Patient Positioning for Treatment of Proximal Ureteral Stones
Optimal Patient Positioning and Strategy for the Treatment of Proximal Ureteral Stones
Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown.
This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency.
A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.
研究概览
详细说明
Ureteroscopy has become a primary modality for the management of ureteral and renal calculi due to its high efficacy, minimally invasive nature, and favorable safety profile. Despite advances in flexible ureteroscopy, laser lithotripsy, and access technologies, proximal ureteral stones remain technically challenging, largely due to their tendency to migrate retrograde into the kidney, leading to prolonged operative time, increased need for flexible ureteroscopy, and lower procedural efficiency.
Stone retropulsion is influenced by laser energy, irrigation flow, ureteral anatomy, and gravitational forces. Several mechanical and laser-based strategies have been explored to mitigate migration, though results have been variable. Patient positioning represents a simple and cost-neutral intervention that may alter stone behavior intraoperatively without requiring additional devices.
Reverse Trendelenburg positioning has recently been shown to reduce proximal stone migration and improve operative efficiency during ureteroscopic treatment of ureteral stones. In a randomized controlled trial, patients positioned in reverse Trendelenburg experienced lower rates of retropulsion, reduced need for conversion to flexible ureteroscopy, and shorter operative times compared with standard positioning. However, this study included stones across multiple ureteral segments and did not focus specifically on proximal ureteral stones, which may have distinct anatomical and migration characteristics.
Conversely, T-tilt positioning has been investigated in the context of intrarenal stone treatment. Prior randomized evidence demonstrated that T-tilt positioning during retrograde intrarenal surgery resulted in higher stone-free rates, likely due to improved gravitational alignment of calyces and enhanced fragment clearance. These findings suggest that positioning may also optimize intrarenal lithotripsy efficiency once stones migrate into the kidney.
For proximal ureteral stones, two competing operative strategies are commonly used in clinical practice: (1) in situ ureteral treatment with efforts to prevent migration, potentially optimized by reverse Trendelenburg positioning, or (2) intentional pushback of the stone into the kidney followed by intrarenal lithotripsy under positioning conditions favorable for fragment clearance, such as T-tilt.
The decision to use one strategy over another is based on surgeon preference. Currently, there are no guidelines or standards favoring either approach. To date, no randomized study has directly compared these two positioning-based strategies for proximal ureteral stones. Given that operative time is strongly associated with anesthesia exposure, procedural cost, complication risk, and resource utilization, it represents a clinically meaningful and objective primary endpoint to evaluate procedural efficiency between approaches.
This study seeks to address an important gap in endourologic practice by determining the optimal positioning strategy for proximal ureteral stone management, with the goal of improving operative efficiency, reducing procedural burden, and informing evidence-based surgical decision-making.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mantu Gupta, MD
- 电话号码:212-241-1272
- 邮箱:mantu.gupta@mountsinai.org
研究联系人备份
- 姓名:Blair Gallante, MPH
- 电话号码:212-241-1272
- 邮箱:blair.gallante@mountsinai.org
学习地点
-
-
New York
-
New York、New York、美国、10019
- 招聘中
- Mount Sinai West
-
首席研究员:
- Mantu Gupta, MD
-
接触:
- Mantu Gupta, MD
- 电话号码:212-241-1272
- 邮箱:mantu.gupta@mountsinai.org
-
接触:
- Blair Gallante, MPH
- 电话号码:212-241-1272
- 邮箱:blair.gallante@mountsinai.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria:
- Adults aged 18 years and older.
- Diagnosed with kidney stones and scheduled for fURS.
- Stone burden > 1 cm and/or multiple stones will be eligible.
- Able and willing to provide informed consent.
Exclusion criteria:
- Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at the institution)
- Untreated UTI
- Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
- Single stone < 1 cm
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Reverse Trendelenburg Position
Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.
|
Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor.
Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.
|
|
有源比较器:T-Tilt Position
Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.
|
Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position.
In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor.
This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total operative time
大体时间:Immediately postoperatively on the day of surgery
|
Operative time will be used to compare procedural efficiency
|
Immediately postoperatively on the day of surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants stone-free
大体时间:From Week 4 to Week 6 postoperatively
|
Proportion of participants without residual stone fragments on postoperative CT imaging
|
From Week 4 to Week 6 postoperatively
|
|
Proportion of procedures requiring additional equipment or procedural maneuvers
大体时间:Immediately after completion of surgery on the day of procedure
|
Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
|
Immediately after completion of surgery on the day of procedure
|
|
Proportion of strategy failure
大体时间:Assessed immediately at completion of surgery on the day of procedure
|
Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
|
Assessed immediately at completion of surgery on the day of procedure
|
|
Incidence of Complications
大体时间:Through postoperative day 30
|
Incidence of postoperative complications, defined as any Clavien-Dindo complications, emergency department visits, or readmission related to the procedure.
Outcome is recorded as the occurrence of a complication event (yes or no).
Each participant is counted once, and the outcome is recorded as a binary variable indicating whether any of these events occurred or did not occur.
|
Through postoperative day 30
|
合作者和调查者
调查人员
- 首席研究员:Mantu Gupta, MD、Icahn School of Medicine at Mount Sinai
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY-26-00168
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.