A Comparative Study of One-handed Lithotripsy and Traditional Lithotripsy in Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone clearance rate
研究概览
简要总结
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this study is to explore the safety and effectiveness of the PCNL with one-handed lithotripsy technique
详细描述
This is a key clinical research project of the University of South China(NO.USCKF201902K01).The goal of this study is to compare the safety,effectiveness and feasibility between the percutaneous nephrolithotomy with one-handed technique and the traditional percutaneous nephrolithotomy in the treatment of upper urinary calculi. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation.For random allocation,participants are randomly grouped by coin toss method.Participants with front side are assigned to experimental group,where they undergo PCNL with one-handed lithotripsy.Participants with reverse side are assigned to control group and undergo traditional PCNL.The doctors managing the operations accept participants and execute the surgical treatments.All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation.Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
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
- Single (Participant)
盲法说明
A single-blind trial in which participants were unaware of the study group and the intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Disease.
- •Participants who agree to undergo one-hand lithotripsy.
排除标准
- •Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function.
- •Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
结局指标
主要结局
Stone clearance rate
时间窗: Day 2 after the surgery
Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi \< 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%)
Renal pelvis mucosal injury rate
时间窗: during the procedure
Number of accidental injuries of renal pelvis mucosa during operation
Operative time
时间窗: during the procedure
From the completion of anesthesia to the end of the suture incision.
Changes in renal bleeding after surgery
时间窗: Hour 3 after the surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
次要结局
- Hospital stay(immediately after the discharge)
- Hospital costs(immediately after the discharge)
研究者
Li Mingyong, MD
Associate professor
The First Affiliated Hospital of University of South China