今天是:2019-06-18 星期二

邓胜和医师: 该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 外科术后吻合口并发症内镜治疗的病例回顾研究
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注册号:

Registration number:

ChiCTR1900023804 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

邓胜和医师: 该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 外科术后吻合口并发症内镜治疗的病例回顾研究 

Public title:

A retrospective study for endoscopic treatment of postoperative anastomotic complications 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

外科术后吻合口并发症内镜治疗的病例回顾研究 

Scientific title:

A retrospective study for endoscopic treatment of postoperative anastomotic complications 

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:

邓胜和 

研究负责人:

蔡开琳 

Applicant:

Shenghe Deng 

Study leader:

Kailin Cai 

申请注册联系人电话:

Applicant telephone:

+86 15927525357 

研究负责人电话:

Study leader's telephone:

+86 13971086496 

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:

dengshenghe@hust.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

caikialin@hust.edu.cn 

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:

湖北武汉江汉区解放大道1277号 

研究负责人通讯地址:

湖北武汉江汉区解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Jianghan District, Wuhan, China 

Study leader's address:

1277 Jiefang Avenue, Jianghan District, Wuhan, China 

申请注册联系人邮政编码:

Applicant postcode:

430022 

研究负责人邮政编码:

Study leader's postcode:

430022 

申请人所在单位:

武汉协和医院胃肠外科 

Applicant's institution:

Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

武汉协和医院胃肠外科 

Primary sponsor:

Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北武汉江汉区解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Jianghan District, Wuhan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

wuhan

单位(医院):

武汉协和医院

具体地址:

江汉区解放大道1277

Institution
hospital:

wuhan union hospital

Address:

jiefang avenue 1277

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

外科术后吻合口并发症 

Target disease:

Postoperative anastomotic complications 

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:

其它 

Study phase:

N/A 

研究目的:

该研究目的为对外科术后吻合口并发症内镜治疗研究。 对外科术后吻合口并发症内镜治疗病例回顾性研究,形成一个系统有效的内镜治疗方法,并对其安全有效性分析。 

Objectives of Study:

The purpose of this study was to study the endoscopic treatment of postoperative anastomotic complications.A retrospective study of endoscopic treatment of anastomotic complications after surgery has formed a systematic and effective endoscopic treatment method and analyzed its safety and effectiveness. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1、回顾分析收集外科术后出现吻合口并发症患者;2、由内镜方式处理。 

Inclusion criteria

1. Retrospective analysis and collection of patients with anastomotic complications after surgery; 2. Endoscopic treatment. 

排除标准:

1、其他并发症患者;2、拒绝此试验。 

Exclusion criteria:

1. Patients with other complications; 2. Reject this study. 

研究实施时间:

Study execute time:

From2019-06-11To 2020-06-11 

干预措施:

Interventions:

组别:

内镜治疗组

样本量:

100

Group:

Observation group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉协和医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Union Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

吻合口并发症类型

指标类型:

主要指标 

Outcome:

Types of anastomotic complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗方法

指标类型:

主要指标 

Outcome:

treatment methods

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗效果

指标类型:

主要指标 

Outcome:

Treatment effect

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈时间

指标类型:

主要指标 

Outcome:

cure time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗中出现相关并发症

指标类型:

主要指标 

Outcome:

other complication

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

此研究为回顾性病例分析研究,回顾性查找相关病例后收集信息,分析数据结果。

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

This study was a retrospective case analysis study, which collected information and analyzed data results after retrospective search of relevant cases

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

华中科技大学

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

Huazhong University of Science and Technology,

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:

华中科技大学

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

Huazhong University of Science and Technology,

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-12
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