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The current Sars-CoV-2 (COVID-19) pandemic has created major changes in how physicians perform routine healthcare for our patients, including elective and non-elective surgical procedures. Beginning on March 16th, 2020 Northwell Health postponed all elective surgeries. As the incidence of COVID-19 cases begins to decrease and hospital volume improves we need to ensure the safety of our patients planning surgical procedures. However, at this time there is a scarcity of data regarding the COVID-19 test conversion rate in surgical patients. Our goal is to determine the COVID-19 test conversion rate in these patients to better guide strategies for restarting surgical care in a large-scale pandemic.
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.
The rapid spread of the COVID-19 infection has led to a near global lockdown including a pause in all elective surgeries [1-6]. Multiple healthcare systems and surgical societies recommended ceasing all elective procedures until this crisis is contained [7-10]. As such, it will be necessary for hospitals to restructure as surgeries increase to protect surgical patients from becoming infected. Our study will be the first to define the test conversion rate of those undergoing surgical procedures during the COVID-19 pandemic. The information gathered from this study can have implications in how surgical centers treat patients during and after this pandemic.
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 PCR and Serology | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Test Conversion | Patients that have negative pre-operative testing that convert to positive testing 14 days post-discharge | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Days from hospital admission to discharge. | 14 days |
| Rate of self-reported COVID-19 exposure | Patients will be asked to describe if they have had any exposure to COVID-19 positive persons after their hospital stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Molmenti, MD, PhD, MBA | Northwell Health | Principal Investigator |
| Aaron Nizam, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 10030 | United States | ||
| Long Island Jewish Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Result | 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. | |
| 32109013 |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
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Prospective Cohort
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|
| 14 days |
| Rate of complications from COVID-19 | If patients contract COVID-19 during the postoperative period, what complications occur? | 14 days |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| Result |
| 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. |
| 32014114 | Result | 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. |
| 31995857 | Result | 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. |
| 32242095 | Result | 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. |
| 32209891 | Result | 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. |
| 32292899 | Result | 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. |
| 32314249 | Result | 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. |
| 32381426 | Result | 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. |
| 32259322 | Result | 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. |
| 32259546 | Result | 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. |
| 32234250 | Result | 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. |
| 34543753 | Derived | 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. |
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |