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临床试验/NCT02849119
NCT02849119Unknown不适用

Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
106
试验地点
2
主要终点
Operative time

研究概览

简要总结

Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared with TP approach.

Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).

详细描述

Partial nephrectomy is the standard treatment for small renal masses. The evolution of minimally invasive partial nephrectomy led to widespread utilization of laparoscopic (LPN) and robotic partial nephrectomy (RPN). Both LPN and RPN can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter OT, less EBL, shorter LOS compared with TP approach.

Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).

The purpose of this study To compare the treatment outcomes of the transperitoneal and retroperitoneal approach during LPN or RPN in treatment of small renal masses.

Inclusion criteria During the study period, a small renal mass (less than 4cm, T1a stage) patients are going to underwent LPN or RPN.

Exclusion criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients are going to undergo LPN or RPN with renal mass =<4cm

排除标准

  • Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy

结局指标

主要结局

Operative time

时间窗: Intraoperative

Operative time of partial nephrectomy

次要结局

  • Change of differential glomerular filtration rate (dGFR) measured by renal scan(Preoperative dGFR and postoperative 1 year)
  • Warm ischemic time (minutes)(Intraoperative)
  • Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification(from date of surgery, to 1 year postoperatively)
  • Overall disease-free survival time (month)(from date of surgery, to 1 year postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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