Development of a rating system for surgeons' non-technical skills.
S Yule, R Flin, S Paterson-Brown...
https://pubmed.ncbi.nlm.nih.gov/17054619/Actively Recruiting
Led by University of Kansas Medical Center · Updated on 2026-05-04
80
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating how having real-time intrarenal pressure IRP measurement available during ureteroscopy affects surgeons behavior when using the LithoVue Elite disposable ureteroscope. The study aims to understand whether this new technology impacts surgical decisions and patient outcomes during treatment for kidney stones or nephrolithiasis. This research also addresses the importance of surgeons non-technical skills in preventing adverse events in the operating room. Participants will be randomly assigned to one of two groups. In the first group, surgeons will perform ureteroscopy with the LithoVue Elite device while seeing real-time IRP monitoring information. In the second group, surgeons will use the same device but without access to the IRP monitoring data. All procedures and follow-up visits will follow standard care practices for both groups. During the study, researchers will observe surgeon behavior using the Non-Technical Skills for Surgeons NOTSS score and look at decision-making differences. They will also monitor patient outcomes such as post-operative infections, pain levels using a visual analog scale, opioid use, and complications up to 30 days after surgery. This approach helps assess both surgical performance and patient safety over the short term.
CONDITIONS
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
J
Jane Ledesma
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University of Kansas Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | URS with LithoVue Elite™ Pressure Monitoring | Standard URS (No Pressure Monitoring Shown) |
|---|---|---|
| What it is | Flexible ureteroscopy with real-time intrarenal pressure monitoring shown to the surgeon throughout the procedure using the LithoVue Elite™ device. | Standard flexible ureteroscopy for kidney stones, performed without displaying real-time intrarenal pressure monitoring data to the surgeon. |
| Role in the study | Intervention group receiving additional intraoperative feedback on pressure to guide surgical actions. | Control group where surgeons conduct the procedure without additional pressure information, reflecting usual practice. |
| Primary use | To determine whether real-time intrarenal pressure monitoring during flexible URS influences surgeon behavior and improves post-operative outcomes. | To evaluate outcomes of standard flexible URS as currently performed, serving as comparison for the addition of IRP monitoring. |
| How it is performed | Real-time intrarenal pressure readings are continuously displayed to the operating surgeon during flexible ureteroscopy, potentially allowing intraoperative adjustments based on pressure feedback. | The surgeon completes flexible ureteroscopy without seeing any live intrarenal pressure data, consistent with standard techniques. |
| Evidence status | Effectiveness and impact on surgical performance and patient outcomes are being studied; no published clinical outcome evidence exists yet for this IRP monitoring approach in URS. | Standard flexible URS is supported by published literature as an accepted treatment for upper tract urinary stones; surgeon technique and perioperative management are key factors. |
| Important limitations | No published clinical outcome data is yet available for direct patient benefit, and the ability of real-time IRP monitoring to reduce complications or improve longer-term results remains to be established. | Standard URS outcomes can vary based on surgeon skill and technique, and elevated intrarenal pressures may contribute to postoperative complications. Routine monitoring of pressure is not yet widely available. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day procedure
Participants undergo flexible ureteroscopy (URS) to treat urinary stones, with or without real-time intra-renal pressure monitoring visible to the surgeon using the LithoVue Elite™ device.
1 surgery visit (in-person)
Duration - Up to 30 days
Participants are monitored for up to 30 days after surgery to assess post-operative infection, pain, opioid use, and other patient outcomes as per standard care.
Follow-up visits per standard of care
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor