Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

NCT ID: NCT05574517

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2024-12-31

Brief Summary

Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

Detailed Description

This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.

Conditions

Urinary Calculi; Percutaneous Nephrolithotomy

Study Design

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

Study Groups

Experimental group(group 1)

Without reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy.

Group Type: EXPERIMENTAL

Without reverse insertion of a ureteral catheter

Intervention Type: PROCEDURE

Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.

Control group(group 2)

Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Without reverse insertion of a ureteral catheter

Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
• Participants who agree to undergo tubeless PCNL
• The participants' maximum diameter of the stone should be less than 3.5cm

Exclusion Criteria

• Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
• Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
• Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
• Renal trauma or congenital malformation of the 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: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of 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

18175878363

Facility Contacts

Mingyong LI

Role: primary

myli1123@126.com

18175878363

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

USCKF201902K01

Identifier Type: -

Identifier Source: org_study_id