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Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital

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ClinicalTrials.gov Identifier: NCT04780594
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Marta Caballero Milan, Hospital Universitari de Bellvitge

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Surgery--Complications Nosocomial Infection Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 2530 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital
Actual Study Start Date : February 13, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : December 9, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases
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.
Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases
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)




Primary Outcome Measures :
  1. Register the post-surgical complications [ Time Frame: 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.


Secondary Outcome Measures :
  1. Register the rate of surgical reintervention [ Time Frame: 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.

  2. Register the ICU admission [ Time Frame: 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.

  3. Register the Hospital stay [ Time Frame: 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.

  4. Register the Mortality [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780594


Locations
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Spain
Marta Caballero
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: Maria Jose MJ Colomina, PhD Head of the Department
  Study Documents (Full-Text)

Documents provided by Marta Caballero Milan, Hospital Universitari de Bellvitge:
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Responsible Party: Marta Caballero Milan, Medical Staff in Anaesthesiology and Reanimation, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT04780594    
Other Study ID Numbers: COVID19 surgical impact
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Caballero Milan, Hospital Universitari de Bellvitge:
COVID19
Hospital stay
mortality
surgery complications
scheduled surgery
emergency surgery
Additional relevant MeSH terms:
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Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes