Incidence of COVID-19 Test Conversion in Post-surgical Patients
NCT ID: NCT04392323
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2020-05-13
2020-10-04
Brief Summary
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Patients will be routinely tested with serology and PCR for COVID-19 24-48 hours prior to their scheduled surgery. Those who provide informed consent will be re-tested 12-16 days after discharge from the hospital to determine any potential nosocomial infection rate. Patients will also answer a few questions during their retest to allow the study team to gauge exposure risk postoperatively after leaving the hospital.
Detailed Description
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There has been a single study examining postoperative nosocomial infections during the initial incubation period in which 100% of patients developed Sars-CoV-2 viral pneumonia, 14 (44%) required ICU admission with mechanical ventilation, and 7 (20.5%) died after ICU admission \[11\]. A second cohort of bariatric surgery patients found that 4 of 4 (100%) developed Sars-CoV-2 infections postoperatively with all patients surviving \[12\]. Another retrospective study found that of 305 patients admitted to the digestive surgery service, 15 (4.9%) developed nosocomial Sars-CoV-2 pneumonia \[13\]. Of this cohort, two patients died, and seven were hospitalized with six discharged at the time of chart review. Another retrospective non-operative hospital cohort found that 34 of 102 adult patients contracted Sars-CoV-2 as a nosocomial infection. In a review of Gynecologic Oncology procedures in Wuhan the overall nosocomial infection rate was 1.59% (3/189) with two of the three patients being discharged by the publication date \[14\]. However, in a retrospective review of a general hospital ward in Hong Kong in which the staff used 'vigilant basic infection control measures' 10 patients and 7 staff members that met the definition for close contact were identified and through contact tracing 76 tests were performed on 52 contacts with no Sars-CoV-2 infections identified \[15\]. Another cohort from Wuhan demonstrated that when performing regional anesthesia (45/49 for Cesarean Section), no anesthetists were infected when complying with level 3 PPE \[16\].
1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
2. Guan, Wei-jie, et al. "Clinical characteristics of coronavirus disease 2019 in China." New England journal of medicine (2020).
3. Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet 2020 January 31 (Epub ahead of print).
4. Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. DOI: 10.1056/NEJMoa2001316.
5. Hanna, T.P., Evans, G.A. and Booth, C.M., 2020. Cancer, COVID-19 and the precautionary principle: prioritizing treatment during a global pandemic. Nature Reviews Clinical Oncology, 17(5), pp.268-270.
6. Brindle, M. and Gawande, A., 2020. Managing COVID-19 in surgical systems. Annals of Surgery.
7. American College of Surgeons (2020). COVID-19: Recommendations for Management of Elective Surgical Procedures. Retrieved March 13, 2020 from https://www.facs.org/covid-19/clinical-guidance/elective-surgery
8. SAGES (2020). SAGES AND EAES RECOMMENDATIONS REGARDING SURGICAL RESPONSE TO COVID-19 CRISIS. Retrieved March 29, 2020 from https://www.sages.org/recommendations-surgical-response-covid-19/
9. American Society of Plastic Surgeons (2020). APS Guidance Regarding Elective and Non-Essential Patient Care. Retrieved March 19th , 2020 from https://www.plasticsurgery.org/for-medical-professionals/covid19-member-resources/previous-statements
10. American College of Obstetrics and Gynecology (2020). Joint Statement: Scheduling Elective Surgeries. Retrieved March 16th, 2020 from https://www.sgo.org/clinical-practice/management/scheduling-elective-surgeries/
11. S. Lei, F. Jiang, W. Su, et al.Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine (2020), p. 100331
12. Aminian A, Kermansaravi M, Azizi S, et al. Bariatric Surgical Practice During the Initial Phase of COVID-19 Outbreak \[published online ahead of print, 2020 Apr 20\]. Obes Surg. 2020;1-4. doi:10.1007/s11695-020-04617-x
13. Luong-Nguyen M, Hermand H, Abdalla S, et al. Nosocomial infection with SARS-CoV-2 within Deparments of Digestive Surgery. \[published ahead of print, 2020 Apr 27\] J of Vis Surg. 2020.
14. Yang S, Zhang Y, Cai J, Wang Z. Clinical Characteristics of COVID-19 After Gynecologic Oncology Surgery in Three Women: A Retrospective Review of Medical Records \[published online ahead of print, 2020 Apr 7\]. Oncologist. 2020;10.1634/theoncologist.2020-0157. doi:10.1634/theoncologist.2020-0157
15. Wong SC, Kwong RT, Wu TC, et al. Risk of nosocomial transmission of coronavirus disease 2019: an experience in a general ward setting in Hong Kong \[published online ahead of print, 2020 Apr 4\]. J Hosp Infect. 2020; doi:10.1016/j.jhin.2020.03.036
16. Zhong Q, Liu YY, Luo Q, et al. Spinal anaesthesia for patients with coronavirus disease 2019 and possible transmission rates in anaesthetists: retrospective, single-centre, observational cohort study \[published online ahead of print, 2020 Mar 28\]. Br J Anaesth. 2020;S0007-0912(20)30161-6. doi:10.1016/j.bja.2020.03.007
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study Group
Patients will be recruited as an outpatient prior to their surgical procedure or during their hospital admission. If they consent, they will provide signed informed consent and will receive testing with serology and PCR for COVID-19 infection at pre-surgical testing 24-48 hours prior to their scheduled procedure. If they consent while inpatient postoperatively, signed informed consent will be procured after they have completed their pre-operative COVID-19 testing. PCR for COVID entails obtaining a nasopharyngeal swab to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital.
