A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses (RALPLPNNX)
A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
研究概览
地位
详细说明
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Camilla Tajzler, BA, CCRA
- 电话号码：35876 905-522-1155
- 邮箱：tajzlec@mcmaster.ca
研究联系人备份
- 姓名：Anil Kapoor, MD, FRCSC
- 电话号码：33218 905-522-1155
- 邮箱：akapoor@mcmaster.ca
学习地点
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8N4A6
- St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
- Patients with SRMs (tumor(s) ≤ 4 cm)
Exclusion Criteria:
- Large tumors > 4.0cm
- Unable to have a general anesthetic
- Unable to comply with post-operative follow-up protocol
- Uncorrectable bleeding diathesis
- Tumors unsuitable for LPN/RALPN technique
- Evidence of metastatic disease
- Prior surgery on the affected kidney
- Ectopic or malrotated kidney
- Mental health condition that precludes informed consent
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Laparoscopic Assisted Partial Nephrectomy
Current standard for partial nephrectomies.
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Robotic (Davinci)
|
|
有源比较器：Robotic Assisted Partial Nephrectomy
Possible new standard for partial nephrectomies.
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Regular Laparoscopic Technique.
|
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 |
|---|---|---|
|
Warm ischemia time
大体时间：Duration of the Surgical Procedure (Nephrectomy)
|
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
|
Duration of the Surgical Procedure (Nephrectomy)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
eGFR
大体时间：Up to 24 months post operatively.
|
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
|
Up to 24 months post operatively.
|
|
Estimated blood loss
大体时间：Duration of the Surgical Procedure (Nephrectomy)
|
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
|
Duration of the Surgical Procedure (Nephrectomy)
|
|
Complication rates as per Clavien-Dindo classification
大体时间：Up to 24 months post-operatively.
|
It will be recorded for the intra-operative, post-operative and follow-up period.
|
Up to 24 months post-operatively.
|
|
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
大体时间：Duration of the Surgical Procedure
|
From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
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Duration of the Surgical Procedure
|
|
Postoperative pain
大体时间：Minutes to hours after nephrectomy up to 3 months post-operatively.
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Minutes to hours after nephrectomy up to 3 months post-operatively.
|
|
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Length of hospital stay
大体时间：3-7 Days
|
Calculated from day of admission to day of discharge from hospital.
|
3-7 Days
|
|
Positive surgical margin rate
大体时间：14 days
|
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery.
Distance to surgical margin will be looked at (mm to cm).
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14 days
|
|
Costs of treatment
大体时间：Up to 1 year
|
Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St.
Joseph Healthcare case-costing system.
The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care.
The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
|
Up to 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
其他研究编号
- RALPLPNNX
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