Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)
A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.
研究概览
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.
- 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.
- 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
注册 (预期的)
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100044
- 招聘中
- Department of Gastroenterology Surgery, Peking University People's Hospital
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接触:
- Zhidong Gao, M.D.
- 电话号码:8610-88326600
- 邮箱:xiaoya-008@163.com
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首席研究员:
- Yingjiang Ye, M.D. & Ph.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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CME surgery for colon cancer
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non-CME surgery for colon cancer
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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 |
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Prognosis assessment of postoperative patients
大体时间:yearly, up to 5 years
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The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.
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yearly, up to 5 years
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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
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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.
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Daily, up to one month
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合作者和调查者
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
一般刊物
- Wang C, Gao Z, Shen Z, Jiang K, Zhou J, Wang S, Ye Y. Five-Year Prognosis of Complete Mesocolic Excision in Patients with Colon Cancer: A Prospective, Nonrandomized, Double-Blind Controlled Trial. J Am Coll Surg. 2022 Oct 1;235(4):666-676. doi: 10.1097/XCS.0000000000000282. Epub 2022 Sep 15.
- Gao Z, Wang C, Cui Y, Shen Z, Jiang K, Shen D, Wang Y, Zhan S, Guo P, Yang X, Liu F, Shen K, Liang B, Yin M, Xie Q, Wang Y, Wang S, Ye Y. Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-year Results From a Prospective, Nonrandomized, Double-blind, Controlled Trial. Ann Surg. 2020 Mar;271(3):519-526. doi: 10.1097/SLA.0000000000003012.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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)?
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