【ChiCTR1900026482】Does the microscopic examination of anastamotic donut after colorectal resection for oncological purposes benefit the outcomes: a medical records based study

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基本信息

登记号

ChiCTR1900026482

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2019-10-12

临床申请受理号

靶点

适应症

Colorectal Cancer

试验通俗题目

Does the microscopic examination of anastamotic donut after colorectal resection for oncological purposes benefit the outcomes: a medical records based study

试验专业题目

Does the microscopic examination of anastamotic donut after colorectal resection for oncological purposes benefit the outcomes: a case records based study

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临床试验信息

试验目的

to identify the efficacy of microscopic analyses of anastomotic donuts. The secondary end points are to identify when the microscopic analyses in warranted and the cost effectiveness of the examinations

试验分类

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试验类型

连续入组

试验分期

回顾性研究

随机化

N/A

盲法

N/A

试验项目经费来源

Institute - No external funding taken.

试验范围

目标入组人数

220

实际入组人数

第一例入组时间

2019-09-27

试验终止时间

2020-09-26

是否属于一致性

入选标准

During 1st January 2015 to 31st December 2018, all patients who underwent circular end to end anastomosis (CEEA) for colorectal cancer at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH & RC), Pakistan were selected. It is a retrospective study with convenient sampling. The ethical approval was sought from Institutional Review Board (IRB) of SKMCH & RC. Data was collected through human information system (HIS), electronic database of SKMCH & RC. It is our practice to examine the donuts produced after stapled anastomosis which are then examined by consultant pathologists. Patients who underwent abdominoperineal resection and permanent colostomy were excluded because of unavailability of donuts. Variables recorded were age, gender, circumferential resection margin (CRM) , clinical T stage, involvement of proximal and distal margins, involvement of proximal and distal donuts , length of proximal and distal margins, length of proximal and distal donuts. Margins are found to be involved if the tumor was found with in 1 mm of margin. If there was any involvement of margins, the actions taken to tackle the condition were also recorded. Calculations were performed with Statistical Package for the Social Sciences (SPSS 20) for Windows version 20 statistical software. Data was described using median with minimum and maximum value for skewly distributed quantitative variables. For categorical variables, number of observations and percentages were reported. The study is complied with the SKMCH and RC guidelines on research involving human subjects.；

排除标准

No；

研究者信息

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试验机构

SKMCH&RC

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