ChiCTR2000039981 版本V1.0 版本创建时间2021/02/22 11:06:49 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：

ChiCTR2000039981 

最近更新日期：

Date of Last Refreshed on：

2020-11-16 01:35:01 

注册时间：

Date of Registration：

2020-11-16 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

The Increase in the Ratio of Transverse Colon Diameter to Lumbar Vertebral Corpus Diameter in Acute Left Colon Tumor Obstruction is Indicator of Morbidity

Public title：

The Increase in the Ratio of Transverse Colon Diameter to Lumbar Vertebral Corpus Diameter in Acute Left Colon Tumor Obstruction is Indicator of Morbidity

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Increase in the Ratio of Transverse Colon Diameter to Lumbar Vertebral Corpus Diameter in Acute Left Colon Tumor Obstruction is Indicator of Morbidity

Scientific title：

The Increase in the Ratio of Transverse Colon Diameter to Lumbar Vertebral Corpus Diameter in Acute Left Colon Tumor Obstruction is Indicator of Morbidity

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：

Ali Kemal Kayapinar 

研究负责人：

Ali Kemal Kayapinar 

Applicant：

Ali Kemal Kayapinar 

Study leader：

Ali Kemal Kayapinar 

申请注册联系人电话：

Applicant telephone：

+90 53 93568585

研究负责人电话：

Study leader's telephone：

+90 53 93568585

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：

alikemalkayapinar@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

alikemalkayapinar@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：

GüNEY MAHALLES? 1140/1 SOKAK, 1 YEN??EH?R - KONAK - ?ZM?R, TüRK?YE

研究负责人通讯地址：

GüNEY MAHALLES? 1140/1 SOKAK, 1 YEN??EH?R - KONAK - ?ZM?R, TüRK?YE

Applicant address：

GüNEY MAHALLES? 1140/1 SOKAK, 1 YEN??EH?R - KONAK - ?ZM?R, TüRK?YE

Study leader's address：

GüNEY MAHALLES? 1140/1 SOKAK, 1 YEN??EH?R - KONAK - ?ZM?R, TüRK?YE

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University of Health Sciences Tepecik Training and Research Hospital, Department of General Surgery,

Applicant's institution：

University of Health Sciences Tepecik Training and Research Hospital, Department of General Surgery,

研究负责人所在单位：

University of Health Sciences Tepecik Training and Research Hospital, Department of General Surgery, Izmir, TURKEY

Affiliation of the Leader：

University of Health Sciences Tepecik Training and Research Hospital, Department of General Surgery,

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

26

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：

University of Health Sciences Tepecik Training and Research Hospital, Ethic Committee

Name of the ethic committee：

University of Health Sciences Tepecik Training and Research Hospital, Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2017-07-13 00:00:00

伦理委员会联系人：

Ethic Committee of University of Health Sciences Tepecik Training and Research Hospital

Contact Name of the ethic committee：

Ethic Committee of University of Health Sciences Tepecik Training and Research Hospital

伦理委员会联系地址：

University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey

Contact Address of the ethic committee：

University of Health Sciences Tepecik Training and Research Hospital, Izmir, 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：

AL? KEMAL KAYAPINAR

Primary sponsor：

AL? KEMAL KAYAPINAR

研究实施负责（组长）单位地址：

University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey

Primary sponsor's address：

University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

none

Target disease：

acute obstructive left-sided colorectal cancer

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

to evaluate the relationship between postoperative complications and preoperative colon diameter increase rate in patients that have undergone Hartman procedure  

Objectives of Study：

to evaluate the relationship between postoperative complications and preoperative colon diameter increase rate in patients that have undergone Hartman procedure

药物成份或治疗方案详述：

A total of 49 patients who underwent HP under emergency conditions due to AOLCRC were included in the study group. Preoperative abdominal computed tomography (CT) of these cases were evaluated and the ratios of the largest diameters of dilated cecum, ascending colon, transverse colon, and descending colon segments to the diameter of the 1st lumbar vertebra corpus (CD / L1-VD) were determined. The control group was composed of 49 cases with similar demographic characteristics who underwent abdominal CT due to other abdominal pathologies, but had not undergone previous abdominal surgery and did not have any bowel disease. The CD / L1-VD ratio of the colon segments of the patients in the control group was measured the same way as the study group. CD / L1-VD ratios in both groups were compared. The relationship between demographic characteristics, preoperative biochemical values, comorbid diseases, tumor pathological stage, operation time and CD / L1-VD ratios of colon segments with postoperative complications (according to Clavien-Dindo classification) were evaluated (retrospective). 

Description for medicine or protocol of treatment in detail：

A total of 49 patients who underwent HP under emergency conditions due to AOLCRC were included in the study group. Preoperative abdominal computed tomography (CT) of these cases were evaluated and the ratios of the largest diameters of dilated cecum, ascending colon, transverse colon, and descending colon segments to the diameter of the 1st lumbar vertebra corpus (CD / L1-VD) were determined. The control group was composed of 49 cases with similar demographic characteristics who underwent abdominal CT due to other abdominal pathologies, but had not undergone previous abdominal surgery and did not have any bowel disease. The CD / L1-VD ratio of the colon segments of the patients in the control group was measured the same way as the study group. CD / L1-VD ratios in both groups were compared. The relationship between demographic characteristics, preoperative biochemical values, comorbid diseases, tumor pathological stage, operation time and CD / L1-VD ratios of colon segments with postoperative complications (according to Clavien-Dindo classification) were evaluated (retrospective). 

纳入标准：

Underwent emergency Hartman procedure due to acute obstructive left-sided colorectal cancer, age ≥18 years(retrospective)

Inclusion criteria

Underwent emergency Hartman procedure due to acute obstructive left-sided colorectal cancer, age ≥18 years(retrospective)

排除标准：

Intraoperative perforation, patients whose abdominal computed tomography weren't done within the last 48 hours preoperatively, and patients that had intraoperative peritonitis carcinomatosis (retrospective)

Exclusion criteria：

Intraoperative perforation, patients whose abdominal computed tomography weren't done within the last 48 hours preoperatively, and patients that had intraoperative peritonitis carcinomatosis (retrospective)

研究实施时间：

Study execute time：

从 From 2017-01-01 00:00:00至 To 2018-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2007-11-01 00:00:00 至 To 2017-11-01 00:00:00  

干预措施：

Interventions：

组别：

case series

样本量：

49

Group：

case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 伊斯梅尔 

市(区县)：

  

Country：

Turkey 

Province：

Izmir 

City：

 

单位(医院)：

University of Health Sciences Tepecik Training and Research Hospital 

单位级别：

大学 

Institution
hospital：

University of Health Sciences Tepecik Training and Research Hospital

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Preoperative transverse colon CD / L1-VD ratio cut-off value

指标类型：

主要指标

Outcome：

Preoperative transverse colon CD / L1-VD ratio cut-off value

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：

Tissue

组织：

colon

Sample Name：

Tissue

Tissue：

colon

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 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）：

It was obtained from the patient database of the University of Health Sciences Tepecik Training and Research Hospital.

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

It was obtained from the patient database of the University of Health Sciences Tepecik Training and Research Hospital.

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：

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)：

是否共享原始数据：

IPD sharing

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）：

无

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

none

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：

It was obtained from the patient database of the University of Health Sciences Tepecik Training and Research Hospital.

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

It was obtained from the patient database of the University of Health Sciences Tepecik Training and Research Hospital.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-16 01:35:01