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

NCT04780594 | Completed

• 1 other identifier: COVID19 surgical impact
• Study Type: observational
• Target: 2,530
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Surgery--Complications; Nosocomial Infection

Keywords

COVID19; Hospital stay; mortality; surgery complications; scheduled surgery; emergency surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Register the rate of surgical reintervention

  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

  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

  PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.

• Register the Mortality

  PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.

Study Arms (2)

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

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

Interventions

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)

Pandemic COVID-19 group (COVID); Pre-pandemic COVID-19 group (PreCOVID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All surgical patients operated, both elective scheduled and emergent cases

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Marta Caballero

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• 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.

  PMID: 34836504 DERIVED

MeSH Terms

Conditions

COVID-19; Cross Infection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Jose MJ Colomina, PhD

  Head of the Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff in Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: February 13, 2020
• Primary Completion: May 15, 2020
• Study Completion: December 9, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

ES (1)