using Easy Go system Endoscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- central, far lateral, recurrent and/or multiple level disc herniation.
- Lateral recess stenosis or spondylolisthesis.
- presence of neurological deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional open lumbar discectomyRemoval of single level lumbar disc herniation through conventional discectomy. | Procedure or surgery | Conventional |
| Percutaneous Endoscopic Translaminar lumbar discectomy.Removal of single level Lumbar disc herniation using endoscope. | Procedure or surgery | Endoscopic |
| Easy Go system EndoscopyThis system will be used to remove herniated disc in endoscopic group | Device | Endoscopic |
Primary outcome
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.
Functional Improvement
Time frame: Up to ten months post operative.
Functional Improvement using modified MacNab's criteria
6 secondary outcomes
Hospital stay.
Time frame: up to one week.
Periprocedural complication.
Time frame: Up to two weeks.
Blood loss
Time frame: intraoperative.
lumbo-sacral MRI
Time frame: Up to six months
Operative time
Time frame: Intraoperative
Wound length
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 17443505Gibson 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.
- Background: PubMed 18500517Gotfryd 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.
- Background: PubMed 25485257Evaniew 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.
- Background: PubMed 25695066Jiang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad T Ahmed, Professor study chair
Head of Neurosurgery Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Conventional open lumbar discectomy, Percutaneous Endoscopic Translaminar lumbar discectomy. and Easy Go system Endoscopy in people with Lumbar Disc Herniation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Preoperative low back pain and radicular pain. (time frame: Up to ten months post operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137485, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 27 Oct 2026.