跳至主要内容
临床试验/NCT02401100
NCT02401100已完成不适用

Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Umeå University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Blood flow measurements

研究概览

简要总结

The purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. The investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. The patients will be recruited at Umeå University Hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. Perianastomotic tissue will also be collected. In the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. Standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. The study will recruit approximately 40 patients during three consecutive years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Planned anterior resection for rectal cancer
  • Willing to participate

排除标准

  • Not willing to participate
  • Unable to consent

结局指标

主要结局

Blood flow measurements

时间窗: Start and end of operation

Laser-Doppler blood flow measurements of the rectal mucosa perfusion below and distal to the anastomosis.

次要结局

  • Anastomotic leakage(90 days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验