Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
- Conditions
- Kidney StoneNephrolithiasis
- Interventions
- Device: INTRARENAL PRESSURE MONITORING VISIBLE
- Registration Number
- NCT06576661
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.
- Detailed Description
Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. We designed a study to to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Males or females over 18 years of age
- Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney
- Total stone burden over 2 cm
- Undergoing bilateral stone treatment during the same procedure
- Patients with known genitourinary anatomical abnormalities
- Uncorrected coagulopathy
- Patients with urinary diversions
- Chronic external urinary catheters
- Women who are pregnant
- Immunosuppressed patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description URS WITH INTRARENAL PRESSURE MONITORING VISIBLE INTRARENAL PRESSURE MONITORING VISIBLE In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.
- Primary Outcome Measures
Name Time Method Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score. Procedure Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
- Secondary Outcome Measures
Name Time Method Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores Procedure Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
Post-operative infection 30-days post-operative Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture
Perioperative patient outcomes as measured by Clavien-Dindo classification system Up to 30 days Intraoperative complications will be categorized based on the Clavien-Dindo classification system
Post-operative pain as measured by Visual analog scale (VAS) Immediately post-operative and up to 7 days The VAS is a valid and reliable method for quantifying pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain possible.
Post-operative pain as measured by opioid use Immediately post-operative and up to 7 days Opioid usage will be tracked
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States