Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Calculi; Percutaneous Nephrolithotomy
• Intervention / Treatment: Procedure: Without reverse insertion of a ureteral catheter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingyong Li, MD; Phone Number: 18175878363; Email: myli1123@126.com

Study Locations

• China
  • Hunan
    • Hengyang, Hunan, China, 421001
      • Recruiting
      • The First Affiliated Hospital of University of South China
      • Contact: Mingyong LI; Phone Number: 18175878363; Email: myli1123@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group(group 1); Without reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy.	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.
No Intervention: Control group(group 2); Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of inflammatory indicators after surgery	Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference	Hour 3 after the surgery
Changes in renal bleeding after surgery	Pre- vs. post-operative difference in hemoglobin and hematocrit values	Hour 3 after the surgery
Changes of renal-function after surgery	Preoperative and postoperative blood creatinine difference	Hour 3 after the surgery
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
Incidence of pneumothorax and hydrothorax	The rate of pneumothorax and hydrothorax after surgery	Day 2 after the surgery
Incidence of ureteral stone street	The rate of ureteral stone street after surgery	Day 2 after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	From the completion of anesthesia to the end of the suture incision.	during the procedure
Duration of hospital stay	From the date of admission to the date of discharge.	immediately after the discharge
Hospital costs	The cost from hospitalization to discharge.	immediately after the discharge
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of South China
• Investigators: Principal Investigator: Mingyong Li, MD, The First Affiliated Hospital of University of South China

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Tubeless; Percutaneous nephrolithotomy; Ureteral catheter; Without reverse insertion; Urinary calculi
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Urolithiasis; Calculi
• Other Study ID Numbers: USCKF201902K01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication.
• IPD Sharing Time Frame: Starting 1 year after publication.
• IPD Sharing Access Criteria: When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No