ChiCTR2100045102 版本V1.1 版本创建时间2021/11/08 00:53:48 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100045102 

最近更新日期：

Date of Last Refreshed on：

 2021-11-08 00:52:36 

注册时间：

Date of Registration：

 2021-04-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

EFFECTS OF PERIOPERATIVE INFLAMMATORY RESPONSE IN CERVICAL CANCER: LAPAROSCOPIC VERSUS OPEN SURGERY

Public title：

EFFECTS OF PERIOPERATIVE INFLAMMATORY RESPONSE IN CERVICAL CANCER: LAPAROSCOPIC VERSUS OPEN SURGERY

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Postoperative NLR and survival in cervical cancer

Scientific title：

Postoperative NLR and survival in 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：

Ji Hoon Sim 

研究负责人：

Hyun-Seok Cho 

Applicant：

Ji Hoon Sim 

Study leader：

Hyun-Seok Cho 

申请注册联系人电话：

Applicant telephone：

 +82 10 9237-2778

研究负责人电话：

Study leader's
telephone：

+82 2 3010-0807

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：

 atlassjh@hanmail.net

研究负责人电子邮件：

Study leader's E-mail：

 chohs@amc.seoul.kr

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：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

研究负责人通讯地址：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

Applicant address：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

Study leader's address：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

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：

韩国峨山医疗中心Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine

Applicant's institution：

Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine

研究负责人所在单位：

韩国峨山医疗中心Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine

Affiliation of the Leader：

Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine

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：

 2020-1779

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：

the institutional review board (IRB) of the Asan Medical Center

Name of the ethic committee：

the institutional review board (IRB) of the Asan Medical Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-03-24 00:00:00

伦理委员会联系人：

Jong Woo CHUNG

Contact Name of the ethic committee：

Jong Woo CHUNG

伦理委员会联系地址：

Asan Medical Center Institutional Review Board, Convergence Innovation Bldg. 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea

Contact Address of the ethic committee：

Asan Medical Center Institutional Review Board, Convergence Innovation Bldg. 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea

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：

The author's own work

Primary sponsor：

The author's own work

研究实施负责（组长）单位地址：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

Primary sponsor's address：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

韩国

省(直辖市)：

首尔

市(区县)：

Country：

Korea

Province：

Seoul

City：

单位(医院)：

峨山医疗中心

具体地址：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

Institution
hospital：

Asan medical center

Address：

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

经费或物资来源：

The author's own work

Source(s) of funding：

The author's own work

研究疾病：

宫颈癌  

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：

To compare postoperative changes in NLR according to surgical methods and determine the effect of these changes on 5-year survival of cervical cancer patients.  

Objectives of Study：

To compare postoperative changes in NLR according to surgical methods and determine the effect of these changes on 5-year survival of cervical cancer patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Patients who underwent ORH or LRH between June 2006 and February 2015.Adult female patients aged ≥18 years were included in the study.

Inclusion criteria

Patients who underwent ORH or LRH between June 2006 and February 2015.Adult female patients aged >=18 to 80 years.

排除标准：

1. Patients who had severe diseases such as cardiovascular disease, hematologic disease, inflammatory disease, and other malignancies;
2. Patients who have received any cervical neoplasia treatment prior to the admission;
3. Patients who converted from laparoscopic surgery to laparotomy;
4. Patients with incomplete data from medical records.

Exclusion criteria：

1. Patients who had severe diseases such as cardiovascular disease, hematologic disease, inflammatory disease, and other malignancies;
2. Patients who have received any cervical neoplasia treatment prior to the admission;
3. Patients who converted from laparoscopic surgery to laparotomy;
4. Patients with incomplete data from medical records.

研究实施时间：

Study execute time：

从 From 2020-11-01 00:00:00至 To 2021-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2006-06-01 00:00:00 至 To 2015-12-31 00:00:00

干预措施：

Interventions：

组别：

cervical cancer

样本量：

 929

Group：

cervical cancer

Sample size：

干预措施：

radical hysterectomy

干预措施代码：

Intervention：

radical hysterectomy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 韩国

省(直辖市)：

 首尔 

市(区县)：

  

Country：

Korea

Province：

Seoul

City：

单位(医院)：

 峨山医疗中心 

单位级别：

 三级 

Institution
hospital：

Asan Medical Center

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

生存率

指标类型：

主要指标

Outcome：

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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

No

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

No randomization Procedure

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）：

N/A

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

not applicable

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：

N/A

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

not applicable

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-04-06 06:14:55