NCT04573868

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 30, 2020

Last Update Submit

September 30, 2020

Conditions

Mortality

Keywords

COVIDSurgery

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Patient who died after surgery 30 days after the surgical procedure

    30 days

Secondary Outcomes (1)

  • Morbidity

    30 days

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who undergo a surgical procedure during the pandemic

You may qualify if:

  • Adult patients who undergo a surgical procedure during the pandemic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salvador Morales-Conde

Seville, 41009, Spain

RECRUITING

Study Officials

  • Salvador Morales-Conde

    Asociacion Española de Cirujanos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvador Morales-Conde

CONTACT

670238582smoralesc@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Unit of Innovation in Minimally Invesive Surgery. Associate Professor of Surgery

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 5, 2020

Study Start

March 1, 2020

Primary Completion

June 30, 2020

Study Completion

September 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

ES(1)