跳至主要内容
临床试验/NCT03322709
NCT03322709Unknown不适用

Minimally Invasive Kidney Transplantation: Surgical Stress and Kidney Injury

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2017年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
Expression of biomarkers of kidney injury

研究概览

简要总结

This study aims to investigate the effect of robot-assisted laparoscopic kidney transplantation on kidney injury by measuring biomarkers of kidney injury which are found in blood and urine to establish if there is a significant difference between robotic and open surgery. The study will also investigate the potential benefits of minimally invasive surgery on the surgical trauma associated with open surgery by assessing the surgical stress response between groups of kidney transplant patients receiving either open or minimally invasive kidney transplants and by comparing wound healing with patients undergoing donor nephrectomy.

详细描述

  1. Introduction

1.1 Background

Living donor kidney transplantation is the optimal treatment for end stage renal disease (ESKD). This process involves a mandatory period of warm and cold ischaemia before the donor kidney is reperfused. The reperfusion injury causes damage to the transplanted kidney that may affect its long term outcome. In living donor kidney transplantation this period of ischaemia is kept to a minimum. However, minimally invasive kidney transplantation (MIKT) has been shown to increase the warm ischaemia time for these patients due to the prolonged anastomosis time and the graft and patient are exposed to pneumoperitoneum for a significant amount of time. It is not clear if these events affect graft outcomes.

Biomarkers of acute kidney injury are of interest in transplantation as they may be used to assess the severity of graft injury and predict the likely clinical outcomes at an early stage. There is evidence that they can predict delayed graft function after kidney transplantation.

MIKT also has the potential in reducing the surgical trauma associated with open surgery due to smaller incisions; this may reduce infections and improve wound healing. Evidence from laparoscopic donor nephrectomy shows clear benefits to patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • patients over 18 years recieving a living donor kidney transplant at our institution

排除标准

  • refuses consent

结局指标

主要结局

Expression of biomarkers of kidney injury

时间窗: 30 days post op

KIM-1, NGAL and Interleukin 18 will be measured pre-op and post operatively up to day 30.

次要结局

  • Wound healing(3 time points post op up to 14 days.)

研究者

申办方类型
Other
责任方
Sponsor

相似试验