ChiCTR2100044822 版本V1.0 版本创建时间2021/03/28 02:31:07 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：

 ChiCTR2100044822 

最近更新日期：

Date of Last Refreshed on：

 2021-03-28 02:30:17 

注册时间：

Date of Registration：

 2021-03-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Closure of Pilonidal Sinus by The Modified Off-Midline Method in The Kurdistan Region

Public title：

Closure of Pilonidal Sinus by The Modified Off-Midline Method in The Kurdistan Region

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Closure of Pilonidal Sinus by The Modified Off-Midline Method in The Kurdistan Region

Scientific title：

Closure of Pilonidal Sinus by The Modified Off-Midline Method in The Kurdistan Region

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：

Azhi Aram Kareem 

研究负责人：

Dawan Jamal Hawezy 

Applicant：

Azhi Aram Kareem 

Study leader：

Dawan Jamal Hawezy 

申请注册联系人电话：

Applicant telephone：

 +96 475 03313301

研究负责人电话：

Study leader's
telephone：

+96 475 01197735

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：

 azhi.kareem@koyauniversity.org

研究负责人电子邮件：

Study leader's E-mail：

 dawan.jamal@koyauniversity.org

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：

Chwarchra st, Koya KOY45, Koya city, Erbil, Kurdistan region-Iraq

研究负责人通讯地址：

Koya KOY45, Koya City, Erbil, Kurdistan region-Iraq

Applicant address：

Chwarchra st, Koya KOY45, Koya city, Erbil, Kurdistan region-Iraq

Study leader's address：

Koya KOY45, Koya City, Erbil, Kurdistan region-Iraq

申请注册联系人邮政编码：

Applicant postcode：

 46017

研究负责人邮政编码：

Study leader's postcode：

 46017

申请人所在单位：

伊拉克Department of Medical Microbiology, Faculty of Science and health, Koya University

Applicant's institution：

Department of Medical Microbiology, Faculty of Science and health, Koya University.

研究负责人所在单位：

伊拉克School of medicine, Koya University and Department of surgery, Shahid Dr. Khalid Teaching Hospital

Affiliation of the Leader：

School of medicine, Koya University and Department of surgery, Shahid Dr. Khalid Teaching 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：

 3

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：

School of medicine Ethic committee

Name of the ethic committee：

School of medicine Ethic committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-06-20 00:00:00

伦理委员会联系人：

Sarmad Raheem Kareem

Contact Name of the ethic committee：

Sarmad Raheem Kareem

伦理委员会联系地址：

Kurdistan Region - F.R. IRAQ

Contact Address of the ethic committee：

Kurdistan Region - F.R. IRAQ

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +96 475 07226654

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：

Koya University

Primary sponsor：

Koya University

研究实施负责（组长）单位地址：

University Park, ?Danielle Mitterrand Boulevard, Koysinjaq

Primary sponsor's address：

University Park, ?Danielle Mitterrand Boulevard, Koysinjaq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊拉克

省(直辖市)：

库尔德斯坦

市(区县)：

Erbil

Country：

Iraq

Province：

Kurdistan

City：

Erbil

单位(医院)：

Shahid Dr.Khalid Teaching Hospital

具体地址：

Zanko St.

Institution
hospital：

Shahid Dr.Khalid Teaching Hospital

Address：

Zanko St.

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Sacrococcygeal Pilonidal Sinus Disease  

Target disease：

Sacrococcygeal Pilonidal Sinus Disease

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The main object of this study is to treat sacrococcygeal pilonidal sinus disease with less invasive surgical method.  

Objectives of Study：

The main object of this study is to treat sacrococcygeal pilonidal sinus disease with less invasive surgical method.

药物成份或治疗方案详述：

A simple surgical technique known as modified off-midline for treating sacrococcygeal pilonidal sinus disease which is an improve in time of recovery and hospitalization. 

Description for medicine or protocol of treatment in detail：

A simple surgical technique known as modified off-midline for treating sacrococcygeal pilonidal sinus disease which is an improve in time of recovery and hospitalization. 

纳入标准：

For the patient to have Sacrococcygeal Pilonidal Sinus Disease.

Inclusion criteria

For the patient to have Sacrococcygeal Pilonidal Sinus Disease.

排除标准：

Not have the disease

Exclusion criteria：

Not have the disease

研究实施时间：

Study execute time：

从 From 2016-09-15 00:00:00至 To 2019-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-09-01 00:00:00 至 To 2020-06-01 00:00:00

干预措施：

Interventions：

组别：

experimental group

样本量：

 596

Group：

experimental group

Sample size：

干预措施：

Closure of Pilonidal Sinus by the Modified Off-Midline Method

干预措施代码：

Intervention：

Closure of Pilonidal Sinus by the Modified Off-Midline Method

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊拉克

省(直辖市)：

 库尔德斯坦地区 

市(区县)：

  

Country：

Iraq

Province：

Kurdistan region

City：

单位(医院)：

 Shahid Dr. Khalid Teaching Hospital 

单位级别：

  

Institution
hospital：

Shahid Dr. Khalid Teaching Hospital

Level of the institution：

测量指标：

Outcomes：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 15 岁 years
最大 Max age 45 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)：

The method was not randomized only individuals with the Sacrococcygeal Pilonidal Sinus Disease were treated.

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

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 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：

The data were collected from each patient in a form then transfer into excel sheet.

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

The data were collected from each patient in a form then transfer into excel sheet.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-28 02:30:17