Tubeless surgery for kidney stones without a ureteral catheter
A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
This study is testing a new way to remove kidney stones without using a ureteral catheter to see if it’s safer and more effective than the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of University of South China Academic / other |
| Locations | 1 site (Hengyang, Hunan) |
| Trial ID | NCT05574517 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of a novel approach to tubeless percutaneous nephrolithotomy (PCNL) that does not involve the reverse insertion of a ureteral catheter. The study compares this method to traditional tubeless PCNL with reverse catheter insertion in patients with upper urinary calculi. It is a prospective, randomized controlled trial conducted at the First Affiliated Hospital of the University of South China, with a follow-up period of one month post-surgery. Participants are randomly assigned to either the experimental or control group, and clinical outcomes are analyzed to assess the benefits of the new technique.
Who should consider this trial
Good fit: Ideal candidates are patients with upper urinary calculi who meet the criteria for PCNL surgery and have stones less than 3.5 cm in diameter.
Not a fit: Patients with infectious stones, complex staghorn stones, or significant surgical contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative discomfort and shorten hospitalization time for patients undergoing kidney stone surgery.
How similar studies have performed: While traditional tubeless PCNL has been shown to be effective, this specific approach without reverse ureteral catheter insertion is novel and has limited prior reports.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hengyang, Hunan
- The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Mingyong Li, MD — The First Affiliated Hospital of University of South China
- Study coordinator: Mingyong Li, MD
- Email: myli1123@126.com
- Phone: 18175878363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.