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A new surgical method of U-shaped myometrial excavation and modified suture approach with uterus preservation for diffuse adenomyosis
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注册号:

Registration number:

ChiCTR1800016740 

最近更新日期:

Date of Last Refreshed on:

2018-06-21 

注册时间:

Date of Registration:

2018-06-21 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

保子宫U形子宫腺肌病病灶挖除术及改良缝合法治疗弥漫性子宫腺肌病 

Public title:

A new surgical method of U-shaped myometrial excavation and modified suture approach with uterus preservation for diffuse adenomyosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

保子宫U形子宫腺肌病病灶挖除术及改良缝合法治疗弥漫性子宫腺肌病的临床观察研究 

Scientific title:

A new surgical method of U-shaped myometrial excavation and modified suture approach with uterus preservation for diffuse adenomyosis 

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:

赵银凯 

研究负责人:

王斌 

Applicant:

Zhao Yinkai 

Study leader:

Wang Bin 

申请注册联系人电话:

Applicant telephone:

+86 15838176861 

研究负责人电话:

Study leader's telephone:

+86 13838345982 

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:

718675624@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zzwangbin2008@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:

河南省郑州市二七区康复前街7号 

研究负责人通讯地址:

河南省郑州市中原区陇海西路180号 

Applicant address:

7 Kangfu Qian Street, Erqi District, Zhengzhou, He'nan, China 

Study leader's address:

180 Longhai Road West, Zhongyuan District, Zhengzhou, He'nan, 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:

郑州大学第三附属医院 

Applicant's institution:

The Third Affiliated Hospital of Zhengzhou University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

郑州华山医院 

Primary sponsor:

Zhengzhou Huashan Hospital 

研究实施负责(组长)单位地址:

河南省郑州市中原区陇海西路180号 

Primary sponsor's address:

180 Longhai Road West, Zhongyuan District, Zhengzhou, He'nan, 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):

河南省

市(区县):

郑州市

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

郑州华山医院

具体地址:

河南省郑州市中原区陇海西路180号

Institution
hospital:

Zhengzhou Huashan Hospital

Address:

180 Longhai Road West, Zhongyuan District, Zhengzhou, He'nan, China

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

郑州大学第三附属医院

具体地址:

河南省郑州市二七区康复前街7号

Institution
hospital:

The Third Affiliated Hospital of Zhengzhou University

Address:

7 Kangfu Road, Erqi District, Zhengzhou, He'nan

经费或物资来源:

郑州华山医院内部科研经费 

Source(s) of funding:

Internal research funds of Zhengzhou Huashan Hoapital 

研究疾病:

弥漫性子宫腺肌病 

Target disease:

diffuse adenomyosis 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

保子宫U形子宫腺肌病病灶挖除术及改良缝合法治疗弥漫性子宫腺肌病的有效性、安全性及可行性研究。 

Objectives of Study:

To evaluate the feasibility, safety, and efficacy of a new surgical method of U-shaped myometrial excavation and modified suture approach with uterus preservation for diffuse adenomyosis. 

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)痛经伴进行性月经过多;(2) 弥漫性腺肌病术前阴道超声b和MRI初步诊断;(3) 要求保留子宫或生育要求;(4) 对包括口服避孕药和GnRHa治疗在内的药物反应不足;(5) 左旋诺孕酮有效或无效;(6) 不能自行或在辅助生殖技术之后生育;(7) 强烈要求进行u形手术,无禁忌症保留子宫;(8) 签署知情同意书。 

Inclusion criteria

1. dysmenorrhea with progressive menorrhagia; 2. diffuse adenomyosis preoperatively preliminary diagnosed by vaginal ultrasound B and MRI; 3. request to keep uterus or having fertility requirements; 4. insufficient response to drugs including oral contraceptives and GnRHa treatment; 5. effective or not effective case by levonorgestrel (Mirena) treatment; 6. inability to give birth by themselves or after assisted reproductive technology; 7. strong requirement to conduct the U-shaped surgery to preserve the uterus without contraindications; and 8. signing the informed consent form. 

排除标准:

严重贫血不适合手术者。 

Exclusion criteria:

Unsuitable for surgery because of severe anemia. 

研究实施时间:

Study execute time:

From2012-01-01To 2016-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

198

Group:

Case series

Sample size:

干预措施:

保子宫U形子宫腺肌病病灶挖除术及改良缝合法

干预措施代码:

Intervention:

U-shaped myometrial excavation and modified suture approach with uterus preservation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

郑州华山医院 

单位级别:

私立医院 

Institution
hospital:

Zhengzhou Huashan Hospital  

Level of the institution:

Proprietary Hospital 

测量指标:

Outcomes:

指标中文名:

子宫体积

指标类型:

主要指标 

Outcome:

Uterine size

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛VAS评分

指标类型:

主要指标 

Outcome:

VAS

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CA 125

指标类型:

主要指标 

Outcome:

Serum CA125

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

月经量

指标类型:

主要指标 

Outcome:

Menorrhagia

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:

部分子宫腺肌病病灶

组织:

子宫

Sample Name:

Part of Adenomyosis lesion of uterus

Tissue:

uterus

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

N/A

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

N/A

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

2019.01.01

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

2019.01.01

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 Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-06-21
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