An observational study in Urolithiasis, sponsored by Chinese University of Hong Kong. Recruiting at 3 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Chinese University of Hong Kong · Observational
This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.
Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.
Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.
New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.
Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.
Patients diagnosed with urinary stones and planned for surgery (including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy (PCNL), laparoscopic ureterolithiasis, open stone procedures etc) in the hospitals will be identified and then enrolled to the study.
Exclusion Criteria:
Cohort of flexible ureteroscopy with flexible and navigable suction ureteral access sheath (fURS FANS) will be studied
Cohort of flexible ureteroscopy with direct in scope suction (DISS) will be studied
Cohort of flexible ureteroscopy with and without real-time intrarenal pressure (IRP) monitoring and/or intrarenal temperature (IRT) will be studied
Cohort of extracorporeal shockwave lithotripsy (SWL) will be studied
Cohort of percutaneous nephrolithotomy with or without intrarenal pressure and temperature monitoring will be studied.
Target Stone status
stone free rate
Time frame: postoperative, at 1 and/or 3 months
Intraoperative parameters
Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics
Time frame: intraoperative
Treatment related complication
The 30-day complications will be graded according to the Clavien-Dindo classification
Time frame: Thirty days after the operation
Recurrence of stone
Stone recurrence rate
Time frame: At 12 months
QOL and pain scores
Pain VAS scores and QOL assessment
Time frame: preoperative, postoperative on day 0 and at follow up
Plan to share: No
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Chinese University of Hong Kong