Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

The First Affiliated Hospital of University of South China

Status

Enrolling

Conditions

Percutaneous Nephrolithotomy

Urinary Calculi

Treatments

Procedure: Without reverse insertion of a ureteral catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05574517

USCKF201902K01

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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