Kidney Stones, Urolithiasis
Conditions
Keywords
kidney stones, manual flexible ureteroscopy, fURS, ILY robot, robotic
Brief summary
The goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (fURS) for kidney stone treatment in adult patients undergoing laser lithotripsy. * Does robotic-assisted lithotripsy using the ILY® robot have the same efficacy as the manual fURS in treating kidney stones? * Is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates? * Does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? Researchers will compare the ILY robotic system with manual fURS to see if robotic intervention can match or improve clinical and ergonomic outcomes. Participants will: * Be randomly assigned to undergo laser lithotripsy with either the ILY robot or manual flexible ureteroscopy * Complete standard pre- and postoperative assessments * Undergo evaluation for stone-free status using a non-contrast CT scan at 30 days postoperatively * Undergo evaluation for postoperative complications
Interventions
PROCEDURERobotic-Assisted Flexible Ureteroscopy
Use of the ILY® robotic system to perform flexible ureteroscopy.
PROCEDUREManual Flexible Ureteroscopy
Conventional flexible ureteroscopy performed manually by the surgeon.
Sponsors
Albert El Hajj
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females ≥ 18 years old * Patients with a normal pelvicalyceal anatomy * Patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity * ASA score I-III * Intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up
Exclusion criteria
* Children \< 18 and pregnant women * Patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (DJ stent placement only will be accepted) or known history of complicated ureteroscopy * Patients in whom stone measurement was not feasible on NCCT or those with concomitant ureteric stones. * ASA score IV * Mentally incapacitated patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy assessed by measuring the stone-free rate (SFR) | 30 days after the index procedure | A patient is considered stone free if there are no visible residual stone fragments after the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative and 30-day Postoperative Outcomes | Perioperatively and 30 days after the procedure | This assessment will account for any complications related to the patient's clinical condition from the procedure through a 4-week postoperative period. |
| Ergonomics | Immediately after the procedure | The NASA Task Load Index will be used to assess for ergonomics. |
| Surgeon safety in terms of radiation exposure | During the procedure | Surgeon safety from ionizing radiation will be assessed by the surgeon wearing 3 dosimeter badges used to detect and record exposure. |
| Intraoperative Parameters | During the procedure | Operative time, draping time, docking time, lasing time (all measured in minutes) |
| Conversion rate | During the procedure | The proportion of cases where a procedure originally planned using the robotic technique had to be converted to manual fURS due to complications, technical difficulties, or failure of equipment. |
Countries
Lebanon
Contacts
Primary ContactAlbert El Hajj, MD
Outcome results
None listed