Percutaneous Nephrolithotomy, Urinary Calculi
Conditions
Keywords
Ureteral catheter, Without reverse insertion, Percutaneous nephrolithotomy, Tubeless, Urinary calculi
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.
Interventions
PROCEDUREWithout reverse insertion of a ureteral catheter
Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.
Sponsors
The First Affiliated Hospital of University of South China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A single-blind trial in which participants were unaware of the study group and the intervention.
Intervention model description
Participants are randomly assigned to an experimental or control group in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ureteral stone street | Day 2 after the surgery | The rate of ureteral stone street after surgery |
| Changes in renal bleeding after surgery | Hour 3 after the surgery | Pre- vs. post-operative difference in hemoglobin and hematocrit values |
| Changes of renal-function after surgery | Hour 3 after the surgery | Preoperative and postoperative blood creatinine difference |
| Pain score after surgery | 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 pneumothorax and hydrothorax | Day 2 after the surgery | The rate of pneumothorax and hydrothorax after surgery |
| Changes of inflammatory indicators after surgery | Hour 3 after the surgery | Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | immediately after the discharge | From the date of admission to the date of discharge. |
| Hospital costs | immediately after the discharge | The cost from hospitalization to discharge. |
| Stone-free rates | 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%). |
| Duration of operation | during the procedure | From the completion of anesthesia to the end of the suture incision. |
Countries
China
Contacts
Primary ContactMingyong Li, MD
Outcome results
None listed