Renal Stone
Conditions
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.
Interventions
PROCEDUREFlexible Ureteroscopy
Ureteroscopic lithotripsy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Total radiation time | during operation | total radiation time in minutes during operation |
Countries
Hong Kong
Contacts
Primary ContactSteffi Kar Kei YUEN, FRCS-Surgery
Outcome results
None listed