ChiCTR2100048866 版本V1.0 版本创建时间2021/07/19 00:04:55 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：

 ChiCTR2100048866 

最近更新日期：

Date of Last Refreshed on：

 2021-07-19 00:03:30 

注册时间：

Date of Registration：

 2021-07-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

THE EFFECTS OF COVID-19 PANDEMIC ON EMERGENCY ANTERIOR ABDOMINAL WALL HERNIA SURGERY

Public title：

THE EFFECTS OF COVID-19 PANDEMIC ON EMERGENCY ANTERIOR ABDOMINAL WALL HERNIA SURGERY

注册题目简写：

English Acronym：

研究课题的正式科学名称：

THE EFFECTS OF COVID-19 PANDEMIC ON EMERGENCY ANTERIOR ABDOMINAL WALL HERNIA SURGERY: IS IT SAFE TO POSTPONE ELECTIVE HERNIA SURGERY IN THE PANDEMIC?

Scientific title：

THE EFFECTS OF COVID-19 PANDEMIC ON EMERGENCY ANTERIOR ABDOMINAL WALL HERNIA SURGERY: IS IT SAFE TO POSTPONE ELECTIVE HERNIA SURGERY IN THE PANDEMIC?

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：

Ahmet Baris Dirim 

研究负责人：

Umit Turan 

Applicant：

Ahmet Baris Dirim 

Study leader：

Umit Turan 

申请注册联系人电话：

Applicant telephone：

 +905336410313

研究负责人电话：

Study leader's
telephone：

+90505304067

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：

 drbarisdirim@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 turanumit@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：

Adana Sehir Egitim ve Arastirma Hastanesi, Genel Cerrahi KlinigiAdana/Turkey

研究负责人通讯地址：

Adana Sehir Egitim ve Arastirma Hastanesi, Genel Cerrahi KlinigiAdana/Turkey

Applicant address：

Adana Sehir Egitim ve Arastirma Hastanesi, Genel Cerrahi KlinigiAdana/Turkey

Study leader's address：

Adana sehir egitim ve arastirma hastanesi, Genel Cerrahi Klinigi

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Adana City Research and Training Hospital

Applicant's institution：

Adana City Research and Training Hospital, General Surgery Department

研究负责人所在单位：

土耳其Adana City Research and Training Hospital

Affiliation of the Leader：

Adana City Research and Training Hospital, General Surgery Department

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：

 1373

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：

Adana City Research and Training Hospital, Clinical Research Committee

Name of the ethic committee：

Adana City Research and Training Hospital, Clinical Research Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-04-22 00:00:00

伦理委员会联系人：

Ganiye Begul Kupeli

Contact Name of the ethic committee：

Ganiye Begul Kupeli

伦理委员会联系地址：

Adana City Research and Training Hospital, Clinical Research Committee, Yüre?ir-Adana-Turkey

Contact Address of the ethic committee：

Adana City Research and Training Hospital, Clinical Research Committee, Yüre?ir-Adana-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：

Ahmet Baris Dirim

Primary sponsor：

Ahmet Baris Dirim

研究实施负责（组长）单位地址：

Adana City Research and Training Hospital, General Surgery Department

Primary sponsor's address：

Adana City Research and Training Hospital, General Surgery Department

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

土耳其

省(直辖市)：

Adana

市(区县)：

Country：

Turkey

Province：

Adana

City：

单位(医院)：

Adana City Research and Training Hospital

具体地址：

Adana City Research and Training Hospital,Yüre?ir Adana

Institution
hospital：

Adana City Research and Training Hospital

Address：

Adana City Research and Training Hospital,Yüre?ir Adana

经费或物资来源：

No

Source(s) of funding：

no

研究疾病：

新型冠状病毒肺炎(COVID-19)  

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

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：

队列研究 

Study design：

Cohort study 

研究目的：

The aim of this study was to investigate the effects of COVID-19 infection on Emergency anteior abdominal wall hernia surgery by comparing the outcomes of patients who underwent during the pandemic with those who underwent the same surgery in the non-pandemic control period a year ago. Furthermore we aimed to share our precautions and experiences during the pandemic.  

Objectives of Study：

The aim of this study was to investigate the effects of COVID-19 infection on Emergency anteior abdominal wall hernia surgery by comparing the outcomes of patients who underwent during the pandemic with those who underwent the same surgery in the non-pandemic control period a year ago. Furthermore we aimed to share our precautions and experiences during the pandemic.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

All emergent anterior abdominal wall surgeries in control and pandeic periods

Inclusion criteria

All emergent anterior abdominal wall surgeries in control and pandeic periods

排除标准：

Emergency surgeries without primary anterior abdominal wall repair surgery were excluded from the study (For example: Repairing the incisional hernia of a patient who had ileus surgery)

Exclusion criteria：

Emergency surgeries without primary anterior abdominal wall repair surgery were excluded from the study (For example: Repairing the incisional hernia of a patient who had ileus surgery)

研究实施时间：

Study execute time：

从 From 2019-03-11 00:00:00至 To 2021-01-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-07-15 00:00:00 至 To 2021-07-16 00:00:00

干预措施：

Interventions：

组别：

Pandemic and Control

样本量：

 66

Group：

Pandemic and Control

Sample size：

干预措施：

Anterior Abdominal Wall Hernia

干预措施代码：

Intervention：

Anterior Abdominal Wall Hernia

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 Adana 

市(区县)：

  

Country：

Turkey

Province：

Adana

City：

单位(医院)：

 Adana City Research and Training Hospital 

单位级别：

 Tertiary Hospital 

Institution
hospital：

Adana City Research and Training Hospital

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Emergent anterior abdominal wall surgeries increased in pandemic period

指标类型：

主要指标

Outcome：

Emergent anterior abdominal wall surgeries increased in pandemic period

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：

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 18 岁 years
最大 Max age 95 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 Procedure (please state who generates the random number sequence and by what method)：

None

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：

No

Blinding：

No

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）：

Not stated

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

Not stated

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 were collected in excel and SPSS database

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

Data were collected in excel and SPSS database

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-07-19 00:03:30