National Study "AEC COVID-19"

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

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.

Study Overview

• Status: Unknown
• Conditions: Mortality

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Salvador Morales-Conde
    • Contact: Salvador Morales; Phone Number: +34646357875; Email: smoralesc@gmail.com
    • Principal Investigator: Salvador Morales-Conde, MD PhD
    • Sub-Investigator: Isaias Alarcón, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients who undergo a surgical procedure during the pandemic

Description

Inclusion Criteria:

Adult patients who undergo a surgical procedure during the pandemic

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patient who died after surgery 30 days after the surgical procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Complictaions after surgery	30 days

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: Salvador Morales-Conde, Asociacion Española de Cirujanos

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; COVID
• Other Study ID Numbers: AEC-COVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No