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临床试验/NCT05574517
NCT05574517招募中不适用

A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion

The First Affiliated Hospital of University of South China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Changes in renal bleeding after surgery

研究概览

简要总结

Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

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 comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. 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 and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. 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

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 Diseases
  • Participants who agree to undergo tubeless PCNL
  • The participants' maximum diameter of the stone should be less than 3.5cm

排除标准

  • Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
  • Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
  • Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
  • Renal trauma or congenital malformation of the urinary system

结局指标

主要结局

Changes in renal bleeding after surgery

时间窗: Hour 3 after the surgery

Pre- vs. post-operative difference in hemoglobin and hematocrit values

Changes of inflammatory indicators after surgery

时间窗: Hour 3 after the surgery

Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference

Changes of renal-function after surgery

时间窗: Hour 3 after the surgery

Preoperative and postoperative blood creatinine difference

Incidence of pneumothorax and hydrothorax

时间窗: Day 2 after the surgery

The rate of pneumothorax and hydrothorax after surgery

Pain score after surgery

时间窗: Hour 3 after the surgery

According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain.

Incidence of ureteral stone street

时间窗: Day 2 after the surgery

The rate of ureteral stone street after surgery

次要结局

  • Duration of operation(during the procedure)
  • Stone-free rates(Day 2 after the surgery)
  • Hospital costs(immediately after the discharge)
  • Duration of hospital stay(immediately after the discharge)

研究者

发起方
The First Affiliated Hospital of University of South China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Mingyong, MD

Associate professor

The First Affiliated Hospital of University of South China

研究点 (1)

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