Clinical trial NCT04434261: Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2
Official title: Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Oncology
Surgery
Keywords: SARS-CoV-2
Surgical Oncology
PT-PCR Screening Test
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with scheduled elective surgery, including all types of cancer

Brief summary: To evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution

Detailed description: Cohort, prospective, observational study to evaluate the incidence of asymptomatic patients with a positive SARS-CoV-2 test detected in the preoperative screening program of the institution.

Eligibility criteria: Inclusion Criteria:

* Patients with elective surgery scheduled at the IBCC, including those diagnosed with any type of cancer;
* Patients who will undergo the screening test for SARS-COV-2 by RT-PCR (nasal swab), according to the guidelines and protocol of the hospital

Exclusion Criteria:

* Urgent or emergency surgery;
* Screening test for SARS-COV-2 not performed
* Incomplete data in the institutional database

Primary outcomes:
measure: Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program
timeFrame: May- December 2020
Secondary outcomes:
measure: Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;
timeFrame: Up to 30 days
measure: Postoperative complications
timeFrame: Up to 30 days
measure: Mortality
timeFrame: 30 days
measure: Delay in the cancer treatment
timeFrame: May 2020- March 2021
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer - IBCC
Study officials:
affiliation: Instituto Brasileiro de Controle do Cancer
name: Andre Lopes, MD
role: PRINCIPAL_INVESTIGATOR
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