- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04780594
Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital
2 mars 2021 uppdaterad av: Marta Caballero Milan, Hospital Universitari de Bellvitge
Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
2530
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Barcelona
-
Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Marta Caballero
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
N/A
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- All surgical patients operated, both elective scheduled and emergent cases
Exclusion Criteria:
- Minor-intermediate surgery that involves discharge from the hospital on the same day of the surgery from the Pre-pandemic period.
- Procedures related to medical treatment or complications of COVID-19 patients, such as chest tubes, extracorporeal oxygenation or tracheostomy.
- Those scheduled elective surgery patients in the Covid period that resulted RT-PCR positive, surgery was posponed, were not considered eligible for the analysis.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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)
|
|
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.
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Register the post-surgical complications
Tidsram: PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Register the rate of surgical reintervention
Tidsram: PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
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
Tidsram: PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
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
Tidsram: PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
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
Tidsram: PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
|
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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Maria Jose MJ Colomina, PhD, Head of the department
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 februari 2020
Primärt slutförande (Faktisk)
15 maj 2020
Avslutad studie (Faktisk)
9 december 2020
Studieregistreringsdatum
Först inskickad
1 mars 2021
Först inskickad som uppfyllde QC-kriterierna
2 mars 2021
Första postat (Faktisk)
3 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- COVID19 surgical impact
Plan för individuella deltagardata (IPD)
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