key: cord-0810150-q30e57fd
authors: Odejinmi, Funlayo; Egbase, Elizabeth; Clark, T Justin; Mallick, Rebecca
title: COVID in Women’s health Reducing the risk of infection to patients and staff during acute and elective hospital admission for gynaecological surgery
date: 2021-03-18
journal: Best Pract Res Clin Obstet Gynaecol
DOI: 10.1016/j.bpobgyn.2021.03.005
sha: 83cff29ddf45bcca1d815805ac537e96ba93003f
doc_id: 810150
cord_uid: q30e57fd

The novel coronavirus SARS-Cov-2 has changed healthcare on a worldwide scale. This highly contagious respiratory virus has overwhelmed healthcare systems. Many staff were redeployed and there was widespread cessation of non-urgent outpatient clinics and surgery. Outpatient clinics and theatre areas were converted to COVID wards and intensive care units. Following the first peak services began to recommence with new triaging and prioritisation guidance to safeguard patients and staff. Different countries and healthcare systems produced differing guidance and in particular, variation in the best approach to continuing acute and elective surgical procedures. This chapter collates and evaluates the increasing international literature concerning the surgical management of gynaecological conditions during the pandemic, such that clear inferences, recommendations and guidance can be generated to aid clinical practice and safeguard against further major disruption arising from further COVID-peaks. The available data are assessed within the context of the current phase of the COVID-19 pandemic.

In late December 2019, the first case of a new respiratory viral disease called coronavirus disease 2019 was reported. This disease was caused by the highly contagious SARS-Cov-2, a β coronavirus measuring between 50-200nm in diameter, which is spread primarily by the respiratory route. The virus spread rapidly across continents overwhelming many health care systems and on the 11 th of March 2020 the World Health Organisation (WHO) declared a global pandemic.

As it continued to spread around the world, the crippling impact of the virus on health care systems and wider society was quickly realised. In order to ease pressure on health services, national lockdowns were imposed across the world with restrictions on travel, work and recreation. Face to face clinical appointments were all but stopped and non-essential surgery was curtailed with only emergency and prioritised cancer surgery continuing. The objective was to reduce viral transmission such that the number of infected people needing health care could be reduced as rapidly as possible, so called "flattening the curve". In this way patient outcomes could be optimised and scarce and diminishing health care facilities conserved. Large numbers of staff were deployed to support the front line COVID-19 effort and facilities such are theatres and outpatient areas were converted to much need COVID-19 wards and intensive care units.

After "flattening the curve" of the first peak of SARS-CoV-2, the issues of long surgical waiting lists due to the cancellation of planned procedures and the resultant negative impact on patients mental and physical wellbeing became apparent. The need to recommence benign gynaecology services and accept the potentially higher risks of COVID-19 transmission with potential increased surgical morbidity and mortality, needed to be weighed up against the morbidity of patient's ongoing and untreated symptoms and the impact of the surgical delay on women's quality of life. These challenges have become more evident with further waves of new variant SARS-CoV-2 infection leading to further peaks of infections, hospital admissions and deaths and ever-increasing demands on already stretched healthcare services.

The aim of this review is to evaluate the evidence to inform the best approach to continuing acute and elective gynaecological procedures, even in the face of further COVID-19 peaks, in order to reduce the risk of transmission of SARS-Cov-2 to staff and other patients whilst also reducing morbidity and potential mortality in patients undergoing elective gynaecological surgery.

The coronavirus (SARS-CoV-2) responsible for COVID-19 is known to be transmitted through the respiratory tract and spread by fomites, contaminated surfaces on to which the virus has fallen, aerosols (particles less than 5μ that evaporate in the air leaving droplet nuclei that are able to remain in the air for hours), droplets (particles greater than 5μ fall to the ground almost immediately by gravity) and on occasion can result from airborne spread (particles that remain suspended in the air and travel a distance).

Dampening transmission of SARS-CoV-2 is primarily achieved by social distancing, the wearing of appropriate personal protective equipment (PPE) and handwashing. In the surgical environment the highest risk of transmission is from aerosol generation at intubation and extubation during general anaesthesia (GA) due to the high viral load in respiratory secretions (1) . The next greatest risk is through aerosol generating procedures (AGP) specific to surgical procedures, although the true risks of this method of transmission is uncertain (2) .

Frontline staff are largely at risk of becoming infected when undertaking AGP and also via direct contact with patients where PPE and social distancing have not been appropriately utilised. The risk of developing COVID-19 in this way is thought to be in the region of 3% and usually tends to occur where healthcare workers care for and are exposed unknowingly to patients who are COVID-19 positive without appropriate PPE (3).

