A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless 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
- visual analog scale (VAS)pain score
研究概览
简要总结
Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.
详细描述
The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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 kidney stones who met the indications for PCNL surgery.
- •the maximum diameter of calculi was less than 35 mm.
- •the width of hydronephrosis effusion was less than 25mm.
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
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.
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
Hemoglobin change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of Hemoglobin between preoperative and postoperative
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
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
Hematocrit change value
时间窗: Day 2 before surgery、hour 3 after the surgery
The change value of Hematocrit between preoperative and postoperative
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.
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
- Operation time(During the procedure)
- Stone free rate(Day 2 after the surgery)
- Medical costs(2 weeks after surgery)
- length of hospital stay(2 weeks after surgery)
研究者
Li Mingyong, MD
Associate professor
The First Affiliated Hospital of University of South China