Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital

June 12, 2020 updated by: Michele Ballabio, Azienda Socio Sanitaria Territoriale di Lodi
The investigators retrospectively evaluated all the patients operated in a high-risk community hospital from the first Italian case of Covid-19 (February 21st) to the April 10th (in order to have at least a 30-days follow-up). The investigators selected those patients who had a preoperative or post-operative positive Real Time - Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 and the clinical outcome of the participants was evaluated in term of need of Intensive Care Unit (ICU) post-operative recovery, medical and surgical complications, length of hospital stay and death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Lodi, Lombardia, Italy, 26900
        • Ospedale di Lodi - ASST Lodi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General population referring to a community hospital during the SARS-CoV-2 outbreak in the Northern Italy

Description

Inclusion Criteria:

  • preoperative or post-operative positive Real Time - Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2
  • surgical procedure in elective or acute care surgery performed under general anesthesia

Exclusion Criteria:

  • patients operated without general anesthesia
  • patients preoperatively intubated for Covid-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19 patients operated (February 21st -April 10th)
Procedure: Surgical procedures performed under general anesthesia
Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale di Lodi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

May 20, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid19nr1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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