Actively Recruiting
A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
Led by The First Affiliated Hospital of University of South China · Updated on 2024-09-24
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a surgical method called tubeless percutaneous nephrolithotomy (PCNL) used to treat upper urinary stones. This trial compares the safety and effectiveness of tubeless PCNL performed without reverse insertion of a ureteral catheter to the traditional method that includes this catheter insertion. The study aims to explore if avoiding the catheter can reduce surgical complications related to the ureter, building on evidence that tubeless PCNL can reduce discomfort, hospital stay, and costs. Participants are randomly assigned to one of two groups: an experimental group receiving tubeless PCNL without reverse ureteral catheter insertion and a control group receiving the traditional tubeless PCNL with catheter insertion. The procedure is performed by doctors at a single center over an anticipated two-year period. Both groups undergo surgery after informed consent is obtained, followed by one month of post-surgery observation. During the study, participants will have their inflammatory markers, renal bleeding, kidney function, and pain levels assessed three hours after surgery. Additional checks for complications like pneumothorax, hydrothorax, and ureteral stone street occur two days after surgery. Secondary outcomes include operation duration, length of hospital stay, hospital costs, and stone-free rates after two days. Clinical data collected throughout will be analyzed to compare the two surgical approaches.
CONDITIONS
Brief Title
Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who meet 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 maximum diameter of the stone should be less than 3.5 cm
- Adults aged 18 to 80 years
You will not qualify if you...
- Presence of infectious stones or complex staghorn stones confirmed by CT and blood tests
- Severe heart or lung insufficiency or abnormal blood clotting function
- Previous PCNL or nephrolithotomy surgery
- Having an indwelling ureteral stent or nephrostomy tube before surgery
- Renal trauma or congenital malformation of the urinary system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and 2 days after surgery
Participants undergo tubeless percutaneous nephrolithotomy surgery either with or without reverse insertion of a ureteral catheter, followed by immediate post-operative monitoring.
1 surgery visit and 2 post-operative visits
Duration - 1 month
Participants are monitored for recovery and potential complications for 1 month after surgery.
Follow-up visits over 1 month
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
Research Team
M
Mingyong Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here