Johnston Thomas James, Baard Joyce, de la Rosette Jean, Doizi Steeve, Giusti Guido, Knoll Thomas, Proietti Silvia, Brehmer Marianne, Emiliani Esteban, Pérez-Fentes Daniel, Osther Palle Jorn Sloth, Seitz Christian, Neal Naomi, Turney Ben, Hasan Mudhar, Traxer Olivier, Wiseman Oliver
Cambridge University Hospitals, Department of Urology, Cambridge, United Kingdom.
AMC University Hospital, Department of Urology, Amsterdam, The Netherlands.
Cent European J Urol. 2018;71(4):453-461. doi: 10.5173/ceju.2018.1787. Epub 2018 Oct 2.
We assessed the clinical performance of a new digital single-use flexible ureteroscope (UscopePU3022).
A prospective cohort study was carried out across 11 centers (July-Oct. 2017). The UscopePU3022 was assessed regarding ease of insertion; deflection, image quality, maneuverability and overall performance using either a visual analog* or Likert scale.
A total of 56 procedures were performed in 11 centers (16 surgeons) with the indication being renal stones in 83%. The median score for ease of scope insertion was 10 (3-10). Intraoperative maneuverability was rated as 'good' in 38% and 'very good' in 52%. Visual quality was rated as 'poor or bad' in 18%, 'fair' in 37% and 'good or very good' in 43%. Two scopes failed intraoperatively (4%). Preoperative and postoperative median upward and downward deflection was 270 degrees. Compared to standard flexible ureteroscopy (f-URS) maneuverability was rated as 'equivalent' in 30% and 'better' in 60%; visual quality was 'worse' in 38% and 'equivalent or better' in 62%; limb fatigue scores were 'better' in 86%; and overall performance was 'worse' in 55% and 'equivalent or better' in 45%.
UscopeTM3022 performed well with regards to maneuverability, deflection and limb fatigue and appears to be at least non-inferior to standard f-URS with regards to these parameters. Poor image quality is a concern for UscopePU3022 with it receiving a low overall performance rating when compared to standard f-URS. Despite this it scored highly when investigators were asked if they would use it in their practice if it was cost-effective to do so.
我们评估了一种新型一次性使用的数字柔性输尿管镜（UscopePU3022）的临床性能。
2017年7月至10月在11个中心开展了一项前瞻性队列研究。使用视觉模拟*或李克特量表对UscopePU3022的插入难易程度、偏转、图像质量、可操作性及总体性能进行评估。
11个中心（16名外科医生）共进行了56例手术，其中83%的手术指征为肾结石。输尿管镜插入的难易程度中位数评分为10（3 - 10）。术中可操作性评为“良好”的占38%，评为“非常好”的占52%。视觉质量评为“差或坏”的占18%，“一般”的占37%，“好或非常好”的占43%。有两个输尿管镜在术中出现故障（4%）。术前及术后向上和向下偏转的中位数为270度。与标准柔性输尿管镜检查（f - URS）相比，可操作性评为“相当”的占30%，评为“更好”的占60%；视觉质量评为“更差”的占38%，评为“相当或更好”的占62%；肢体疲劳评分评为“更好”的占86%；总体性能评为“更差”的占55%，评为“相当或更好”的占45%。
UscopeTM3022在可操作性、偏转和肢体疲劳方面表现良好，在这些参数方面似乎至少不劣于标准f - URS。图像质量较差是UscopePU3022的一个问题，与标准f - URS相比，其总体性能评分较低。尽管如此，当被问及如果该输尿管镜具有成本效益他们是否会在实践中使用时，研究人员给出了较高的评分。
