NCT05574517

Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital of University of South China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Calculi
• Percutaneous Nephrolithotomy

Interventions

Type	Name	Description
PROCEDURE	Without 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.

Timeline

• Start date: 2022-10-07
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-10
• Last updated: 2024-09-24

Locations

1 site across 1 country: China