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.
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. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGSurgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.
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.
Time frame: Procedure
Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores
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.
Time frame: Procedure
Post-operative infection
Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture
Time frame: 30-days post-operative
Perioperative patient outcomes as measured by Clavien-Dindo classification system
Intraoperative complications will be categorized based on the Clavien-Dindo classification system
Time frame: Up to 30 days
Post-operative pain as measured by Visual analog scale (VAS)
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.
Time frame: Immediately post-operative and up to 7 days
Post-operative pain as measured by opioid use
Opioid usage will be tracked
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Time frame: Immediately post-operative and up to 7 days