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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780594
• Other study ID #: COVID19 surgical impact
• Status: Completed
• Start date: February 13, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: March 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2530
• Est. completion date: December 9, 2020
• Est. primary completion date: May 15, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Cross Infection
• Nosocomial Infection
• Surgery--Complications

Intervention

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)

Locations

Country	Name	City	State
Spain	Marta Caballero	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.