key: cord-0877897-8kmsej7i
authors: Kavanagh, F.G.; James, D.L.; Brinkman, D.; Cornyn, S.; Murphy, C.; O'Neill, S.; O'Shea, R.; Affendi, A.; B.Lang; O'Connor, A.; Keogh, I.; Lang, E.; Russell, J.; O'Brien, D.; Sheahan, P.
title: Safety of elective paediatric surgery during the coronavirus disease 2019 pandemic
date: 2021-08-08
journal: Int J Pediatr Otorhinolaryngol
DOI: 10.1016/j.ijporl.2021.110861
sha: c220c799853bd254e65076a1d3a88956f2df2e79
doc_id: 877897
cord_uid: 8kmsej7i

INTRODUCTION: Corona-virus Disease 2019 (COVID-19) has had a huge impact on the delivery of healthcare worldwide, particularly elective surgery. There is a lack of data regarding risk of postoperative COVID-19 infection in children undergoing elective surgery, and regarding the utility of pre-operative COVID-19 testing, and preoperative “cocooning” or restriction of movements. The purpose of this present study was to examine the safety of elective paediatric Otolaryngology surgery during the COVID-19 pandemic with respect to incidence of postoperative symptomatic COVID-19 infection or major respiratory complications. MATERIALS AND METHODS: Prospective cohort study of paediatric patients undergoing elective Otolaryngology surgery between September and December 2020. Primary outcome measure was incidence of symptomatic COVID-19 or major respiratory complications within the 14 days after surgery. Parents of prospectively enrolled patients were contacted 14 days after surgery and enquiry made regarding development of postoperative symptoms, COVID-19 testing, or diagnosis of COVID-19. RESULTS: 302 patients were recruited. 125 (41.4%) underwent preoperative COVID-19 RTPCR testing. 66 (21.8%) restricted movements prior to surgery. The peak 14-day COVID-19 incidence during the study was 302.9 cases per 100,000 population. No COVID-19 infections or major respiratory complications were reported in the 14 day follow up period. CONCLUSION: The results of our study support the safety of elective paediatric Otolaryngology surgery during the pandemic, in the setting of community incidence not exceeding that observed during the study period.

The corona disease 2019 pandemic has had a major adverse impact on surgical services globally. Elective surgery has been particularly impacted. During the initial stages of the outbreak, much hospital capacity was diverted to care of patients with However, even as the initial surge passed, concerns persisted regarding the safety of elective surgery, due to the risks of elective surgical patients becoming symptomatic with COVID-19 in the perioperative period, with risks of severe respiratory complications, as well as risk of nosocomial outbreaks. At the same time, risks due to delay or cancellation of elective procedures have increased. To minimize the risks of elective surgery, new protocols have been introduced, encompassing additional protectives measures such as personal protective equipment, social distancing within healthcare facilities, and pre-operative testing of patients booked for elective surgery.

The considerations for elective paediatric surgery in the context of the pandemic are different than to the adult population. Firstly, the available data suggests that children are less susceptible to acquiring COVID-19 than adults [1] , particularly those younger than 12 to 14 years [2] . In the USA, children <18 years account for approximately 10-12% of laboratory confirmed cases to the Centers for Disease Control and Prevention [3] . Secondly, children who do acquire COVID-19 are more likely to have a very mild disease course, with only 2.5-4% requiring hospitalization [4] , and an estimated 26% of cases remaining asymptomatic [5] .

However, severe disease can develop among children with COVID-19, with critical care requirement reported up to 33% among children requiring hospitalization [6] . Of note, while high case fatality ratios of 20-25% have been reported among adults who develop COVID-19 J o u r n a l P r e -p r o o f in the peri-operative period, there is minimal data on corresponding outcomes in children [7] [8]. Finally, preoperative testing of children is more problematic than adults, due to greater difficulty obtaining nasopharyngeal swabs, which can be an unpleasant experience for small children and poor co-operation, which may reduce the accuracy of the results.

The purpose of the present study was to assess the safety of elective paediatric surgery during the COVID-19 pandemic with respect to perioperative COVID- 19 J o u r n a l P r e -p r o o f Cork). Two of the participating hospitals are dedicated children's hospitals and national paediatric referral centres for tertiary paediatric otolaryngology care. The other three hospitals were also adult hospitals. All served as regional otolaryngology referral centres, with children admitted to dedicated pediatric wards. 4 of the 5 hospitals were 'COVIDreceiving' hospitals, and one (Cork) non-COVID receiving.

Inclusion criteria were all paediatric patients presenting for elective otolaryngology surgery between September 5 and December 18, 2020. Exclusion criteria were patients presenting for emergency surgery. Paediatric was defined as aged less than 16 years at the time of surgery. Parents were invited to participate in the study by a member of the surgical team at the time of hospital admission. Parents agreeable to participate were then formally contacted by the research coordinator in the days immediately after surgery, and informed consent for the study was given over the telephone.

Study data were collected and managed using a secure web-based software platform REDCap hosted at the RCSI [9] . Variables collected included patient demographics, diagnosis, details of surgery performed, whether patients had "cocooned" (self-isolated) prior to hospital admission (including a cessation of educational activities), preoperative screening procedures, length of hospital stay, and post-operative cocooning.

Prior to hospital admission, standard pre-operative questionnaires, covering details of any respiratory symptoms, any contact with known case of COVID-19, or travel outside Ireland 

Community incidence data for the entire population and for children was obtained from the Health Surveillance Protection Centre (HSPC) [10] . For the calculation of COVID-19 incidence in children, a cut-off of 18 years was used, correlating to data available from the HSPC. As the participating centres were located in 4 different locations in Ireland, and as all served as regional referral centers for surrounding counties, national incidence rather than incidence in local counties is given.

The study was reported according to STROBE and SAMPL guidelines [11] [12] . Missing data were recorded where applicable. Descriptive statistics were performed including frequencies and percentages for categorical data and means (standard deviations, SD) for continuous data. Confidence intervals (95%) were constructed for incidence rates of positive COVID-19 using exact Poisson confidence intervals. Where zero frequencies were observed, only the upper confidence limit is reported. Statistical analysis was performed with Stata Release 16.

During the study period in the respective institutions 742 paediatric otolaryngology procedures were carried out. 373 parents or guardians of patients were approached for inclusion from 5 institutions across the Republic of Ireland. Of these 8 did not consent to the study and 63 were uncontactable for follow-up despite 3 or more telephone calls attempts. Therefore, 302 patients were enrolled from the five institutions. Demographics and procedure information is shown in Major Ear Surgery with drilling 9

Adenoidectomy with grommets 5

Tongue tie release 6

Manipulation of Nasal Bones 5

Other 12 

Based on an observed frequency of zero from a sample of 302 patients, an upper 95% confidence limit of 1·2% is estimated for the risk of symptomatic COVID-19 infection in the postoperative period.

3.6 Community Incidence:

The 14-day incidence of confirmed COVID-19 cases for the Republic of Ireland per 100,000 population is shown in Figure 1 . The 14-day incidence of confirmed cases for children per 100,000 is shown in Figure 2 . The 14-day incidence reached a peak around the midpoint of the study from October 11 th to 18 th with peak 14-day incidence in the whole population of 302.9 and among children 118.9 per 100,000 respectively. Figure 3 shows the temporal distribution of surgical cases performed on the study participants throughout the study period. 20 11-7-20 11-14-20 11-21-20 11-28-20 12-5-20 12-12-20 12-19-20 J o u r n a l P r e -p r o o f in an increased incidence of peri-operative complications varying in severity from minor respiratory symptoms to death [13] [14] , yet little data has been published regarding the consequences of anaesthesia and surgery for children with SARS-CoV-2 infection specifically.

Preoperative COVID-19 testing has become widely adopted among adult patients as a means of reducing the risk of COVID-19 in hospitals. Current policies for testing of paediatric cases range from universal testing of all patients [15] to varying protocols depending on community transmission rates. In the present study, there was significant variation in testing protocols between the participating units. Among the 177 participants not undergoing preoperative testing, there were no cases of postoperative symptomatic COVID-19 infections. However, it is likely that this low incidence of postoperative infection is mainly related to the low community transmission rates in Ireland during the period of the J o u r n a l P r e -p r o o f study, rather than providing any conclusive evidence that preoperative COVID-19 testing of children is unnecessary.

