Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Irrigation pressure around the dura
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Follow-up duration > 6 months.
- •Complete clinical and follow-up data available.
- •Voluntary participation and signed informed consent.
排除标准
- •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.
研究组 & 干预措施
0.9 m Fluid Bag Height + Longitudinal Incision
UBE surgery with 0.9 m fluid bag height and longitudinal incision.
干预措施: Unilateral Biportal Endoscopic Surgery (Procedure)
0.9 m Fluid Bag Height + Transverse Incision
UBE surgery with 0.9 m fluid bag height and transverse incision.
干预措施: Unilateral Biportal Endoscopic Surgery (Procedure)
1.0 m Fluid Bag Height + Transverse Incision
UBE surgery with 1.0 m fluid bag height and transverse incision.
干预措施: Unilateral Biportal Endoscopic Surgery (Procedure)
1.0 m Fluid Bag Height + Longitudinal Incision
UBE surgery with 1.0 m fluid bag height and longitudinal incision.
干预措施: Unilateral Biportal Endoscopic Surgery (Procedure)
结局指标
主要结局
Irrigation pressure around the dura
时间窗: During surgery
Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.
次要结局
未报告次要终点
研究者
Fan Zhang
The First Affiliated Hospital of Kunming Medical University
First Affiliated Hospital of Kunming Medical University