key: cord-0980444-x5l8i15z authors: Kho, Rosanne M; Chang, Olivia H; Hare, Adam; Schaffer, Joseph; Hamner, Jen; Northington, Gina M; Metcalfe, Nina Durchfort; Iglesia, Cheryl B; Zelivianskaia, Anna S; Hur, Hye-Chun; Seaman, Sierra; Mueller, Margaret G; Milad, Magdy; Ascher-Walsh, Charles; Kossl, Kelsey; Rardin, Charles; Siddique, Moiuri; Murphy, Miles; Heit, Michael title: Surgical Outcomes in Benign Gynecologic Surgery Patients during the COVID-19 Pandemic (SOCOVID study) date: 2021-08-23 journal: J Minim Invasive Gynecol DOI: 10.1016/j.jmig.2021.08.011 sha: de8dd5faf22afbb8780f9a2496ff2b944c87bf9d doc_id: 980444 cord_uid: x5l8i15z Study Objective To determine the incidence of perioperative COVID-19 in women undergoing benign gynecologic surgery, and to evaluate perioperative complication rates in patients with active, prior or no prior SARS-CoV-2 infection. Design Multicenter prospective cohort study Setting Ten institutions in the United States Patients Patients over the age of 18 years who underwent benign gynecologic surgery from July 1, 2020 to December 31, 2020 were included. All patients were followed from the time of surgery until 10 weeks post-operatively. Those with intra-uterine pregnancy or known gynecologic malignancy were excluded. Interventions Benign gynecologic surgery Measurements The primary outcome was the incidence of perioperative COVID-19 infections which was stratified as 1) prior COVID-19 infection, 2) pre-operative COVID-19 infection and 3) post-operative COVID-19 infection. Secondary outcomes included adverse events and mortality following surgery, as well as predictors for post-operative COVID-19 infection. If surgery was delayed due to the COVID-19 pandemic, the reason for postponement and any subsequent adverse event was recorded. Main Results Of 3423 patients included for final analysis, 189 (5.5%) postponed their gynecologic surgery during the pandemic. Forty-three patients (1.3% of total cases) were due to a history of COVID-19. The majority (182 [96.3%]) had no sequelae attributed to surgical postponement. Following hospital discharge to 10 weeks post-operatively, 39 (1.1%) patients became infected with SARS-CoV-2. The mean duration of time between hospital discharge and the follow-up positive COVID-19 test was 22.1 ± 12.3 days (range 4-50 days). Eleven (31.4% of post-operative COVID-19 infections, 0.3% of total cases) of the newly diagnosed COVID-19 infections occurred within 14 days of hospital discharge. On multivariable logistic regression, living in the Southwest (adjOR 6.8) and single-unit increase in age-adjusted Charlson co-morbidity index (adjOR 1.2) increased the odds of post-operative COVID-19 infection. Peri-operative complications were not significantly higher in patients with a history of prior positive COVID-19 compared to those without a history of COVID-19, though the mean duration of time between prior COVID-19 diagnosis and surgery was 97 days (14 weeks). Conclusion In this large multi-center prospective cohort study of benign gynecologic surgeries, only 1.1% of patients developed a post-operative COVID-19 infection, with 0.3% of infection in the immediate 14-days after surgery. The incidence of post-operative complications was not different in those with and without prior COVID-19 infections. Precis: Only 0.3% of patients developed COVID-19 in the 14-days after benign gynecologic surgery. There were no differences in peri-operative complications in those with and without prior COVID-19 infections. Study Objective: To determine the incidence of perioperative COVID-19 in women undergoing benign gynecologic surgery, and to evaluate perioperative complication rates in patients with active, prior or no prior SARS-CoV-2 infection. Setting: Ten institutions in the United States Patients: Patients over the age of 18 years who underwent benign gynecologic surgery from July 1, 2020 to December 31, 2020 were included. All patients were followed from the time of surgery until 10 weeks post-operatively. Those with intra-uterine pregnancy or known gynecologic malignancy were excluded. Elective and non-urgent surgeries resumed in mid-2020 once personal protective equipment and COVID-19 testing became more readily available. To continue caring for patients with non-urgent conditions, we witnessed a rapid scale-up of telemedicine. 2 When surgical cases resumed, it was estimated that 41% of U.S. adults delayed or deferred care during the pandemic. 3 This delay may reflect adherence to stay-at-home orders, pandemic circumstances making access to medical care difficult or fear of contracting or spreading COVID-19 despite implementation of universal COVID testing pre-operatively across major institutions. 