今天是:2020-08-03 星期一

中国硅胶乳房假体隆乳术效果和安全性评价的前瞻性真实世界研究
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注册号:

Registration number:

ChiCTR2000034574 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国硅胶乳房假体隆乳术效果和安全性评价的前瞻性真实世界研究 

Public title:

Prospective real-world study on the effectiveness and safety evaluation of breast augmentation with silicone implant in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国硅胶乳房假体隆乳术效果和安全性评价的前瞻性真实世界研究 

Scientific title:

Prospective real-world study on the effectiveness and safety evaluation of breast augmentation with silicone implant in China 

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:

沈泽仁 

研究负责人:

徐靖宏 

Applicant:

Shen Zeren 

Study leader:

Xu Jinghong 

申请注册联系人电话:

Applicant telephone:

+86 13732229034 

研究负责人电话:

Study leader's telephone:

+86 13732229034 

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:

zrshen@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

1304017@zju.edu.cn 

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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, China 

Study leader's address:

79 Qingchun Road, Shangcheng District, Hangzhou, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Medical College of Zhejiang 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:

快审第307号 

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:

浙江大学医学院附属第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethic Committee of The First Affiliated Hospital of Medical College of Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-07 

伦理委员会联系人:

厉有名 

Contact Name of the ethic committee:

Li Youming 

伦理委员会联系地址:

浙江省杭州市上城区庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Shangcheng District, Hangzhou, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Medical College of Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Shangcheng District, Hangzhou, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital of Medical College of Zhejiang University

Address:

79 Qingchun Road, Shangcheng District

经费或物资来源:

横向课题经费 

Source(s) of funding:

Horizontal project 

研究疾病:

原发性乳腺发育不良、哺乳后乳房萎缩伴或不伴轻度下垂 

Target disease:

Mammary dyplasia 

研究疾病代码:

 

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 

研究目的:

1. 基于国内真实世界评估不同条件下(乳房假体形状、手术切口入路、假体置入层次)假体隆乳术的效果和安全性;调查国内患者BIA-ALCL的发病风险。 2. 更新国内假体隆乳术指南;制定BIA-ALCL指南。 

Objectives of Study:

1. Based on the domestic real-world, to evaluate the effectiveness and safety of breast augmentation under different conditions (breast implant shape, surgical incision approach, implant placement plane), and to investigate the risk of BIA-ALCL in domestic patients. 2. To update domestic breast augmentation guidelines, and to develop BIA-ALCL guidelines. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

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:

浙江大学医学院附属第一医院整形外科等3个中心收治的原发性乳腺发育不良、哺乳后乳房萎缩伴或不伴轻度下垂要求行假体隆乳术的受试者, 年龄18-60岁,女性, 术后能够配合乳房护理及按摩, 所有受试者均签署知情同意书。 

Inclusion criteria

1. Subjects with primary mammary dysplasia, breast atrophy after lactation with or without mild ptosis who required prosthetic augmentation mammoplasty in three centers including the First Affiliated Hospital of Zhejiang University Medical College; 2. Aged 18-60, female; 3. Patients who can cooperate with breast care and massage after operation; 4. All subjects should sign informed consent. 

排除标准:

(1)存在或既往有其他乳腺疾病患者; (2)既往有自体脂肪隆乳术或假体取出术等乳房整形手术史者; (3)既往行任何乳腺手术者; (4)病史提示有严重心、肺、肝、肾功能障碍者; (5)妊娠及哺乳期妇女。 

Exclusion criteria:

1. Patients with or having other breast diseases in the past; 2. Those who have a history of breast plastic surgery such as breast augmentation with autologous fat or removal of prosthesis; 3. Patients who have undergone any previous breast surgery; 4. Patients with severe heart, lung, liver and kidney dysfunction indicated by medical history; 5. Pregnant and lactating women. 

研究实施时间:

Study execute time:

From2020-07-07To 2030-07-07 

征募观察对象时间:

Recruiting time:

From2020-07-07To 2025-07-07 

干预措施:

Interventions:

组别:

胸大肌后平面组

样本量:

220

Group:

Subpectoral plane group

Sample size:

干预措施:

假体置入胸大肌后平面

干预措施代码:

Intervention:

Subpectoral plane

Intervention code:

组别:

乳腺后平面组

样本量:

220

Group:

Subglandular plane group

Sample size:

干预措施:

假体置入乳腺后平面

干预措施代码:

Intervention:

Subpectoral plane

Intervention code:

组别:

胸肌筋膜后平面组

样本量:

220

Group:

Subfascial plane group

Sample size:

干预措施:

假体置入胸肌筋膜后平面

干预措施代码:

Intervention:

Subfascial plane

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Medical College of Zhejiang University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州整形医院 

单位级别:

三级 

Institution
hospital:

Hangzhou Plastic Surgery Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University of traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

手感(包膜挛缩)

指标类型:

主要指标 

Outcome:

Capsular contracture

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

形态

指标类型:

主要指标 

Outcome:

Breast morphology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受试者满意度

指标类型:

主要指标 

Outcome:

Breast-Q test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肿

指标类型:

次要指标 

Outcome:

hematoma

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清肿

指标类型:

次要指标 

Outcome:

seroma

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感染

指标类型:

次要指标 

Outcome:

infection

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

二次手术

指标类型:

次要指标 

Outcome:

reoperation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳头感觉减退及麻木

指标类型:

次要指标 

Outcome:

nipple numbness

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉收缩显形

指标类型:

次要指标 

Outcome:

muscle movement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

假体显形

指标类型:

次要指标 

Outcome:

implant visualization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

假体移位

指标类型:

次要指标 

Outcome:

implant malplacement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

假体破裂

指标类型:

次要指标 

Outcome:

implant rupture

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

两侧不对称

指标类型:

次要指标 

Outcome:

asymmetry

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳房结节

指标类型:

次要指标 

Outcome:

breast nodules

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳房植入物相关性间变性大细胞淋巴瘤

指标类型:

次要指标 

Outcome:

BIA-ALCL

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:

乳房假体周围积液

组织:

Sample Name:

Effusion

Tissue:

Around breast implant

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 years
最大 Max age 60 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):

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

N/A

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:

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):

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

N/A

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:

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

N/A

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-10
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