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ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

2015年8月17日 更新者:Michał Pędziwiatr、Jagiellonian University

Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.

研究概览

地位

完全的

详细说明

All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.

Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.

For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.

研究类型

观察性的

注册 (实际的)

143

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Kraków、波兰、31-501
        • 2nd Department of General Surgery

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2013-2014. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items

描述

Inclusion Criteria:

  • colorectal cancer
  • laparoscopic resection
  • perioperative care according to ERAS principles

Exclusion Criteria:

  • Patients submitted initially for open or emergency surgery
  • with complex cancer who required multi-organ resection
  • patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Group 1 (≤4 days)
Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).
Group 1 (>4 days)
In group 2 were patients whose hospital stay was longer than 4 days.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Hospital length of stay (days)
大体时间:participants will be followed for the duration of hospital stay, an expected average of 4 days
participants will be followed for the duration of hospital stay, an expected average of 4 days

次要结果测量

结果测量
措施说明
大体时间
Compliance with ERAS protocol (%)
大体时间:participants will be followed for the duration of hospital stay, an expected average of 4 days
Compliance (%) will be calculated as the number of pre and intraoperative interventions fulfilled/13*100% (number of pre- and intraoperative protocol elements included into compliance calculations)
participants will be followed for the duration of hospital stay, an expected average of 4 days
Complication rate (%)
大体时间:up to 30 days post surgery
up to 30 days post surgery
Readmission rate (%)
大体时间:up to 30 days post surgery
up to 30 days post surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michał Pędziwiatr, MD, PhD、2nd Department of Surgery, Jagiellonian University, Krakow, Poland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年1月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2015年8月13日

首先提交符合 QC 标准的

2015年8月17日

首次发布 (估计)

2015年8月19日

研究记录更新

最后更新发布 (估计)

2015年8月19日

上次提交的符合 QC 标准的更新

2015年8月17日

最后验证

2015年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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