Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

NCT ID: NCT05578807

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2025-01-10

Brief 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.

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.

Conditions

Nephrolithotomy, Percutaneous; Kidney Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

without reverse ureteral catheter insertion

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role: lead

Responsible Party

Li Mingyong, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingyong Li, MD.

Role: STUDY_DIRECTOR

the First Affiliated Hospital of the University of South China

Locations

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingyong Li, MD.

Role: CONTACT

myli1123@126.com

137-8648-4606 ext. +86

Facility Contacts

Mingyong Li

Role: primary

myli1123@126.com

18175878363 ext. +86

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020SK51801

Identifier Type: -

Identifier Source: org_study_id