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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
第三军医大学第三附属医院(大坪医院) |
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Applicant's institution: |
Daping Hospital, the Third Military Medical University, Chongqing, China |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
The ethics committee of the third clinical hospital, Third military medical university |
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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 |
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Contact Name of the ethic committee: |
Jingjing Wang |
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伦理委员会联系地址: |
重庆市渝中区长江支路10号 |
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Contact Address of the ethic committee: |
10 Changjiang Branch Road, Chongqing, China |
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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) |
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Primary sponsor: |
Daping Hospital, the Third Military Medical University |
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研究实施负责(组长)单位地址: |
重庆市渝中区长江支路10号 |
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Primary sponsor's address: |
10 Changjiang Branch Road,Chongqing,China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自选课题 |
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Source(s) of funding: |
optional research topic |
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研究疾病: |
下消化道疾病 |
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Target disease: |
Disease of lower digestive tract |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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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 |
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Objectives of Study: |
Comparative study of the preparation of lactose and polyethylene glycol in two intestinal preparation methods |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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. |
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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. |
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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. |
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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: |
从From2017-10-01至To 2018-03-31 |
征募观察对象时间: Recruiting time: |
从From2017-10-01至To 2018-03-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
random number table |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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 |