The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Location status: Recruiting
NCT Number: NCT07837427
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Kunming, Yunnan, 650032, China
Location status: Recruiting
Background: Unilateral biportal endoscopy (UBE) is a minimally invasive spine surgery technique that has been increasingly used for lumbar disc herniation, spinal stenosis, and other degenerative conditions. Irrigation fluid is essential in UBE to maintain the surgical space and control bleeding. However, the pressure of irrigation fluid may be associated with complications such as neck pain, seizures, and increased intracranial pressure. The height of the fluid bag and the direction of the surgical incision are two controllable factors that may influence actual irrigation pressure and surgical field clarity, but prospective clinical evidence is lacking.
Objective: This study aims to investigate the effects of different fluid bag heights (0.9 m vs. 1.0 m) and incision directions (horizontal vs. vertical) on irrigation pressure, surgical field clarity, blood loss, and early postoperative pain and functional recovery in patients undergoing UBE surgery. Additionally, disc tissue collected during surgery will be used to explore the relationship between disc degeneration and factors such as sex, age, mechanical stress, and injury.
Design: This is a single-center, prospective, randomized controlled trial. Approximately 80 patients scheduled for UBE surgery at the First Affiliated Hospital of Kunming Medical University will be enrolled. Patients will be randomly assigned to one of four groups: (1) 0.9 m fluid bag height + horizontal incision; (2) 0.9 m fluid bag height + vertical incision; (3) 1.0 m fluid bag height + horizontal incision; (4) 1.0 m fluid bag height + vertical incision. Intraoperative irrigation pressure around the dura will be continuously measured. Surgical field clarity, blood loss, and early postoperative outcomes will be recorded. Patients will be followed for at least 6 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
UBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal).
Time frame: During surgery
Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.
Contact information is provided by the study sponsor or research team.
Fan Zhang
Other
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