Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

Kidney Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578807
• Other study ID #: 2020SK51801
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: January 10, 2025

Study information

• Verified date: October 2023
• Source: The First Affiliated Hospital of University of South China
• Contact: Mingyong Li, MD.
• Phone: 137-8648-4606
• Email: myli1123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 10, 2025
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Nephrolithotomy, Percutaneous

Intervention

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.

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	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.
Primary	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
Primary	Neutrophils granulocyte change value	The change value of Neutrophils granulocyte between preoperative and postoperative	Day 2 before surgery?hour 3 after the surgery
Primary	Hemoglobin change value	The change value of Hemoglobin between preoperative and postoperative	Day 2 before surgery?hour 3 after the surgery
Primary	Hematocrit change value	The change value of Hematocrit between preoperative and postoperative	Day 2 before surgery?hour 3 after the surgery
Primary	Rate of renal subcapsular hematoma	The proportion of postoperative renal subcapsular hematoma in all patients	Day 2 after the surgery
Primary	Serum creatinine change value	The change value of Serum creatinine between preoperative and postoperative	Day 2 before surgery?Hour 3 after the surgery
Primary	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
Primary	Rate of hydrothorax	Hydrothorax appeared on the surgical side.	Day 2 after the surgery
Secondary	Stone free rate	Residual stone less than 4mm in diameter was considered to have been cleared.	Day 2 after the surgery
Secondary	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
Secondary	length of hospital stay	Length of hospital stay indicated the number of days between the operation date and discharge date	2 weeks after surgery
Secondary	Medical costs	All medical expenses incurred to treat stones.	2 weeks after surgery