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Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study protocol
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注册号：

Registration number：

 ChiCTR-IOR-17012460 

最近更新日期：

Date of Last Refreshed on：

 2017-08-24 17:06:34 

注册时间：

Date of Registration：

 2017-08-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study protocol

Public title：

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study protocol

注册题目简写：

English Acronym：

Acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer

研究课题的正式科学名称：

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study protocol

Scientific title：

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study protocol

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：

劉芸宏 

研究负责人：

劉芸宏 

Applicant：

LIU Yunhong 

Study leader：

LIU Yunhong 

申请注册联系人电话：

Applicant telephone：

 +852 39433517

研究负责人电话：

Study leader's
telephone：

+852 39433517

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：

 yunhongyt@163.com

研究负责人电子邮件：

Study leader's E-mail：

 yunhongyt@163.com

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：

香港中文大學利黃瑤璧樓

研究负责人通讯地址：

香港中文大學利黃瑤璧樓

Applicant address：

Esther Lee Building, the Chinese University of Hong Kong

Study leader's address：

Esther Lee Building, the Chinese University of Hong Kong

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：

香港中文大學

Applicant's institution：

the Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

the Chinese University of Hong Kong

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：

 2017.363-T

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：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-08-14 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

香港中文大學

Primary sponsor：

the Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港中文大學利黃瑤璧樓

Primary sponsor's address：

6F, Esther Lee Building, CUHK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學

具体地址：

香港中文大學利黃瑤璧樓

Institution
hospital：

the Chinese University of Hong Kong

Address：

6F, Esther Lee Building, CUHK

经费或物资来源：

None

Source(s) of funding：

none

研究疾病：

結直腸癌  

Target disease：

colorectal cancer

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Quantitative Phase The purpose is to test the effectiveness of acupressure on shortening the first time of flatus passage and defecation and relieving gastrointestinal dysfunctional symptoms among patients with colorectal cancer surgery. Our hypotheses are that acupressure could significantly shorten the first time of flatus and defecation and relieve gastrointestinal dysfunctional symptoms in the intervention group compared with sham group. Qualitative Phase The purpose is to explore patients acceptability, perceived benefits and limitations of acupressure in an effort to understand the process of acupressure.  

Objectives of Study：

Quantitative Phase The purpose is to test the effectiveness of acupressure on shortening the first time of flatus passage and defecation and relieving gastrointestinal dysfunctional symptoms among patients with colorectal cancer surgery. Our hypotheses are that acupressure could significantly shorten the first time of flatus and defecation and relieve gastrointestinal dysfunctional symptoms in the intervention group compared with sham group. Qualitative Phase The purpose is to explore patients acceptability, perceived benefits and limitations of acupressure in an effort to understand the process of acupressure.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. patients are unable to communicate due to language barrier or severe cognitive impairment;
2. patients with skin infections or defects in lower limbs which will hinder the accuracy of locating ST36 or get infection worse;
3. patients are scheduled to have more than one surgery during this hospitalization;
4. patients with coagulation disorders or peripheral vascular disease or having signs of compromised circulation in lower limbs.

Exclusion criteria：

1. patients are unable to communicate due to language barrier or severe cognitive impairment;
2. patients with skin infections or defects in lower limbs which will hinder the accuracy of locating ST36 or get infection worse;
3. patients are scheduled to have more than one surgery during this hospitalization;
4. patients with coagulation disorders or peripheral vascular disease or having signs of compromised circulation in lower limbs.

研究实施时间：

Study execute time：

从 From 2017-10-09 00:00:00至 To 2018-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-10-09 00:00:00 至 To 2018-05-31 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 39

Group：

Experimental group

Sample size：

干预措施：

acupressure

干预措施代码：

Intervention：

acupressure

Intervention code：

组别：

Control group

样本量：

 39

Group：

Control group

Sample size：

干预措施：

sham acupressure

干预措施代码：

Intervention：

sham acupressure

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 山東 

市(区县)：

 濟南 

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

 山東大學齊魯醫院 

单位级别：

 三甲医院 

Institution
hospital：

Qilu Hospital of Shandong University

Level of the institution：

Tertiary A hospital

测量指标：

Outcomes：

指标中文名：

the first passage of flatus and defecation

指标类型：

主要指标

Outcome：

the first passage of flatus and defecation

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：

组织：

Sample Name：

none

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 岁 years
最大 Max age 100 岁 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）：

A sequence of block randomized number with block size at 8 will be generated by computer.

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

A sequence of block randomized number with block size at 8 will be generated by computer.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

The patients, outcome assessors, and all other medical staffs will be unaware of allocation condition.

Blinding：

The patients, outcome assessors, and all other medical staffs will be unaware of allocation condition.

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）：

Through published paper and dissertation

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

Through published paper and dissertation

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：

The collected data will remain strictly confidential and be used only for this study. Any personal information of participants will not appear in the research report. After the end of the study, all the information will be destroyed.

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

The collected data will remain strictly confidential and be used only for this study. Any personal information of participants will not appear in the research report. After the end of the study, all the information will be destroyed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-08-24 17:06:34
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