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临床试验/NCT01892059
NCT01892059Unknown不适用

A Randomized Controlled Trial Comparing the Segmental Artery Clamping and Main Renal Artery Clamping During Laparoscopic Partial Nephrectomy

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5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
100
试验地点
1
主要终点
Glomerular Filtration Rate

研究概览

简要总结

The purpose of this study is to compare the efficacy and safety of the segmental artery clamping and main renal artery clamping during laparoscopic partial nephrectomy

详细描述

Renal tumor patients,for whom laparoscopic partial nephrectomy is suitable, will be randomly divided into two groups,segmental artery clamping group and main artery clamping group. All procedures were performed by the same laparoscopic surgeon. Blood loss, operation time, warm ischemia time, complications and affected renal function before and after operation will be recorded and compared. The safety and efficiency of laparoscopic partial nephrectomy with segmental renal artery clamping will be evaluated in comparison with the conventional main renal artery clamping technique.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •20<age<70yr
  • •Stage T1a
  • •Patients volunteered for this study and provided written informed consent

排除标准

  • •Bilateral renal tumor
  • •tumor of solitary kidney
  • •glomerulonephritis
  • •renal insufficiency
  • •GFR of invalid kidney less than 30ml/min
  • •presence of suspect metastasis
  • •serious systematic disease: severe coagulation disorders
  • •important organ insufficiency and severe psychological disease

研究组 & 干预措施

Segmental artery clamping

Experimental

Patients with Renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of segmental renal artery clamping will performed.

干预措施: Segmental artery clamping (Procedure)

Main renal artery clamping

Active Comparator

Patients with renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of traditional main renal artery clamping will be performed.

干预措施: Main renal artery clamping (Procedure)

结局指标

主要结局

Glomerular Filtration Rate

时间窗: 3 months postoperative

次要结局

  • warm ischemia time(during surgery)

研究者

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

Changjun Yin

Head of Urology Department

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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