Other methods of human-to-human transmission of the virus via blood and faeces have also been described (4, 5) . SARS-COV-2 viral RNA has been detected in faeces in up to 67% of COVID-19 cases (5, 6), however live infectious particles have only been described in a small number of cases (1-2%) (5) . While it is clear that this route of transmission is possible, the low prevalence of live viral particles suggests a reassuringly low risk of transmission during gynaecological surgery. SARS-COV-2 RNA viraemia is detected in 97% of COVID-19 cases however, the actual viral RNA load is low, suggesting a very small risk of transmission from exposure to infected blood within CO 2 aerosols or smoke during surgery (7) .

Of concern to gynaecologists would be the possibility of transmission of the virus through the female reproductive tract. Initial reports suggested that the virus was not present in the female genital tract (6, 8) J o u r n a l P r e -p r o o f However, a later report by Schwartz and colleagues detected SARS-CoV-2 in vaginal swabs using reverse transcriptase polymerase chain reaction (RT-PCR) in 2 of 35 patients studied (9) . Reassuringly there have been no reports of the virus being transmitted through the vaginal secretions. Conflicting evidence exists for the presence of SARS-CoV-2 in the semen of infected males. Li et al. described the presence of SARS-CoV-2 in 16% of semen samples from 38 men tested during the acute and recovery phase of COVID-19 (10) . Conversely a smaller study of 12 men in the acute and recovering phase of COVID-19 by Song et al. found no evidence of SARS-CoV-2 in semen samples (11) . The virus has also been found in the urine of patients infected by SARS-CoV-2 with a low rate of positivity (12) . Based on all the available evidence, it appears there is a very low risk of SARS-CoV-2 viral transmission via the female genital tract particularly in asymptomatic patients (13) , especially if they have negative PCR tests.

Another potential theoretical source of transmission is through aerosolisation of peritoneal fluid during surgery, however evidence is conflicting. Coccolini and colleagues reported on the first case of SARS-CoV-2 found in the peritoneal fluid of a COVID-19 patient (14) , whilst conversely, Ngaserin and colleagues reported the absence of SARS-CoV-2 in peritoneal fluid in an infected patient undergoing a laparoscopic appendicectomy (15) .

Anxieties arose from the possibility of SARS-CoV-2 within surgical smoke, generated when using energy generating devices (electrosurgery, lasers or ultrasonic devices) during gynaecological surgery, acting as a potential source of transmission.

Surgical smoke generation or 'plume' is the gaseous by-product that is created by energy generating devices during surgery. At surgery the heat produced by the action of energy modalities on tissue cells, causes the affected cells to rupture at boiling point and produce a plume that can contain dangerous substances, at the same time the surrounding cells become charred causing toxic necrosis and the release of contaminants into the atmosphere including viral particles (16) . There is evidence that viruses other than SARS-CoV-2 exist in surgical smoke plumes, but evidence of transmission is rare (17) . The potential for transmission is extrapolated from other pathogens and evidence gathered from previous pandemics.

Activated Corynebacterium, human papillomavirus (HPV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) have been detected in surgical smoke (18) (19) (20) (21) . The presence of HPV DNA has been reported in approximately 40% of smoke plumes following loop excision biopsy of the cervix (22). Liu J o u r n a l P r e -p r o o f and colleagues outlined HPV transmission in four cases linking surgical smoke to the transmission of HPV in previously fit health care workers undertaking benign gynaecological surgery (16) . In HBV positive patients undergoing operative laparoscopic procedures, the presence of HBV has been found in surgical smoke in over 90% of cases (23) .

Initial NHS pandemic infection prevention control suggested that high speed devices may generate aerosols (24) . Ultrasonic devices, being high frequency oscillating devices, could thus hypothetically add to the risk (25) . However, for such a risk to exist, there would need to be evidence of viral particles within the plume, evidence of stability of the virus within the plume coupled with evidence of virulence of the particle and transmissibility. To date there is no evidence of viral particle transmission within aerosols generated by ultrasonic devices (21) . To date there is no evidence that the SARS-CoV-19 virus is found in any smoke plumes generated by the multitude of energy generating devices (monopolar, bipolar, ultrasonic) used in minimal access or open surgery, however there remains a theoretical risk (26, 27) and thus protective precautions need to be taken. Obstetricians and Gynaecologists adopted a cautious but more balanced tone in the absence of clear data (29) . Some believed that the CO 2 pneumoperitoneum required for laparoscopic procedures resulted in the stagnation of contaminants including viral particles that could subsequently become aerosolised during the release of CO 2 such as during the removal of trocars port or specimens. There is however little evidence against using the minimal access approach to surgery (30, 31) . The advantages of minimal access surgery over open surgery is well documented with decreased blood loss, decreased hospital stay, less pain and earlier return to normal activity (32, 33) and thus the use of minimal access surgery would meet the key objectives of managing the pandemic i.e. reducing hospital stay and increasing bed capacity, reducing time and potential exposure to the virus in hospital and help "flatten the curve".

