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Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

Endoscopic Bi-portal Decompression Versus Microscopic Decompression in Cases of Lumbar Canal Stenosis

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06381167
Enrollment
52
Registered
2024-04-24
Start date
2024-05-31
Completion date
2027-10-31
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Keywords

Endoscopic bi-portal decompression, Microscopic decompression, Lumbar canal stenosis

Brief summary

To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.

Detailed description

Lumbar canal stenosis is a disease caused by the compression of the dural sac and nerve root due to various factors such as hypertrophy of the ligamentum flavum (LF), facet joint hypertrophy, disc herniation, and spondylolisthesis, resulting in low back pain, leg pain with or without numbness, intermittent claudication, and bladder and bowel dysfunction in which intermittent neurogenic claudication is the main feature (1, 2). Traditional surgical approaches include open laminotomy decompression, foraminotomy, discectomy, and fusion. Conventional open lumbar decompression has a long history and has the advantages of adequate decompression and clear visualization of neural structures, while surgical invasiveness and extensive stripping of paraspinal muscles and soft tissues may lead to a series of problems such as postoperative low back pain, spinal instability, and prolonged hospital stay and time to return to normal life after the operation (3). Minimally invasive spine surgery has become increasingly popular in recent years. Unilateral bi-portal endoscopy (UBE) was proposed by Heo in 2017 to treat degenerative lumbar spinal diseases with less damage to the paraspinal muscles (4). Minimally invasive decompression was introduced as a tissue-sparing alternative and applied to lumbar central stenosis. Minimally invasive decompression revealed good clinical outcomes comparable to those of conventional surgery (5, 6). It also showed a reasonable operative time, shorter hospital stay, and reduced blood loss, time to mobilization, postoperative pain, and narcotic use when compared to that seen with conventional surgery (7). However, it presents some disadvantages, including poor visualization, difficulty of instrument manipulation, potential to induce inadequate decompression, and longer operative time than other minimally invasive surgeries (8).

Interventions

PROCEDUREEndoscopic Decompressive Laminectomy

the patients will undergo block randomization for either endoscopic or microscopic decompression

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with acquired degenerative lumbar canal stenosis. Age \>40 years. Single or Double level stenosis

Exclusion criteria

* Post-traumatic lumbar canal stenosis. Previous spine surgery. Multi-level stenosis more than 2 levels. Associated instability e.g. spondylolisthesis. Spinal diseases (e.g., ankylosing spondylitis, infection, spine tumor, fracture, or neurologic disorders).

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index ODI scores for low back pain and neuropathic painone year3,6 and 12-month follow-up after surgery

Secondary

MeasureTime frameDescription
visual analog scale (VAS) score for low back and lower extremity radiating painone year3,6 and 12-month follow-up after surgery
European Quality of Life-5 Dimensions (EQ-5D) scoreone year3,6 and 12-month follow-up after surgery
painDETECT scoreone year3,6 and 12-month follow-up after surgery

Contacts

Primary ContactAli Soliaman Noman, MSc
alisoliman@med.nvu.edu.eg00201097038046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026