Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

Not Applicable

Not yet recruiting

• Conditions: Renal Stone

• Registration Number: NCT06660914
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

Detailed Description

This is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. All consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. Patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-11
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age ≥ 18 years old with informed consent
• Being willing and able to provide written informed consent

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Exclusion Criteria

• Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
• American Society of Anesthesiologists (ASA) physical status classification system >3
• Untreated urinary tract infection
• Renal stones > 3cm in diameter

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone-free rate at 1 month	Month 1	Stone-free rate at 1 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments \<2mm

Secondary Outcome Measures

Name	Time	Method
Stone-free rate at 3 month	Month 3	If not stone free at 1 month, stone-free rate at 3 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments \<2mm
Operative time	During operation	the time from insertion of an endoscope into the urethra to the completion of stent placement
Lasing Time	During operation	The total lasing time in minutes during operation
Total laser energy used	During operation	Total laser energy used during operation
Total radiation dose	During operation	Total radiation dose during operation
Total radiation time	during operation	total radiation time in minutes during operation
Length of hospital stay	On Discharge	defined from the day of surgery to the day of discharge, counted in days.
Postoperative pain	Baseline, Week 1 and Week 12	By visual analogue scores from 0-10, the highest score the more pain.
Surgeon radiation exposure	During operation	By radiation dosimeter

Trial Locations

Locations (1)

North District Hospital; 🇭🇰 Sheung Shui, Hong Kong