Lumbar Disc HerniationNCT07151651
A Comparison Between Biportal and Uniportal Endoscopic Lumbar Discectomy
A study testing Endoscopic lumbar discectomy in people with Lumbar Disc Herniation, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to provide a detailed comparison between different methods of lumbar discectomy by the use of different types of spine endoscopy to evaluate the benefits and drawbacks of each type Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Endoscopic lumbar discectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients should fulfill the following criteria
- Patients aged 18-70 years.
- single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI.
- Persistent symptoms not responding to conservative management (≥6 weeks).
Who cannot join
- All patients should not have any of the following criteria
- Multilevel disc herniation.
- Previous lumbar spine surgery, trauma or injection.
- Severe spinal stenosis.
- Severe osteoporosis, infection, or malignancy or autoimmune disease affecting the spine.
- Uncontrolled medical comorbidities contraindicating surgery.
- Instability: spondylolisthesis>grade 1
- Marked obesity.(BMI >35-40 kg/m2 )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mohamed Ibrahim Amin, Assesstant lecturer contact
About this study
Official title: Endoscopic Lumbar Discectomy: A Comparative Study Between Uniportal and Biportal Endocopic Techniques on Clinical and Surgical Outcomes
This study aims to provide a detailed comparison between different methods of lumbar discectomy by the use of different types of spine endoscopy to evaluate the benefits and drawbacks of each type
Read the detailed description
The aim of this study is to compare between uniportal and biportal endoscopic techniques in patients with lumbar disc herniation in terms of efficacy, safety, and learning curve of endoscopic spine surgery .The research will focus on clinical outcomes, functional recovery, complication rates, patient satisfaction and surgical proficiency in different endoscopic spine surgery techniques, including uniportal and biportal approaches assessing their relative advantages and limitations.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Endoscopic lumbar discectomy
- Keywords
- Lumar discectomy, Endoscopy, Uniportal, Biportal
- 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.
Endoscopic lumbar discectomyProcedure or surgery
Uniportal and boportal endoscopic lumbar discectomy (transforaminal or interlaminar)
| Study group | Role | What they receive |
|---|---|---|
| Patients with lumbar disc prolapse | Active comparator | 1. Patients aged 18-70 years.
2. single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI.
3. Persistent symptoms not responding to conservative management (≥6 weeks). Receives: Procedure: Endoscopic lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures After endoscopic lumbar discectomy Pain relief
1-Pain Relief: Visual Analog Scale (VAS for leg and back pain)
Measured: 12 weeks up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective study will be conducted at Sohag and Cairo University Hospitals on 60 patients diagnosed with lumbar disc herniation, undergoing endoscopic lumbar discectomy.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibraheem Amin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151651
- Sponsor's protocol ID
- Sohag-Med-25-8---4MD
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is not collected yet
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Lumbar Discectomy: A Comparative Study Between Uniportal and Biportal Endocopic Techniques on Clinical and Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07151651
- Acronym / sponsor ID
- Sohag-Med-25-8---4MD
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumar discectomy, Endoscopy, Uniportal, Biportal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Sep 2025 (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 aims to provide a detailed comparison between different methods of lumbar discectomy by the use of different types of spine endoscopy to evaluate the benefits and drawbacks of each type
Detailed description
The aim of this study is to compare between uniportal and biportal endoscopic techniques in patients with lumbar disc herniation in terms of efficacy, safety, and learning curve of endoscopic spine surgery .The research will focus on clinical outcomes, functional recovery, complication rates, patient satisfaction and surgical proficiency in different endoscopic spine surgery techniques, including uniportal and biportal approaches assessing their relative advantages and limitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective study will be conducted at Sohag and Cairo University Hospitals on 60 patients diagnosed with lumbar disc herniation, undergoing endoscopic lumbar discectomy.
| Arm | Type | Receives |
|---|---|---|
| Patients with lumbar disc prolapse | Active comparator | Procedure: Endoscopic lumbar discectomy1. Patients aged 18-70 years. 2. single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI. 3. Persistent symptoms not responding to conservative management (≥6 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients should fulfill the following criteria
Key exclusion criteria (8 listed)
- All patients should not have any of the following criteria
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 |
|---|---|---|
| Endoscopic lumbar discectomyUniportal and boportal endoscopic lumbar discectomy (transforaminal or interlaminar) | Procedure or surgery | Patients with lumbar disc prolapse |
Primary outcome
Primary outcome measures After endoscopic lumbar discectomy Pain relief
Time frame: 12 weeks up to 2 years
1-Pain Relief: Visual Analog Scale (VAS for leg and back pain)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data is not collected yet
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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.
mohamed Ibrahim Amin, Assesstant lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic lumbar discectomy in people with Lumbar Disc Herniation, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed Ibrahim Amin, Assesstant lecturer (002 010 215 64439 ext. 010 215 64439, Mohamed-ataya@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures After endoscopic lumbar discectomy Pain relief (time frame: 12 weeks up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.