High Versus Low Power Settings During Ureteroscopic Laser Lithotripsy
ConditionRenal Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaukeland University Hospital
About this trial
The primary aim of the study is to compare the operative times following ureteroscopic lithotripsy for renal stones with Thulium Fiber Laser using low and high power settings.
Secondary aims are to compare the results of low and high power settings in terms of stone free rates, laser time, laser activation patterns, intraoperative and postoperative complications.
Patients ≥ 18 years with renal stones (8-25 mm) scheduled for ureteroscopic lithotripsy at the Day Surgery Clinic at Haukeland University Hospital in Bergen, Norway, are eligible for inclusion in the study. After written consent and inclusion, patients are randomised to laser lithotripsy using either low power settings (Group 1: 4-6 Watt, short pulse mode) or high power settings (Group 2: 16-18 Watt, short pulse mode). The ureteroscopic procedures are performed in general anaesthesia using a standardised technique. All patients are followed up with a low dose CT scan 3 months post endoscopically to assess stone free status as well as a consultation at the outpatient clinic.
Results and data for the two randomisation groups are compared according to the aims of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years scheduled for URS lithotripsy for renal stones, 8-25 mm, at the day surgery unit at Haukeland University Hospital
Disqualifiers
Concomitant ureteral stone
Urinary diversion
Active infection
Untreated cancer in the upper urinary tract
Trial design
Design model
Parallel
Treatments tested in this trial
Laser power settings (Thulium Fiber Laser)
Other interventionUreteroscopic lithotripsy using low power laser settings (0.4 - 0.6 J at 10 Hz corresponding to 2.4 - 6.0 Watts) or high power laser settings (0.4 J at 40 Hz, 0.6 J at 30 Hz or 0.8 J at 20 Hz corresponding to 16 - 18 Watts).
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Group 1 - low power laser settingsExperimental treatment 1 intervention
Group B: Group 2 - high power laser settingsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Operative time
Surgical time in minutes, counted from start of the procedure with insertion of the cystoscope until emptying the bladder in the end.
Time frame
During surgery (approximately 1 hour), registered immediately after surgerySecondary outcomes
1
Stone free rate
Assessment of stone free status (or the presence of residual fragments) on low dose CT 3 months post endoscopically.
Time frame
3 months post endoscopically2
Laser activation patterns - duration
Duration of laser activation periods during laser lithotripsy in seconds
Time frame
During surgery (approximately 1 hour), registered immediately after surgery3
Laser activation patterns - number
Number of laser activation periods during laser lithotripsy
Time frame
During surgery (approximately 1 hour), registered immediately after surgery4
Intraoperative complications
Complications occurred during the endoscopic procedure (bleeding, perforation, avulsion, mucosal abrasion, blurred vision)
Time frame
During surgery (approximately 1 hour), registered immediately after surgerySponsors and contacts
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Source ClinicalTrials.gov