4 For patients who did subsequently proceed with surgery during the pandemic, there are limited data on surgical outcomes during the COVID-19 pandemic including outcomes in patients actively or previously infected with SARS-CoV-2. This study was designed to understand peri-operative COVID-19 infection rates and how COVID-19 impacts surgical outcomes in women undergoing benign gynecologic surgery. The primary objective of our study is to determine the incidence of peri-operative COVID-19 in women undergoing benign gynecologic surgeries. Our secondary aims were to determine the incidence of surgical morbidity and mortality in gynecologic patients undergoing surgery with an active SARS-CoV-2 infection, prior infection, or no infection, in addition to identifying predictors for post-operative COVID-19 infection. This multicenter prospective cohort study was conducted at ten institutions across the United States to evaluate the surgical outcomes of patients undergoing benign gynecologic surgeries during the COVID-19 pandemic (SOCOVID study). Ten institutions were selected to attempt to capture a wide geographic cohort and variety of benign gynecologic procedures. Institutional review board (IRB) approval was obtained at each site. All patients over the age of 18 years old who underwent benign gynecologic surgery from July 1, 2020 to December 31, 2020 were included. All patients were prospectively followed from the time of surgery until 10 weeks post-operatively to capture wide practice variations across ten sites. Those with intra-uterine pregnancy or known gynecologic malignancy were excluded. Peri-operative variables of interest were extracted from the medical record, including retrospective data for demographics and variables related to COVID infection (Appendix, Table 1 ). The Charlson co-morbidity index, a tool that has been studied to predict mortality based on scoring of medical comorbidities, was calculated for all patients with age and non-age adjustments. 5 As previously published, all patients received pre-operative COVID-19 testing up to 5 days before scheduled surgery per institutional protocols. 4 A total of 3541 patients were included in the prospective cohort from ten surgical sites from July 1 st 2020 until December 31 st 2020. After removing entries for missing or inconsistent data, a total of 3423 entries (96.7%) were included for final analysis. Our study period occurred during the second and third peak of COVID-19 infections in the United States. Figure Table 1 . Surgical variables including the most commonly performed surgeries are shown in Table 2 . The most commonly performed surgery was hysteroscopy (17.5%), followed by laparoscopic adnexal surgery (13.6%) then total laparoscopic hysterectomy (12.5%). Most surgeries were elective (96.5%). One hundred and eighty-nine ( Table 3 . On bivariate analysis, there were significant differences in age and body-mass index, race/ethnicity, region of country, and occupation in healthcare between groups. Twenty-seven (0.8%) patients had a positive requisite pre-operative COVID-19 test. Among these 27 patients, 5 (18.5%) had a prior COVID infection, and retesting was not There were 104 (3%) intraoperative complications associated with gynecologic surgery. In the cohort, 277 (8.1%) patients developed immediate post-operative complications. The most common were pain, nausea/vomiting and blood product transfusion. Details are available in the Appendix, Table 2 . There were no cases of newly diagnosed COVID-19 infection in the immediate post-operative hospitalization period. There was one death postoperatively during hospitalization, that was neither due to a COVID-19 diagnosis nor a surgical complication. were two deaths post-operatively after hospital discharge due to cancer-related complications, that were neither due to a COVID-19 diagnosis nor a surgical complication. Any intraoperative, immediate post-operative, or post-discharge follow-up complications were not significantly higher in patients who had a positive COVID-19 test at any time prior to gynecologic surgery compared to all others (Table 5) . To date, the SOCOVID study is the largest known national prospective cohort study in the United States that evaluates benign gynecologic surgery outcomes during the SARS-CoV-2 pandemic. We found a low incidence ( Our study showed that only 0.3% of the study population tested newly positive for however, because universal post-operative COVID testing was not conducted as part of our study, the reported incidence may be an underestimation of post-operative infections. In this study of mostly minimally invasive gynecologic surgery, only 1.3% of benign surgical cases from July 1 to December 31, 2020 were postponed due to a pre-operative COVID-positive test. Fortunately, most of these patients did not suffer any sequelae as a result of surgical postponement though this likely is because most patients in our cohort were undergoing elective surgeries. Most cases for benign gynecologic conditions such as uterine fibroids, abnormal uterine bleeding or pelvic organ prolapse were categorized as Tier 1a (defined as low acuity and non-life-threatening illness) with the previously published "Elective Surgery Acuity Scale". 