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Risk factors of intestinal complications after colorectal surgery
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注册号:

Registration number:

ChiCTR1800019374 

最近更新日期:

Date of Last Refreshed on:

2018-11-07 

注册时间:

Date of Registration:

2018-11-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

结直肠癌术后腹部并发症危险因素分析 

Public title:

Risk factors of intestinal complications after colorectal surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

结直肠癌术后腹部并发症危险因素分析 

Scientific title:

Risk factors of intestinal complications after colorectal surgery 

研究课题代号(代码):

Study subject ID:

ZK2015A32 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

江慧洪 

研究负责人:

林谋斌 

Applicant:

Huihong Jiang 

Study leader:

Moubin Lin 

申请注册联系人电话:

Applicant telephone:

+86 15000085783 

研究负责人电话:

Study leader's telephone:

+86 15000085783 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

1710470@tongji.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

1500142@tongji.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市杨浦区河间路1015号职业病科3楼转化医学中心 

研究负责人通讯地址:

上海市杨浦区河腾越路450号杨中心医院2号楼11楼主任办公室 

Applicant address:

1015 Hejian Road, Shanghai, China 

Study leader's address:

450 Tengyue Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200090 

研究负责人邮政编码:

Study leader's postcode:

200090 

申请人所在单位:

上海市杨浦区中心医院(同济大学附属杨浦医院) 

Applicant's institution:

Yangpu Hospital, Tongji University School of Medicine, Shanghai 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

LL-2018-SCI-002 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市杨浦区中心医院伦理委员会 

Name of the ethic committee:

Ethics Committee, Yangpu Hospital, Tongji University School of Medicine, Shanghai 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-06 

伦理委员会联系人:

王佩菊 

Contact Name of the ethic committee:

Peiju Wang 

伦理委员会联系地址:

上海市杨浦区河腾越路450号杨中心医院5号楼211室 

Contact Address of the ethic committee:

450 Tengyue Road, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-65690520 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海市杨浦区中心医院(同济大学附属杨浦医院) 

Primary sponsor:

Yangpu Hospital, Tongji University School of Medicine, Shanghai 

研究实施负责(组长)单位地址:

上海市杨浦区河腾越路450号 

Primary sponsor's address:

450 Tengyue Road, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市杨浦区中心医院(同济大学附属杨浦医院)

具体地址:

上海市杨浦区河腾越路450号

Institution
hospital:

Yangpu Hospital, Tongji University School of Medicine, Shanghai

Address:

450 Tengyue Road, Shanghai, China

经费或物资来源:

上海市卫生和计划生育委员会项目(ZK2015A32) 

Source(s) of funding:

Project of Shanghai Municipal Commission of Health and Family Planning, No. ZK2015A32 

研究疾病:

结直肠癌 

Target disease:

Colorectal cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

分析结直肠癌术后肠道并发症的相关危险因素。 

Objectives of Study:

This study aimed to invesigate the risk factors of intestinal complications after colorectal surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

① 患者年龄≥18岁,无性别限制; ② 2013年1月至2018年10月期间在上海市杨浦区中心医院行肿瘤切除手术,术后病理确诊为结直肠癌,结合患者的临床及影像学检查等结果,参照UICC TNM分期标准,诊断为I-IV期结直肠癌; ③ 有完整的临床和病理资料。 

Inclusion criteria

1. Patients were aged above 18 years with no sex restriction; 2. Patients were newly diagnosed and received colorectal surgery at Yangpu Hospital from January 2013 to October 2018. All colorectal cancers were confirmed histologically. Tumor were staged according to TNM classification (Version 8.0); 3. Patients had complete clinical data. 

排除标准:

①术后病理显示为非结直肠癌病变; ②患者资料不齐全。 

Exclusion criteria:

1. Postoperative pathology showed that the case was not primary colorectal cancer; 2. Patients' data were not complete. 

研究实施时间:

Study execute time:

From2018-11-10To 2019-02-28 

干预措施:

Interventions:

组别:

Case series

样本量:

1876

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市杨浦区中心医院(同济大学附属杨浦医院) 

单位级别:

三级乙等 

Institution
hospital:

Yangpu Hospital, Tongji University School of Medicine, Shanghai  

Level of the institution:

Tertiary B Hospital 

测量指标:

Outcomes:

指标中文名:

肠道并发症

指标类型:

主要指标 

Outcome:

Intestinal complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

无样本

组织:

Sample Name:

No sample

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

在2019年6月30日,将以Excel形式上传原始数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Data will be upload by Excel before 30 June 2019

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集使用病例记录表,数据管理使用SPSS软件

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data were collected by Case record rorm, and were managed by SPSS software.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-11-07
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