Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

NCT ID: NCT06381167

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-10-31

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).

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic bi-portal decomprssion

patients with lumbar canal stenosis will undergo endoscopic decompression

Group Type: EXPERIMENTAL

Endoscopic Decompressive Laminectomy

Intervention Type: PROCEDURE

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

Microscopic decompression

patients with lumbar canal stenosis will undergo microscopic decompression

Group Type: EXPERIMENTAL

Endoscopic Decompressive Laminectomy

Intervention Type: PROCEDURE

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

Interventions

Endoscopic Decompressive Laminectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Microscopic Decompressive Laminectomy

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ali Soliman Ali Noman

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ali Soliaman Noman, MSc

Role: CONTACT

alisoliman@med.nvu.edu.eg

00201097038046

References

Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.

Reference Type: BACKGROUND

PMID: 31542473 (View on PubMed)

Heo DH, Son SK, Eum JH, Park CK. Fully endoscopic lumbar interbody fusion using a percutaneous unilateral biportal endoscopic technique: technical note and preliminary clinical results. Neurosurg Focus. 2017 Aug;43(2):E8. doi: 10.3171/2017.5.FOCUS17146.

Reference Type: BACKGROUND

PMID: 28760038 (View on PubMed)

Wang X, Tian Z, Mansuerjiang M, Younusi A, Xu L, Xiang H, Cao L, Wang C. A single-arm retrospective study of the clinical efficacy of unilateral biportal endoscopic transforaminal lumbar interbody fusion for lumbar spinal stenosis. Front Surg. 2023 Jan 23;9:1062451. doi: 10.3389/fsurg.2022.1062451. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36756660 (View on PubMed)

Other Identifiers

Endoscopic decompression

Identifier Type: -

Identifier Source: org_study_id