Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
URS WITH 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.
干预措施: INTRARENAL PRESSURE MONITORING VISIBLE (Device)
URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE
In Arm 2, participants will undergo URS LithoVue Elite™ without the real-time IRP monitoring information visible to the surgeon. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.
结局指标
主要结局
Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.
时间窗: 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.
次要结局
- Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores(Procedure)
- Post-operative infection(30-days post-operative)
- Perioperative patient outcomes as measured by Clavien-Dindo classification system(Up to 30 days)
- Post-operative pain as measured by Visual analog scale (VAS)(Immediately post-operative and up to 7 days)
- Post-operative pain as measured by opioid use(Immediately post-operative and up to 7 days)
研究者
Bristol Whiles, MD
Professor of Urology
University of Kansas Medical Center