Lumbar Spinal StenosisENDOLSSNCT07562035
Endoscopic Versus Conventional Lumbar Decompression for Lumbar Canal Stenosis
A study testing Interlaminar Uniportal Endoscopic Lumbar Decompression and Open Lumbar Laminectomy in people with Lumbar Spinal Stenosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is a randomized controlled trial comparing interlaminar uniportal endoscopic bilateral lumbar decompression with conventional open laminectomy in patients with degenerative lumbar canal stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Interlaminar Uniportal Endoscopic Lumbar Decompression and Open Lumbar Laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2023to 26 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with degenerative lumbar spinal stenosis based on clinical and radiological findings.
- Patients presenting with neurogenic claudication and/or radicular leg pain. Patients indicated for surgical decompression after failure of conservative treatment.
- Age 18 years and above. Patients able to provide informed consent.
Who cannot join
- Patients with previous lumbar spine surgery at the same level. Patients with spinal instability requiring fusion. Presence of spinal infection, tumor, or traumatic pathology. Severe comorbid conditions contraindicating surgery. Patients with incomplete clinical or follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes Evaluation of Interlaminar Endoscopic Uniportal Bilateral Lumbar Decompression Versus Open Laminectomy for Degenerative Lumbar Canal Stenosis
This is a randomized controlled trial comparing interlaminar uniportal endoscopic bilateral lumbar decompression with conventional open laminectomy in patients with degenerative lumbar canal stenosis. The study aims to evaluate and compare clinical outcomes including pain relief, functional improvement, operative parameters, and recovery profile between both surgical techniques. Patients will be followed postoperatively for one day outcomes, one month, and six months to assess effectiveness and safety of each procedure.
Read the detailed description
This randomized controlled trial was designed to compare the clinical and surgical outcomes of interlaminar uniportal endoscopic bilateral lumbar decompression versus conventional open laminectomy in patients diagnosed with degenerative lumbar canal stenosis. Lumbar spinal stenosis is a common degenerative condition that results in neurogenic claudication, radicular pain, and functional disability due to compression of neural elements.
The study was conducted at Ain Shams University Hospitals and Damanhour Medical National Institute. Patients meeting inclusion criteria were diagnosed based on clinical evaluation and radiological confirmation using MRI. Eligible patients were randomized into two groups: one group underwent minimally invasive interlaminar uniportal endoscopic bilateral decompression, while the other group underwent conventional open laminectomy.
The primary objective of the study was to compare the effectiveness of both surgical techniques in terms of pain relief and functional improvement. Secondary objectives included comparison of operative time, intraoperative blood loss, postoperative hospital stay, complication rates, muscle injury markers, and time to return to normal activity.
Patients were evaluated preoperatively and postoperatively using standardized clinical assessment tools. Postoperative follow-up was conducted at one day postoperative period, one month, and six months to assess both early and mid-term outcomes.
The hypothesis of the study is that minimally invasive endoscopic decompression provides equivalent or superior clinical outcomes compared to conventional open laminectomy, with the advantage of reduced tissue trauma, less postoperative pain, faster recovery, and shorter hospital stay.
This study aims to contribute to the growing evidence supporting minimally invasive spine surgery techniques and to provide high-quality comparative data to guide surgical decision-making in degenerative lumbar canal stenosis.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Interlaminar Uniportal Endoscopic Lumbar Decompression, Open Lumbar Laminectomy
- Keywords
- Lumbar spinal stenosis-Endoscopic lumbar decompression-Open laminectomy-Interlaminar decompression-Neurogenic claudication-RCT
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interlaminar Uniportal Endoscopic Lumbar DecompressionProcedure or surgery
Also called Endoscopic lumbar decompression, Uniportal spine endoscopy
Minimally invasive interlaminar uniportal endoscopic decompression of the lumbar spinal canal performed for treatment of degenerative lumbar spinal stenosis. The procedure aims to relieve neural compression while preserving posterior spinal structures and reducing tissue trauma compared to open surgery.
