High Versus Low Power Settings During Ureteroscopic Laser Lithotripsy - a Prospective, Randomised Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥ 18 years scheduled for URS lithotripsy for renal stones, 8-25 mm, at the day surgery unit at Haukeland University Hospital

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Contact Information
Primary
Øyvind Ulvik, Assoc Prof
doc.ulvik@online.no
+47 90918595
Backup
Mathias S Æsøy, MD
mathias.asoy@gmail.com
Time Frame
Start Date: 2023-01-23
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 150
Treatments
Experimental: Group 1 - low power laser settings
4-6 Watts, short pulse mode. 0.4 - 0.6 J at 10 Hz.
Experimental: Group 2 - high power laser settings
16-18 Watts, short pulse mode. 0.4 J / 40 Hz, 0.6 J / 30 Hz or 0.8 J / 20 Hz.
Related Therapeutic Areas
Sponsors
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov