ChiCTR-IIC-17012635 版本V1.1 版本创建时间2018/09/23 00:19:31 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR-IIC-17012635 

最近更新日期：

Date of Last Refreshed on：

2017-09-10 16:20:18 

注册时间：

Date of Registration：

2017-09-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

術後早期恢復方案在腹腔鏡肥胖症手術患者中的可行性和安全性

Public title：

Feasibility and Safety of Early Recovery After Surgery (ERAS) Protocol in Patient Undergoing Laparoscopic Bariatric Surgeries

注册题目简写：

English Acronym：

Early recovery after surgery for obesity

研究课题的正式科学名称：

術後早期恢復方案在腹腔鏡肥胖症手術患者中的可行性和安全性

Scientific title：

Feasibility and Safety of Early Recovery After Surgery (ERAS) Protocol in Patient Undergoing Laparoscopic Bariatric Surgeries

研究课题代号(代码)：

Study subject ID：

 2017.318

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：

CUHK_CCRB00566

申请注册联系人：

Mr Freddie Chiu 

研究负责人：

Cindy Tsui 

Applicant：

Mr Freddie Chiu 

Study leader：

Cindy Tsui 

申请注册联系人电话：

Applicant telephone：

+852 35052735

研究负责人电话：

Study leader's telephone：

+852 35052735

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：

freddie@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

cindytsui@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/464

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/464

申请注册联系人通讯地址：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究负责人通讯地址：

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

Applicant address：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Study leader's address：

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2017.318

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2017-07-07 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：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Primary sponsor：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Primary sponsor's address：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

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)：

Department of Surgery, The Chinese University of Hong Kong

具体地址：

Department of Surgery, The Chinese University of Hong Kong

Institution
hospital：

Department of Surgery, The Chinese University of Hong Kong

Address：

Department of Surgery, The Chinese University of Hong Kong

经费或物资来源：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Source(s) of funding：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Target disease：

early recovery bariatric surgery obesity

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

術後早期恢復方案在腹腔鏡肥胖症手術患者中的可行性和安全性  

Objectives of Study：

Feasibility and Safety of Early Recovery After Surgery (ERAS) Protocol in Patient Undergoing Laparoscopic Bariatric Surgeries

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Adults undergoing laparoscopic bariatric surgery including sleeve gastrectomy, gastric banding, gastric plication and gastric bypass (Roux-en Y gastric bypass (RYGB) or duodeno-jejunal bypass (DJB)).

Inclusion criteria

Adults undergoing laparoscopic bariatric surgery including sleeve gastrectomy, gastric banding, gastric plication and gastric bypass (Roux-en Y gastric bypass (RYGB) or duodeno-jejunal bypass (DJB)).

排除标准：

less than 18 years of age;
history of drug abuse, opioid dependence or chronic pain.

Exclusion criteria：

less than 18 years of age;
history of drug abuse, opioid dependence or chronic pain.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2017-09-14 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Case series

样本量：

60

Group：

Case series

Sample size：

干预措施：

Not Applicable

干预措施代码：

Intervention：

Not Applicable

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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)：

Department of Surgery, The Chinese University of Hong Kong 

单位级别：

大學 

Institution
hospital：

Department of Surgery, The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

feasibility of bariatric ERAS program

指标类型：

主要指标

Outcome：

feasibility of bariatric ERAS program

Type：

Primary indicator

测量时间点：

测量方法：

The overall compliance rate and compliance rate for each ERAS element will be recorded.

Measure time point of outcome：

Measure method：

The overall compliance rate and compliance rate for each ERAS element will be recorded.

指标中文名：

length of hospital stay and time to discharge from post anaesthesia care unit; postoperative hypoxic event, emetic event and pain control.

指标类型：

次要指标

Outcome：

length of hospital stay and time to discharge from post anaesthesia care unit; postoperative hypoxic event, emetic event and pain control.

Type：

Secondary indicator

测量时间点：

测量方法：

For parameters concerning patient's recovery, time to tolerate first food and water, time for mobilization will be measured from patient’s medical records.

Measure time point of outcome：

Measure method：

For parameters concerning patient's recovery, time to tolerate first food and water, time for mobilization will be measured from patient’s medical records.

采集人体标本：

Collecting sample(s)
from participants：

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 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）：

N/A

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

N/A

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：

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

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-09-10 16:19:55