General SurgeryNCT04430062
Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital
An observational study of General Surgery and Disease Outbreaks, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- General Surgery, Disease Outbreaks
- What is being tested?
- Surgical procedures performed under general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General population referring to a community hospital during the SARS-CoV-2 outbreak in the Northern Italy
Who may be able to join
- 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
Who cannot join
- patients operated without general anesthesia
- patients preoperatively intubated for Covid-19
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- General Surgery, Disease Outbreaks
- Being tested
- Surgical procedures performed under general anesthesia
- Keywords
- Surgery, Covid-19, SARS-CoV-2, Surgical outcome
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedures performed under general anesthesiaProcedure or surgery
Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 patients operated (February 21st -April 10th) | Not described Receives: Procedure: Surgical procedures performed under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 May 2020
- Primary completion20 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Ballabio, Azienda Socio Sanitaria Territoriale di Lodi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430062
- Sponsor's protocol ID
- Covid19nr1
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcome of Covid-19 Surgical Patients: Case-series of a High-risk Area Community Hospital
- ClinicalTrials.gov ID
- NCT04430062
- Acronym / sponsor ID
- Covid19nr1
- Conditions
- General Surgery, Disease Outbreaks
- Keywords
- Surgery, Covid-19, SARS-CoV-2, Surgical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di LodiUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 patients operated (February 21st -April 10th) | – | Procedure: Surgical procedures performed under general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population referring to a community hospital during the SARS-CoV-2 outbreak in the Northern Italy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients operated without general anesthesia
- patients preoperatively intubated for Covid-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedures performed under general anesthesiaSurgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection | Procedure or surgery | Covid-19 patients operated (February 21st -April 10th) |
Primary outcome
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery and Disease Outbreaks, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.