Furthermore, Mintz and colleagues, in their narrative review, concluded that if laparoscopy is performed in a closed cavity allowing containment of smoke and aerosols with smoke evacuation systems it may be safer for patients and healthcare workers as long as there was no contraindication for laparoscopy (34) . In the HPV study, by Ferenczy and colleagues, they concluded that with the use of evacuation systems and J o u r n a l P r e -p r o o f PPE there was no evidence of viral contamination on the skins of surgeons undertaking procedures with energy devices (35) . Thus, with the novel SARS-CoV-19 virus, though there is a lack of evidence of superiority of open surgery over laparoscopic surgery, (36) every means should be taken to protect healthcare workers from possible contamination (37) .

Mechanical filters capture smoke close to the source of production minimising exposure to health care practitioners in the theatre environment and maintain a clear operating field. High efficiency particulate filters are able to filter suspended compounds retaining particles of greater than 0.3μ with an efficiency of 99.7% whilst ultra-low particulate air (UPLA) filters have an efficacy of 99.9% for particles greater than 0.1μ (17) . The most effective filter is the triple filter system which consists of a UPLA, a pre filter and a charcoal element that captures toxic fumes and vapours. Some devices have the ability to maintain low intraperitoneal pressures as well as eliminate particles e.g. Airseal™. Other non-filtration devices such as Ultravision™ prevent the build up of smoke and particles electrostatically to maintain a clear field negating the need to vent smoke into the theatre environment (38) . However the use of these devices are often limited by cost of disposables and maintenance as they are not as cost effective as simple filtration devices such as the ClearFlow ultra™ (Laprosurge Ltd UK) device that meet the same regulatory particle extraction standard (39) . A summary of commercially available smoke/gas filtration and evacuation systems are summarised in Table 1 A review of the current guidance and recommendations from gynaecological, endoscopic and minimal access societies and agencies is summarised below ( Table 2 does not suggest conflict but rather represents variation in the specific type and detail of recommendations presented. Only two of the 11 international society

recommendations specifically advocated open as opposed to laparoscopic surgery. A specific recommendation for laparoscopic intervention over laparotomy was limited to one society, with all other societies specifying a preferential route for abdominal surgery the context of the COVID-19 pandemic.

There was clear consensus for using techniques which would minimise the formation of bioaerosols and the spread of viral particulate from the abdominal cavity, which include minimising the use of electrocautery devices and liberal use of suction devices.

J o u r n a l P r e -p r o o f Table 2 • Where electrosurgery is used, facilitate the extraction of surgical smoke by using active suction connected to the outflow in a closed circuit.

• Suction devices, smoke evacuation filters and retrieval devices should be utilised to prevent aerosol transmission, and remove smoke, aerosol and the CO 2 pneumoperitoneum during procedures.

• Avoid uncontrolled dispersal of surgical smoke into the theatre atmosphere o Only evacuate surgical smoke via the tap on ports when attached to a smoke evacuation filter or by direct suction using a vacuum suction unit.

• Avoid uncontrolled dispersal of CO 2 pneumoperitoneum into the theatre atmosphere o Only evacuate the pneumoperitoneum via direct suction using a vacuum suction unit.

• Avoid explosive dispersion of body fluids when removing trocars and retrieving specimens. would be true negatives whilst one person who tests positive will not have COVID-19 and 24% would be negative, but have COVID-19 (60) . This illustrates that when screening patients prior to surgery PCR testing alone will not identify all patients thus the test needs to be combined with a detailed history and temperature checks in RT-PCR negative patients and should be applied for all emergency patients even if they test negative.

Studies have highlighted that clinical outcomes appear to be worse in asymptomatic patients undergoing to be lower when patients are managed in COVID free pathways (63, 64) .

After the initial and subsequent lockdown periods in the UK, the evidence was clear that patients were suffering due to delays in surgical treatment in gynaecology (65) . Negopodiev and colleagues, using a

Bayesian beta-regression model, estimated that more than 28 A rapid scale-up of surgery was undoubtedly needed to prevent this backlog increasing further, but gynaecological surgical services needed to be safe, sustainable and resilient to pressure particularly any potential future COVID peaks. High surgical standards must be maintained, to ensure patient safety and optimise clinical outcomes. One concern expressed is that patient care could be compromised if less experienced, low volume surgeons are utilised in an attempt to expedite the large backlog of patients.

Moreover, patient choice may be compromised if less invasive laparoscopic surgery is not offered because such surgeons do not have the necessary competencies (67) .

The theatre environment is designed to prevent intraoperative contamination. All patients being discharged to a care home or a hospice should be tested up to 48 hours prior to discharge. A surgical pathway is proposed in Figure 1 .