The role of preoperative "cocooning" or restriction of movements is difficult to elucidate from the present study. Adherence to cocooning in children is reported to be poor and is not recommended as a routine practice for children undergoing elective surgery [16] . In the present study, we also observed low levels of patient cocooning, however, this did not appear to impact adversely on outcomes. It should be noted that for the entire study period, even though enhanced restrictions were put in place when incidence spiked in late October, normal educational activities for children continued throughout the study period.

The main difference between the present study and previous papers is that while the main outcome measure in other studies was the incidence of positive tests for COVID-19 among patients presenting for preoperative testing, the purpose of the present paper was to examine the incidence of symptomatic COVID-19 or adverse postoperative outcome in the 14 days after surgery, with the main outcome measure established by systematic 14-day follow-up in all participants. Because of the variable incubation period of COVID-19, ranging up to 14 days, we believe this design gave us the optimal opportunity to detect any cases of symptomatic COVID-19 or respiratory complications that may have presented after hospital discharge. The only study to our knowledge to include formal 14-days follow up of patients was that by Sii et al. In a much smaller cohort of 66 patients undergoing elective surgery with negative preoperative test, the authors reported no case of COVID-19 at 14-day followup [17] . 

The major limitation of the current study is that due to the high incidence of asymptomatic infection in children, and the fact that three children with postoperative respiratory symptoms were not tested for COVID-19 in the postoperative period, it is possible that some cases of postoperative COVID-19 remained undetected. We also did not enquire about presence of gastrointestinal symptoms, which may be a symptom of COVID-19 in paediatric patients [18] . However, the absence of any major respiratory complications in the post-operative period would suggest that the risks of adverse postoperative outcome among elective Otolaryngology surgery among asymptomatic children during the pandemic is very low. An additional consideration is that our results should be interpreted in the setting of the 14-day incidence of COVID-19 in Ireland during the study period, and so may J o u r n a l P r e -p r o o f not be extrapolatable to periods of surge in disease incidence. In particular, our findings regarding lack of benefit of preoperative testing may not be applicable to periods of increased community transmission. A further weakness is the fact that only 41% of patients undergoing elective surgery at participating hospitals during the study period were enrolled in the study. Achieving high enrollment in this study was challenging, due to the need for prospective enrollment and consenting of all participants in 5 separate sites. In view of the significant logistics to carry out the study, we were very pleased with the enrollment rate.

However, we cannot rule out selection bias which may have impacted results. Finally, most of the enrolment in this study occurred before the appearance of novel more transmissible variants of SARS-CoV-2 in Ireland, in particular the B.1.1.7 strain [19] . However, evidence to date does not suggest that children are any more susceptible to this new strain [20] . On the other hand, major advantages of the study include the systematic 14-day follow up of patients, which gave us the best opportunity to capture any cases of symptomatic COVID-19 or respiratory complications.

In the present study, we report no cases of postoperative symptomatic COVID-19 or major respiratory complication among any of the 302 children enrolled in this study. Based on sample size we estimated the upper limit of the 95% confidence interval for risk of postoperative COVID-19 to be 1.2%. These findings would suggest that in the setting of community incidence comparable to that present in Ireland during the time period of the study, which reached a peak of 302.9 for adults and 118.9 per 100,000 population, elective otolaryngological surgery during the COVID-19 pandemic is safe and associated with low risk of COVID-19 infection or complications. 3. In the 14 days after the operation did your child and members of the household restrict their social interactions?

4. In the 14 days after the operation did your child attend school/creche/daycare? J o u r n a l P r e -p r o o f

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Grey: 14 day Incidence rates of confirmed COVID-19 cases per 100,000 population in Ireland Orange: 14 day Incidence rates of confirmed COVID-19 cases per 100,000 paediatric population in Ireland Blue: The number of cases carried out per week of the study

We would like to thank the many surgeons and nurses who cooperated with this study. The authors wish to acknowledge Kathleen Bennett in the RCSI Data Science Centre (DSC) for the providing statistical advice and support and Kiernan Ryan, director of the Department of Surgical Affairs in the RCSI, Brid Moran, Collette Tully, National Office of Clinical Audit,

Funding:This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.J o u r n a l P r e -p r o o f

 This study has shown that it is safe to proceed with elective paediatric surgery during the current pandemic when community transmission levels are low.  Further work is required to elucidate the exact role of 'cocooning'/ self-isolating in the role of disease prevention.