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分层旋转术:治疗上睑缺损的新方法
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注册号:

Registration number:

ChiCTR1800018990 

最近更新日期:

Date of Last Refreshed on:

2018-10-20 

注册时间:

Date of Registration:

2018-10-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

分层旋转术:治疗上睑缺损的新方法 

Public title:

Lamellar Rotation Surgery: A New Procedure For Repairing Upper Eyelid Defects 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

分层旋转术:治疗上睑缺损的新方法 

Scientific title:

Lamellar Rotation Surgery: A New Procedure For Repairing Upper Eyelid Defects 

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:

李青吉 

研究负责人:

李青吉 

Applicant:

Qingji Li 

Study leader:

Qingji Li 

申请注册联系人电话:

Applicant telephone:

+86 13920518915 

研究负责人电话:

Study leader's telephone:

+86 13920518915 

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:

liqingji@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

liqingji@sina.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:

天津市南开区复康路102号 

研究负责人通讯地址:

天津市南开区复康路102号 

Applicant address:

102 Fukang Road, Nankai District, Tianjin, China 

Study leader's address:

102 Fukang Road, Nankai District, Tianjin, 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:

天津爱尔眼科医院 

Applicant's institution:

Tianjin Aier Eye Hospital 

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:

20131001 

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:

天津爱尔眼科医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Tianjin Aier Eye Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

曹向荣 

Contact Name of the ethic committee:

Xiangrong Cao 

伦理委员会联系地址:

天津爱尔眼科医院 

Contact Address of the ethic committee:

Tianjin Aier Eye Hospital 

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:

天津爱尔眼科医院 

Primary sponsor:

Tianjin Aier Eye Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路102号 

Primary sponsor's address:

102 Fukang Road, Nankai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津爱尔眼科医院

具体地址:

天津市南开区复康路102号

Institution
hospital:

Tianjin Aier Eye Hospital

Address:

102 Fukang Road, Nankai District, Tianjin, China

经费或物资来源:

天津爱尔眼科医院 

Source(s) of funding:

Tianjin Aier Eye Hospital 

研究疾病:

上睑缺损 

Target disease:

Upper eyelid defect 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

研究治疗上睑缺损的一种改进术式的效果 

Objectives of Study:

To report a new technique for repairing full-thickness upper eyelid defects. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

由于肿瘤术后、外伤的原因造成上睑缺损的患者 

Inclusion criteria

The patients with upper eyelid full-thickness defects who caused by tumour excision or trauma 

排除标准:

严重的全身疾病 

Exclusion criteria:

Severe systemic disease 

研究实施时间:

Study execute time:

From2013-10-01To  

干预措施:

Interventions:

组别:

Cases

样本量:

3

Group:

Cases

Sample size:

干预措施:

手术治疗

干预措施代码:

Intervention:

Surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津爱尔眼科医院 

单位级别:

专科一级 

Institution
hospital:

Tianjin Aier Eye Hospital  

Level of the institution:

Specialized one 

测量指标:

Outcomes:

指标中文名:

外观和功能

指标类型:

主要指标 

Outcome:

Appearance & function

Type:

Primary 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

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

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

No

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):

发表论文

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

publish an article

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

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

Case Record

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-20
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