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Recruiting Not applicable

Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery

NCT07837427 · tracked via the Priya Life Science China tracker
Sponsor
Fan Zhang
Phase
Not applicable
Started
2026-02-05
Last updated
2026-09-23

Condition(s) studied

Lumbar Disc HerniationLumbar Spinal StenosisLumbar Degenerative Disease

Investigational drug(s) / intervention(s)

Unilateral Biportal Endoscopic Surgery

Unilateral Biportal Endoscopic Surgery: UBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal).

Study summary

This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. During this surgery, fluid is used to keep the surgical area clear and to control bleeding. The pressure of this fluid may affect how clear the surgical view is, how much bleeding occurs, and how well patients recover after surgery. We will also collect disc tissue removed during surgery to study how disc degeneration is related to factors such as sex, age, mechanical stress, and injury. About 80 patients aged 18 to 75 who are scheduled for UBE surgery at our hospital will take part. Patients will be randomly assigned to one of four groups based on two things: the height of the fluid bag (0.9 meters or 1.0 meters) and the direction of the surgical cut (horizontal or vertical). We will measure the fluid pressure around the spinal covering during surgery and record how clear the surgical view is. After surgery, we will track patients' pain and recovery for at least 6 months. This study has been approved by the hospital ethics committee.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age \>= 18 years and \< 75 years. * Patients scheduled for unilateral biportal endoscopic (UBE) surgery for lumbar degenerative disease at the First Affiliated Hospital of Kunming Medical University between February 2026 and December 2027. * Follow-up duration \> 6 months. * Complete clinical and follow-up data available. * Voluntary participation and signed informed consent. Exclusion Criteria: * History of tuberculosis, infection, tumor, or trauma. * Severe cardiac, hepatic, or renal insufficiency. * History of chronic lung disease, liver disease, HIV infection, diabetes, or renal insufficiency. * Psychiatric disorders or inability to comply with follow-up. * Severe osteoporosis. * Pregnant or lactating women.

Primary outcome measure(s)

  • Irrigation pressure around the dura — During surgery
    Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Kunming Medical University Kunming Yunnan Recruiting
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 NCT07837427 on ClinicalTrials.gov ↗ ← All trials in China