Total tubeless percutaneous nephrolithotomy without a ureteral catheter
A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless Percutaneous Nephrolithotomy
This study is testing a new way to perform kidney stone surgery without using a ureteral catheter to see if it leads to fewer complications and a quicker recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (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 | NCT05578807 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a modified surgical technique for total tubeless percutaneous nephrolithotomy (PCNL) that eliminates the need for retrograde insertion of a ureteral catheter. The study aims to compare this new approach with conventional total tubeless PCNL in terms of postoperative complications, stone-free rates, operation time, length of hospital stay, and medical costs. It is a single-center, single-blind, randomized trial involving 100 subjects, who will be assigned to either the experimental group or the control group. The trial is expected to provide insights into the safety and efficacy of this innovative surgical method.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with kidney stones suitable for PCNL surgery, specifically those with stones less than 35 mm in diameter and minimal hydronephrosis.
Not a fit: Patients with infectious calculi, severe cardiac or pulmonary issues, or previous surgeries on the affected side are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced pain and shorter recovery times for patients undergoing kidney stone surgery.
How similar studies have performed: Previous studies have shown the safety and efficacy of total tubeless PCNL, but this specific approach of avoiding ureteral catheter insertion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with kidney stones who met the indications for PCNL surgery. * the maximum diameter of calculi was less than 35 mm. * the width of hydronephrosis effusion was less than 25mm. Exclusion Criteria: * patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes. * Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications. * Patients with previous history of PCNL surgery on the affected side or nephrotomy. * Patients with indwelling double J tube or nephrostomy tube before operation. * Patients with renal trauma or congenital anomalies of urinary system.
Where this trial is running
Hengyang, Hunan
- The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Mingyong Li, MD.
- Email: myli1123@126.com
- Phone: 137-8648-4606
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.