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Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)

2016年8月17日 更新者:Shan Wang

A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.

In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in which the same principle of TME in rectal cancer has been applied to the colon. More and more surgeons pay attention to the rationality of this surgical approach. However, the clinical application researches are still few, in particular the prospective controlled study is still none. This clinical trial will compare the CME group and non-CME group to evaluate the outcome and safety of CME for apply in clinic.

研究概览

地位

未知

条件

详细说明

Materials and Methods:

All the patients with colon cancer will undergo elective radical operation. The observations were recorded during the operation and on the postoperative specimens. Intra-operative photographs were taken at various stages, as were photographs of the postoperative specimen. According to the CME operation keypoints, all the photographs will accept third-party assessment of the expert group, while the third-party expert group will not participate in the management of patients. Both of The evaluators and research doctors are double-blind state. The postoperative patients will divided into two groups according to the results of the assessment. The clinical and pathological data of the patients as well as follow-up information will be recorded and collected.

  1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues morphometry of two groups, the prognosis, lymph nodes harvest and removal of the mesocolic area were investigated. Outcomes of interest also include disease-free survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the correlation between mesocolic area and height, weight, body surface area and body mass index.
  2. Safety of CME CME group and non-CME group were compared the differences of security, included operation time, blood loss, postoperation complications, flatus restoring time, defecation restoring time, drainage removal time, Diet restoring time, drainage volume in three days after surgery, hospital deaths, the exhaust time, hospitalization time and hospitalization costs. In addition, the feasibility of CME techniques as the surgical approach of choice for elderly patients was also evaluated.

研究类型

观察性的

注册 (预期的)

450

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

    • Beijing
      • Beijing、Beijing、中国、100044
        • 招聘中
        • Department of Gastroenterology Surgery, Peking University People's Hospital
        • 接触:
        • 首席研究员:
          • Yingjiang Ye, M.D. & Ph.D.

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

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult patients of colon caner in China

描述

Inclusion Criteria:

  • Clinical diagnosis of colon cancer;
  • Clinical stage Ⅰ ~ Ⅲ;
  • Undergoing colorectal surgery for the first time;
  • Accept laparotomy;
  • Accept radical resection;
  • More than 18 years.

Exclusion Criteria:

  • Emergency surgery;
  • Preoperative neoadjuvant chemoradiotherapy history;
  • Combined with other malignant diseases;
  • Pathological stage Ⅳ patients with colon cancer.

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
CME surgery for colon cancer
non-CME surgery for colon cancer

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prognosis assessment of postoperative patients
大体时间:yearly, up to 5 years
The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.
yearly, up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Safety assessment of the patients in perioperation period
大体时间:Daily, up to one month
Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.
Daily, up to one month

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。

赞助

调查人员

  • 研究主任:Yingjiang Ye, M.D. & Ph.D.、Peking University People's Hospital

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

2012年11月1日

初级完成 (预期的)

2017年11月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2012年11月4日

首先提交符合 QC 标准的

2012年11月7日

首次发布 (估计)

2012年11月12日

研究记录更新

最后更新发布 (估计)

2016年8月18日

上次提交的符合 QC 标准的更新

2016年8月17日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • PKPH-CME
  • Z121100005312015 (其他赠款/资助编号:Science and Technology Project of Bejing, China)
  • TG-2015-002 (其他赠款/资助编号:Capital health development research project)
  • 20130001120064 (其他赠款/资助编号:Doctoral Program of Higher Education)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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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