Open Lumbar LaminectomyProcedure or surgery
Also called Conventional laminectomy, Open decompression surgery
Standard open lumbar laminectomy performed for decompression of the spinal canal in patients with degenerative lumbar spinal stenosis. The procedure involves removal of posterior bony and ligamentous structures to relieve neural compression.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Decompression Group | Experimental | Patients undergo interlaminar uniportal endoscopic bilateral lumbar decompression for treatment of degenerative lumbar spinal stenosis. Receives: Procedure: Interlaminar Uniportal Endoscopic Lumbar Decompression |
| Open Laminectomy Group | Active comparator | Patients undergo conventional open laminectomy for treatment of degenerative lumbar spinal stenosis Receives: Procedure: Open Lumbar Laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability (Oswestry Disability Index - ODI)
The Oswestry Disability Index (ODI) will be used to evaluate functional disability related to lumbar spinal stenosis. The ODI is a validated questionnaire assessing limitations in activities of daily living, including pain intensity, personal care, walking, sitting, standing, and social function. Scores range from 0 to 100, with higher scores indicating greater disability. Outcomes will be compared between patients undergoing interlaminar endoscopic and conventional open lumbar decompression.
Measured: Preoperative, 1 month, and 6 months postoperative
Postoperative Leg Pain (VAS-Leg Score)
Radicular leg pain will be assessed using the Visual Analogue Scale (VAS), a validated 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will rate their leg pain intensity preoperatively and at follow-up intervals. This measure reflects the severity of nerve root compression symptoms and will be used to compare the effectiveness of interlaminar endoscopic versus conventional open lumbar decompression
Measured: Preoperative, 1 day, 1 month, and 6 months postoperative
Postoperative Back Pain (VAS-Back Score)
Low back pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated patient-reported outcome measure ranging from 0 (no pain) to 10 (worst imaginable pain). This scale evaluates the severity of axial back pain associated with degenerative lumbar spinal stenosis. Measurements will be obtained preoperatively and at follow-up intervals to compare pain relief between interlaminar endoscopic and conventional open lumbar decompression techniques.
Measured: Preoperative, 1 day, 1 month, and 6 months postoperative
Claudication Distance
Claudication distance will be assessed as the maximum walking distance a patient can achieve before the onset of neurogenic claudication symptoms, such as leg pain, numbness, or weakness. This measure reflects functional limitation due to lumbar spinal stenosis and will be used to evaluate improvement after interlaminar endoscopic versus open lumbar decompression.
Measured: Preoperative, 1 month, and 6 months postoperative
Secondary outcomes (5)
Operative Time
Duration of surgery measured in hours from skin incision to wound closure in patients undergoing endoscopic versus open lumbar decompression.
Measured: Intraoperative
Length of Hospital Stay
Duration of hospitalization measured in days from surgery to discharge.
Measured: From surgery to hospital discharge (typically within 1-5 days postoperative)
Postoperative Complications
Incidence of postoperative complications including infection, dural tear, neurological deficit, and reoperation.
Measured: Up to 6 months postoperative
Time to Return to Work
Time taken for patients to resume normal daily activities or return to work after surgery.
Measured: Up to 6 months postoperative
Creatine Phosphokinase (CPK) Level
Serum creatine phosphokinase (CPK) levels will be measured as a biomarker of muscle injury associated with surgical intervention. Levels will be compared between endoscopic and open lumbar decompression groups to assess the degree of muscle damage.
Measured: 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start11 Jun 2023
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- Participants were randomized into two parallel groups comparing endoscopic versus open decompression."
