The British Rhinology Society National COVID-19 Study: Resuming Elective Surgery*

Background: As elective services resumed in the aftermath of the first wave of the SARS-CoV-2 pandemic, the British Rhinology Society and Juniors Committees carried out a national prospective study in order to assess and optimise safety and efficacy of surgery. Methodology: Data from 1063 cases was collected from 111 centres in the United Kingdom (excluding Northern Ireland) within the study period (1st June – 14th August 2020), and a three week follow-up period to assess whether there were any cases of SARS-CoV-2 amongst patients and staff. Results: 89.2% of procedures took place in England. 90.6% of patients had minimal comorbidities (ASA Grade 1 or 2). 98.4% of patients were known to have a COVID negative status prior to surgery, with the majority (99.8%) investigated through Viral PCR alone. The most common form of pre-operative shielding was to self-isolate for 14 days (82.5% of cases). 32.6% of cases were performed in an alternative theatre environment, and in 5.3% the private sector was used for NHS patients. In 21.6% of procedures, unfamiliar anaesthetic teams were used, and in 19.2% unfamiliar theatre teams. There was a higher probability of unfamiliar theatre staff or anaesthetist, when operating in an alternative theatre environment. Trainees were not present in theatre in 24.2% of cases. Full PPE (Personal Protective Equipment) was worn by the operating surgeon in 64.1% of cases. No patients or staff were reported to have developed SARS-CoV-2 in the three week period following surgery. Intra-operative challenges were reported in 19.7% of cases and were primarily associated with impaired communication (8.8%) or impaired vision (6.9%). There was a higher chance of challenges reported when unfamiliar theatre teams were present. Conclusions: This data suggests that overall, the resumption of rhinological elective services has been performed safely with no cases of SARS-CoV-2 reported in patients or staff. We must consider the challenges of operating in unfamiliar environments together with surgical and/or anaesthetic teams, as well as the impact on training.


Introduction
The SARS-CoV-2 pandemic has significantly impacted upon the provision of services in healthcare systems throughout the world. In the United Kingdom, in view of the need to prioritise resources whilst protecting emergency and cancer services during the first wave of the pandemic, cases were initially risk stratified (1,2) , and those deemed to be low priority either cancelled or postponed.
Although it has since been confirmed that this was incorrectly reported, an initial case from Wuhan whereby 14 theatre staff members were allegedly infected following transsphenoidal pituitary surgery raised considerable alarm over potential aerosolisation of the virus when performing rhinological surgery (3,4) .
As fatalities began to plateau (5) , reducing the need for reallocation of resources and the waiting times for elective operating increased (6) ; there became a stronger emphasis on the resumption of routine elective activity (7) . Simultaneously, our understanding of the disease process continues to improve in order to try and undertake this with minimal risk.
In May 2020, NHS England published their roadmap to safely bring back elective activity (8) . This framework included the need for careful planning, rigorous monitoring and continuous improvement. However, the results of a survey of 1741 surgeons in June 2020 commissioned by the Royal College of Surgeons of England (9) , highlighted significant challenges in re-starting elective surgery, which included a lack of capacity in interdependent services (46%), lack of staff (35%), lack of access to testing, and insufficient PPE (21%).
The British Rhinological Society (BRS) and BRS Juniors' councils highlighted the need to monitor safety during the recommencement of rhinological operating.

Aims and objectives
The aim of this study was to collect prospective data to assess the safety and challenges encountered when initiating elective rhinological surgery in the United Kingdom following the first wave of the pandemic. Specific objectives included addressing the following: • When and where are we performing elective rhinological surgery?

Basic demographics
Overall, 111 centres in 16  were no statistically significant difference between our cohort of patients and the UK population (15) between Caucasians and non-Caucasians (p=0.06).
The mean number of rhinological procedures performed in the UK on a week-by-week basis was 88.6 ± 45.8 (equivalent to 18.0 cases ± 9.9 per day). The majority of procedures were performed in England (89.2%), followed by Scotland (9.2%) and Wales (1.6%). Figure 2 shows the cumulative workload in each nation and Figure 3 shows the types of procedures performed, with functional procedures the most common.

Comorbidities
The majority of patients (90.6%) had minimal comorbidities and were categorised as either ASA grade 1 and 2 (     of cases, and a powered drill in 7.62% (Table 5). When powered instrumentation was utilised, the operating surgeons were noted to have worn full PPE in 68.1% of cases. The use of powered instruments did not significantly statistically change over time.

