Percutaneous Nephrolithotomy Without a Ureteral Catheter

NCT ID: NCT05598671

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2025-02-01

Brief Summary

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.

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.

Conditions

Nephrolithotomy Percutaneous; Kidney Calculi

Study Design

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

Study Groups

without reverse insertion of a ureteral catheter

Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter

Group Type: EXPERIMENTAL

PCNL without reverse insertion of a ureteral catheter

Intervention Type: PROCEDURE

The ureteral catheter was not retrograde inserted during PCNL

Conventional

Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PCNL without reverse insertion of a ureteral catheter

The ureteral catheter was not retrograde inserted during PCNL

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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, MD.

Role: primary

myli1123@126.com

18175878363 ext. +86

Other Identifiers

nhfy0520

Identifier Type: -

Identifier Source: org_study_id