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

NCT ID: NCT04780594

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2020-12-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19 Surgery--Complications Nosocomial Infection

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Intervention Type 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)

All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis.

The study evaluates all surgical patients operated, both elective scheduled and emergent cases

Intervention Type 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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Marta Caballero Milan

Medical Staff in Anaesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Jose MJ Colomina, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of the Department

Locations

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Marta Caballero

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 34836504 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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COVID19 surgical impact

Identifier Type: -

Identifier Source: org_study_id

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