ChiCTR2100046920 版本V1.2 版本创建时间2022/01/11 04:18:13 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：

 ChiCTR2100046920 

最近更新日期：

Date of Last Refreshed on：

 2022-01-11 04:17:59 

注册时间：

Date of Registration：

 2021-05-31 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

MANAGEMENT OF COMPLICATED COLON DIVERTICULITIS

Public title：

MANAGEMENT OF COMPLICATED COLON DIVERTICULITIS

注册题目简写：

English Acronym：

研究课题的正式科学名称：

DOES LOCALIZATION CHANGE TREATMENT MANAGEMENT IN COMPLICATED COLON DIVERTICULITIS? OUTCOMES OF CONSERVATIVE VERSUS SURGICAL MANAGEMENT IN RIGHT AND LEFT-SIDED DIVERTICULITIS: RETROSPECTIVE STUDY.

Scientific title：

DOES LOCALIZATION CHANGE TREATMENT MANAGEMENT IN COMPLICATED COLON DIVERTICULITIS? OUTCOMES OF CONSERVATIVE VERSUS SURGICAL MANAGEMENT IN RIGHT AND LEFT-SIDED DIVERTICULITIS: RETROSPECTIVE STUDY.

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：

Nihan ACAR 

研究负责人：

Nihan ACAR 

Applicant：

Nihan ACAR 

Study leader：

Nihan ACAR 

申请注册联系人电话：

Applicant telephone：

 +90 53 54758108

研究负责人电话：

Study leader's
telephone：

+90 53 54758108

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：

 cosgunnihan@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 cosgunnihan@hotmail.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：

Izmir Ataturk Egitim ve Arastirma Hastanesi, Bas?n Sitesi, KARABA?LAR, IZMIR, TURKEY

研究负责人通讯地址：

Izmir Ataturk Egitim ve Arastirma Hastanesi, Bas?n Sitesi, KARABA?LAR, IZMIR, TURKEY

Applicant address：

Izmir Ataturk Egitim ve Arastirma Hastanesi, Bas?n Sitesi, KARABA?LAR, IZMIR, TURKEY

Study leader's address：

Izmir Ataturk Egitim ve Arastirma Hastanesi, Bas?n Sitesi, KARABA?LAR, IZMIR, TURKEY

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：

土耳其Izmir Katip ?elebi University Ataturk Training and Research Hospital

Applicant's institution：

Izmir Katip ?elebi University Ataturk Training and Research Hospital

研究负责人所在单位：

土耳其Izmir Katip ?elebi University Ataturk Training and Research Hospital

Affiliation of the Leader：

Izmir Katip ?elebi University Ataturk Training and Research 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：

 619

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：

Izmir Katip elebi University Non-Interventional Clinical Studies Institutional Review Board

Name of the ethic committee：

Izmir Katip elebi University Non-Interventional Clinical Studies Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-02-13 00:00:00

伦理委员会联系人：

Dr. Baris KILICCIOGLU

Contact Name of the ethic committee：

Dr. Baris KILICCIOGLU

伦理委员会联系地址：

Izmir Ataturk Eitim ve Aratrma Hastanes, Basn Sitesi, KARABA?LAR, IZMIR, TURKEY

Contact Address of the ethic committee：

Izmir Ataturk Eitim ve Aratrma Hastanes, Basn Sitesi, KARABA?LAR, IZMIR, TURKEY

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：

None

Primary sponsor：

None

研究实施负责（组长）单位地址：

None

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Complicated colonic diverticulitis  

Target disease：

Complicated colonic diverticulitis

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：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

This study mainly aimed to evaluate the clinical features of CD from a single-centre, display the differences according to colonic localizations, and present treatment approaches. In addition, secondary endpoints were determined as the demographic and clinical features affecting the surgical decision-making.  

Objectives of Study：

This study mainly aimed to evaluate the clinical features of CD from a single-centre, display the differences according to colonic localizations, and present treatment approaches. In addition, secondary endpoints were determined as the demographic and clinical features affecting the surgical decision-making.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. To be diagnosed with complicated diverticulitis;
2. To be treated by hospitalization;
3. To undergo colonoscopy (preoperative, intraoperative or during the follow-up).

Inclusion criteria

1. To be diagnosed with complicated diverticulitis;
2. To be treated by hospitalization;
3. To undergo colonoscopy (preoperative, intraoperative or during the follow-up).

排除标准：

1. To be diagnosed with uncomplicated diverticulitis;
2. To receive outpatient treatment;
3. To have rectum diverticulitis;
4. The absence of a current colonoscopy;
5. Lacking follow-up data.

Exclusion criteria：

1. To be diagnosed with uncomplicated diverticulitis;
2. To receive outpatient treatment;
3. To have rectum diverticulitis;
4. The absence of a current colonoscopy;
5. Lacking follow-up data.

研究实施时间：

Study execute time：

从 From 2020-02-12 00:00:00至 To 2020-05-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-01-01 00:00:00 至 To 2019-12-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 45

Group：

1

Sample size：

干预措施：

Right colon diverticulitis

干预措施代码：

Intervention：

Right colon diverticulitis

Intervention code：

组别：

2

样本量：

 208

Group：

2

Sample size：

干预措施：

Left colon diverticulitis

干预措施代码：

Intervention：

Left colon diverticulitis

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 Izmir 

市(区县)：

  

Country：

Turkey

Province：

Izmir

City：

单位(医院)：

 Izmir Katip ?elebi University Ataturk Training and Research Hospital 

单位级别：

 Research and Training Hospital 

Institution
hospital：

Izmir Katip ?elebi University Ataturk Training and Research Hospital

Level of the institution：

Research and Training Hospital

测量指标：

Outcomes：

指标中文名：

Dfferences according to colonic localizations

指标类型：

主要指标

Outcome：

Dfferences according to colonic localizations

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：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 21 岁 years
最大 Max age 90 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

No randomization, retrospective design

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

No randomization, retrospective design

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

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）：

Institutional database (Probel Hospital Information Management System)

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

Institutional database (Probel Hospital Information Management System)

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：

Data collection was performed retrospectively from the database.

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

Data collection was performed retrospectively from the database.

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：

  2021-05-31 01:28:28