Laser Lithotripsy During URS - Holmium vs Thulium

Haukeland University Hospital120 enrolled

Overview

The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. The outcomes of the URS procedures are compared for the two treatment arms.

The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total. Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. The outcomes of the URS procedures are compared for the two treatment arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Urolithiasis

Interventions

Holmium:YAG laser machineDEVICE

Ureteroscopy with Holmium:YAG laser lithotripsy

Thulium Fiber laser machineDEVICE

Ureteroscopy with Thulium Fiber laser lithotripsy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway Exclusion Criteria: * Known pathology of the upper urinary tract * Untreated infection

Locations (1)

Haukeland University Hospital

Bergen, Vestland, Norway

Outcomes

Primary Outcomes

Stone Free Rate

Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.

Time frame: 3 months after the URS

Secondary Outcomes

Operating Time

Surgical operating time

Time frame: Decided immediately after the surgery

Intraoperative Complications

Intraoperative complications leading to abruption of the URS procedure

Time frame: Decided immediately after the surgery

Postoperative Complications

Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.

Time frame: Within 3 months post endoscopically

Postoperative JJ-stenting

How many needed postendoscopic stunting following the URS procedure

Time frame: Decided immediately after the surgery

Data from ClinicalTrials.gov

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