National Study "AEC COVID-19"

Mortality Clinical Trial

Official title:

National Study "AEC COVID-19" on Patients Undergoing Surgical Intervention During the SARS-CoV-2 Pandemic.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573868
• Other study ID #: AEC-COVID
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: Salvador Morales-Conde
• Phone: 670238582
• Email: smoralesc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. With a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the COVID-19 pandemic, with the aim of improving their treatment in the event of a second wave. The great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks.

The national study "AEC COVID-19" is a collaborative study (in the style of those carried out at European level such as Eurosurg, Globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. It is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses:

• Patients with COVID-19 have high mortality.

• Patients with both oncological and benign pathologies have high morbidity.

The situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

Adult patients who undergo a surgical procedure during the pandemic

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Mortality

Locations

Country	Name	City	State
Spain	Salvador Morales-Conde	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patient who died after surgery 30 days after the surgical procedure	30 days
Secondary	Morbidity	Complictaions after surgery	30 days