Introduction

The rapid pandemic status of coronavirus disease 2019 (COVID-19) caused by a novel virus—severe acute respiratory syndrome coronavirus 2 (SARS COV 2)—has taken tragic proportions and created havoc in health care systems across the globe. There has been a recent surge of COVID-19 infection in India. As of 26 May 2020, 145,380 new cases and 4167 deaths were reported in the country [1]. This potentially long-winding epidemic situation in India has overwhelmed the capacity of outpatient facilities, emergency departments (EDs), hospitals, and intensive care units, leading to critical shortages of staff, space, and supplies, resulting in patient outcomes and safety being compromised. This crisis resulted in significant challenges for decision-makers to balance the need for the continued delivery of other health services. Thus, it is essential to strengthen the health systems and reorganize the service delivery in response to COVID-19 crisis. During this rapidly changing environment, a set of evidence-based and consensus-driven guidelines from a professional expert peer group is the need of the hour.

Healthcare workers must determine a novel way to address issues such as—who should have surgery and how it should be performed. Strict personal and institutional practices need to be adopted, and policies to allow “new best practices” must be implemented to ensure the best prevention measures against COVID-19 infection in public, and indeed, private healthcare facilities. WHO has issued a wide range of technical guidance on the COVID-19 response emphasizing the important health system measures and policies reflecting clinical and public health action [2]. In addition, detailed guidelines were published by national and international bodies such as MOHFW [3] as well as SAGES and EAES [4] on surgical strategies in relation to COVID-19 crisis.

Although these guidelines are empirical, The Association of Surgeons of India (ASI) has embarked upon bringing out Consensus Statements that aim to empower the surgical fraternity in India with regard to decision making, resource allocation, infection prevention/control measures among patients and healthcare staff, indications for triage and management of cancer patients, prioritization of surgical approaches and maintaining core essential services across the continuum of care (Fig. 1). Based on frontline practical experiences and standard national as well as international guidelines as a framework to describe the recommendations, a panel of experts developed evidence-based Consensus Opinion on wide ranging issues, which is applicable to all public and private healthcare settings across India.

Fig. 1
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Depicting the various roles of a surgeon during COVID-19 pandemic

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In the wake of the COVID-19 pandemic, these guidelines could help healthcare professionals provide timely, high-quality surgical care that achieves the best outcomes for patients, while minimizing the risk of infection.

Consensus Group

The consensus panel comprised of ASI President, chief office bearers of ASI, former ASI Presidents (2015–2019), and a couple of eminent professionals, which included heads of the major teaching institutions, both in the government and private sectors. After procuring active inputs from across the country, 27 key questions that needed to be addressed were identified. These questions were further subsectioned and sent out by email to the panel members across India well before calling for a web-based virtual expert consensus Panel discussion. An online meeting of the consensus group members, presided and moderated by the President of ASI, was held on May 3, 2020. Panel members presented the evidence and practical recommendations for each of the questions allotted to them. The consensus was derived from all the 27 key questions, and to ensure accuracy, the proceedings of this meeting were audio recorded. The consensus-based document outlines several topics concerning the various activities involved in the process of care and defines the gamut of precautions for surgeons to follow.

Key Recommendations on Professional Attire, Transportation, Infection Control, and Preventive Measures

Transmission within healthcare setting plays an important role in the spread of the disease [5]. Standard preventive measures need to be carried out by surgeons to protect oneself, patients as well as family members, and equally, to minimize the contamination. Institutional infection prevention practices should be established in the care of patients and healthcare workers all of the time. In these unprecedented times, health care providers need to meticulously take all preventive measures available even while commuting to and from the hospital. Table 1 summarizes the general precautions recommended by ASI for surgeons to pursue.

Table 1 ASI general recommendations for surgeons
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Consensus Guidelines for Scheduling the Appointments

Sticking to the guidelines for “social distancing” will ensure safety. Patient scheduling is a critical task to mitigate the spread of the novel coronavirus and to protect the patients, their families, and workforce by avoiding unnecessary exposure. Every patient visiting hospital should be wearing a mask and must be encouraged to fill up a comprehensive online registration form or seek prior appointment regarding purpose of hospital visit and urgency, which should also include with brief history about cough/fever. Only one entry/exit point should be permitted to the hospital, and strict hygiene measures such as hand sanitization at the entrance must be made mandatory to the patients. To rule out a fever, a temperature check must be performed.

Patients should be encouraged to visit the OPD alone (unless physically challenged), and it would be wise for patients to request their accompanying persons to stay in the car during his/her appointment. Minors must be allowed to be accompanied with only one parent/guardian to avoid crowding. Most importantly, it is crucial to ensure that patients inform the hospital right away regarding their travel history including of their household members and any signs of COVID-19 symptoms to reschedule the appointments in order to reduce the risk of contamination [6].

