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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Surgery--Complications; Nosocomial Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 2530

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Marta Caballero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Maria Jose MJ Colomina, PhD, Head of the department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: COVID19; mortality; surgery complications; Hospital stay; emergency surgery; scheduled surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Iatrogenic Disease; COVID-19; Cross Infection
• Other Study ID Numbers: COVID19 surgical impact

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No