跳至主要内容
临床试验/NCT04466696
NCT04466696已完成不适用

Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

University of Rome Tor Vergata0 个研究点目标入组 82 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
主要终点
Postoperative length of stay

研究概览

简要总结

Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items.

The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together.

Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • colorectal cacer
  • hystologic diagnosis of adenocarcinoma of the colon/rectum
  • clinically staged T4
  • written informed consent to surgery obtained

排除标准

  • pregnancy
  • failure to perform colonic or rectal resection
  • synchronous cancer at time of colorectal cancer diagnosis

结局指标

主要结局

Postoperative length of stay

时间窗: 30 days

number of days from surgery to discharge

次要结局

未报告次要终点

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Sigismondo Sica

Associate Professor, Head of Department

University of Rome Tor Vergata

相似试验