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Clinical Trials in China / NCT06719037
Recruiting Not applicable

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

NCT06719037 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Not applicable
Started
2024-12-08
Last updated
2025-01-07

Condition(s) studied

Lumbar Spinal Stenosis

Investigational drug(s) / intervention(s)

Endo-Surgi Plus endoscopic surgeryUnilateral biportal endoscopic surgeryMicrodiscectomy

Endo-Surgi Plus endoscopic surgery: Endo-Surgi Plus endoscopic surgery, as a new type of percutaneous endoscopic lumbar discectomy (PELD), features a larger working channel and represents an optimized single-channel endoscopic technique. However, it still has the limitations inherent in single-channel endoscopy.

Unilateral biportal endoscopic surgery: Unilateral biportal endoscopic discectomy (UBE) is characterized by its separate endoscopic and working channels, and the ability to use traditional open instruments, making it a convenient and versatile technique. It is a commonly used spinal endoscopic surgery in clinical practice.

Microdiscectomy: Microdiscectomy (MD) is a mature minimally invasive technique that uses a microscope to treat lumbar spinal stenosis. As early as 1999, prospective randomized controlled studies confirmed that it has equally excellent clinical efficacy compared to open surgery, with less surgical trauma. It is currently the classic minimally invasive surgical approach for treating lumbar spinal stenosis.

Study summary

The purpose of this study is to conduct a multicenter comparison of the clinical efficacy of Endo-Surgi Plus endoscopic technique, UBE endoscopic technique, and microdiscectomy technique in the treatment of lumbar spinal stenosis, and to compare the differences in the incidence of complications, surgical trauma, and other aspects among the three surgical techniques for the treatment of lumbar spinal stenosis.

Each group of patients received either Endo-Surgi Plus endoscopy, UBE, or microdiscectomy decompression through the Quadrant channel. All patients were routinely administered low-dose hormones, dehydrating agents, and neurotrophic drugs postoperatively. Patients were required to strictly avoid strenuous activities and heavy lifting in the lumbar region for three months after surgery. Upon discharge, patients were provided with the same lumbar and back muscle rehabilitation exercises and other postoperative recovery-related discharge education. Each group of patients was followed up for at least one year, with follow-up including outpatient visits, physical examinations, questionnaire scoring, and necessary auxiliary examinations.

Both two endoscopic surgeries, as surgical techniques that have been used in clinical practice for many years, have their efficacy confirmed by various studies. The investigator proposes that these two techniques may have similar clinical efficacy to microdiscectomy, while also offering the advantage of being less invasive. The aim of this study is to validate these assumptions. At the same time, there may be some differences between the two endoscopic surgeries that require further verification.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with single-segment lumbar spinal stenosis through CT and MRI imaging combined with clinical symptoms; * Symptoms in the lumbar region and lower extremities corresponding to the imaging findings; * Patients who have not responded to three months of conservative treatment; * Informed consent from family members regarding the surgical procedure and associated risks. Exclusion Criteria: * Patients with multi-segment lumbar disc herniation, malignant spinal tumors, spinal deformities, and other diseases. * Patients with comorbidities such as cardiovascular diseases, cerebrovascular diseases, or those with mental abnormalities, communication difficulties, or other issues that may affect clinical evaluation. * Patients with a history of previous lumbar surgery.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06719037 on ClinicalTrials.gov ↗ ← All trials in China