Analysis of surgical errors in closed malpractice claims at 4 liability insurers.
Selwyn O Rogers, Atul A Gawande, Mary Kwaan...
https://pubmed.ncbi.nlm.nih.gov/16857439Actively 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
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Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
J
Jane Ledesma
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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