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术前口服碳水化合物治疗对甲状腺肿瘤患者术后早期恢复质量的影响
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注册号:

Registration number:

ChiCTR1900024731 

最近更新日期:

Date of Last Refreshed on:

2019-07-25 

注册时间:

Date of Registration:

2019-07-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术前口服碳水化合物治疗对甲状腺肿瘤患者术后早期恢复质量的影响 

Public title:

Effects of preoperative oral carbohydrate therapy on the quality of early postoperative recovery in patients with thyroid tumor 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术前口服碳水化合物治疗对甲状腺肿瘤患者术后早期恢复质量的影响 

Scientific title:

Effects of preoperative oral carbohydrate therapy on the quality of early postoperative recovery in patients with thyroid tumor 

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:

王顺 

研究负责人:

林菁艳 

Applicant:

Shun Wang 

Study leader:

Jingyan Lin 

申请注册联系人电话:

Applicant telephone:

+86 18148040132 

研究负责人电话:

Study leader's telephone:

+86 15983771119 

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:

635245417@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

419931094@qq.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:

四川省南充市文化路63号 

研究负责人通讯地址:

四川省南充市文化路63号 

Applicant address:

63 Wenhua Road, Nanchong, Sichuan  

Study leader's address:

63 Wenhua Road, Nanchong, Sichuan 

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:

川北医学院 

Applicant's institution:

North Sichuan Medical College 

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:

2019ER(R)075-01 

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:

川北医学院附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Affiliated Hospital of North Sichuan Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-18 

伦理委员会联系人:

黄洁美 

Contact Name of the ethic committee:

Jiemei Huang 

伦理委员会联系地址:

四川省南充市文化路63号 

Contact Address of the ethic committee:

63 Wenhua Road, Nanchong, Sichuan  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0817-2262124 

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:

川北医学院附属医院 

Primary sponsor:

Affiliated Hospital of North Sichuan Medical College 

研究实施负责(组长)单位地址:

四川省南充市顺庆区涪江路234号 

Primary sponsor's address:

234 Fujiang Road, Shunqing District, Nanchong, Sichuan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

南充

Country:

China

Province:

Sichuan

City:

Nanchong

单位(医院):

川北医学院附属医院

具体地址:

顺庆区涪江路234号

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College

Address:

234 Fujiang Road, Shunqing District

经费或物资来源:

研究生经费 

Source(s) of funding:

Graduate fund 

研究疾病:

甲状腺肿瘤 

Target disease:

Thyroid tumor 

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:

探索性研究/预试验 

Study phase:

研究目的:

探究术前口服碳水化合物治疗对甲状腺肿瘤患者术后早期恢复质量的影响。 

Objectives of Study:

To investigate the effect of preoperative oral carbohydrate therapy on early postoperative recovery quality in patients with thyroid tumor. 

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)18-65岁; (2)18kg/m2

Inclusion criteria

1 Aged 18-65 years; 2 18kg/m2

排除标准:

(1)有明显的心脏、肺、肝脏或肾脏疾病史; (2)糖尿病患者; (3)需要清醒气管插管患者; (4)既往脑血管意外和其他神经系统疾病患者; (5)长期服用影响中枢神经系统的药物、慢性苯二氮卓类药物和/或阿片类药物服用的患者; (6)胃肠排空延迟患者; (7)拒绝参加试验的患者。 

Exclusion criteria:

1 Obvious history of heart, lung, liver or kidney diseases; 2 Diabetes patients; 3 Patients who need to be awake after endotracheal intubation; 4 Patients with previous cerebrovascular accidents and other neurological diseases; 5 Patients taking drugs affecting the central nervous system, chronic benzodiazepines and/or opioids for a long period of time; 6 Patients with delayed gastrointestinal emptying; 7 Patients who refused to participate in the study. 

研究实施时间:

Study execute time:

From2019-07-18To 2020-07-18 

征募观察对象时间:

Recruiting time:

From2019-07-20To 2020-07-10 

干预措施:

Interventions:

组别:

A组

样本量:

30

Group:

A Group

Sample size:

干预措施:

术前口服300ml碳水化合物

干预措施代码:

Intervention:

Preoperative oral administration of 300ml of carbohydrate

Intervention code:

组别:

B组

样本量:

30

Group:

B Group

Sample size:

干预措施:

术前口服300ml蒸馏水

干预措施代码:

Intervention:

Preoperative oral administration of 300ml distilled water

Intervention code:

组别:

C组

样本量:

30

Group:

C Group

Sample size:

干预措施:

术前一晚禁饮禁食

干预措施代码:

Intervention:

The night before surgery, no food or drinks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

南充 

Country:

China 

Province:

Sichuan 

City:

Nanchong 

单位(医院):

川北医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

QOR-15量表评分

指标类型:

主要指标 

Outcome:

Qor-15 scale 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:

术后并发症

指标类型:

主要指标 

Outcome:

Postoperative complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

围术期血糖变化

指标类型:

主要指标 

Outcome:

Perioperative blood glucose changes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中生命体征

指标类型:

次要指标 

Outcome:

Intraoperative vital signs

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:

组织:

Sample Name:

No sample

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 65 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):

由本研究专业统计人员使用专业软件随机产生。

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

Random Generation by Professional Statisticians Using Professional Software.

盲法:

未说明

Blinding:

Not stated

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

2021年1月通过ResMan共享,http://www.medresman.org

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

IPD will be public accessable via ResMan from January 2021.(http://www.medresman.org)

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:

由指定人员先进行纸质数据采集,采集后由其负责人将数据录入电脑管理以备后期统计分析。

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

The designated personnel shall first collect the paper data, and then the person in charge shall input the data into the computer for later statistical analysis.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-25
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