COVID-19 PANDEMIC: ADVISORY AND CONSENSUS STATEMENT FOR THE PROVISION OF SURGICAL SERVICES FROM THE ASSOCIATION OF PAEDIATRIC SURGEONS OF PAKISTAN (APSP)

This is an advisory and consensus statement of the Association of Paediatric Surgeons of Pakistan (APSP) regarding guidelines for providing surgical services to the children. This can be implemented for other surgical services as well.

Novel Coronavirus disease (COVID-19) caused by SARS-CoV-2, starting from Wuhan (China) has now spread globally affecting 12,010,593 people all over the world with 548,057 mortality, including 237,489 cases from Pakistan including 5000 mortality till the writing of advisory. [1] The incidence in children varies between 0.8% and 3%. [2][3] [4][5] Among these, many patients need surgical interventions both emergent and elective. [6][7] [8] Most of the children who contract COVID-19 infection usually remain asymptomatic, thus can spread infection unknowingly to healthcare professionals, especially during surgery. In a recent study done in USA,12 patients turned out as COVID-19 positive among 1200 operated patients when tested for it. [6] This reflects a constant and considerable threat of transmitting the infection to the surgeons and surgical team. [9][10] [11] This can result in a shortage of senior surgeons if they are continuously exposed to corona cases due to infection and quarantine. [9] As the pediatric surgical workforce is already very short in Pakistan so there is a dire need to safe it. Moreover, difficulties in the provision and use of personal protective equipment along with compromised theater conditions (not compatible with COVID-19 requirement) need guidelines and a workable plan. There is considerable morbidity and mortality of surgical interventions in patients with active COVID-19. [12][13] So, it is preferable to defer elective surgeries in such patients until the pandemic is over. [14] However operative interventions on pediatric and neonatal emergent surgical conditions like intestinal atresia, intestinal obstruction, intestinal volvulus, trauma, etc., cannot be deferred. Establishing dedicated operative facilities compatible with the requirement for surgical care of COVID-19 patients is a solution in these circumstances.

Triaging surgery during COVID-19
A committee consisting of a pediatric surgeon as lead, anesthetist, and physician dealing with COVID cases, histopathologist, and radiologist as needed pediatric oncologist or gastroenterologist should be formed. The surgical cases should be categorized into; 1. Emergency, need operation within 24 hours. 2. Emergent, need operation 24 to 72 hours 3. Semi Elective: a less than one month 4. Semi Elective: b category till 3 months and 5. Elective: More than 3 months A detailed categorization is discussed in WOFAPS consensus statement, NHS UK, and by ACS America. [15] [16][17] Following guidelines should be followed: a) Emergency and emergent should be dealt with safely as discussed in the next section. b) Elective surgery should not be continued until the wave of the pandemic is over and full facilities for screening and testing available. c) Semi elective category especially oncology, and surgeries where the outcome can be changed with the passage of time like biliary atresia should be operated after getting a PCR test. [15] [16] d) Semi elective category b should be deferred unless forced to do due to disease condition.

Establishing a COVID-OT
2.1 Dedicated COVID Theater: A dedicated operating facility for COVID-19 cases having at least two operation theaters (OT) should be developed. It should be away from other non-COVID operation theatres and be labeled with clear and visible signage preferably in the local language. [18] Location: The COVID Theater should be located near a COVID facility like Corona isolation/HDU/ICU. If it is not feasible, a part of operation theater complex, which is relatively on a side of the main theater complex and easily reachable with a minimal and straight pathway from the COVID facility, should be designated as COVID-OT.

Heating Ventilation and Air Conditioning (HVAC) of COVID-OT
The majority of operation theaters in Pakistan and other developing countries are either lacking any pressure gradient (usually in the periphery and private setting) or have positive pressure to prevent the ingress of virus and bacterial particles into the theater. COVID-19 situation demands a negative pressure facility to stop the spread of viral loaded particles to corridors or other ORs in order to prevent the spread of infection to other theater staff. [22][23] Moreover, in the majority of setups either split air conditioners or central air-conditioning system in use. Only a few facilities have laminar airflow systems installed in ORs.
3.1 Ideal COVID-Theater: Ideally COVID-OT should have a negative pressure with a pressure gradient of at least 5 Pa. It should have a separate HVAC system and air handling unit (AHU) which should be away from other parts of the hospital like indoor units, outdoor units, and administration areas. If it is already connected to these units, then the ducts going to such areas should be blocked. The AHU should preferably take 100% fresh air and disposable exhaust air should be disposed of about 30 feet away from the sucking point of fresh air by AHU. [18] [24] There should be an installation of HEPA filters both in the incoming air ducts and outgoing ducts. [25] [26] A facility of laminar airflow in the theater provides additional protection by streamlining air in such a way that air flows from the ducts to the top of the operation table and moves to the floor (away from operation table) where it is sucked out by exhaust ducts. [15] [26] 3.2 Makeshift arrangement: The theater which has a facility of split air conditioning or in which running of central air conditioning is not possible due to attachment with other non-COVID areas, those theaters can be used as follows. Two split air conditioning units (2 tones refrigerating capacity) can be installed in OR to circulate the air in a single room. Windows and doors should be kept minimally open so that some fresh outside air can enter the room or an exhaust fan (preferably with filter) should be applied to suck in the outside fresh air with filtration. Another exhaust fan (preferably with filter) should be applied below the level of the operating

