Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

Urinary Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574517
• Other study ID #: USCKF201902K01
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: The First Affiliated Hospital of University of South China
• Contact: Mingyong Li, MD
• Phone: 18175878363
• Email: myli1123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Percutaneous Nephrolithotomy
• Urinary Calculi
• Urolithiasis

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of South China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of inflammatory indicators after surgery	Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference	Hour 3 after the surgery
Primary	Changes in renal bleeding after surgery	Pre- vs. post-operative difference in hemoglobin and hematocrit values	Hour 3 after the surgery
Primary	Changes of renal-function after surgery	Preoperative and postoperative blood creatinine difference	Hour 3 after the surgery
Primary	Pain score after surgery	According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain.	Hour 3 after the surgery
Primary	Incidence of pneumothorax and hydrothorax	The rate of pneumothorax and hydrothorax after surgery	Day 2 after the surgery
Primary	Incidence of ureteral stone street	The rate of ureteral stone street after surgery	Day 2 after the surgery
Secondary	Duration of operation	From the completion of anesthesia to the end of the suture incision.	during the procedure
Secondary	Duration of hospital stay	From the date of admission to the date of discharge.	immediately after the discharge
Secondary	Hospital costs	The cost from hospitalization to discharge.	immediately after the discharge
Secondary	Stone-free rates	Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi < 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%).	Day 2 after the surgery