Kidney Stone, Nephrolithiasis
Conditions
Keywords
Intrarenal Pressure, LithoVue Elite
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. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.
Interventions
DEVICEINTRARENAL PRESSURE MONITORING VISIBLE
In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
1. Undergoing bilateral stone treatment during the same procedure 2. Patients with known genitourinary anatomical abnormalities 3. Uncorrected coagulopathy 4. Patients with urinary diversions 5. Chronic external urinary catheters 6. Women who are pregnant 7. Immunosuppressed patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTJane Ledesma
PRINCIPAL_INVESTIGATORBristol B Whiles, MD
University of Kansas Medical Center
Outcome results
None listed