Renal Stone Treatment Global Registry
ConditionUrolithiasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient at the age of 18 or above
Disqualifiers
Patient is unable to give consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 5 trial groupsGroup A: FLEXOR-FANS (flexible and navigable suction ureteral access sheath)
Group B: DISS (Direct in scope suction)
Group C: Flexible ureteroscopy - IRP / IRT
Group D: Shockwave lithotripsy (SWL)
Group E: Percutaneous nephrolithotomy (PCNL)
Trial outcomes
Primary outcomes
1
Target Stone status
stone free rate
Time frame
postoperative, at 1 and/or 3 monthsSecondary outcomes
1
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
intraoperative2
Treatment related complication
The 30-day complications will be graded according to the Clavien-Dindo classification
Time frame
Thirty days after the operation3
Recurrence of stone
Stone recurrence rate
Time frame
At 12 months4
QOL and pain scores
Pain VAS scores and QOL assessment
Time frame
preoperative, postoperative on day 0 and at follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov