Endoscopic Versus Conventional Lumbar Decompression for Lumbar Canal Stenosis

NCT07562035 | Completed

• 1 other identifier: FMASU MD323/2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis-Endoscopic lumbar decompression-Open laminectomy-Interlaminar decompression-Neurogenic claudication-RCT

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Preoperative, 1 month, and 6 months postoperative

Secondary Outcomes (5)

• Operative Time

  Intraoperative

• Length of Hospital Stay

  From surgery to hospital discharge (typically within 1-5 days postoperative)

• Postoperative Complications

  Up to 6 months postoperative

• Time to Return to Work

  Up to 6 months postoperative

• Creatine Phosphokinase (CPK) Level

  1 day postoperative

Study Arms (2)

Endoscopic Decompression Group

EXPERIMENTAL

Patients undergo interlaminar uniportal endoscopic bilateral lumbar decompression for treatment of degenerative lumbar spinal stenosis.

Procedure: Interlaminar Uniportal Endoscopic Lumbar Decompression

Open Laminectomy Group

ACTIVE COMPARATOR

Patients undergo conventional open laminectomy for treatment of degenerative lumbar spinal stenosis

Procedure: Open Lumbar Laminectomy

Interventions

Interlaminar Uniportal Endoscopic Lumbar Decompression PROCEDURE

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.

Also known as: Endoscopic lumbar decompression, Uniportal spine endoscopy

Endoscopic Decompression Group

Open Lumbar Laminectomy PROCEDURE

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.

Also known as: Conventional laminectomy, Open decompression surgery

Open Laminectomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• General Organization for Teaching Hospitals and Institutes: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related Publications (1)

• 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)

  RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mohammad Yousof Aboukila, MD

  Ain Shams University, Faculty of Medicine, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Department of Neurosurgery

Model Details: Participants were randomized into two parallel groups comparing endoscopic versus open decompression."

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start: June 11, 2023
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)