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Complications and Mortality Following Emergency Digestive Surgery During the COVID-19 Pandemic

NCT04479150 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5307

Last updated 2021-02-23

No results posted yet for this study

Summary

A multi-centre, observational cohort study will be carried out in consecutive patients operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic' cohort, which will include all patients \[COVID-19-positive or negative\] operated on for emergency digestive pathology during the months of March to June 2020; and the control cohort, which will include all patients operated on for emergency digestive pathology during the months of March to June 2019.

Information will be gathered on demographic characteristics, clinical and analytical parameters, scores on the usual risk scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific factors for patients infected with SARS-CoV-2, complications and postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be detailed whether or not the patient was infected with SARS-CoV-2.

The main objective will be to determine the incidence of postoperative complications and mortality. This variable will be analysed in the "full analysis set" population. Secondary objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.

Conditions

  • Covid19
  • Surgery--Complications

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Javier Osorio, MD, PhD · Hospital Universitary de Bellvitge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479150 on ClinicalTrials.gov