Actively Recruiting

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

Efficacy and Safety of Endo-Surgi Plus Endoscopy, UBE Endoscopy, and Microdiscectomy Decompression Techniques for the Treatment of Lumbar Spinal Stenosis: A Prospective Multicenter Study

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

324

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing three minimally invasive surgical techniques for treating lumbar spinal stenosis: Endo-Surgi Plus endoscopic surgery, unilateral biportal endoscopic (UBE) surgery, and microdiscectomy. Lumbar spinal stenosis is a condition where the space in the lower spine narrows, compressing nerves and causing pain. The study aims to evaluate the clinical effectiveness, complication rates, and surgical trauma among these three approaches to better understand their benefits and differences. Participants are randomly assigned to receive one of the three surgeries. Each patient undergoes decompression surgery through specific channels: Endo-Surgi Plus uses a larger single-channel endoscope, UBE uses separate endoscopic and working channels allowing traditional instruments, and microdiscectomy uses a microscope-assisted minimally invasive technique. After surgery, all patients receive low-dose hormone treatment, dehydrating agents, and neurotrophic drugs, along with standardized rehabilitation exercises and recovery education. The study includes at least one year of follow-up. During the study, patients will have scheduled outpatient visits, physical exams, questionnaires, and necessary tests to monitor progress and recovery. Researchers will measure disability using the Oswestry Disability Index (ODI) at one year post-surgery, along with pain scores, quality of life surveys, MRI scans, and surgical details such as blood loss and operation time. Data will be analyzed to compare outcomes and safety across the three surgical methods, with follow-up continuing for at least 12 months.

CONDITIONS

Brief 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 combined with clinical symptoms
  • Symptoms present in the lumbar region and lower limbs matching imaging results
  • No improvement after at least three months of conservative treatment
  • Informed consent obtained from family members 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 disease, cerebrovascular disease, mental health disorders, communication difficulties, or other conditions affecting clinical evaluation
  • History of previous lumbar spine surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery and immediate postoperative period

Participants undergo one of three minimally invasive surgical procedures: Endo-Surgi Plus endoscopic surgery, unilateral biportal endoscopic surgery, or microdiscectomy to relieve symptoms of lumbar spinal stenosis.

1 surgery visit and immediate postoperative assessments

Follow-up

Duration - 1 year postoperatively

Participants are monitored for recovery and clinical outcomes with assessments including functional disability, pain, quality of life, MRI imaging, and safety evaluations.

Visits at 1 day, 3 months, 6 months, and 1 year postoperatively

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