Theater settings
These recommendations are equally applicable to non-COVID OTs during the pandemic.
1. Equipment in theater and its management: All unnecessary equipment, consumable items, trolleys, cabinets, and cupboards should be removed from theaters to prevent the spread of virus loaded aerosol. Assembling of any equipment should be carried outside of OR. [28] 2. All the equipment inside OR, like anesthesia machines/workstations, cautery, suction devices, monitors, cables, should be covered with transparent impermeable plastic wrapping and this wrapping should be changed after every operation. [28] [29] 3. Three trolleys, one for anesthesia drugs and equipment, second for surgical equipment, and third for linen (prepared outside of OR) are allowed to enter OR at appropriate times as required.
4. Try to use disposable equipment, like breathing circuits, facemasks, endotracheal tubes, cautery leads, suction nozzles, and tubes; dispose of properly after the operation. [25[29] [28] If there is a need to reuse them then disinfect them as per CDC disinfection rule with appropriate disinfection agent for at least 10 minutes. [30][19] 5. Human resource management during operation: There should be a predefined minimum number of staff; one surgeon, one assistant, one nurse, one operation theatre assistant (OTA), one helping nurse, and a sanitary worker must be assigned a single OR as a surgical team. Similarly, for an anesthesia team, one anesthetist and one anesthesia technician are sufficient for one OR. A transport person and a support person should remain outside OR. OR staff should not be changed or added during operation unless deemed necessary. Similarly, one anesthetist should remain ready nearby and can be called in OR, if needed. [19] 6. During induction, surgeons and scrub nurse should stay outside of OR, and enter OR should enter OR when induction is completed and at least 3-5 cycles of air exchanges have occurred or at least 5 to 10 minutes have passed. [18][19]

Screening and PCR testing before surgery
There is still a shortage of PCR testing and free availability of PPEs till now in Pakistan and 3rd world countries. So to get PCR done before emergency/emergent surgery is still a challenge to pediatric surgeons. Resuming elective and semi elective surgery purely depends upon the facility of free availability of PCR testing. The association recommends: 1. Every patient in the category of semi elective and elective should only be operated after getting PCR testing.
2. If parents/guardians have suggested history they should also be tested.
3. If indicated X-Ray chest and HR-CT should be performed in cases with PCR positive and signs and symptoms of COVID.
4. Role immunological testing should only be supplemental to PCR as discussed in these two articles. [15] [31] 5. The emergency/emergent cases should be dealt on level 4 protection if unable to get PCR as discussed in PPEs section.

The decision regarding Surgical Procedures in Suspected or Confirmed COVID Patient
The justification for performing a surgical intervention should be based on thorough history, signs, symptoms, and contact evaluation and should be discussed at length in a multidisciplinary meeting including at least 2 senior surgeons, anesthetist, parents or guardian as applicable, histopathologist, pediatric oncologist, pediatric gastroenterologist (as applicable). The final decision of a multidisciplinary team to perform a surgical procedure will not be challengeable.

Personal protective equipment during COVID-19
Regarding PPEs, guidelines provided by WHO, CDC, and local authorities should be followed. [

Movement of Patients suspected/confirmed cases of COVID
Shifting Pathway: The patient should be shifted wearing N-95 or at least double three-ply surgical mask, cap, autoclave-able/disposable theater clothes, completely covered with a transparent plastic sheath, using a separate predefined pathway reserved for COVID-19 patient. [29] This pathway should be sprayed with a disinfectant just after shifting of the patient. The shifting team should wear complete PPEs of level 4 protection and obey general precautions of hand hygiene and social distances religiously. [29] [35] 9. Intraoperative management 1. Preoperative assessment: Preoperative assessment, premedication, and documentation should be performed either in the COVID area by anesthesia personnel with level-4 PPEs, or more easily in the COVID designated OR skipping the preoperative area. [37] 2. Induction of patient: The patient should be induced in the COVID theater with full anesthetic precautions.
3. Use of Drapes for patients: During COVID-19, pandemic, regular OR dress/clothes should be avoided, and the patient is draped with water-resistant disposable drapes. 4. Recovery of the patient: The patient should be recovered in the same COVID Theater and be directly shifted back to the COVID patient area(HDU/ICU) without staying in recovery through the same defined pathway. [29] 5. Aerosol generating procedure: Aerosol generating procedures like anesthesia induction/extubation, nebulization, suctioning, high flow nasal oxygen therapy, CPAP, BiPAP, and operative procedures like bronchoscopy, esophagoscopy, colonoscopy, and laparoscopy, etc. may result in more spread of viral load in theater thus predisposing healthcare workers to the COVID-19 infection. [26][37] [38] Therefore in addition to level 4 PPE, Powered Air Purifying Respirator (PAPR) should be used; alternatively, N-95/FF2/FFP3 can be used if PAPR is not available. Face shield or goggles, shoe cover, double gloves, and coverall should be used as already pointed out. PAPR is a better option, especially for respiratory aerosol-generating procedures. [35] 6. Use of unipolar, bipolar/advanced bipolar cautery, ultrasonic Harmonic scalpel, and Ligasure. These all are aerosol-generating equipment and a potential source of infection to HCW. Cautery must be used minimally with a suitable power setting to reduce the aerosol spread. High-energy devices like a harmonic scalpel and Ligasure should be attached to a smoke suction devices if available, to reduce the spread of virus-laden particles. [ Intercom facility or one mobile phone covered by plastic wrapping should be present in OT for outside communication.
9. The interval between operations: There should be an adequate interval of about one hour between next operation, to shift the patient as per proper protocols, disinfect the equipment, dispose of disposable items, and to disinfect the required equipment, theater, operating table, anesthesia machine, screens, and other equipment. [18] 10. Oxygen and logistic supply: The biogases supply and other equipment including PPEs, PAPR, drugs, gadgets, and other necessary things should be available in adequate quantity so that the operation can be completed in minimum time with minimum hindrance.

