Percutaneous Nephrolithotomy Without a Ureteral Catheter

A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy

Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.

Study Overview

• Status: Recruiting
• Conditions: Kidney Calculi; Nephrolithotomy Percutaneous
• Intervention / Treatment: Procedure: PCNL without reverse insertion of a ureteral catheter

Detailed Description

The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant.

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

Contacts and Locations

• Study Contact: Name: Mingyong Li, MD.; Phone Number: +86 137-8648-4606; 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, MD.; Phone Number: +86 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:

· 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.

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: without reverse insertion of a ureteral catheter; Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter	Procedure: PCNL without reverse insertion of a ureteral catheter; The ureteral catheter was not retrograde inserted during PCNL
No Intervention: Conventional; Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of fever	Fever was defined as axillary temperature greater than 38.5 ° C.	From the day of surgery to the day of discharge, up to 2 weeks.
White blood cell count change value	The change value of White blood cell count between preoperative and postoperative	Day 2 before surgery、hour 3 after the surgery
Neutrophils granulocyte change value	The change value of Neutrophils granulocyte between preoperative and postoperative	Day 2 before surgery、hour 3 after the surgery
Hemoglobin change value	The change value of Hemoglobin between preoperative and postoperative	Day 2 before surgery、hour 3 after the surgery
Hematocrit change value	The change value of Hematocrit between preoperative and postoperative	Day 2 before surgery、hour 3 after the surgery
Rate of renal subcapsular hematoma	The proportion of postoperative renal subcapsular hematoma in all patients	Day 2 after the surgery
Serum creatinine change value	The change value of Serum creatinine between preoperative and postoperative	Day 2 before surgery、Hour 3 after the surgery
visual analog scale (VAS)pain score	0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.	Hour 2 after the surgery
Rate of hydrothorax	Hydrothorax appeared on the surgical side.	Day 2 after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Residual stone less than 4mm in diameter was considered to have been cleared.	Day 2 after the surgery
Operation time	Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture	During the procedure
length of hospital stay	Length of hospital stay indicated the number of days between the operation date and discharge date	2 weeks after surgery
Medical costs	All medical expenses incurred to treat stones.	2 weeks after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of South China
• Investigators: Study Director: Mingyong Li, MD., the First Affiliated Hospital of the University of South China

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: nhfy0520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be made available to other researchers after the study Report are published.
• IPD Sharing Time Frame: One year after the study report was published,but the duration is uncertain.
• 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
• product manufactured in and exported from the U.S.: No