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加速康复外科改善慢性鼻-鼻窦炎围手术期应激的随机对照研究
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注册号:

Registration number:

ChiCTR1800015791 

最近更新日期:

Date of Last Refreshed on:

2018-04-20 

注册时间:

Date of Registration:

2018-04-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

加速康复外科改善慢性鼻-鼻窦炎围手术期应激的随机对照研究 

Public title:

A randomized pilot stduy of Enhanced Recovery After Surgery for attenuating stress in perioperative period of Chronic Rhinosinusitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

加速康复外科改善慢性鼻-鼻窦炎围手术期应激的随机对照研究 

Scientific title:

A randomized pilot stduy of Enhanced Recovery After Surgery for attenuating stress in perioperative period of Chronic Rhinosinusitis 

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:

吴喜福 

研究负责人:

吴喜福 

Applicant:

Xifu Wu 

Study leader:

Xifu Wu 

申请注册联系人电话:

Applicant telephone:

+86 13760689049 

研究负责人电话:

Study leader's telephone:

+86 13760689049 

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:

wuxifuent@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wuxifuent@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:

广东省广州市天河路600号 

研究负责人通讯地址:

广东省广州市天河路600号 

Applicant address:

600 Tianhe Road, Guangzhou, Guangdong, China 

Study leader's address:

600 Tianhe Road, Guangzhou, Guangdong, 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:

中山大学附属第三医院 

Applicant's institution:

Third Affiliated Hospital of Sun Yat-sen University 

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:

2018-02-011-01 

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:

中山大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of Third Affiliated Hospital of Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-15 

伦理委员会联系人:

黄桂珍 

Contact Name of the ethic committee:

Guizhen Huang 

伦理委员会联系地址:

广东省广州市天河路600号 

Contact Address of the ethic committee:

600 Tianhe Road, Guangzhou, Guangdong, 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:

中山大学附属第三医院 

Primary sponsor:

Third Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市天河路600号 

Primary sponsor's address:

600 Tianhe Road, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第三医院

具体地址:

广东省广州市天河路600号

Institution
hospital:

Third Affiliated Hospital of Sun Yat-sen University

Address:

600 Tianhe Road, Guangzhou, Guangdong, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

慢性鼻-鼻窦炎 

Target disease:

Chronic Rhinosinusitis 

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:

优化慢性鼻-鼻窦炎围手术期治疗方案、改善患者围手术期应激,加速患者康复。 

Objectives of Study:

To optimize the perioperative treatment of chronic rhinosinusitis, improve patients' perioperative stress, and accelerate the recovery of patients. 

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:

①理解和配合实施方案;②患有无严重慢性疾病如高血压、肺结核、心脏病和精神心理障碍等;③术前检查无手术禁忌的患者;④年龄18~60岁。 

Inclusion criteria

1. The patients agreed to cooperate with the ERAS treatment or traditional treatment; 2. The patients had no severe chronic diseases such as hypertension, tuberculosis, heart disease and psychological disorder; 3. The preoperative examination had shown no surgical contraindication; 4. Aged 18 and 60 years. 

排除标准:

①无法理解和配合实施方案;②患有严重慢性疾病如高血压、肺结核、心脏病和精神心理障碍等;③年龄<18岁或>60岁。 

Exclusion criteria:

1. The patients couldn't understand the ERAS or traditional protocols and couldn't cooperate with related treatments; 2. The patients had severe chronic diseases such as hypertension, tuberculosis, heart disease and psychological disorder. 

研究实施时间:

Study execute time:

From2018-05-01To 2020-04-30 

干预措施:

Interventions:

组别:

ERAS组

样本量:

100

Group:

ERAS group

Sample size:

干预措施:

ERAS治疗

干预措施代码:

Intervention:

ERAS treatment

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

traditional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第三医院 

单位级别:

三甲医院 

Institution
hospital:

Third Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

炎症因子

指标类型:

主要指标 

Outcome:

inflammatory factors

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

pain score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量问卷

指标类型:

主要指标 

Outcome:

questionnaires of quality-of-life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间和住院费用

指标类型:

主要指标 

Outcome:

hospitalization stay and hospitalization expenses

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

次要指标 

Outcome:

postoperative complications

Type:

Secondary 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:

血液

组织:

Sample Name:

Blood

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

随机数字表法

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

试验完成后6个月内公开/ 中国临床试验注册中心

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

Within six months after the trial complete/ Chinese clinical trial registry center

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:

病例记录表和电子采集和管理系统

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

case record form and electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-04-20
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