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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFan Zhang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unilateral Biportal Endoscopic Surgery

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: 0.9 m Fluid Bag Height + Transverse IncisionExperimental treatment 1 intervention
Group B: 0.9 m Fluid Bag Height + Longitudinal IncisionExperimental treatment 1 intervention
Group C: 1.0 m Fluid Bag Height + Transverse IncisionExperimental treatment 1 intervention
Group D: 1.0 m Fluid Bag Height + Longitudinal IncisionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Irrigation pressure around the dura

Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.

Time frame
During surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fan Zhang

Lead sponsor

First Affiliated Hospital of Kunming Medical University

Sponsor institution

National Natural Science Foundation of China

Collaborator