Kidney stone surgery without a ureteral catheter
A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy
NA · The First Affiliated Hospital of University of South China · NCT05598671
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 better recovery for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of University of South China (other) |
| Locations | 1 site (Hengyang, Hunan) |
| Trial ID | NCT05598671 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of performing percutaneous nephrolithotomy (PCNL) without the traditional reverse insertion of a ureteral catheter. The study is designed as a single-center, single-blind, randomized trial involving 200 subjects who will be assigned to either the experimental group receiving the new approach or the control group undergoing traditional PCNL. The primary focus is on the incidence of postoperative complications, while secondary outcomes include stone-free rates, operation time, length of hospital stay, and medical costs. The trial aims to determine if this novel approach can reduce complications associated with the standard procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with upper urinary tract stones who are eligible for PCNL surgery.
Not a fit: Patients with infectious calculi, severe cardiac or pulmonary issues, previous PCNL surgery on the affected side, or other significant surgical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer postoperative complications and improved recovery for patients undergoing kidney stone surgery.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: · Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery. 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.
Conditions: Nephrolithotomy Percutaneous, Kidney Calculi