今天是:2019-08-22 星期四

儿童嵌顿性腹股沟疝对睾丸发育的影响
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注册号:

Registration number:

ChiCTR1900024600 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

儿童嵌顿性腹股沟疝对睾丸发育的影响 

Public title:

Effect of incarcerated inguinal hernia on testicular development in children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

预判嵌顿疝患儿存在严重睾丸缺血损伤的公式的建立和初步验证 

Scientific title:

Establish and Preliminary Verification of a Formula for Predicting Severe Testicular Ischemic Injury in Children with Incarcerated Hernia 

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:

夏冰山 

研究负责人:

张德迎 

Applicant:

Bingshan Xia 

Study leader:

Deying Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15320477479 

研究负责人电话:

Study leader's telephone:

+86 13594136249 

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:

1390882335@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

dzdy199@126.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:

中国重庆市渝中区中山二路136号重庆医科大学附属儿童医院泌尿外科 

研究负责人通讯地址:

中国重庆市渝中区中山二路136号重庆医科大学附属儿童医院泌尿外科 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400014 

研究负责人邮政编码:

Study leader's postcode:

400014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing 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)年伦审(研)第(89)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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institutional Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-08 

伦理委员会联系人:

卢仲毅 

Contact Name of the ethic committee:

Zhongyi Lu 

伦理委员会联系地址:

重庆市渝中区中山二路136号重庆医科大学附属儿童医院 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023-63664659 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号重庆医科大学附属儿童医院 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

Yuzhong

单位(医院):

重庆医科大学附属儿童医院

具体地址:

中国重庆市渝中区中山二路136号重庆医科大学附属儿童医院

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

嵌顿性腹股沟疝 

Target disease:

Incarcerated Inguinal Hernia 

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:

其它 

Study phase:

N/A 

研究目的:

继发于嵌顿性腹股沟疝的睾丸缺血性损伤是需要急诊处理的儿科急症。一些病例中严重的睾丸缺血性损伤没有被及时诊断,延误了治疗。本项研究中,我们的目的是建立预判嵌顿疝患儿存在严重睾丸缺血损伤的公式并进行初步验证。 

Objectives of Study:

Testicular ischemia injury, caused by incarcerated inguinal hernia is a surgical emergency in the pediatric population, requiring prompt intervention. Some severe testicular ischemia injuries are not detected promptly, and treatment has been delayed. In this study, a formula for predicting severe testicular ischemia injury in children with incarcerated inguinal hernia will be created. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 曾经患有单侧嵌顿疝并在我院行疝囊高位结扎和同侧睾丸探查手术的患儿; 2. 签署知情同意书。  

Inclusion criteria

1. Patients with unilateral IIH undergoing ipsilateral testicular exploration in the Children's Hospital of Chongqing Medical University; 2. Agree to sign the consent form.  

排除标准:

1. 合并患有隐睾、双侧腹股沟疝、鞘膜积液、精索静脉曲张、感染、睾丸扭转; 2. 由于其他疾病、或全身状况很差,预期生存时间不超过1年; 3. 患儿父母拒绝随访。 

Exclusion criteria:

1. Patients had cryptorchidism,bilateral hernias,hydrocele,varicocele,concurrent infection,concurrent testicular torsion; 2. Patients with other diseases or poor general condition who are expected to survive less than 1 year; 3. Patients whose parents refused follow-up.  

研究实施时间:

Study execute time:

From2019-07-18To 2019-09-30 

干预措施:

Interventions:

组别:

病例组

样本量:

591

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children’s Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

腹股沟疝嵌顿时间

指标类型:

主要指标 

Outcome:

The time between incarceration occurring occurrence and surgical removal

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠管和睾丸损伤程度(术中发现)

指标类型:

主要指标 

Outcome:

Ddegree of intestinal injury and testicular injury discovered during surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前睾丸血供(通过超声检查)

指标类型:

主要指标 

Outcome:

The blood supply of the affected testicles indicated by preoperative CDS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标 

Outcome:

Age

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往嵌顿疝手法复位次数

指标类型:

次要指标 

Outcome:

Previous manual reduction times

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:

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 0.1 years
最大 Max age 10 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

本研究为观察性研究,不涉及随机方法

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):

文章发表

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

Article publication

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

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-18
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