ChiCTR2100041712 版本V1.0 版本创建时间2021/03/21 15:08:13 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：

 ChiCTR2100041712 

最近更新日期：

Date of Last Refreshed on：

 2021-01-02 04:11:09 

注册时间：

Date of Registration：

 2021-01-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

A CASE SERIES ON MANAGEMENT OF SUPERIOR MESENTERIC ARTERY THROMBOSIS AND INCORPORATION OF A NEW TECHNIQUE USING ARTIFICIAL BOWEL CONDUIT

Public title：

A CASE SERIES ON MANAGEMENT OF SUPERIOR MESENTERIC ARTERY THROMBOSIS AND INCORPORATION OF A NEW TECHNIQUE USING ARTIFICIAL BOWEL CONDUIT

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A CASE SERIES ON MANAGEMENT OF SUPERIOR MESENTERIC ARTERY THROMBOSIS AND INCORPORATION OF A NEW TECHNIQUE USING ARTIFICIAL BOWEL CONDUIT

Scientific title：

A CASE SERIES ON MANAGEMENT OF SUPERIOR MESENTERIC ARTERY THROMBOSIS AND INCORPORATION OF A NEW TECHNIQUE USING ARTIFICIAL BOWEL CONDUIT

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：

Dr RP Singh 

研究负责人：

Dr RP Singh 

Applicant：

Dr RP Singh 

Study leader：

Dr RP Singh 

申请注册联系人电话：

Applicant telephone：

 +91 9811217164

研究负责人电话：

Study leader's
telephone：

+91 9811217164

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：

 rpsm2501@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 rpsm2501@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：

208, KOHAT ENCLAVE, PITAMPURA, DELHI 110034, INDIA

研究负责人通讯地址：

208, KOHAT ENCLAVE, PITAMPURA, DELHI 110034, INDIA

Applicant address：

208, KOHAT ENCLAVE, PITAMPURA, DELHI 110034, INDIA

Study leader's address：

208, KOHAT ENCLAVE, PITAMPURA, DELHI 110034, INDIA

申请注册联系人邮政编码：

Applicant postcode：

 110034

研究负责人邮政编码：

Study leader's postcode：

 110034

申请人所在单位：

印度德里SAROJ超级专科医院

Applicant's institution：

SAROJ SUPER SPECIALITY HOSPITAL, MADHUBAN CHOWK, ROHINI, DELHI 110085, INDIA

研究负责人所在单位：

印度德里SAROJ超级专科医院

Affiliation of the Leader：

SAROJ SUPER SPECIALITY HOSPITAL, MADHUBAN CHOWK, ROHINI, DELHI 110085, INDIA

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：

 2019/88

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

INTERNAL ETHICAL COMMITTEE OF SAROJ SUPERSPECIALITY HOSPITAL

Name of the ethic committee：

INTERNAL ETHICAL COMMITTEE OF SAROJ SUPERSPECIALITY HOSPITAL

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

INTERNAL ETHICAL COMMITTEE OF SAROJ SUPERSPECIALITY HOSPITAL

Contact Name of the ethic committee：

INTERNAL ETHICAL COMMITTEE OF SAROJ SUPERSPECIALITY HOSPITAL

伦理委员会联系地址：

SAROJ SUPER SPECIALITY HOSPITAL, MADHUBAN CHOWK, ROHINI, DELHI 110085, INDIA

Contact Address of the ethic committee：

SAROJ SUPER SPECIALITY HOSPITAL, MADHUBAN CHOWK, ROHINI, DELHI 110085, INDIA

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：

Dr RP Singh

Primary sponsor：

Dr RP Singh

研究实施负责（组长）单位地址：

208, KOHAT ENCLAVE, PITAMPURA, DELHI, 110034, INDIA

Primary sponsor's address：

208, KOHAT ENCLAVE, PITAMPURA, DELHI, 110034, 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)：

德里

市(区县)：

Country：

India

Province：

Delhi

City：

单位(医院)：

Saroj Super Speciality Hospital

具体地址：

Institution
hospital：

Saroj Super Speciality Hospital

Address：

Saroj Super Specialty Hospital, Madhuban Chowk, Rohini, Delhi, 110085, India

经费或物资来源：

No

Source(s) of funding：

NONE

研究疾病：

Superior mesenteric artery thrombosis  

Target disease：

Superior mesenteric artery thrombosis

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Primary aim is to report on series of patients presenting with SMAT focusing on challenges in diagnosis and management. Secondary aim is to present an innovative surgical procedure for difficult to handle gut due to revascularisation induced injury.  

Objectives of Study：

Primary aim is to report on series of patients presenting with SMAT focusing on challenges in diagnosis and management. Secondary aim is to present an innovative surgical procedure for difficult to handle gut due to revascularisation induced injury.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The study is a case series of prospectively collected data of 43 consecutive patients with SMAT from 2016 to 2019 at a single center. Six patients having cardio-respiratory arrest and mortality prior to taking up for surgery were excluded and the rest 37 patients who underwent surgery were included in this study. Data was collected for their demographic profile, preoperative and postoperative variables. Outcomes of the patients were analysed and a new technique was incorporated.

Inclusion criteria

The study is a case series of prospectively collected data of 43 consecutive patients with SMAT from 2016 to 2019 at a single center. Six patients having cardio-respiratory arrest and mortality prior to taking up for surgery were excluded and the rest 37 patients who underwent surgery were included in this study. Data was collected for their demographic profile, preoperative and postoperative variables. Outcomes of the patients were analysed and a new technique was incorporated.

排除标准：

Six patients having cardio-respiratory arrest and mortality prior to taking up for surgery were excluded

Exclusion criteria：

Six patients having cardio-respiratory arrest and mortality prior to taking up for surgery were excluded

研究实施时间：

Study execute time：

从 From 2016-07-10 00:00:00至 To 2019-12-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-07-10 00:00:00 至 To 2019-12-20 00:00:00

干预措施：

Interventions：

组别：

case series

样本量：

 37

Group：

Case series

Sample size：

干预措施：

Artificial Bowel Conduit

干预措施代码：

Intervention：

Artificial Bowel Conduit

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 德里 

市(区县)：

  

Country：

India

Province：

Delhi

City：

单位(医院)：

 Saroj Super Specialty Hospital 

单位级别：

 三级 

Institution
hospital：

Saroj Super Specialty Hospital

Level of the institution：

Teritary

测量指标：

Outcomes：

指标中文名：

Mortality

指标类型：

主要指标

Outcome：

Mortality

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：

Vitals

组织：

Sample Name：

Vitals

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 48 岁 years
最大 Max age 80 岁 years

性别：

男性

Gender：

Male

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)：

not applicable

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）：

The data can be collected from the hospital data record

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

The data can be collected from the hospital data record

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 can be collected from the hospital data record

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

The data can be collected from the hospital record data

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-01-02 04:11:09