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COVID-19 has been a challenge for hospitals; there was an obvious need to reconvert many spaces in specific areas to attend this pathology, without forgetting the attention to other pathologies and surgery. The objective of the investigators is to evaluate the impact of this pandemic in the patients who underwent surgery in Bellvitge University Hospital, analyzing 2 periods of time: the months before the COVID-19 peak and the COVID-19 peak months.
A total of 2.530 procedures have been evaluated in this retrospective observational study. Two groups have been generated (pre-pandemic period and pandemic period), classified into scheduled and emergency surgery. The investigators determined age, type of surgery and specialty, hospital stay, destination at discharge including mortality and severity according to Diagnostic Related to Group (DRG) scale. The investigators have also determined the number of confirmed COVID-19 infections in patients who underwent surgery during these 2 periods and evaluated if the infection was due to a nosocomial infection (confirmation of the COVID-19 during the hospitalization period). Comparisons were made between subgroups: scheduled surgery performed during the 2 periods and emergency surgery performed during the 2 periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-pandemic COVID-19 group (PreCOVID) | All patients who underwent surgery from 13th January until 29th February 2020, which are considered free of COVID-19 patients, therefore pre-pandemic period. |
| |
| Pandemic COVID-19 group (COVID) | All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The study evaluates all surgical patients operated, both elective scheduled and emergent cases | Procedure | Administrative database was automatically collected. That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures. A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases. According to the Diagnoses-related Groups (DRG's). the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Register the post-surgical complications | Register and Compare the Rate of Surgical Reintervention between both periods. | PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020. |
| Measure | Description | Time Frame |
|---|---|---|
| Register the rate of surgical reintervention | Register and compare the Rate of reintervention between both periods. | PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020. |
| Register the ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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The requirement to include patients was that they required surgery, either urgent or scheduled, during the periods described (PreCOVID and COVID). As there is no paediatric service in the hospital, the minimum age of the sample is 18 years old but there is no maximum age for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jose MJ Colomina, PhD | Head of the Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marta Caballero | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34836504 | Derived | Caballero-Milan M, Colomina MJ, Marin-Carcey LA, Viguera-Fernandez L, Bayona-Domenge R, Garcia-Ballester S, Lopez-Farre A, Ruiz-Buera L, Sanz-Iturbe M, Alvarez-Villegas D, Jenssen-Paz EC, Puig-Sanz G, Arcos-Terrones A, Belmonte-Cuenca C, Perelada-Alonso E, Blasco-Blasco F, Sabate A. Impact of the SARS-CoV-2 (COVID19) pandemic on the morbidity and mortality of high risk patients undergoing surgery: a non-inferiority retrospective observational study. BMC Anesthesiol. 2021 Nov 26;21(1):295. doi: 10.1186/s12871-021-01495-3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2020 | Feb 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
register and compare the ICU admission between both periods. |
| PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020. |
| Register the Hospital stay | register and compare the ICU admission between both periods. | PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020. |
| Register the Mortality | register and compare the Mortality between both periods. | PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |