今天是:2022-08-12 星期五

膜间隙解剖的妇科恶性肿瘤手术对盆内筋膜及盆底功能的影响研究:一项观察性双向队列研究
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注册号:

Registration number:

ChiCTR2200061877 

最近更新日期:

Date of Last Refreshed on:

2022-07-06 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膜间隙解剖的妇科恶性肿瘤手术对盆内筋膜及盆底功能的影响研究:一项观察性双向队列研究 

Public title:

Effect of gynecologic malignant tumor surgery based on membranous space anatomy on pelvic fascia and pelvic floor function: an observational ambispective cohort study 

注册题目简写:

妇科恶性肿瘤手术对盆内筋膜及盆底功能的影响研究 

English Acronym:

Effect of gynecologic malignant tumor surgeryon pelvic fascia and pelvic floor function 

研究课题的正式科学名称:

基于子宫内膜癌观察研究二水平支持的架构与功能研究 

Scientific title:

The anatomical and functional observation of the level II support structure of vagina in patients undergoing staging surgery for endometrial carcinoma 

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:

赵小峰 

研究负责人:

赵小峰 

Applicant:

Zhao Xiaofeng 

Study leader:

Zhao Xiaofeng 

申请注册联系人电话:

Applicant telephone:

13868020212 

研究负责人电话:

Study leader's telephone:

13868020212 

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:

zhxf@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhxf@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学士路1号 

研究负责人通讯地址:

浙江省杭州市上城区学士路1号 

Applicant address:

Zhejiang University School of Medicine, Xueshi Rd no.1 

Study leader's address:

Zhejiang University School of Medicine, Xueshi Rd no.1 

申请注册联系人邮政编码:

Applicant postcode:

310000 

研究负责人邮政编码:

Study leader's postcode:

310000 

申请人所在单位:

浙江大学医学院附属妇产科医院 

Applicant's institution:

Women's Hospital, School of Medicine, 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:

K2021041 

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:

浙江大学医院附属第四医院伦理委员会 

Name of the ethic committee:

Zhao Xiaofeng 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-04-21 

伦理委员会联系人:

徐键 

Contact Name of the ethic committee:

Xu Jian 

伦理委员会联系地址:

浙江省义乌市商城大道1号 

Contact Address of the ethic committee:

1 Shangcheng Avenue, Yiwu, 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:

浙江大学医学院附属妇产科医院 

Primary sponsor:

Women's Hospital, School of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区学士路1号 

Primary sponsor's address:

1st Xueshi Road, Hangzhou, 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妇产科医院

具体地址:

上城区,学士路1号

Institution
hospital:

Women's Hospital, School of Medicine, Zhejiang University

Address:

1st Xueshi Road, Hangzhou, Zhejiang, China

经费或物资来源:

浙江省基础公益研究项目(项目编号:LGF22H040018) 

Source(s) of funding:

Basic Public Welfare Research Project of Zhejiang Province (Project No.:LGF22H040018) 

研究疾病:

盆腔脏器脱垂 

Target disease:

Pelvic organ prolapse 

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:

观察基于膜间隙解剖的妇科恶性肿瘤手术对盆内筋膜及盆底功能的影响 

Objectives of Study:

观察基于膜间隙解剖的妇科恶性肿瘤手术对盆内筋膜及盆底功能的影响 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

自纳入日起所有在浙江大学医学院附属第四医院因子宫良恶性疾病行基于膜间隙解剖的子宫切除的病人,包括经腹手术与经腹腔镜手术,同时排除标准中设定的病人 

Inclusion criteria

All patients with benign and malignant uterine diseases underwent hysterectomy based on membrane space anatomy in the Fourth Affiliated Hospital of Zhejiang University Medical College, including transabdominal surgery and laparoscopic surgery 

排除标准:

1.有严重或不能控制的内科疾病,不能接受手术者 2.重要脏器移植病史,免疫性疾病史 3.严重精神疾病史,大脑功能失调病史 4.滥用药物或吸毒史 5.患有其他恶性肿瘤 6.同时接受其他药物或手术临床实验者 7.不能或不愿意签署知情同意书者 拒绝本研究术式手术 8.不能或不愿意遵守研究要求者 9.研究人员认为其他原因不适合临床试验者 10.单纯修补后壁者(只做第一层的缺陷位置的特异修补) 11. 严重阴道畸形 12.既往手术或外伤考虑盆腔间隙已经破坏者 13.盆底神经、肌肉功能异常者 

Exclusion criteria:

1. Those who have serious or uncontrollable medical diseases and cannot accept surgery 2. History of important organ transplantation and immune diseases 3. History of severe mental illness and brain dysfunction 4. Drug abuse or drug abuse history 5. Suffering from other malignant tumors 6. Those who have received clinical trials of other drugs or operations at the same time 7. Those who are unable or unwilling to sign informed consent will refuse the operation of this study 8. Unable or unwilling to comply with the research requirements 9. Researchers believe that other reasons are not suitable for clinical trials 10. Simple repair of the rear wall (only special repair of the defect position of the first layer) 11. Severe vaginal malformation 12. Those whose pelvic space has been damaged due to previous operation or trauma 13. Patients with abnormal pelvic floor nerve and muscle function 

研究实施时间:

Study execute time:

From2022-06-25To 2029-01-01 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2029-01-01 

干预措施:

Interventions:

组别:

样本量:

50

Group:

None

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

ZheJiang 

市(区县):

Hangzhou 

Country:

 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

手术前后妇科检查POP-Q评分

指标类型:

主要指标 

Outcome:

POP-Q score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

磁共振测量盆腔器官的位置

指标类型:

次要指标 

Outcome:

Evaluation of pelvic organ location in pelvic magnetic resonance imaging

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:

组织:

Sample Name:

None

Tissue:

None

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

None

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):

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

none

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

待文章发表后,直接与通讯作者联系

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

After the article is published, contact the corresponding author directly

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:

A standard data collection and management system include a CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-07-06
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