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两种肠道准备方案乳果糖与聚乙二醇肠道准备效果的对比研究
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注册号:

Registration number:

ChiCTR1800015940 

最近更新日期:

Date of Last Refreshed on:

2018-05-01 

注册时间:

Date of Registration:

2018-05-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

两种肠道准备方案乳果糖与聚乙二醇肠道准备效果的对比研究 

Public title:

Comparative study of the preparation of lactose and polyethylene glycol in two intestinal preparation methods 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

两种肠道准备方案乳果糖与聚乙二醇肠道准备效果的对比研究 

Scientific title:

Comparative study of the preparation of lactose and polyethylene glycol in two intestinal preparation methods 

研究课题代号(代码):

Study subject ID:

 

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:

李春霞 

研究负责人:

兰春慧 

Applicant:

Chunxia Li 

Study leader:

Chunhui Lan 

申请注册联系人电话:

Applicant telephone:

+86 15902375220 

研究负责人电话:

Study leader's telephone:

+86 13896067955 

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:

vlcx33@126.com 

研究负责人电子邮件:

Study leader's E-mail:

Lanchunhui@dphospital.tmmu.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:

重庆市渝中区长江支路10号 

研究负责人通讯地址:

重庆市渝中区长江支路10号 

Applicant address:

10 Changjiang Branch Road, Chongqing, China 

Study leader's address:

10 Changjiang Branch Road, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

第三军医大学第三附属医院(大坪医院) 

Applicant's institution:

Daping Hospital, the Third Military Medical University, Chongqing, China  

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:

2017-56 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

第三军医大学第三临床附属医院伦理委员会 

Name of the ethic committee:

The ethics committee of the third clinical hospital, Third military medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-25 

伦理委员会联系人:

王晶晶 

Contact Name of the ethic committee:

Jingjing Wang 

伦理委员会联系地址:

重庆市渝中区长江支路10号 

Contact Address of the ethic committee:

10 Changjiang Branch Road, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

第三军医大学第三附属医院(大坪医院) 

Primary sponsor:

Daping Hospital, the Third Military Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区长江支路10号 

Primary sponsor's address:

10 Changjiang Branch Road,Chongqing,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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

第三军医大学第三附属医院(大坪医院)

具体地址:

重庆市渝中区长江支路10号

Institution
hospital:

Daping Hospital, the Third Military Medical University, Chongqing, China

Address:

10 Changjiang Branch Road, Chongqing, China

经费或物资来源:

自选课题 

Source(s) of funding:

optional research topic  

研究疾病:

下消化道疾病 

Target disease:

Disease of lower digestive tract 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

两种肠道准备方案乳果糖与聚乙二醇肠道准备效果的对比研究 

Objectives of Study:

Comparative study of the preparation of lactose and polyethylene glycol in two intestinal preparation methods 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

因行肠镜检查需要进行肠道准备的门诊患者;年龄18-70岁,男女不限;美国麻醉医师协会(ASA)分级为I-III级;能正确回答问卷调查;签署知情同意书. 

Inclusion criteria

Outpatients requiring bowel preparation for colonoscopy; Aged 18-70, male and female; The American association of anesthesiologists (ASA) I-III; To be able to answer the questionnaire correctly; Signed informed consent. 

排除标准:

麻醉药物过敏史者;严重的心、肺、肝、肾和代谢疾病、电解质紊乱;肠穿孔,肠梗阻,肠道活动性出血;妊娠或哺乳期妇女;精神障碍;糖尿病. 

Exclusion criteria:

A history of anaphylaxis; Serious heart, lung, liver,kidney and metabolic diseases, electrolyte disorders; Intestinal perforation, intestinal obstruction, intestinal activity bleeding; Pregnant or lactating women; Mental disorders, diabetes. 

研究实施时间:

Study execute time:

From2017-10-01To 2018-03-31 

征募观察对象时间:

Recruiting time:

From2017-10-01To 2018-03-30 

干预措施:

Interventions:

组别:

PEG组

样本量:

88

Group:

PEG group

Sample size:

干预措施:

聚乙二醇肠道清洁

干预措施代码:

Intervention:

The intestinal cleaning by polyethylene glycol

Intervention code:

组别:

乳果糖组

样本量:

88

Group:

Lactulose group

Sample size:

干预措施:

肠道清洁

干预措施代码:

Intervention:

The intestinal cleaning by Lactulose

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学第三附属医院(大坪医院) 

单位级别:

三甲 

Institution
hospital:

Daping Hospital, the Third Military Medical University, Chongqing, China  

Level of the institution:

Tertiary A hospital  

测量指标:

Outcomes:

指标中文名:

BBPS得分

指标类型:

主要指标 

Outcome:

BBPS score

Type:

Primary indicator 

测量时间点:

结肠镜检查完毕

测量方法:

Measure time point of outcome:

The colonoscopy is over

Measure method:

指标中文名:

息肉检出率

指标类型:

主要指标 

Outcome:

Polyp detection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

主要指标 

Outcome:

Satisfaction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

主要指标 

Outcome:

Adverse events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内镜操作时间

指标类型:

主要指标 

Outcome:

Endoscopic operating time

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

随机数字表

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

random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

大坪医院官方网站

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

official websit of DaPing hospital:www.dph-fsi.com

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:

保存于大坪医院野战外科研究所

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

saved in Research Institute of Suigery,Daping hospital

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-05-01
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