COVID-19 PCR and Serology
PCR for COVID entails obtaining a nasopharyngeal swab (a cotton tip introduced via the nose to obtain a sample) to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital. Serology implies that a blood sample will be obtained by venipuncture. A volume of 50 ml (about 4 tablespoons) or less of blood will be obtained.
Interventions
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COVID-19 PCR and Serology
PCR for COVID entails obtaining a nasopharyngeal swab (a cotton tip introduced via the nose to obtain a sample) to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital. Serology implies that a blood sample will be obtained by venipuncture. A volume of 50 ml (about 4 tablespoons) or less of blood will be obtained.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18.
3. Written Voluntary Informed Consent.
Exclusion Criteria
2. Prior documented COVID-19 Infection.
3. Current hospital inpatient prior to procedure.
4. Person Under Investigation for COVID-19 infection.
5. Current use of antiviral medications.
6. Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) .
7. Documented immunodeficiency.
8. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
9. Outpatient procedures with planned same-day discharge.
18 Years
ALL
Yes
Sponsors
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Northwell Health
OTHER
Responsible Party
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Ernesto Molmenti
Vice Chairman of Surgery - Chief of Innovation. North Shore University Hospital, Northwell Health. Professor of Surgery, Medicine, and Pediatrics, Zucker School of Medicine at Hofstra/Northwell
Principal Investigators
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Ernesto Molmenti, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Aaron Nizam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Countries
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References
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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
Hanna TP, Evans GA, Booth CM. Cancer, COVID-19 and the precautionary principle: prioritizing treatment during a global pandemic. Nat Rev Clin Oncol. 2020 May;17(5):268-270. doi: 10.1038/s41571-020-0362-6.
Brindle ME, Gawande A. Managing COVID-19 in Surgical Systems. Ann Surg. 2020 Jul;272(1):e1-e2. doi: 10.1097/SLA.0000000000003923. No abstract available.
Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.
Aminian A, Kermansaravi M, Azizi S, Alibeigi P, Safamanesh S, Mousavimaleki A, Rezaei MT, Faridi M, Mokhber S, Pazouki A, Safari S. Bariatric Surgical Practice During the Initial Phase of COVID-19 Outbreak. Obes Surg. 2020 Sep;30(9):3624-3627. doi: 10.1007/s11695-020-04617-x.
Luong-Nguyen M, Hermand H, Abdalla S, Cabrit N, Hobeika C, Brouquet A, Goere D, Sauvanet A. Nosocomial infection with SARS-Cov-2 within Departments of Digestive Surgery. J Visc Surg. 2020 Jun;157(3S1):S13-S18. doi: 10.1016/j.jviscsurg.2020.04.016. Epub 2020 Apr 27.
Yang S, Zhang Y, Cai J, Wang Z. Clinical Characteristics of COVID-19 After Gynecologic Oncology Surgery in Three Women: A Retrospective Review of Medical Records. Oncologist. 2020 Jun;25(6):e982-e985. doi: 10.1634/theoncologist.2020-0157. Epub 2020 Apr 7.
Wong SCY, Kwong RT, Wu TC, Chan JWM, Chu MY, Lee SY, Wong HY, Lung DC. Risk of nosocomial transmission of coronavirus disease 2019: an experience in a general ward setting in Hong Kong. J Hosp Infect. 2020 Jun;105(2):119-127. doi: 10.1016/j.jhin.2020.03.036. Epub 2020 Apr 4.
Zhong Q, Liu YY, Luo Q, Zou YF, Jiang HX, Li H, Zhang JJ, Li Z, Yang X, Ma M, Tang LJ, Chen YY, Zheng F, Ke JJ, Zhang ZZ. Spinal anaesthesia for patients with coronavirus disease 2019 and possible transmission rates in anaesthetists: retrospective, single-centre, observational cohort study. Br J Anaesth. 2020 Jun;124(6):670-675. doi: 10.1016/j.bja.2020.03.007. Epub 2020 Mar 28.
Nizam A, Nimaroff ML, Menzin AW, Goldberg GL, Miyara SJ, Molmenti E. Nosocomial COVID-19 infection in women undergoing elective cesarean delivery: a prospective cohort study. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100490. doi: 10.1016/j.ajogmf.2021.100490. Epub 2021 Sep 17.
Other Identifiers
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IRB #20-0404
Identifier Type: -
Identifier Source: org_study_id