Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

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

Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.

Study Overview

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

Detailed Description

The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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): 100
• 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; Phone Number: +86 18175878363; Email: myli1123@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with kidney stones who met the indications for PCNL surgery.
• the maximum diameter of calculi was less than 35 mm.
• the width of hydronephrosis effusion was less than 25mm.

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: Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter; In total tubeless percutaneous nephrolithotomy surgery, there is no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no need to change the position, and no need to re-sterilize and lay towels.	Procedure: without reverse ureteral catheter insertion; In contrast to conventional total tubeless percutaneous nephrolithotomy, there was no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no change in position, and no repeated disinfection.
No Intervention: Conventional total tubeless percutaneous nephrolithotomy; In total tubeless percutaneous nephrolithotomy surgery, there is reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, need to change the position, and need to re-sterilize and lay towels.

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.
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
White blood cell count change value	The change value of White blood cell count between preoperative and	Day 2 before surgery、hour 3 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
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
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

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): September 28, 2022
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

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: 2020SK51801

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