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/Actively Recruiting
Led by Qilu Hospital of Shandong University · Updated on 2025-01-07
324
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis
X
Xinyu Yang, M.D.
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Qilu Hospital of Shandong University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/27074067/Qilu Hospital of Shandong University
Lead Sponsor