Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06719037

Comparison of Endo-Surgi Plus Endoscopy, Unilateral Biportal Endoscopy, and Microdiscectomy for Treating Lumbar Spinal Stenosis in a Multicenter Study

Led by Qilu Hospital of Shandong University · Updated on 2025-01-07

324

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing three surgical methods—Endo-Surgi Plus endoscopic technique, Unilateral Biportal Endoscopic (UBE) technique, and microdiscectomy—for treating lumbar spinal stenosis, a condition where the spinal canal narrows and compresses nerves, leading to pain and mobility issues. This condition is common, especially in older adults, and surgery is often recommended when symptoms do not improve with conservative treatments. The study aims to evaluate the clinical effectiveness, complication rates, and surgical trauma differences among these three minimally invasive techniques. Patients in the study receive one of the three surgical treatments: Endo-Surgi Plus endoscopy, which uses a larger working channel for single-channel endoscopic surgery; UBE, which employs separate channels for viewing and working and allows use of traditional surgical tools; or microdiscectomy, a well-established minimally invasive surgery using a microscope. After surgery, all patients receive low-dose hormones, dehydrating agents, and neurotrophic drugs, and are advised to avoid heavy lifting and strenuous lumbar activities for three months. They also follow the same rehabilitation exercises and recovery education. The study includes a follow-up period of at least one year. Participants undergo outpatient visits, physical exams, and complete questionnaires during follow-up to assess recovery and outcomes. Researchers measure the Oswestry Disability Index scores one year after surgery to evaluate disability levels related to back pain. The study monitors for complications and surgical trauma differences. Outcome assessors and analysts remain blinded to treatment groups to reduce bias. The trial plans to include 324 patients, with statistical analyses comparing the effectiveness and safety of the three surgical approaches.

CONDITIONS

Official Title

Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with single-segment lumbar spinal stenosis confirmed by CT and MRI along with matching clinical symptoms
  • Symptoms present in the lumbar region and lower limbs corresponding to imaging
  • No improvement after three months of conservative treatment
  • Informed consent provided by family regarding surgery and risks
Not Eligible

You will not qualify if you...

  • Multi-segment lumbar disc herniation, malignant spinal tumors, spinal deformities, or other spinal diseases
  • Presence of cardiovascular, cerebrovascular, or mental health conditions affecting clinical evaluation
  • Communication difficulties or other issues impacting evaluation
  • History of previous lumbar spine surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

X

Xinyu Yang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Clinical Application of Large Channel Endoscopic Systems with Full Endoscopic Visualization Technique in Lumbar Central Spinal Stenosis: A Retrospective Cohort Study.

Shuo Han, Xiangxu Zeng, Kai Zhu...

https://pubmed.ncbi.nlm.nih.gov/36057015