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NCT Number: NCT04780594

Impact of the COVID-19 Pandemic on the Surgical Activity of 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Cross Infection Disease Attributes Iatrogenic Disease Infections Lung Diseases Nidovirales Infections Nosocomial Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Surgery--Complications Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marta Caballero

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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