A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Calculi
- Sponsor
- The First Affiliated Hospital of University of South China
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Changes in renal bleeding after surgery
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Li Mingyong, MD
Associate professor
The First Affiliated Hospital of University of South China
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in renal bleeding after surgery
Time Frame: Hour 3 after the surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Changes of inflammatory indicators after surgery
Time Frame: Hour 3 after the surgery
Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference
Changes of renal-function after surgery
Time Frame: Hour 3 after the surgery
Preoperative and postoperative blood creatinine difference
Incidence of pneumothorax and hydrothorax
Time Frame: Day 2 after the surgery
The rate of pneumothorax and hydrothorax after surgery
Pain score after surgery
Time Frame: 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
Time Frame: Day 2 after the surgery
The rate of ureteral stone street after surgery
Secondary Outcomes
- 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)