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

NCT04434261 | Unknown

• 1 other identifier: 33467320.0.0000.0072
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV-2; Oncology; Surgery

Keywords

SARS-CoV-2; Surgical Oncology; PT-PCR Screening Test

Outcome Measures

Primary Outcomes (1)

• Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program

  Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center

  May- December 2020

Secondary Outcomes (4)

• Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;

  Up to 30 days

• Postoperative complications

  Up to 30 days

• Mortality

  30 days

• Delay in the cancer treatment

  May 2020- March 2021

Study Arms (1)

Patients tested for SARS-CoV-2

Patients who underwent the preoperative screening program for SARS-CoV-2

Diagnostic Test: PT-PCR test for SARS-CoV-2

Interventions

PT-PCR test for SARS-CoV-2 DIAGNOSTIC_TEST

Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients

Patients tested for SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with scheduled elective surgery, including all types of cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

Instituto Brasileiro de Controle do Cancer - IBCC

São Paulo, Brazil

RECRUITING

Related Publications (17)

• Shinde RS, Naik MD, Shinde SR, Bhandare MS, Chaudhari VA, Shrikhande SV, Dcruz AK. To Do or Not to Do?-A Review of Cancer Surgery Triage Guidelines in COVID-19 Pandemic. Indian J Surg Oncol. 2020 Jun;11(2):175-181. doi: 10.1007/s13193-020-01086-7. Epub 2020 May 11.

  PMID: 32395064 BACKGROUND

• Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.

  PMID: 32066541 BACKGROUND

• Romanzi A, Galletti M, Macchi L, Putorti A, Rossi F, Scolaro R, Vannelli A. Awake laparotomy: is locoregional anesthesia a functional option for major abdominal surgeries in the COVID-19 era? Eur Rev Med Pharmacol Sci. 2020 May;24(9):5162-5166. doi: 10.26355/eurrev_202005_21211.

  PMID: 32432781 BACKGROUND

• Wang H, Zhang L. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e181. doi: 10.1016/S1470-2045(20)30149-2. Epub 2020 Mar 3. No abstract available.

  PMID: 32142621 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28.

  PMID: 32345594 BACKGROUND

• Tan KK, Moran BJ, Solomon MJ. Avoiding collateral mortality in a pandemic - time to change our mindset in surgical oncology. Nat Rev Clin Oncol. 2020 Jul;17(7):383-385. doi: 10.1038/s41571-020-0383-1.

  PMID: 32372035 BACKGROUND

• Tuech JJ, Gangloff A, Di Fiore F, Michel P, Brigand C, Slim K, Pocard M, Schwarz L. Strategy for the practice of digestive and oncological surgery during the Covid-19 epidemic. J Visc Surg. 2020 Jun;157(3S1):S7-S12. doi: 10.1016/j.jviscsurg.2020.03.008. Epub 2020 Mar 31.

  PMID: 32249098 BACKGROUND

• Schrag D, Hershman DL, Basch E. Oncology Practice During the COVID-19 Pandemic. JAMA. 2020 May 26;323(20):2005-2006. doi: 10.1001/jama.2020.6236. No abstract available.

  PMID: 32282023 BACKGROUND

• Bourget-Murray J, Heard BJ, Bansal R, Johnson AS, Powell J. Postoperative fever in the time of COVID-19. Can J Surg. 2020 May 8;63(3):E231-E232. doi: 10.1503/cjs.004720.

  PMID: 32386473 BACKGROUND

• Bartlett DL, Howe JR, Chang G, Crago A, Hogg M, Karakousis G, Levine E, Maker A, Mamounas E, McGuire K, Merchant N, Shibata D, Sohn V, Solorzano C, Turaga K, White R, Yang A, Yoon S; Society of Surgical Oncology. Management of Cancer Surgery Cases During the COVID-19 Pandemic: Considerations. Ann Surg Oncol. 2020 Jun;27(6):1717-1720. doi: 10.1245/s10434-020-08461-2. Epub 2020 Apr 8. No abstract available.

  PMID: 32270420 BACKGROUND

• Tilmans G, Chenevas-Paule Q, Muller X, Breton A, Mohkam K, Ducerf C, Mabrut JY, Lesurtel M. Surgical outcomes after systematic preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening. Surgery. 2020 Aug;168(2):209-211. doi: 10.1016/j.surg.2020.05.006. Epub 2020 May 18. No abstract available.

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• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29.

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• Peak CM, Kahn R, Grad YH, Childs LM, Li R, Lipsitch M, Buckee CO. Individual quarantine versus active monitoring of contacts for the mitigation of COVID-19: a modelling study. Lancet Infect Dis. 2020 Sep;20(9):1025-1033. doi: 10.1016/S1473-3099(20)30361-3. Epub 2020 May 20.

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• Ganesh Kumar N, Drolet BC. COVID-19 - Implications on and of Surgical Practices: Where Do We Draw the Line? Ann Surg. 2020 Aug;272(2):e45-e46. doi: 10.1097/SLA.0000000000004009. No abstract available.

  PMID: 32675491 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Andre Lopes, MD

  Instituto Brasileiro de Controle do Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Lopes, MD

CONTACT

+551134744242; andrelopes1002@hotmail.com

Alayne Yamada, PhD

CONTACT

+551134744242; alayne.pesquisa@ibcc-mooca.org.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 16, 2020
• Study Start: May 11, 2020
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available in a scientific publication
• Access Criteria: There are no sharing Access Criteria

Locations

BR (1)