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临床试验/NCT01809119
NCT01809119Unknown不适用

Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
242
试验地点
1
主要终点
Surgical Complications

研究概览

简要总结

Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with renal tumor cT1N0M0; (<7 cm)
  • •Normal renal function (serum creatinine <1.2 and glomerular filtration rate> 60mL/min/1.73m2)
  • •Tumor only

排除标准

  • •Functional or anatomical solitary kidney
  • •Horseshoe kidney, ectopic or malformed
  • •Clinical contraindication to surgery
  • •Contraindication to laparoscopic surgery
  • •Association with other renal pathologies
  • •Evidence of lymph node or systemic disease in preoperative staging

研究组 & 干预措施

Laparoscopic Partial Nephrectomy

Experimental

Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy

干预措施: Partial nephrectomy (Procedure)

Open Partial Nephrectomy

Active Comparator

Patients with kidney neoplasms submitted to open partial nephrectomy

干预措施: Partial nephrectomy (Procedure)

结局指标

主要结局

Surgical Complications

时间窗: 6 months

次要结局

  • Oncological outcomes(5 years)
  • Renal Function(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Francisco Dall'Oglio

M.D. Associate Professor

University of Sao Paulo

研究点 (1)

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