OPD consultation, Pre and Post-operative care in suspected/confirmed COVID and non-COVID patients
1. OPD and emergency consultancy should be done with all precautions as advised in international and national guidelines, at least wearing a three-ply double surgical mask, disposable gloves, and preferably disposable surgical gown/disposable plastic sheet coverall. [15][32] [34] 2. Direct physical examination if possible should be avoided.
3. Telemedicine should be used for follow up cases till the pandemic is over. [43] 4. COVID-19 negative patients can be managed in surgical wards postoperatively with a mandatory assessment of temperature and respiratory system to investigate any new episode of fever or cough.
5. If develops symptoms suggestive of COVID, these patients should be strongly suspected of COVID-19 and be isolated till testing turns out negative.
6. The isolation room should be preferably negatively pressured, with sufficient oxygen supply and nebulization facility. [22][35] 7. Level-4 protection should be observed during ward rounds in strongly suspected or confirmed cases of COVID-19 with special precautionary measures to avoid contact with patients' secretions/body fluids.
8. If COVID-19 infection is confirmed or was previously identified, the medical staff involved in the care or surgery should be isolated for 14 days after the surgery.
9. In case of major surgery or critical nature of the procedure in a confirmed case of COVID-19, the patient should be managed in COVID specific HDU/ICU equipped with necessary monitoring facilities and ventilators. 10. The COVID specific areas should have all the facilities of donning/doffing and necessary PPE for the healthcare workers as indicated in the above text.

Workforce management
Surgical staff should be pooled and preferably a rotational Rota of 8 to 12 hours should be opted.

Handling Histopathological specimens
The specimens should be immersed in 10% buffered formalin (quantity should be 10 times for smaller, and double for bigger one). It should be collected in tight fit plastic boxes, which should be sealed in leakproof double plastic bags. The plastic bags should be wiped clean and should be labeled properly with patient data, and clearly indicating about COVID status, before sending for examination. The form should not be handled with gloves contaminated with blood, body fluids, or any other infected material.

Training of surgical staff
A thorough and comprehensive training program regarding donning, doffing, triaging patients both in OPD and emergency, and doing rounds in wards and attending theater should be developed by the surgical team under the guidance of senior faculty as per requirement of WHO and CDC and CEAG. It should cover all human resources including surgeons, nursing staff, and paramedical staff of all surgical sections. Different online training programs are also available. Local protocols as discussed in this advisory should be practiced in the units and an audit of all processes should be conducted regularly after every week to rectify the deficiencies.

Rehearsal/Mock drill
1. Rehearsal or training should be provided to OT staff for correct donning and doffing of Personal Protective Equipment (PPE) including coverall gown, N-95/FFP3/K-95 face mask, eye shields/face shields/visor, and gloves.
2. Mock drills of a surgical procedure from wheeling in to wheeling out of patients from operation theatre should also be practiced to get accustomed to knowing practical problems.
It is reemphasized that the cornerstone of safety is to wear masks, do regular hand washing, and maintain a physical distance.
This document is an advisory and consensus statement from APSP based on current literature, available evidence/resources, and expert opinion of pediatric surgical lead. It is apposite to mention that new evidence is continuously evolving and guidelines are being upgraded regularly.
Let's join hands with each other and work together to maintain the health of our great nation especially children and our future in Pakistan.
Disclaimer: As the information on COVID-19 is changing every day based on recent research and recommendations, therefore, these guidelines may be updated and subject to change. Neither the editorial staff of the journal nor the authors claim any responsibility in case any harm is inflicted using these guidelines. End-users must check other sources as well before using guidelines suitable to their local circumstances.

Authors Contribution
Muhammad Saleem was the : main principal author of this document and have main responsibility given by APSP for the Advisory. Nabila Talat, Imran Hashim, Muhammad Javaid Khan, and Asif Iqbal, helped in literature review and wrote few portions of the advisory. All authors have substantial contribution in writing this advisory and approved final version.
Conflict of Interest MS, NT, IH, and AI are the : members of the editorial team.