Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
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
Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy
干预措施: Partial nephrectomy (Procedure)
Open Partial Nephrectomy
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
Marcos Francisco Dall'Oglio
M.D. Associate Professor
University of Sao Paulo
