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

Surgery Clinical Trial

— ASTANA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434261
• Other study ID #: 33467320.0.0000.0072
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Andre Lopes, MD
• Phone: +551134744242
• Email: andrelopes1002[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 30, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology
• SARS-CoV-2
• Surgery

Intervention

Diagnostic Test:
• PT-PCR test for SARS-CoV-2
Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients

Locations

Country	Name	City	State
Brazil	Instituto Brasileiro de Controle do Cancer - IBCC	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Lancet. 2020 Jun 9;:. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Romanzi A, Galletti M, Macchi L, Putortì 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. — View Citation

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. — View Citation

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 May 11:1-7. doi: 10.1007/s13193-020-01086-7. [Epub ahead of print] Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

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