Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06381167

Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Endoscopic Decompressive Laminectomy

Procedure

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

Other names: Microscopic Decompressive Laminectomy

Primary outcomes

  1. Oswestry Disability Index ODI scores for low back pain and neuropathic pain

    Time frame: one year

    3,6 and 12-month follow-up after surgery

Secondary outcomes

  1. visual analog scale (VAS) score for low back and lower extremity radiating pain

    Time frame: one year

    3,6 and 12-month follow-up after surgery

  2. European Quality of Life-5 Dimensions (EQ-5D) score

    Time frame: one year

    3,6 and 12-month follow-up after surgery

  3. painDETECT score

    Time frame: one year

    3,6 and 12-month follow-up after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Soliaman Noman, MSc

CONTACT

[email protected]

00201097038046

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.