Impact on training
Trainees were not present in theatre for 24.2% of procedures (Table 6). Overall, they were involved in 72% of procedures, of which the largest cohort was part performing the procedure with trainer scrubbed (STS).

Challenges and outcomes reported
Intra-operative challenges were reported in 19.7% of cases, with the largest proportion of issues being communication in theatre (8.84%) followed by impaired vision (6.87%) due to the use of PPE (Table 7). There was a significant increase in challenges

Discussion
This national study provides us with data on the initiation of rhinological surgery following the first wave of the SARS-CoV-2 pandemic in the United Kingdom and its impact. Overall, 1063 patients were included from 96 centres. The distribution across England and Scotland is reflective of their respective populations from the Office of National Statistics, with a smaller data catchment noted from Wales (1.6% vs 4.9%, p<0.001) (17) .

Patient selection
The high proportion of rhinological surgery that is undertaken for functional reasons (67.17%) is reflected in our data. This would be categorised as lower priority according to national guidance provided by ENTUK (2) and the Federation of Surgical Specialty Associations (18) , and was therefore postponed during the height of the pandemic. Throughout the course of the duration of the study, as elective services resume, a higher proportion of functional rhinological surgery occurred ( Figure   3). The majority of this (56%) was being performed in COVID free centres.
We also see that the majority of patients (90.6%) who underwent rhinological surgery had minimal comorbidities (ASA grade 1 or 2). A higher proportion (20%) of those undergoing cancer surgery were ASA 3 or 4 with only 7.8% of those undergoing functional surgery being ASA grades 3 or 4. This suggests that patients deemed to be at higher risk were likely to be postponed wherever possible. The association between those undergoing functional surgery and respiratory disease is reflective of the known association between sinonasal disease and asthma (19) .  Table 3. COVID status and pre-operative management. [ALL]

N=1063
Pre-Operative Self-Isolation Period:  (20) , and this is likely to be at its optimum with an anaesthetist most familiar with the surgical procedure.

Testing, PPE and complications
It was useful to know that the vast majority of patients (98.4%) were assessed to be COVID negative, primarily through Viral PCR and the majority of patients (82.5%) self-isolated for a fourteen day period.
With regards to personal protection in theatre, full PPE was used by 64.1% of surgeons. Adequate PPE is important (21,22) . However, full PPE may not be required for all patients. National guidance provided by Public Health England advises that patients should be risk stratified (23) , and surgeons undertaking procedures in those who are deemed to be low risk for example can use a surgical mask, and eye protection if necessary. This is particularly important to note due to the challenges reported with the use of PPE (communication issues (8.84%) and visual issues (6.87%)).
There were no reports of shortage of PPE for staff members.
One of the main outcomes of this audit was to assess patient and staff safety regarding elective rhinological operating, specifically with respect to viral transmission. Significantly, there were no reported cases of SARS-CoV-2 in patients or staff members post procedure. This suggests that compliance with the current guidance regarding testing and PPE facilitates safe practice with respect to elective rhinological surgery. Further evidence based guidance as we increase our understanding of the disease process is useful (24,25) .
The rate of complications overall was 5.9%. This is comparable to previous literature (26,27) , and once again highlights the fact that

Training and skill retention
In a quarter of cases, trainees were not present in theatre. This highlights some of the issues surrounding the role of junior doctors during the pandemic. The pressure on the medical workforce during the COVID pandemic, together with increased staff sickness, resulted in many junior doctors being redeployed (28) .
Furthermore, the risk of aerosolisation and the need for a quicker turnover of patients due to limited hospital capacity, often resulted in trainees being less involved. This is compounded by the small number of rhinological procedures performed in a day between all three nations (minimum: 1 case a day, median: 17 cases a day, maximum: 39 cases a day) which could potentially impact upon overall exposure to rhinological procedures. The Joint Committee of Surgical Training has published guidance for trainees to maximise the opportunities available (29) .

Limitations
This is the largest study performed to investigate the current experience in rhinological procedures during the SARS-CoV-2 pandemic. The limitations of our audit are primarily associated with data collection and its quality. The majority of data was collected by trainees, and this does introduce some bias as some procedures that trainees were not directly involved in may not have been captured. There was a follow-up at three weeks to determine whether patients had acquired COVID-19, however it is likely that such data would have been challenging to assess accurately due to the logistical difficulties associated with following up all members of staff, and the rate of untested, minimally symptomatic, or false negative COVID cases. Hence the possibility that some of this data may not have been included should be taken into account.

Conclusions and considerations for the future
This study suggests that the initiation of elective rhinological