Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

April 19, 2024 updated by: Ali Soliman Ali Noman, Assiut University

Endoscopic Bi-portal Decompression Versus Microscopic Decompression in Cases of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic bi-portal decomprssion
patients with lumbar canal stenosis will undergo endoscopic decompression
Procedure: Endoscopic Decompressive Laminectomy
the patients will undergo block randomization for either endoscopic or microscopic decompression
Other Names:
  • Microscopic Decompressive Laminectomy
Experimental: Microscopic decompression
patients with lumbar canal stenosis will undergo microscopic decompression
Procedure: Endoscopic Decompressive Laminectomy
the patients will undergo block randomization for either endoscopic or microscopic decompression
Other Names:
  • Microscopic Decompressive Laminectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
European Quality of Life-5 Dimensions (EQ-5D) score
Time Frame: one year
3,6 and 12-month follow-up after surgery
one year
painDETECT score
Time Frame: one year
3,6 and 12-month follow-up after surgery
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endoscopic decompression

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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