A Randomized Controlled Trial Comparing Robotic Flexible Ureteroscopy With Standard Flexible Ureteroscopy for Treatment of Renal Stones - A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Renal Stone
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Stone-free rate at 1 month
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
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.
Investigators
NG Chi Fai
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years old with informed consent
- •Being willing and able to provide written informed consent
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
Outcomes
Primary Outcomes
Stone-free rate at 1 month
Time Frame: 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 Outcomes
- Stone-free rate at 3 month(Month 3)
- Operative time(During operation)
- Lasing Time(During operation)
- Total laser energy used(During operation)
- Total radiation dose(During operation)
- Total radiation time(during operation)
- Length of hospital stay(On Discharge)
- Postoperative pain(Baseline, Week 1 and Week 12)
- Surgeon radiation exposure(During operation)