EndoscopeNCT07060846
Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients
A study testing Endoscopic lumbar discectomy and Open lumbar discectomy in people with Endoscope and Open, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to compare the endoscopic versus open lumbar discectomy in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endoscope, Open, Lumbar Discectomy
- What is being tested?
- Endoscopic lumbar discectomy and Open lumbar discectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2025to 1 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years.
- Both sexes.
- Patients suffering from prolapsed lumbar disc postero-lateral, single level disc herniation at L4-5 or L5-S1 level with low back pain and unilateral radiculopathy and failure of conservative treatment for 12 weeks
Who cannot join
- Extraforaminal disc herniation.
- Recurrent and/or multiple level discs prolapses.
- Spondylolisthesis.
- Prior lumbar surgery at the same spinal level.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University (Damietta)
Damietta, 0000-0001-6746-3024
Awad M Hegab, MD, 00201061833482, Dr.awadhegab@gmail.com
Ahmed Taha, MD
About this study
Official title: Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients: A Randomized Controlled Trial
This study aims to compare the endoscopic versus open lumbar discectomy in diabetic patients.
Read the detailed description
Diabetes mellitus (DM) is a highly prevalent disease with the capacity to adversely affect nearly every major organ system. DM has been demonstrated as a risk factor for a variety of complications within medical and surgical spheres Open lumbar discectomy is the most common surgical discectomy technique and is considered by many to be the gold standard.
Endoscopic lumbar discectomy allowed spinal surgeons to decompress a symptomatic lumbar nerve root by using an endoscopic minimally invasive surgical approach.
- Conditions
- Endoscope, Open, Lumbar Discectomy, Diabetes Mellitus
- Being tested
- Endoscopic lumbar discectomy, Open lumbar discectomy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic lumbar discectomyProcedure or surgery
Patients will undergo endoscopic lumbar discectomy.
Open lumbar discectomyProcedure or surgery
Patients will undergo an open lumbar discectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will undergo endoscopic lumbar discectomy. Receives: Procedure: Endoscopic lumbar discectomy |
| Group II | Active comparator | Patients will undergo an open lumbar discectomy. Receives: Procedure: Open lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of low back pain
The patients will be evaluated clinically using Visual Analogue Score (VAS) for low back pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Measured: 48 hours postoperatively
Secondary outcomes (5)
Degree of radicular pain
The patients will be evaluated clinically using Visual Analogue Score (VAS) for radicular pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Measured: 48 hours postoperatively
Length of hospital stay
Length of hospital stay will be recorded from admission till discharge from hospital.
Measured: 1 week postoperatively
Intraoperative blood loss
Intraoperative blood loss will be recorded.
Measured: Intraoperatively
Operative time
Operative time will be recorded from the start of surgery till the end of surgery.
Measured: Intraoperatively
Wound length
Wound length will be recorded.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start19 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopeStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Awad Mohamed Hegab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060846
- Sponsor's protocol ID
- DFM-IRB 00012367-25-06-009
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Open Lumbar Discectomy in Diabetic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07060846
- Acronym / sponsor ID
- DFM-IRB 00012367-25-06-009
- Conditions
- Endoscope, Open, Lumbar Discectomy, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jul 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 compare the endoscopic versus open lumbar discectomy in diabetic patients.
Detailed description
Diabetes mellitus (DM) is a highly prevalent disease with the capacity to adversely affect nearly every major organ system. DM has been demonstrated as a risk factor for a variety of complications within medical and surgical spheres Open lumbar discectomy is the most common surgical discectomy technique and is considered by many to be the gold standard.
Endoscopic lumbar discectomy allowed spinal surgeons to decompress a symptomatic lumbar nerve root by using an endoscopic minimally invasive surgical approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Endoscopic lumbar discectomyPatients will undergo endoscopic lumbar discectomy. |
| Group II | Active comparator | Procedure: Open lumbar discectomyPatients will undergo an open lumbar discectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 75 years.
- Both sexes.
- Patients suffering from prolapsed lumbar disc postero-lateral, single level disc herniation at L4-5 or L5-S1 level with low back pain and unilateral radiculopathy and failure of conservative treatment for 12 weeks
Key exclusion criteria (4 listed)
- Extraforaminal disc herniation.
- Recurrent and/or multiple level discs prolapses.
- Spondylolisthesis.
- Prior lumbar surgery at the same spinal level.
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 discectomyPatients will undergo endoscopic lumbar discectomy. | Procedure or surgery | Group I |
| Open lumbar discectomyPatients will undergo an open lumbar discectomy. | Procedure or surgery | Group II |
Primary outcome
Degree of low back pain
Time frame: 48 hours postoperatively
The patients will be evaluated clinically using Visual Analogue Score (VAS) for low back pain and radicular pain. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
5 secondary outcomes
Degree of radicular pain
Time frame: 48 hours postoperatively
Length of hospital stay
Time frame: 1 week postoperatively
Intraoperative blood loss
Time frame: Intraoperatively
Operative time
Time frame: Intraoperatively
Wound length
Time frame: Intraoperatively
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 and Open lumbar discectomy in people with Endoscope and Open, run by Al-Azhar 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 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 Awad M Hegab, MD (00201061833482, Dr.awadhegab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of low back pain (time frame: 48 hours postoperatively). 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 22 Jul 2025.