The organisation

Organisations responsible for patient care need to endeavour that surgery remains safe; thus, a number of considerations are essential. Firstly, redeployed staff must be re-assimilated to ensure adequate staffing and the safe running od surgical units. Many staff would have been redeployed to other departments within or outside their hospitals to help fight the COVID-19 pandemic. There is also a need to factor in staff absences related to COVID-19. During the first peak staff absence ranged from 20.4% to 24.7% in the first 6 weeks of the outbreak and fell to between 9.2% and 13.8% between weeks 7 and 12 worldwide. Where elective surgery carried on it was possible to maintain 75% of elective work (72) . The re-allocation of facilities is also essential, as many outpatient rooms, waiting areas and theatre spaces were utilised in the expansion of COVID-19 related patient care. It is also essential that there is adequate critical care capacity for high-risk elective patients before routine surgery is recommenced.

It is imperative that separate pathways are in place for both elective and non-elective patients, as well as COVID positive and negative patients, to protect both patients and staff. This may involve utilising separate floors, buildings or even hospitals and should specifically include separate theatres, recovery areas and ward facilities as well as separate staff groups. "COVID free" staff should be screened daily using an J o u r n a l P r e -p r o o f appropriate questionnaire as well as undergoing rapid PCR antigen testing if symptomatic. Regular swab testing to ensure asymptomatic COVID infection is not missed is also recommended and lateral flow testing is being rolled out NHS wide. The role of IgG antibody testing in staff screening is currently unknown, however if coupled with the vaccine will likely become a gamechanger in the fight against COVID-19.

A recent study by Kane status of the patient is unknown. The decision to wear full PPE in cases where the patient has screened and tested negative should be based on local guidance. The ability to sustain safe gynaecological surgery will also depend on the background COVID-19 infection rate within the community and there should be predetermined levels where surgery would be considered unsafe.

The nationwide roll out of the COVID-19 vaccine is likely to be a pivotal moment in the final push towards fully "flattening the curve" and allowing services to normalise. There are challenges to a nationwide vaccination programme and a targeted approach has been deemed essential with national strategies to combat the transmission of SARS-CoV-19 based on priority groups within the population being vaccinated first. This includes frontline medical staff, as this group of workers are not only at increased risk of getting COVID-19 they are likely to be a source of nosocomial infection (75). The importance of vaccination may J o u r n a l P r e -p r o o f serve to replete the workforce available to combat COVID-19 during the peaks and also allow staff to contribute to the re-establishment of elective surgery after the peaks.

The pre-operative vaccination of patients, particularly those who were previously deemed unsuitable for surgery due to their high COVID-19 risks, may be pivotal in the scaling up of the reintroduction of elective surgery and potential reduction of morbidity and mortality (76) . In the long-term widespread vaccination of both patients and clinicians will be key to both reducing transmission and patients morbidity and mortality. Guidelines are already emerging on how surgeons and patients should be cognisant of the side effects of vaccination and how long patients will need to wait before surgery post vaccination (77) so that side-effects of the vaccines are not confused with potential complications of surgery.

It is clear that COVID-19 will continue to test healthcare service for years to come, however suspending elective surgery at every potential "peak" is not the long-term answer and will only result in worsening backlogs and poor patient experiences and outcomes. Robust surgical pathways must be in place to combat further crises. Patient selection, prioritisation and consent are key to reducing surgical morbidity and mortality and inadvertent transmission. Non-surgical methods of treatment should be explored as a first line, if appropriate, however if the decision for surgery is made each patient should undergo an individualised risk assessment. Consent is key and patients should be aware of the increased surgical risks associated with COVID-19. Green COVID-free surgical sites for elective gynaecological surgery, with regular staff screening, should be established. All surgery undertaken should be done so with the appropriate PPE and in the correct theatre environment. Appropriate COVID precautions should be taken for open, laparoscopic and hysteroscopy surgery. Long term vaccination is likely to play a key role in the full restoration of services, however before all staff and patients can be given the vaccine, priority may be given to particularly vulnerable patients awaiting surgery to further reduce potential risks.

All authors declare no conflicts of interest

• COVID-19 has had a significant impact on gynaecological services and robust green COVID free pathways must be developed to withstand further peaks. J o u r n a l P r e -p r o o f • Safe surgical technique is essential in reducing the potential risk of COVID-19 transmission.

• Peri-operative COVID-19 infection is associated with increased patient morbidity and mortality.

• Screening surgical patients (RT-PCR testing and symptoms questionnaire) is key to both reducing the risks of horizontal viral transmission and the increased morbidity and mortality associated with undergoing a surgical procedure while COVID-19 positive.

• All gynaecological surgery should be undertaken the appropriate PPE and in the correct theatre environment.

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