今天是:2019-12-13 星期五

妇科腹腔镜手术后不同类型的疼痛的发病率和危险因素的分析
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注册号:

Registration number:

ChiCTR1900024568 

最近更新日期:

Date of Last Refreshed on:

2019-07-17 

注册时间:

Date of Registration:

2019-07-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

妇科腹腔镜手术后不同类型的疼痛的发病率和危险因素的分析 

Public title:

Incidence and risk factors of different types of pain after gynecological laparoscopic surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

妇科腹腔镜手术后不同类型的疼痛的发病率和危险因素的分析 

Scientific title:

Incidence and risk factors of different types of pain after gynecological laparoscopic surgery 

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:

黄陆平 

研究负责人:

黄陆平 

Applicant:

Luping Huang 

Study leader:

Luping Huang 

申请注册联系人电话:

Applicant telephone:

+86 13587891399 

研究负责人电话:

Study leader's telephone:

+86 13587891399 

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:

308893839@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

308893839@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:

浙江省温州市瓯海区南白象上蔡村 

研究负责人通讯地址:

浙江省温州市瓯海区南白象上蔡村 

Applicant address:

Shangcai Village, South Baixiang, Ouhai District, Wenzhou, Zhejiang, China 

Study leader's address:

Shangcai Village, South Baixiang, Ouhai District, Wenzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

325000 

研究负责人邮政编码:

Study leader's postcode:

325000 

申请人所在单位:

温州医科大学附属第一医院麻醉科 

Applicant's institution:

Department of Anesthesia, The First Affliated Hospital of Wenzhou Medical 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:

2019-030 

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:

温州医科大学附属第一医院临床研究专业伦理委员会  

Name of the ethic committee:

Ethics Committee of clinical research in the First Affiliated Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-10 

伦理委员会联系人:

金嵘 

Contact Name of the ethic committee:

Rong Jin 

伦理委员会联系地址:

浙江省温州市温州医科大学第一附属医院 

Contact Address of the ethic committee:

The First Affliated Hospital of Wenzhou Medical University 

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:

wyyyll01@163.com 

研究实施负责(组长)单位:

浙江省温州市温州医科大学第一附属医院麻醉科  

Primary sponsor:

Department of Anesthesia, The First Affliated Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市瓯海区南白象上蔡村 

Primary sponsor's address:

Shangcai Village, South Baixiang, Ouhai District, Wenzhou, Zhejiang, 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):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第一医院

具体地址:

瓯海区南白象上蔡村

Institution
hospital:

the First Affiliated Hospital of Wenzhou Medical University

Address:

Shangcai Village, South Baixiang, Ouhai District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

子宫平滑肌瘤,宫颈上皮内瘤变,子宫腺肌症等 

Target disease:

Leiomyoma of uterus, cervical intraepithelial neoplasia, adenomyosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

分析妇科腹腔镜术后不同类型的疼痛的发病率和相关危险因素,建立不同类型的术后疼痛的预测模型。 

Objectives of Study:

To analyze the incidence and related risk factors of different types of pain after gynecological laparoscopic surgery, and to establish different types of pain prediction models. 

药物成份或治疗方案详述:

术前:年龄、职业、文化水平、体重指数、术前焦虑、术前有无疼痛(月经痛、手术部位疼痛、手术部位外的疼痛)、有无使用镇痛药物、婚育史(未婚、顺产、剖宫产、流产次数)、吸烟饮酒史、体育锻炼、慢性病史、术后疼痛的期望值、子宫大小、体温、血压。术中:手术时间、麻醉时间、trocar内径和孔数、引流管数(根)、术中镇痛药量、有无腹腔粘连。术后:导尿管留置的时间、引流管留置的时间、引流量、PACU追加镇痛药时间和量、病房追加镇痛药的量和时间.  

Description for medicine or protocol of treatment in detail:

Preoperative: age, occupation, education level, body mass index, preoperative anxiety, preoperative pain (pain, menstrual pain, surgery surgical site outside the pain), without the use of analgesic drugs, obstetrical history (unmarried, birth, cesarean section, abortion), smoking and drinking history, physical exercise and the history of chronic disease, postoperative pain expectation, uterine size, body temperature, blood pressure. Operation: operation time, anesthesia time, trocar diameter and hole number, the number of drainage tube (root), intraoperative analgesia, no abdominal adhesion. The time of indwelling catheter, the time of indwelling catheter, the volume of drainage, the time and amount added analgesics in PACU the amount and time of additional analgesics in the ward were recorded.  

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

全身麻醉下择期行妇科腹腔镜手术患者,签署知情同意书。 

Inclusion criteria

Patients undergoing elective gynecological laparoscopic surgery with general anesthesia signed informed consent. 

排除标准:

精神方面的问题,合作困难,严重的肝肾功能障碍,术中中转开腹手术, 

Exclusion criteria:

mental problems, cooperation difficult, serious liver and kidney dysfunction, intraoperative anesthesia and laparotomy, 

研究实施时间:

Study execute time:

From2019-07-17To 2023-07-17 

干预措施:

Interventions:

组别:

4

样本量:

1000

Group:

four

Sample size:

干预措施:

no

干预措施代码:

no

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

wenzhou 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

术后疼痛

指标类型:

主要指标 

Outcome:

postoperative pain

Type:

Primary indicator 

测量时间点:

术后1年内

测量方法:

疼痛数字评分法

Measure time point of outcome:

one year after operation

Measure method:

NRS

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

血管

Sample Name:

blood

Tissue:

vein

人体标本去向

使用后销毁 

说明

半年

Fate of sample:

Destruction after use 

Note:

half an year

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 80 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机

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

Non-randomized

盲法:

N/A

Blinding:

N/A

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):

2023.6在临床试验公共管理平台ResMan上公布

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

the data will be published in the public management platform of clinical trials ResMan in June 2019

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:

原始记录保存在医院的HIS系统,CRF采用纸质版本保存在医院档案室.

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

The original records are kept in the hospital's HIS system, and CRF is kept in the hospital Archives room.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-17
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