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CompletedNCT04430062Updated Jun 16, 2020

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

An observational study in General Surgery and Disease Outbreaks, sponsored by Azienda Socio Sanitaria Territoriale di Lodi. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Azienda Socio Sanitaria Territoriale di Lodi · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
14
Sex
All
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Study 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.

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Conditions studied

  • General Surgery
  • Disease Outbreaks

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Keywords

  • Surgery
  • Covid-19
  • SARS-CoV-2
  • Surgical outcome
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In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 14 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

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Lead sponsor

Azienda Socio Sanitaria Territoriale di Lodi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

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

    Procedure: Surgical procedures performed under general anesthesia

Interventions

  • ProcedureSurgical procedures performed under general anesthesia

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

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What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 30 days

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Study locations

1 site
  • Ospedale di Lodi - ASST Lodi
    Lodi, Lombardia 26900, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04430062
Lead sponsor
Azienda Socio Sanitaria Territoriale di Lodi
Responsible party
Michele Ballabio (Michele Ballabio, MD, Principal Investigator, Azienda Socio Sanitaria Territoriale di Lodi) — Principal investigator
First posted
Jun 12, 2020
Start date
May 1, 2020
Primary completion
May 20, 2020
Completion
May 30, 2020
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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