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- General Organization for Teaching Hospitals and Institutes
- Responsible party
- Principal investigator, Mohammad Yousof Mohammad, Ain Shams University
- Investigators
- Mohammad Yousof Aboukila, MD, Principal investigator, Ain Shams University, Faculty of Medicine, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562035
- Sponsor's protocol ID
- FMASU MD323/2023
- Acronym
- ENDOLSS
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboukila MY, et al. "Outcomes Evaluation of Interlaminar Endoscopic Uniportal Bilateral Lumbar Decompression versus Open Laminectomy for Degenerative Lumbar Canal Stenosis." Ain Shams University, Department of Neurosurgery, 2026. (Unpublished clinical study / thesis)
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Evaluation of Interlaminar Endoscopic Uniportal Bilateral Lumbar Decompression Versus Open Laminectomy for Degenerative Lumbar Canal Stenosis
- ClinicalTrials.gov ID
- NCT07562035
- Acronym / sponsor ID
- ENDOLSS / FMASU MD323/2023
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis-Endoscopic lumbar decompression-Open laminectomy-Interlaminar decompression-Neurogenic claudication-RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- General Organization for Teaching Hospitals and Institutes
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 1 May 2026 (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 is a randomized controlled trial comparing interlaminar uniportal endoscopic bilateral lumbar decompression with conventional open laminectomy in patients with degenerative lumbar canal stenosis. The study aims to evaluate and compare clinical outcomes including pain relief, functional improvement, operative parameters, and recovery profile between both surgical techniques. Patients will be followed postoperatively for one day outcomes, one month, and six months to assess effectiveness and safety of each procedure.
Detailed description
This randomized controlled trial was designed to compare the clinical and surgical outcomes of interlaminar uniportal endoscopic bilateral lumbar decompression versus conventional open laminectomy in patients diagnosed with degenerative lumbar canal stenosis. Lumbar spinal stenosis is a common degenerative condition that results in neurogenic claudication, radicular pain, and functional disability due to compression of neural elements.
The study was conducted at Ain Shams University Hospitals and Damanhour Medical National Institute. Patients meeting inclusion criteria were diagnosed based on clinical evaluation and radiological confirmation using MRI. Eligible patients were randomized into two groups: one group underwent minimally invasive interlaminar uniportal endoscopic bilateral decompression, while the other group underwent conventional open laminectomy.
The primary objective of the study was to compare the effectiveness of both surgical techniques in terms of pain relief and functional improvement. Secondary objectives included comparison of operative time, intraoperative blood loss, postoperative hospital stay, complication rates, muscle injury markers, and time to return to normal activity.
Patients were evaluated preoperatively and postoperatively using standardized clinical assessment tools. Postoperative follow-up was conducted at one day postoperative period, one month, and six months to assess both early and mid-term outcomes.
The hypothesis of the study is that minimally invasive endoscopic decompression provides equivalent or superior clinical outcomes compared to conventional open laminectomy, with the advantage of reduced tissue trauma, less postoperative pain, faster recovery, and shorter hospital stay.
This study aims to contribute to the growing evidence supporting minimally invasive spine surgery techniques and to provide high-quality comparative data to guide surgical decision-making in degenerative lumbar canal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel groups comparing endoscopic versus open decompression."
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Decompression Group | Experimental | Procedure: Interlaminar Uniportal Endoscopic Lumbar DecompressionPatients undergo interlaminar uniportal endoscopic bilateral lumbar decompression for treatment of degenerative lumbar spinal stenosis. |
| Open Laminectomy Group | Active comparator | Procedure: Open Lumbar LaminectomyPatients undergo conventional open laminectomy for treatment of degenerative lumbar spinal stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with degenerative lumbar spinal stenosis based on clinical and radiological findings.
- Patients presenting with neurogenic claudication and/or radicular leg pain. Patients indicated for surgical decompression after failure of conservative treatment.
- Age 18 years and above. Patients able to provide informed consent.
Key exclusion criteria (1 listed)
- Patients with previous lumbar spine surgery at the same level. Patients with spinal instability requiring fusion. Presence of spinal infection, tumor, or traumatic pathology. Severe comorbid conditions contraindicating surgery. Patients with incomplete clinical or follow-up data.
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 |
|---|---|---|
| Interlaminar Uniportal Endoscopic Lumbar DecompressionAlso: Endoscopic lumbar decompression, Uniportal spine endoscopyMinimally invasive interlaminar uniportal endoscopic decompression of the lumbar spinal canal performed for treatment of degenerative lumbar spinal stenosis. The procedure aims to relieve neural compression while preserving posterior spinal structures and reducing tissue trauma compared to open surgery. | Procedure or surgery | Endoscopic Decompression Group |
| Open Lumbar LaminectomyAlso: Conventional laminectomy, Open decompression surgeryStandard open lumbar laminectomy performed for decompression of the spinal canal in patients with degenerative lumbar spinal stenosis. The procedure involves removal of posterior bony and ligamentous structures to relieve neural compression. | Procedure or surgery | Open Laminectomy Group |
Primary outcome
Functional Disability (Oswestry Disability Index - ODI)
Time frame: Preoperative, 1 month, and 6 months postoperative
The Oswestry Disability Index (ODI) will be used to evaluate functional disability related to lumbar spinal stenosis. The ODI is a validated questionnaire assessing limitations in activities of daily living, including pain intensity, personal care, walking, sitting, standing, and social function. Scores range from 0 to 100, with higher scores indicating greater disability. Outcomes will be compared between patients undergoing interlaminar endoscopic and conventional open lumbar decompression.
Postoperative Leg Pain (VAS-Leg Score)
Time frame: Preoperative, 1 day, 1 month, and 6 months postoperative
Radicular leg pain will be assessed using the Visual Analogue Scale (VAS), a validated 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will rate their leg pain intensity preoperatively and at follow-up intervals. This measure reflects the severity of nerve root compression symptoms and will be used to compare the effectiveness of interlaminar endoscopic versus conventional open lumbar decompression
Postoperative Back Pain (VAS-Back Score)
Time frame: Preoperative, 1 day, 1 month, and 6 months postoperative
Low back pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated patient-reported outcome measure ranging from 0 (no pain) to 10 (worst imaginable pain). This scale evaluates the severity of axial back pain associated with degenerative lumbar spinal stenosis. Measurements will be obtained preoperatively and at follow-up intervals to compare pain relief between interlaminar endoscopic and conventional open lumbar decompression techniques.
Claudication Distance
Time frame: Preoperative, 1 month, and 6 months postoperative
Claudication distance will be assessed as the maximum walking distance a patient can achieve before the onset of neurogenic claudication symptoms, such as leg pain, numbness, or weakness. This measure reflects functional limitation due to lumbar spinal stenosis and will be used to evaluate improvement after interlaminar endoscopic versus open lumbar decompression.
5 secondary outcomes
Operative Time
Time frame: Intraoperative
Length of Hospital Stay
Time frame: From surgery to hospital discharge (typically within 1-5 days postoperative)
Postoperative Complications
Time frame: Up to 6 months postoperative
Time to Return to Work
Time frame: Up to 6 months postoperative
Creatine Phosphokinase (CPK) Level
Time frame: 1 day postoperative
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 1 May 2026.
- Results publicationAboukila MY, et al. "Outcomes Evaluation of Interlaminar Endoscopic Uniportal Bilateral Lumbar Decompression versus Open Laminectomy for Degenerative Lumbar Canal Stenosis." Ain Shams University, Department of Neurosurgery, 2026. (Unpublished clinical study / thesis)
- Individual participant dataSharing planned: No
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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 Yousof Aboukila, MD principal investigator
Ain Shams University, Faculty of Medicine, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interlaminar Uniportal Endoscopic Lumbar Decompression and Open Lumbar Laminectomy in people with Lumbar Spinal Stenosis, run by Ain Shams 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 1 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 1 May 2026. 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?
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?
Functional Disability (Oswestry Disability Index - ODI) (time frame: Preoperative, 1 month, and 6 months postoperative). The study lists 4 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 NCT07562035, which also lists 1 linked publication.
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 1 May 2026.