Development and Evaluation of a Surgical Planning Tool for Urolithiasis Surgery: Kidney Stone Calculator
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Concordance
研究概览
简要总结
Urolithiasis is a frequent pathology, for which flexible ureteroscopy with endocorporeal laser lithotripsy has become the most frequently used surgical treatment. This procedure is limited to 90 minutes and will depend mainly on the total lithiasis volume. Knowing the duration of lithotripsy before the operation would allow to foresee situations of iterative procedures and to improve the patient's path (ambulatory or conventional surgery, work stoppage, optimization of operating times and operating room occupation times). "Kidney Stone Calculator" is a free tool capable of providing a calculi volumetry and predicting the duration of endocorporeal laser lithotripsy.
The main objective of this study would be to evaluate the performance of the Kidney Stone Calculator in estimating the duration of laser lithotripsy during flexible ureteroscopy for renal calculi, by analyzing the agreement between the estimated and actual lithotripsy durations, evaluated by an intraclass correlation coefficient and its 95% confidence interval Eligible patients will be those scheduled for flexible ureteroscopy for renal calculi described on a non-injected abdominopelvic scan. A total of 240 patients over a 15-month inclusion period is planned, with a follow-up time of 3 months.
详细描述
Urolithiasis is a common disease (10% of the general population). A quarter of patients will require surgery to treat a kidney stone. Ureteroscopy with endocorporeal laser lithotripsy is spreading and represents now the procedure of choice to treat a kidney stone. Its duration is variable and limited to 90min for infectious reasons. Having a tool to predict the duration of the procedure would allow to plan the patient's stay in the best possible way with a triple interest (patient, practitioner and administration).
"KIDNEY STONE CALCULATOR"(KSC) was developed to improve operative planning for lithiasis surgery. KSC estimates the total lithiasis volume from the patient's preoperative CT scan, using computer density segmentation, and then provides an estimate of the LLE duration (DEs) based on the computational density and laser parameters (energy, frequency, laser fiber diameter, laser type). Our KSC tool also allows the selection of laser parameters to optimize the duration of the computation fragmentation. These parameters could therefore also have an influence on the lithotripsy duration.
A first evaluation of KSC was performed in 2020 using operative data from 26 patients showing a small difference between the actual (Def) and estimated (Des) lithotripsy durations (median difference:14% (Q1-Q3(5.4-24.8);p = 0.36). The agreement between estimated and actual duration assessed by a CCI was 0.92 [0.78 - 0.97]. The duration of lithotripsy corresponded, together with the recovery time of the residual fragments, to half of the total operative time. Therefore, we would be able to predict the operative time with this tool. To date, this is the only study to estimate the duration of lithotripsy during an endoscopic kidney stone procedure.
We hypothesize a good concordance between estimated (Des) via KSC and actual (Def) lithotripsy durations during URS for renal calculi. This study will allow us to confirm the results of our pilot study and also to study the factors (patient (anatomy, number of stones and their positions and/or volumes, intraoperative), material used, experience of the operator) influencing Des.
Our study protocol plan to enroll 223 patients on 4 centers, on a prospective observational design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •One or more kidney stones documented on a preoperative non-injected abdominopelvic CT scan
- •scheduled for flexible ureteroscopy with endocorporeal laser lithotripsy
- •using a reference laser (Holmium:YAG or Thulium Fiber)
- •no opposition to the reuse of care data for research
排除标准
- •Ureteral calculi
- •Encrusted JJ stent
- •Percutaneous surgical stone management
- •Planned monobloc extraction of the stone
- •Suspicion of struvite type stone (phosphasto-amoniacal-magnesium)
结局指标
主要结局
Concordance
时间窗: 3 months
Concordance between estimated and actual laser lithotripsy times during flexible ureteroscopy for kidney stones, assessed by an intraclass correlation coefficient and its 95% confidence interval
次要结局
- Comparison of the surgeon's planned laser parameters and those used during the procedure for lithiasis fragmentation(3 months)
- Correlation between Des and Def according to demographic, anatomical, number and types of calculi and their position, material(3 months)