Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2

• Conditions: Surgery; Oncology; SARS-CoV-2
• Interventions: Diagnostic Test: PT-PCR test for SARS-CoV-2

• Registration Number: NCT04434261
• Lead Sponsor: Instituto Brasileiro de Controle do 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.

Study Timeline

• Study Start: 2020-05-11
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Primary Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients tested for SARS-CoV-2	PT-PCR test for SARS-CoV-2	Patients who underwent the preoperative screening program for SARS-CoV-2

Primary Outcome Measures

Name	Time	Method
Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program	May- December 2020	Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Up to 30 days	Postoperative complications will be recorded, according to the Clavien-Dindo classification.
Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;	Up to 30 days	Describe the incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test.
Delay in the cancer treatment	May 2020- March 2021	Assess the impact of delayed cancer treatment
Mortality	30 days	To evaluate the risk of all-cause mortality

Trial Locations

Locations (1)

Instituto Brasileiro de Controle do Cancer - IBCC; 🇧🇷 Sao Paulo, Brazil