跳至主要内容
临床试验/NCT03899012
NCT03899012已完成不适用

Validation of the Data Quality of the EVEREG Incisional Hernia Surgery Registry

Hospital Universitari Joan XXIII de Tarragona.1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
337
试验地点
1
主要终点
Data accuracy

研究概览

简要总结

Objective: The objective of the study is to verify and validate the data collected in the EVEREG Incisional Hernia Surgery Registry between 2012 and 2018 through an audit process.

Methods: An audit of registered cases (Incisional Hernia Patients undergoing surgery) from 2012 to 2018, and a descriptive analysis of these data will be performed Expected results: The study could show that the EVEREG Incisional Hernia Registry is a reliable source of information, valid for carrying out specific and exhaustive analysis that may lead to high quality publications.

Relevance: The standardization of the data collection is very important to compare outcomes between different centers. This study will allow us to verify the accuracy of the collected data

详细描述

Objective: The objective of the study is to verify and validate the data collected in the EVEREG Incisional Hernia Surgery Registry between 2012 and 2018 through an audit process Secondary objective are a descriptive analysis of the registered data and a comparison with the outcomes published in other studies

Background The high volume of data obtained by well-validated registries allows them to be considered appropriate for the study of their multiple variables, even when the differences are small and the variables are rare.

The use of registries of abdominal wall surgery has been extended in recent years worldwide and the analysis of their data has already improved the knowledge and treatment of this pathology of high prevalence. The National Registry of Incisional Hernia (EVEREG), is promoted by the Section of Abdominal Wall and Sutures of the Spanish Association of Surgeons, collecting the data prospectively. It began in July 2012. In December 2018 it included data from 160 Spanish hospitals, and a total of 9780 cases of incisional hernias. Hernias related to a previous laparotomy are included, primary ventral hernias are not recorded, and the first analyzes have already been published.

The validity of any registry is based on the accuracy of the data. For this reason, it is considered very important to perform the audit in the centers where the data have been recorded in the EVEREG on-line registry.

METHODOLOGY

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • data of all the patients treated in the Hospitals of Catalonia and included in the EVEREG registry of Hernia Incisional from July 2012 to December 2018

排除标准

  • Patients not registered previously in the EVEREG registry

结局指标

主要结局

Data accuracy

时间窗: 2 Years

Determining the case ascertainment percentage for the Spanish EVEREG Incisional Hernia Surgery Registry

次要结局

未报告次要终点

研究者

发起方
Hospital Universitari Joan XXIII de Tarragona.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carles Olona Casas

Consultant General and Digestive Surgeon

Hospital Universitari Joan XXIII de Tarragona.

研究点 (1)

Loading locations...

相似试验