Consensus Guidelines for the Management of Cancer Patients

Cancer patients are more susceptible to COVID-19 infection because malignancy and anticancer therapy result in an immunosuppressive state [7]. There is evidence to suggest that cancer patients who contracted COVID-19 have more than triple the risk for severe health events including admission to the intensive care unit for invasive ventilation and rapid clinical deterioration [8]. The case fatality rate was 5.6%, higher than the overall reported case fatality (2.3%) from COVID-19 [9]. Cancer is a semi-emergency disease and its treatment is time-bound. There are 2 aspects to consider:

  • Impact of COVID per se on cancer patients

  • Impact of cancer on COVID patients

Several experts in an international position paper have published some suggestions on the management of cancer patients in the COVID-19 era [10]. Surgical Society of Oncology (SSO) in affiliation with BSO and ISO has proposed three categories for cancer management as depicted in Table 2. There is rapid deterioration of general condition in COVID-affected cancer patients. First golden rule as a doctor is, “Do no harm.” Delay in treatment not only results in stage migration and a need for more radiotherapy/chemotherapy but also causes a significant economic impact. Therefore, decision-based stratification and triage by telecommunication [11] should be performed for the assessment of severity of the disease, co-existing comorbidities, and logistics. In case of treatment, a special format is needed to take consent for cancer patients specifying the risk involved to self and to the attended and outcome mortality difference. All MDTs for managing cancer patients should be organized on virtual telecommunication [12].

Table 2 SSO guidelines in alliance with BSO and ISO have proposed three categories as follows
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Two studies published in China and Taiwan revealed that treatment delays in category II and category III were independent risk factors for increased cancer-related mortality. Delay of 3 months showed a drop of 1-year survival from 91 to 60% and decrease in 5-year survival from 71 to 38%.

Consensus Guidelines for Prioritization of Surgeries

In the face of pressures placed by the COVID-19 pandemic, elective surgeries have been restricted to alleviate the risk of transmission of the virus among patients and OR staff during aerosol-generating procedures and to preserve essential resources [13,14,15]. Few guidelines have been offered from surgical societies to help address details for different surgical considerations and prioritization [16, 17]; however, these guidelines provide only very broad rather than very specific recommendations. Facility’s resources, priorities, and patient needs must be taken into account, and prioritization process should be adjustable to meet local, regional, and national circumstances [18]. A surgical review committee, comprising of surgeon, anesthetist, and nursing personnel, is essential to provide defined, transparent, and responsive guidelines for the hospital. The expert panel recommended certain guidelines to support health service leaders by identifying key domains that should be covered in pandemic preparedness plans.

While elective surgical and endoscopic cases remain on hold, emergency procedures cannot be postponed. These surgeries require careful planning and prioritizing to ensure proper treatment and safety measures are taken. Surgery must proceed regardless of knowing whether or not the patient is COVID-19 positive in emergency situations where surgeries that cannot wait for the results of a 12-h test. If a COVID-19 positive case is identified, it is vitally important to isolate them from new patients and other staff members. This may need to be followed up with referral to a COVID-19 hospital. Elective surgeries should be commenced once COVID-19 curve shows a continuous decline for 15 days. However, the expert consensus group recommends that surgeons follow local State & Ministry of Health & Family Welfare (MoHFW) guidelines in this regard.

Consensus Guidelines for Precautions to Be Taken During OPD Procedures and Visiting ER Rooms

  • Routine OPD work should be kept to a minimum. This will ensure less crowding and reduce transmission outside clinics. If avoidable, no relatives should be allowed and social distancing must be practiced within clinics and hospitals, with waiting-room chairs placed six feet apart, and all patients/attendants must wear a mask in the waiting area and should be instructed on cough and sneeze hygiene.

  • Doctor’s clinics should be well ventilated and patients should maintain minimum six feet social distance except during physical examination.

  • The doctor should wear a surgical mask, a face shield, and scrub hands with soap and water and use an alcohol-based disinfectant after interaction with each patient.

  • In case of minor surgeries in the OPD, patients must be explained about individual risks of coming to the hospital, office, or surgery center for surgery during the pandemic.

  • Essential minor surgeries must only be performed after screening and wearing adequate PPE preferably under local or regional anesthesia.

  • There are many surgical procedures that are not considered emergency; hence, it is recommended to look for non-surgical options if available.

  • While visiting patients in ER, initial consultation should be performed via phone with the casualty staff.

  • History taking and asking for necessary investigations must be done on phone, and the patient is to be examined only after ensuring that he/she does need an emergency surgery.

  • All precautions must be taken in order to minimize contact with the patient and relatives.

  • Only one attendant is to be allowed with the patient. Social distancing norms are to be maintained as far as possible.