9 This may affirm that the tiered ranking systems developed to reintroduce elective cases appropriately triaged cases. Furthermore, in the event that elective procedures are to be postponed or delayed in the future, our data shows that postponement of these types of elective surgery did not lead to significant morbidity or mortality. When looking at the 1. to the pandemic, same-day discharge was shown to be feasible 10 with no differences seen in readmission after hysterectomy 11 or pelvic organ prolapse surgery. 12 In light of the current pandemic, our study suggests the additional benefit of limiting the duration of post-operative hospital stay to also include reduced odds of acquiring nosocomial COVID infection. In patients with active COVID-19 infections undergoing surgery, there is a reported increase in surgical mortality and complications, 13 There are several strengths to this study. This prospective study design allowed us to follow all patients during the study period to capture all peri-operative COVID-19 infections and the associated complications. The multi-center design of this study allowed the inclusion of a diverse population of women undergoing a variety of mostly elective, minimally invasive and outpatient gynecologic surgeries. All centers underwent training to ensure standardized data entry. There are several limitations to this study. To coordinate IRB approval across 10 studysites, data collection did not begin until July 1, 2020 which was after the initial peak of cases in the Northeast. Furthermore, we do not have a complete geographic representation of the United States. We planned to have sites from the West coast, but again due to IRB-related issues our West coast sites were unable to enroll subjects. 18.8 ± 49.7 (range = 0.17 -1620), MIGS = minimally-invasive gynecologic surgery. REI = Reproductive Endocrinology and Infertility, ASA = American Society of Anesthesiologists; BSO = bilateral salpingooophorectomy; All data presented as N(%), mean ± standard deviation unless otherwise specified First Travel-related Case of 2019 Novel Coronavirus Detected in United States | CDC Online Newsroom | CDC A guide for urogynecologic patient care utilizing telemedicine during the COVID-19 pandemic: review of existing evidence Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns -United States Institutional protocols for coronavirus disease 2019 testing in elective gynecologic surgery across sites for the Society of Gynecologic Surgeons' Surgical Outcomes during the COVID-19 pandemic (SOCOVID) study A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) The incubation period of coronavirus disease 2019 (CoVID-19) from publicly reported confirmed cases: Estimation and application Joint Statement on Re-introduction of Hospital and Office-based Procedures for the Practicing Urogynecologist and Gynecologist Systematic review of same-day discharge after minimally invasive hysterectomy Readmission Rates after Same-Day Discharge Compared with Postoperative Day 1 Discharge after Benign Laparoscopic Hysterectomy Comparison of 30-Day Readmission After Same-Day Compared With Next-Day Discharge in Minimally Invasive Pelvic Organ Prolapse Surgery Factors Associated with Surgical Mortality and Complications among Patients with and without Coronavirus Disease Mortality and pulmonary complications in patients undergoing surgery with perioperative sars-cov-2 infection: An international cohort study Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia Incidence of Venous Thromboembolism and Mortality in Patients with Initial Presentation of COVID-19 Andrew's COVID-19 surgery safety (StACS) study: The Burns Centre experience Minimal impact of COVID-19 outbreak on the postoperative morbidity and mortality following emergency general surgery procedures: Results from a 3-month observational period Timing of surgery following SARS-CoV-2 infection: an international prospective cohort study Uterine weight and complications after abdominal, laparoscopic, and vaginal hysterectomy *Positive pre-operative COVID-19 tests included those who tested positive remote from surgery, or those who tested positive pre-operatively per institutional testing protocols Negative pre-operative COVID-19 tests include patients who tested negative, had pending or inconclusive tests BMI = body-mass index; Only statistically significant bivariate associations are shown. All data presented as N(%), mean ± standard deviation unless otherwise specified Only statistically significant bivariate associations are shown. All data presented as N(%), mean ± standard deviation unless otherwise specified Appendix - Table 1 .