ChiCTR2000033787 版本V1.0 版本创建时间2020/06/12 12:09:20 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：

 ChiCTR2000033787 

最近更新日期：

Date of Last Refreshed on：

 2020-06-12 12:01:52 

注册时间：

Date of Registration：

 2020-06-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Evaluation of scoring systems in acute appendicitis

Public title：

Evaluation of scoring systems in acute appendicitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Evaluation of Alvarado scoring, RIPASA scoring and AIR scoring systems in acute appendicitis

Scientific title：

Evaluation of Alvarado scoring, RIPASA scoring and AIR scoring systems in acute appendicitis

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：

Meer Chisthi M 

研究负责人：

Meer Chisthi M 

Applicant：

Meer Chisthi M 

Study leader：

Meer Chisthi M 

申请注册联系人电话：

Applicant telephone：

 +91 94 46560110

研究负责人电话：

Study leader's
telephone：

+91 94 46560110

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：

 meerchisthi@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 meerchisthi@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：

General surgery department, Government Medical College, Trivandrum, India

研究负责人通讯地址：

General surgery department, Government Medical College, Trivandrum, India

Applicant address：

General surgery department, Government Medical College, Trivandrum, India

Study leader's address：

General surgery department, Government Medical College, Trivandrum, India

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：

印度喀拉拉邦特里凡得琅政府医学院普通外科

Applicant's institution：

General surgery department, Government Medical College Trivandrum

研究负责人所在单位：

印度喀拉拉邦特里凡得琅政府医学院普通外科

Affiliation of the Leader：

General surgery department, Government Medical College Trivandrum

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：

 IEC.No.07/15/2017/MCT

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：

Human Ethics Committee

Name of the ethic committee：

Human Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-07-07 00:00:00

伦理委员会联系人：

Secretary, Human Ethics Committee

Contact Name of the ethic committee：

Secretary, Human Ethics Committee

伦理委员会联系地址：

Department of Pharmacology, Medical College, Thiruvananthapuram. 695011, India

Contact Address of the ethic committee：

Department of Pharmacology, Medical College, Thiruvananthapuram. 695011, India

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +91 47 12528378

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：

Anilkumar Surendran

Primary sponsor：

Anilkumar Surendran

研究实施负责（组长）单位地址：

General surgery department, Government Medical College, Trivandrum, India

Primary sponsor's address：

General surgery department, Government Medical College, Trivandrum, India

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

印度

省(直辖市)：

喀拉拉邦

市(区县)：

Country：

India

Province：

Kerala

City：

单位(医院)：

Government Medical College Trivandrum

具体地址：

Government Medical College Trivandrum

Institution
hospital：

Government Medical College Trivandrum

Address：

General surgery department, Government Medical College Trivandrum

经费或物资来源：

No funding

Source(s) of funding：

No funding

研究疾病：

Appendicitis  

Target disease：

Appendicitis

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

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 estimate the predictive accuracy of Alvarado score and AIR score and RIPASA score against the reference standard of histopathology in patients undergoing emergency appendicectomy at Government Medical college Thiruvananthapuram.  

Objectives of Study：

To estimate the predictive accuracy of Alvarado score and AIR score and RIPASA score against the reference standard of histopathology in patients undergoing emergency appendicectomy at Government Medical college Thiruvananthapuram.

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 undergoing emergency appendicectomy for suspected appendicitis. [Acute (1 week or less) non traumatic right iliac fossa pain consistent with a diagnosis of appendicitis, i.e. pain associated with nausea, anorexia, vomiting and fever along with clinical signs as tenderness and rebound tenderness in right iliac fossa.] Or USG suggestive of appendicitis.

Inclusion criteria

Patients undergoing emergency appendicectomy for suspected appendicitis. [Acute (1 week or less) non traumatic right iliac fossa pain consistent with a diagnosis of appendicitis, i.e. pain associated with nausea, anorexia, vomiting and fever along with clinical signs as tenderness and rebound tenderness in right iliac fossa.] Or USG suggestive of appendicitis.

排除标准：

Patients with a history of abdominal trauma, Patients with age less than 12 years, Abdominal pain of duration more than one week, Patients with non RIF pain.

Exclusion criteria：

Patients with a history of abdominal trauma, Patients with age less than 12 years, Abdominal pain of duration more than one week, Patients with non RIF pain.

研究实施时间：

Study execute time：

从 From 2018-01-01 00:00:00至 To 2019-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-01-01 00:00:00 至 To 1990-01-01 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

HISTOPATHOLOGY, MASS

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

HISTOPATHOLOGY, MASS

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

Alvarado score and AIR score and RIPASA score

Index test:

Alvarado score and AIR score and RIPASA score

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

Patients undergoing emergency appendicectomy for suspected appendicitis

例数:

Sample size:

107

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients undergoing emergency appendicectomy for suspected appendicitis

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 喀拉拉邦 

市(区县)：

  

Country：

India

Province：

Kerala

City：

单位(医院)：

 Government Medical College Trivandrum 

单位级别：

 三级医院 

Institution
hospital：

Government Medical College Trivandrum

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

RIPASA and AIR superior to MASS

指标类型：

主要指标

Outcome：

RIPASA and AIR superior to MASS

Type：

Primary indicator

测量时间点：

After surgery

测量方法：

Measure time point of outcome：

After surgery

Measure method：

指标中文名：

SEN, SPE, ACC

指标类型：

主要指标

Outcome：

SEN, SPE, ACC

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：

Blood

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 12 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）：

N/A

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

No randomization

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：

Not stated

Blinding：

Not stated

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://data.mendeley.com/datasets/b9tb8mmm43/1

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

https://data.mendeley.com/datasets/b9tb8mmm43/1

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：

https://data.mendeley.com/datasets/b9tb8mmm43/1

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

https://data.mendeley.com/datasets/b9tb8mmm43/1

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-06-12 12:01:52