Consensus Guidelines for Personal Protective Equipment

PPE are designed to protect the health care workers by minimizing the exposure to biological agents [19]. Standard components of PPE kit include a face shield, goggles, mask, gloves, cover all/gowns, head cover, and shoe cover. However, all PPE are not similar. The Association of Spanish Surgeons [20], as well as the Centers for Disease Control in both the USA [21] and in China [22], specifically recommend use of N95 respirators without valves for surgeries with aerosol-generated procedures on COVID-19 patients. Australia’s Department of Health encourages N95 use for “high-level contact” with infected patients [23].

The World Health Organization (WHO) recently published PPE guidance and preventive measures such as hand rub with 70% alcohol before wearing and after removal of gloves, but did not specify that surgical procedures required N95 respirators [24, 25]. On contrary, MOHFW recommended two types of masks, triple-layer medical mask and N-95 respirator mask, depending upon the personnel and work environment [19]. However, it is encouraged that the healthcare workers must take preventive measures in strict accordance with the epidemic assessment level [26]. In addition, Table 3 summarizes recommendations from expert panel on the optimal use of PPE and its disposal for protecting surgeons while performing their duties.

Table 3 Recommendations for use of PPE for surgeons [19]
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Consensus Guidelines on Classifying Urgent Category Surgeries and Adapting Surgical Techniques to Reduce Exposure Risks

During the beginning of the COVID-19 pandemic, surgeries were classified into various tiers depending on the urgency of surgery. Most elective surgeries like hernia (up to tier 2b) were advised to be postponed. For most cancer surgeries (tier 3a and 3b), postponement is not advised by ACS at the moment though it may subject to change [27].

On contrary, aerosol-generating procedures (AGPs) are procedures performed on patients that are more likely to generate higher concentrations of infectious respiratory aerosols than coughing, sneezing, talking, or breathing. The evidence on the possibility of patient to surgeon transmission of SARS-CoV-2 during droplet- and aerosol-generating procedures is still sparse [28]. However, it is important to recognize that open surgical procedures can generate plume with similar devices. Previous evidence identified the viral and bacterial aerosols in surgical plumes in both laparoscopic and open procedures [29,30,31,32]. Smoke evacuation device usage in line with pre-existing OR guidelines may reduce aerosol exposure in both open and laparoscopic procedures [33]. Although laparoscopy is found to result in decreased length of stay and faster recovery as compared with open surgery, it is unclear about the extent of surgeon risk of exposure to aerosolized viral particles during laparoscopy as discussed earlier. Recommendations from CDC suggest the use of enhanced respiratory PPE greater than N95 level for certain aerosol-generating procedures [34].

The American College of Surgeons stated an insufficient evidence to recommend for/against an open versus laparoscopy approach. SAGES guidelines recommend the use of filters for the released CO2 during laparoscopy and robotic surgery. In Table 4, expert panel provided reasonable recommendations for the list of AGPs, current surgical practices, and postponement of surgeries in group of patients. Table 5 shows comparison of different risk factors across open, laparoscopic, and robotic-assisted surgery under COVID-19 circumstances.

Table 4 Recommendations on surgical practices and postponement of surgeries
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Table 5 Risk comparison of open, laparoscopic, and robotic-assisted surgery under COVID-19 circumstances [35, 36]
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Consensus Guidelines on Organizing Emergency Surgery, COVID Testing, and Post-operative Care

Healthcare centers must organize dedicated protocols and workforce training. Usage of surgical appliances and staff must be well contemplated and balanced [37]. Surgical procedures on all suspected COVID-19 patient should be postponed wherever possible until infection clearance is confirmed. However, a fundamental issue in emergency surgery is to consider every patient as COVID positive in order to minimize infection spread and usual precautions must be taken. Before discharge, COVID-19 test is not recommended for patients, as per current Govt. guidelines. In Table 6, the expert panel outlines recommended clinical pathways during life-threatening emergencies, consensus on testing patients before discharge, and minimizing the contamination risk to the patients postoperatively.

Table 6 Recommendations on emergency surgery, COVID testing, and post-operative care
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Consensus Guidelines on Diagnosis/Treatment of Post-op COVID Complications, and Surgical Recommendations on COVID-Recovered Patients

Latest evidence suggests that surgery may accelerate and aggravate disease progression of COVID-19 [14]. All patients developed COVID-19 pneumonia shortly after surgery with abnormal findings on chest computed tomographic scans. Considering the evidence available, expert panel looked into these concerns and following recommendations were outlined to address these challenges as depicted in Table 7.

