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前庭大腺囊肿引流装置的研发和应用
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注册号:

Registration number:

ChiCTR1900027995 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

前庭大腺囊肿引流装置的研发和应用 

Public title:

Development and application of drainage device for large vestibular gland cyst  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

前庭大腺囊肿引流装置的研发和应用 

Scientific title:

Development and application of drainage device for large vestibular gland cyst  

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:

杨晓敏 

研究负责人:

杨晓敏 

Applicant:

Xiaomin Yang 

Study leader:

Xiaomin Yang 

申请注册联系人电话:

Applicant telephone:

+86 13511328099 

研究负责人电话:

Study leader's telephone:

+86 13511328099 

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:

13511328099@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13511328099@163.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:

浙江嘉兴中环南路1882号5号楼10A 

研究负责人通讯地址:

浙江嘉兴中环南路1882号5号楼10A 

Applicant address:

1882 South Zhonghuan Road, Jiaxing, Zhejiang, China 

Study leader's address:

1882 South Zhonghuan Road, Jiaxing, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

314001 

研究负责人邮政编码:

Study leader's postcode:

314001 

申请人所在单位:

嘉兴市第一医院 

Applicant's institution:

Jiaxing First 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:

LS2019-275 

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:

嘉兴市第一医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Jiaxing First Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-29 

伦理委员会联系人:

浦以凤 

Contact Name of the ethic committee:

Yifeng Pu 

伦理委员会联系地址:

浙江嘉兴中环南路1882号3号楼3楼 

Contact Address of the ethic committee:

Floor 3, Third Building, 1882 South Zhonghuan Road, Jiaxing, Zhejiang, 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:

嘉兴市第一医院 

Primary sponsor:

Jiaxing First Hospital  

研究实施负责(组长)单位地址:

浙江嘉兴中环南路1882号 

Primary sponsor's address:

1882 South Zhonghuan Road, Jiaxing, 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):

嘉兴

Country:

China

Province:

Zhejiang

City:

Jiaxing

单位(医院):

嘉兴市第一医院

具体地址:

浙江嘉兴中环南路1882号

Institution
hospital:

Jiaxing First Hospital

Address:

1882 South Zhonghuan Road

经费或物资来源:

单位自筹 

Source(s) of funding:

self financing 

研究疾病:

前庭大腺囊肿 

Target disease:

Cyst of vestibular gland  

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:

设计并完善前庭大腺引流装置,申请专利。 使用完善后的前庭大腺引流装置完成至少20例病例,收集使用过程中的各种数据,完成病例随访,总结经验,完善产品,并撰写论文。 发表论文1篇,专利1项。 

Objectives of Study:

Design and perfect the drainage device of vestibular gland, apply for patent. At least 20 cases were completed by using the perfect drainage device of vestibular gland. All kinds of data were collected during the use process, case follow-up was completed, experience was summarized, products were improved, and papers were written. Published 1 paper and 1 patent.  

药物成份或治疗方案详述:

1.试验组:选取门诊前庭大腺囊肿患者,随机分组,入组患者签署知情同意书后,予门诊放置前庭大腺引流器,宣教护理方法,3天后拆除装置,评价疗效。并于术后1周、1月,3月,1年共随访4次。随访方式包括:电话随访和面诊。 2.对照组:门诊前庭大腺囊肿患者,随机分组,入对照组者,按常规收住院手术治疗。行前庭大腺造口术,术后引流纱条填塞3天,后于术后1周、1月,3月,1年共随访4次。随访方式包括:电话随访和面诊。 3.临床对比研究:通过本项目根据试验组和对照组数据,对比观察手术时间、住院天数、并发症等情况,统计分析判断前庭大腺引流装置的有效性和便捷性。 

Description for medicine or protocol of treatment in detail:

1. Experimental group: Patients with large vestibular gland cyst in outpatient department were randomly divided into two groups. After signing the informed consent, the patients in the group were placed with large vestibular gland drainage device in outpatient department, and the methods of education and nursing were used. After 3 days, the device was removed to evaluate the efficacy. The patients were followed up 4 times in one week, one month, three months and one year. Follow up methods include: telephone follow-up and face-to-face consultation; 2. Control group: outpatients with large vestibular gland cyst were randomly divided into two groups, and those in the control group were treated by routine surgery. The patients were followed up for 4 times in 1 week, 1 month, 3 months and 1 year. Follow up methods include: telephone follow-up and face-to-face consultation; 3. Clinical comparative study: according to the data of the experimental group and the control group, the operation time, hospital stay and complications were observed, and the effectiveness and convenience of the vestibular gland drainage device were statistically analyzed. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

育龄期女性,初发或复发的前庭大腺囊肿患者,囊肿大于2cm,伴有行走异物感、疼痛、逐渐增大等症状,愿意接受并签署治疗同意书。 

Inclusion criteria

Women of childbearing age, the first or recurrent patients with large vestibular gland cyst, the cyst is more than 2cm, accompanied by walking foreign body feeling, pain, gradually increasing and other symptoms, are willing to accept and sign the treatment consent 

排除标准:

①儿童及绝经患者; ②合并其他基础疾病; ③未经性生活者; ④不愿接受本治疗方法或有精神经疾患者; ⑤血液系统疾病。 

Exclusion criteria:

1. children and menopausal patients; 2. combined with other basic diseases; 3. without sexual life; 4. patients with mental disorders; 5. blood system diseases.  

研究实施时间:

Study execute time:

From2020-01-01To 2023-11-28 

干预措施:

Interventions:

组别:

1

样本量:

20

Group:

1

Sample size:

干预措施:

前庭大腺引流装置

干预措施代码:

Intervention:

Drainage device of vestibular gland

Intervention code:

组别:

2

样本量:

20

Group:

2

Sample size:

干预措施:

前庭大腺囊肿造口术

干预措施代码:

Intervention:

Cystostomy of vestibular gland

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):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴市第一医院 

单位级别:

三级甲等 

Institution
hospital:

Jiaxing First Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operative time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恢复时间

指标类型:

主要指标 

Outcome:

recovery time

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:

blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 30 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):

No. 患者进入门诊就诊后,根据奇偶数,推荐治疗方法

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

No. After the patient enters the outpatient service, the treatment method is recommended according to odd even number

盲法:

No

Blinding:

No

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):

2022.12.31

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

2022.12.31

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:

数据采集和管理由专门培训的护理人员承担,做纸质和电子就诊档案。

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

Data collection and management shall be undertaken by specially trained nurses, who shall make paper and electronic medical records.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-12-07
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