A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hemoglobin change value
研究概览
简要总结
Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.
详细描述
The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant.
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)
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
- •· Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.
排除标准
- •patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes.
- •Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications.
- •Patients with previous history of PCNL surgery on the affected side or nephrotomy.
- •Patients with indwelling double J tube or nephrostomy tube before operation.
- •Patients with renal trauma or congenital anomalies of urinary system.
结局指标
主要结局
Hemoglobin change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of Hemoglobin between preoperative and postoperative
visual analog scale (VAS)pain score
时间窗: Hour 2 after the surgery
0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.
Rate of hydrothorax
时间窗: Day 2 after the surgery
Hydrothorax appeared on the surgical side.
Rate of fever
时间窗: From the day of surgery to the day of discharge, up to 2 weeks.
Fever was defined as axillary temperature greater than 38.5 ° C.
Serum creatinine change value
时间窗: Day 2 before surgery、Hour 3 after the surgery
The change value of Serum creatinine between preoperative and postoperative
Hematocrit change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of Hematocrit between preoperative and postoperative
White blood cell count change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of White blood cell count between preoperative and postoperative
Neutrophils granulocyte change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of Neutrophils granulocyte between preoperative and postoperative
Rate of renal subcapsular hematoma
时间窗: Day 2 after the surgery
The proportion of postoperative renal subcapsular hematoma in all patients
次要结局
- Stone free rate(Day 2 after the surgery)
- Operation time(During the procedure)
- length of hospital stay(2 weeks after surgery)
- Medical costs(2 weeks after surgery)
研究者
Li Mingyong, MD
Associate professor
The First Affiliated Hospital of University of South China