Table 7 Post-op COVID complications and surgical recommendations
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Consensus Guidelines on Pre-op Screening of COVID-19

Extending the logic of COVID-19 testing to all admitted patients is reasonable given the cost concerns, and the delay in patient management is taken care of. Currently, there are 3 options available for pre-op screening and the expert panel discussed about availability of each options and the considerations are summarized in Table 8:

Table 8 Recommendations for Pre-Op screening of COVID-19
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Consensus Guidelines on Ideal OT Specifications and Practicalities

Ideal operation theater specifications are still under consideration. One important recommendation is negative-pressure operation room. The use of stapler is preferred as it reduces operation time coupled with other better clinical outcomes [38].

In Indian set-ups, there are three types of hospitals:

  1. a.

    Small-size nursing home set-up with single operation room

  2. b.

    Mid/large-size private institutes with multiple operating rooms (in one place or at different places)

  3. c.

    Mid/large-size public-funded institutes with multiple operating rooms (in one place or at different places)

Sudden changes incorporated to ideal operation rooms will not be possible in all the above set-ups. In cases of multi-operation room set-up, a dedicated operating room may be ear-marked. In the post lock-down period, it is advisable to have dedicated COVID theaters. Have separate donning and doffing area. However, the suggestion at present would be:

➢ Stagger the operations

➢ No visitors or observers in OT

➢ Minimum HCWs in operating room during anesthesia

➢ Controlled smoke (aerosol) evacuations—suggestions are still dynamic

➢ Complete PPE protection during surgery

➢ Minimum HCWs during reversal from anesthesia

➢ Use of minimal energy source

➢ Sanitize the room with 1% hypochlorite solution (every equipment used)

➢ Surgeons and personnel not needed for intubation should remain outside the operating room until anesthesia induction and intubation are completed for patients with or suspected of having COVID-19 infection

➢ Keep the doors of OT open for sufficient time between cases (1 h between cases)

Key Recommendations on Additional Measures

  • The risk of transmission of COVID-19 through transfusion of blood and components is now only theoretical and likely minimal [39]. There is no restriction on blood transfusion. Any actions taken to mitigate risk are therefore precautionary. Guidelines issued by National Blood Transfusion Council, MoHFW, and standard laboratory biosafety practices, based on national or international guidelines, should be followed in all circumstances.

  • With regard to medico-legal aspects, there is no law on COVID morbidity and mortality. Hence, one has to be guided by the notification issued by the MoHFW. A separate consent explaining morbidity and mortality of surgery is advisable.

  • Costs get escalated with use of PPE for all involved in surgery and postoperative care. It is estimated to be over Rs. 15,000 per case. Agencies like ESI/CGHS/ECHS and even insurance need to be informed and directed through the MoHFW to exclude the cost from the package for operations agreed upon.

  • Surgeons above 65 years are advised to avoid getting into health care activities during the COVID era. The proposed blanket insurance for healthcare workers by central government will not become applicable to such people in case the infection is proved to be from clinical practice.

  • COVID-19 will not disappear anytime soon and will be part and parcel of our lives in the foreseeable future. And therefore, any travel or on-site meetings will pose a definite risk to the healthcare personnel. The governmental policy (updated from time to time) would guide the future with specific regard to conducting/attending such meetings. ASI’s flagship annual Regional Refresher Courses and the newly introduced National Skills Enhancement Programme for postgraduates (NSEP PGs) starting in June 2020 ushers in a new era in the Association’s e-learning teaching schedule.

  • Revised ICMR guidelines recommend hydroxychloroquine as chemoprophylaxis for all asymptomatic healthcare workers involved in containment and treatment of COVID-19 with dosage of 400 mg twice a day on day 1, followed by 400 mg once weekly for next 7 weeks, to be taken with meals. It further recommends use beyond 8 weeks on weekly dosage with strict monitoring of clinical and ECG parameters, and one ECG should be done anytime during the course of prophylaxis [40].

Conclusion

In a very short period, health care systems and society have been tremendously impacted by COVID-19. It appears that the fight against this pandemic disease will be long-lasting. The proposed mitigation strategies highlighted by this expert panel underscore the urgent need for revised decision-making and appropriate resource allocation, which would enable the broader healthcare community to prevail during these difficult times. It is important to have robust mechanisms, strategies, and protocols in place for infection prevention, screening/triage, use of PPE, modification of infrastructure, and processes, while taking utmost care to protect the healthcare professionals, all along. These consensus guidelines would hopefully enable ASI members in performing their professional responsibilities without being the pivot of disease transmission. Most importantly, it is also crucial to evaluate the effectiveness of adapted strategies more often for longer-term health system capacity building.

This advisory was prepared based upon information available up to 26 May 2020. COVID-19 is a fast-changing scenario and practice guidelines may change accordingly. Looking up the Indian Council of Medical Research (ICMR) and MOHFW websites from time to time is essential to get the latest and up to date information.