NCT04430062

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

19 days

First QC Date

June 11, 2020

Last Update Submit

June 12, 2020

Conditions

Keywords

SurgeryCovid-19SARS-CoV-2Surgical outcome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 days

Study Arms (1)

Covid-19 patients operated (February 21st -April 10th)

Procedure: Surgical procedures performed under general anesthesia

Interventions

Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection

Covid-19 patients operated (February 21st -April 10th)

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Lodi - ASST Lodi

Lodi, Lombardy, 26900, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michele Ballabio, MD, Principal Investigator

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 12, 2020

Study Start

May 1, 2020

Primary Completion

May 20, 2020

Study Completion

May 30, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations