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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic flexible ureteroscopy with ILY® Robot platform | Experimental | Robotic ILY® is a flexible ureteroscopy holder with multiple degrees of freedom telemanipulated with a wireless controller. This allows the surgeon to work easily at a distance from the patient and prevents them from exposing to the source of ionizing radiation. |
|
| Standard flexible ureteroscopy | Active Comparator | Standard flexible ureterscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible Ureteroscopy | Procedure | Ureteroscopic lithotripsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate at 1 month | 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 | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate at 3 month | 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 | Month 3 |
| Operative time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steffi Kar Kei YUEN, FRCS-Surgery | Contact | 35052625 | steffiyuen@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Chi Fai NG, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North District Hospital | Recruiting | Sheung Shui | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37337653 | Background | Bravo-Balado A, Fontanet S, Skolarikos A, Gozen AS, Somani BK, Traxer O, Papatsoris A, Ruiz Martinez A, Keller EX, Pietropaolo A, Tonyali S, Tailly T, Esperto F, Liatsikos E, Kanashiro AK, Angerri O, Emiliani E. Estimated Radiation Dose to the Lens During Endourologic Procedures: The Role of Leaded Glasses and the ALARA Protocol-An ESU/ESUT-YAU Endourology Group Collaboration. J Endourol. 2023 Aug;37(8):935-939. doi: 10.1089/end.2023.0061. | |
| 21683380 |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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the time from insertion of an endoscope into the urethra to the completion of stent placement |
| During operation |
| Lasing Time | The total lasing time in minutes during operation | During operation |
| Total laser energy used | Total laser energy used during operation | During operation |
| Total radiation dose | Total radiation dose during operation | During operation |
| Total radiation time | total radiation time in minutes during operation | during operation |
| Length of hospital stay | defined from the day of surgery to the day of discharge, counted in days. | On Discharge |
| Postoperative pain | By visual analogue scores from 0-10, the highest score the more pain. | Baseline, Week 1 and Week 12 |
| Surgeon radiation exposure | By radiation dosimeter | During operation |
| Background |
| Desai MM, Grover R, Aron M, Ganpule A, Joshi SS, Desai MR, Gill IS. Robotic flexible ureteroscopy for renal calculi: initial clinical experience. J Urol. 2011 Aug;186(2):563-8. doi: 10.1016/j.juro.2011.03.128. Epub 2011 Jun 16. |
| 27604670 | Background | Geavlete P, Saglam R, Georgescu D, Multescu R, Iordache V, Kabakci AS, Ene C, Geavlete B; -. Robotic Flexible Ureteroscopy Versus Classic Flexible Ureteroscopy in Renal Stones: the Initial Romanian Experience. Chirurgia (Bucur). 2016 Jul-Aug;111(4):326-9. |
| 38478076 | Background | El-Hajj A, Abou Chawareb E, Zein M, Wahoud N. First prospective clinical assessment of the ILY(R) robotic flexible ureteroscopy platform. World J Urol. 2024 Mar 13;42(1):143. doi: 10.1007/s00345-024-04869-7. |
| 32557097 | Background | Klein J, Charalampogiannis N, Fiedler M, Wakileh G, Gozen A, Rassweiler J. Analysis of performance factors in 240 consecutive cases of robot-assisted flexible ureteroscopic stone treatment. J Robot Surg. 2021 Apr;15(2):265-274. doi: 10.1007/s11701-020-01103-5. Epub 2020 Jun 16. |
| 29215822 | Background | Tae BS, Balpukov U, Cho SY, Jeong CW. Eleven-year Cumulative Incidence and Estimated Lifetime Prevalence of Urolithiasis in Korea: a National Health Insurance Service-National Sample Cohort Based Study. J Korean Med Sci. 2018 Jan 8;33(2):e13. doi: 10.3346/jkms.2018.33.e13. |
| 28213860 | Background | Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017 Sep;35(9):1301-1320. doi: 10.1007/s00345-017-2008-6. Epub 2017 Feb 17. |
| 26077357 | Background | Geraghty R, Abourmarzouk O, Rai B, Biyani CS, Rukin NJ, Somani BK. Evidence for Ureterorenoscopy and Laser Fragmentation (URSL) for Large Renal Stones in the Modern Era. Curr Urol Rep. 2015 Aug;16(8):54. doi: 10.1007/s11934-015-0529-3. |
| 27238616 | Background | Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27. |
| 33720938 | Background | Park IW, Kim SJ, Shin D, Shim SR, Chang HK, Kim CH. Radiation exposure to the urology surgeon during retrograde intrarenal surgery. PLoS One. 2021 Mar 15;16(3):e0247833. doi: 10.1371/journal.pone.0247833. eCollection 2021. |
| 35751350 | Background | Mansoor SN, Al Arabia DH, Rathore FA. Ergonomics and musculoskeletal disorders among health care professionals: Prevention is better than cure. J Pak Med Assoc. 2022 Jun;72(6):1243-1245. doi: 10.47391/JPMA.22-76. |
| 8817961 | Background | Allaire PE, Kim HC, Maslen EH, Olsen DB, Bearnson GB. Prototype continuous flow ventricular assist device supported on magnetic bearings. Artif Organs. 1996 Jun;20(6):582-90. |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |