Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

NCT05574517 | Recruiting DMC

• 1 other identifier: USCKF201902K01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Calculi; Percutaneous Nephrolithotomy

Keywords

Ureteral catheter; Without reverse insertion; Percutaneous nephrolithotomy; Tubeless; Urinary calculi

Outcome Measures

Primary Outcomes (6)

• Changes of inflammatory indicators after surgery

  Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference

  Hour 3 after the surgery

• Changes in renal bleeding after surgery

  Pre- vs. post-operative difference in hemoglobin and hematocrit values

  Hour 3 after the surgery

• Changes of renal-function after surgery

  Preoperative and postoperative blood creatinine difference

  Hour 3 after the surgery

• Pain score after surgery

  According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain.

  Hour 3 after the surgery

• Incidence of pneumothorax and hydrothorax

  The rate of pneumothorax and hydrothorax after surgery

  Day 2 after the surgery

• Incidence of ureteral stone street

  The rate of ureteral stone street after surgery

  Day 2 after the surgery

Secondary Outcomes (4)

• Duration of operation

  during the procedure

• Duration of hospital stay

  immediately after the discharge

• Hospital costs

  immediately after the discharge

• Stone-free rates

  Day 2 after the surgery

Study Arms (2)

Experimental group(group 1)

EXPERIMENTAL

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

Procedure: Without reverse insertion of a ureteral catheter

Control group(group 2)

NO INTERVENTION

Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter.

Interventions

Without reverse insertion of a ureteral catheter 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.

Experimental group(group 1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingyong Li, MD

  The First Affiliated Hospital of University of South China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyong Li, MD

CONTACT

18175878363; myli1123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A single-blind trial in which participants were unaware of the study group and the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Participants are randomly assigned to an experimental or control group in parallel.

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 10, 2022
• Study Start: October 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 1 year after publication.
• 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.

Locations

CN (1)