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检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Dr. Judy Hayek, please contact us for uploading approved file of ethical committee. Minimally Invasive Versus Open Surgery for Women with Stage 1A1 and Stage 1A2 Cervical Cancer: a Medical Records Based Study
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注册号：

Registration number：

 ChiCTR2100050877 

最近更新日期：

Date of Last Refreshed on：

 2022-05-09 10:56:17 

注册时间：

Date of Registration：

 2021-09-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Dr. Judy Hayek, please contact us for uploading approved file of ethical committee. Minimally Invasive Versus Open Surgery for Women with Stage 1A1 and Stage 1A2 Cervical Cancer: a Medical Records Based Study

Public title：

Minimally Invasive Versus Open Surgery for Women with Stage 1A1 and Stage 1A2 Cervical Cancer: a Medical Records Based Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Minimally Invasive Versus Open Surgery for Women with Stage 1A1 and Stage 1A2 Cervical Cancer

Scientific title：

Minimally Invasive Versus Open Surgery for Women with Stage 1A1 and Stage 1A2 Cervical Cancer

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：

Judy Hayek 

研究负责人：

Ioannis Alagkiozidis 

Applicant：

Judy Hayek 

Study leader：

Ioannis Alagkiozidis 

申请注册联系人电话：

Applicant telephone：

 +1 724 989 6447

研究负责人电话：

Study leader's
telephone：

+1 718 226 9210

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：

 j.hayek92@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 alagkiozidis@gmail.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：

52 Cheever Place, Brooklyn, New York, United States of America

研究负责人通讯地址：

52 Cheever Place, Brooklyn, New York, United States of America

Applicant address：

52 Cheever Place, Brooklyn, New York, United States of America

Study leader's address：

52 Cheever Place, Brooklyn, New York, United States of America

申请注册联系人邮政编码：

Applicant postcode：

 11231

研究负责人邮政编码：

Study leader's postcode：

 10305

申请人所在单位：

Northwell Health

Applicant's institution：

Northwell Health

研究负责人所在单位：

Northwell Health

Affiliation of the Leader：

Northwell Health

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：

 20-0556

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：

Human Research Protection Program- Institutional Review Board (IRB)

Name of the ethic committee：

Human Research Protection Program- Institutional Review Board (IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-01-12 00:00:00

伦理委员会联系人：

Khan, Tanzin

Contact Name of the ethic committee：

Khan, Tanzina

伦理委员会联系地址：

125 Community Drive, Great Neck, NY 11201, USA

Contact Address of the ethic committee：

125 Community Drive, Great Neck, NY 11201, USA

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：

Northwell Health

Primary sponsor：

Northwell Health

研究实施负责（组长）单位地址：

52 Cheever Place, Brooklyn, New York, United States of America

Primary sponsor's address：

52 Cheever Place, Brooklyn, New York, United States of America

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

美国

省(直辖市)：

纽约

市(区县)：

布鲁克林

Country：

United States

Province：

New York

City：

Brooklyn

单位(医院)：

Northwell Health

具体地址：

52 Cheever Place, Apt 3

Institution
hospital：

Northwell Health

Address：

52 Cheever Place, Apt 3

经费或物资来源：

Northwell Health

Source(s) of funding：

Northwell Health

研究疾病：

Cervical Cancer  

Target disease：

Cervical Cancer

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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

Primary outcome: Comparing overall survival between patients undergoing minimally invasive (MIS) vs open surgical management, for treatment of cervical cancer stages IA1 and IA2 Secondary outcome: Comparing hospital stay after surgery, readmission and 90-day mortality for patients with cervical cancer stages IA1 and IA2 undergoing minimally invasive vs open surgical management.  

Objectives of Study：

Primary outcome: Comparing overall survival between patients undergoing minimally invasive (MIS) vs open surgical management, for treatment of cervical cancer stages IA1 and IA2 Secondary outcome: Comparing hospital stay after surgery, readmission and 90-day mortality for patients with cervical cancer stages IA1 and IA2 undergoing minimally invasive vs open surgical management.

药物成份或治疗方案详述：

Patient data was obtained from the National Cancer Database. Analysis included the Cox regression model to assess for non-inferiority of minimally invasive surgery compared to open surgery in treatment of cervical cancer stages IA1 and IA2. Multivariate analyses was used to study readmission rate and length of stay after surgery. We controlled for possible confounding effect of age, race, histology type and pathology factors. SPSS will be used for all analyses. 

Description for medicine or protocol of treatment in detail：

Patient data was obtained from the National Cancer Database. Analysis included the Cox regression model to assess for non-inferiority of minimally invasive surgery compared to open surgery in treatment of cervical cancer stages IA1 and IA2. Multivariate analyses was used to study readmission rate and length of stay after surgery. We controlled for possible confounding effect of age, race, histology type and pathology factors. SPSS will be used for all analyses. 

纳入标准：

Inclusion criteria

排除标准：

Patients who did not undergo surgery as primary treatment modality.

Exclusion criteria：

Patients who did not undergo surgery as primary treatment modality.

研究实施时间：

Study execute time：

从 From 2010-09-01 00:00:00至 To 2016-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2010-01-01 00:00:00 至 To 2016-12-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 6230

Group：

Case series

Sample size：

干预措施：

No

干预措施代码：

Intervention：

No

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 美国

省(直辖市)：

 纽约 

市(区县)：

 布鲁克林 

Country：

United States

Province：

New York

City：

Brooklyn

单位(医院)：

 Northwell Health at Staten Island University Hospital 

单位级别：

 三级医院 

Institution
hospital：

Northwell Health at Staten Island University Hospital

Level of the institution：

Tertiary care center

测量指标：

Outcomes：

指标中文名：

overall survival

指标类型：

主要指标

Outcome：

overall survival

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：

No

组织：

Sample Name：

No

Tissue：

none taken

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

No samples taken

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 18 岁 years
最大 Max age 100 岁 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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

否No

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）：

https://www.facs.org/quality-programs/cancer/ncdb

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

https://www.facs.org/quality-programs/cancer/ncdb

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：

Provided by the National Cancer Database PUF application

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

Provided by the National Cancer Database PUF application

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-09-05 22:21:34
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