Introduction

As the COVID-19 pandemic rages across the world with no end or clear treatment in sight, its prevention is of paramount importance. Prevention of patient-to-patient transmission and prevention of patient-to-Health Care Professionals (HCPs) transmission is the main focus of this effort. Personal protective equipment (PPE) plays a fundamental role in the prevention of spread to HCPs; especially in a surgical setting. However, the term “PPE,” a contemporary buzzword, is not standardized and broadly includes a variety of masks, respirators, gloves, gowns, or body covers. Furthermore, meeting its universal demand has been hindered by economic reasons, misinformation, panic buying, and stockpiling during a pandemic. Rationale use of PPEs is the need of the hour not only because of its cost but also since the majority of the countries have not witnessed the pandemic’s peak, yet some are facing the second wave, logistically forcing us to be ready for a long-drawn battle [1]. The medical world responded quickly to the current pandemic and came out with many rapidly emerging guidelines; however, most of these did not pass the stringent tests of the quality of evidence and methodology because the necessary clinical experience/evidence is still evolving [2, 3]. This prompted us to perform a scoping review of surgery guidelines that emerged during the COVID-19 pandemic to identify the appropriate PPE recommendations, appraise their quality, and propose a strategy to optimize the PPE usage.

Methods

This rapid scoping review of guidelines on surgery and laparoscopic surgery during COVID-19 was conducted according to the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) protocol and did not need prior registration [4].

Search Strategy

The following databases were searched from January 1, 2020, to July 31, 2020, for relevant studies: Medline, Embase, Global Health, Scopus, Web of Science Core Collection, WHO, Global Index Medicus, and Google Scholar. The search strategy included terms related to clinical practice guidelines and its synonyms (“clinical pathway,” “clinical protocol,” “consensus,” “consensus development conference,” “critical pathways,” “guidelines,” “practice guidelines,” “health planning guidelines,” “guideline,” “practice guideline,” “position statement,” “policy statement,” “practice parameter,” “best practice,” “standards,” “recommendations”) and coronavirus diseases and its synonyms (“SARS-cov 2,” “covid 19,” “coronavirus,” “novel coronavirus,” “coronavirus covid-19”) and personal protective equipment and its synonyms (“PPE,” “N95,” “Respirator”). Apart from scholarly/published material, hand-searching of key international surgical associations, minimal access surgery associations and laparoscopic and endoscopic surgery associations and a grey literature search was also performed.

The inclusion criterion was that the guidelines on surgery/laparoscopic surgery must have been produced by a national/international academic association/organization, in English literature. Exclusion criteria were guidelines exclusively concerned with anesthesia procedure; regional/hospital/government guidelines; non-peer-reviewed guidelines; commentaries, reviews, viewpoints, opinions, case series, case reports, or recommendations from individual author or group of authors or institutes.

Two reviewers (SKY and VA) reviewed the potential abstracts and if required, full texts of the search material to select the studies that appeared to be a “best fit” with stated objectives. Full articles of selected studies were reviewed in detail, and resolution of any disagreements was done in consultation with third and fourth authors (PA and DS).

Data Synthesis

An all-inclusive list of relevant geographical, methodological, surgical, and evaluation of evidence parameters was made after a preliminary review of included guidelines. The various parameters included in the evaluation were the country of origin, level of evidence, and special attention to the recommendations on types/indications/donning method/disposal of PPE. The parameters were identified in every included guideline and were finally tabulated in a standardized Microsoft Excel Version 16 form. The result was assessed for each of the criteria and evaluated as recommended/not recommended/not available. Quality of evidence was graded according to GRADE guidelines: as very low/ low/ moderate/high [5].

Result

The initial search yielded a total of 1725 studies, out of these 41 guidelines on surgery and laparoscopic surgery during COVID-19 matching with pre-defined criteria were chosen and evaluated in this rapid scoping review (Fig. 1).

Fig. 1
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Flow chart summarizing the results of the screening process and study selection as per the PRISMA guideline

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A summary of all guidelines with the origin of their country, academic association, type of study, type of evidence and recommendations based on various surgical/technical parameters are shown in Table 1 [6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46].

Table 1 The status of the recommendations on PPE during COVID-19 Vis à Vis guidelines of the societies included in the study (in order of evolution)
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In general, guidelines on types/indications/method/disposal of PPE were embedded within a document that primarily focused on surgery/laparoscopic surgery, and recommendations provided by them were mostly non-specific covering a narrow range of items (Table 2).

Table 2 The distribution of the recommendations on PPE during the COVID-19 in the included studies (n = 41)
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A maximum number of guidelines originated from individual National associations (27/41), followed by regional societies (9/41) and international societies (5/41). Globally, only 8/41 guidelines were published by national associations from LMICs. None of the guidelines qualified to be evidence-based clinical practice guidelines in terms of the level of evidence and the methodology adopted for the development of guidelines. The level of evidence was uniformly rated “low,” as assessed by GRADE guidelines, as they were based on level 3 evidence and grade C recommendations (Table 1) [4]. The most commonly recommended PPE was in the form of gloves (unspecified, 90.24%), head cap (90.24%), N95 respirator (82.92%), front doffing gown (90.24%), and face shield (87.80%). Though the N95 respirator (filtering facepiece mask; FFP2 in one) was the most commonly recommended respirator, a surgical mask (2 or 3 layered) was recommended in 5/41 and powered air-purifying respirators (PAPR) in only 1/41 guidelines. Enhanced personal protective equipment (EPPE) suit was recommended in 92.68% of COVID-19 positive patients and 55.53% of COVID-19 negative patients. Use of EPPE in positive patients by all staff members in OR was recommended by 68.29% of guidelines, while 12.19% were not in favor of that. High-risk aerosol-generating procedures (HAGP) were poorly defined in most of the guidelines on minimally invasive surgery (17); however, the use of EPPE in HAGP was recommended in 9/17 guidelines irrespective of COVID-19 status, 7 did not recommend and 6 did not mention it. The donning and doffing technique of PPE was described in only 21.95% of studies. Disposal of PPE was either not described or was poorly described in almost all guidelines. Surprisingly, there was no guidance on decontamination and re-use of face shield/respirators. None of the guidelines took into consideration the optimization of the supply/utilization of PPE. Universal preoperative testing was recommended in only 58.53% of cases and was not recommended in 26.82% of patients, while it was not mentioned in 12.19% of guidelines. The PPE recommendations did not vary with the emergency and routine settings.

Discussion

HCPs are on the frontline in this war against the COVID-19 pandemic and are therefore most vulnerable to exposure from an infected patient. Such infections are as high as one in ten HCPs getting infected in some countries and many of them have succumbed to the infection. This is the reason for the focus on the safety of HCPs against accidental infection from their patients. PPE works as a barrier between an individual’s skin, mouth, nose, or eyes, and viral/ bacterial infections, and includes gloves, medical masks, respirators, eye protection, gowns, aprons, and shoe covers. The use of PPE has been shown to provide a high level of protection even in the face of heavy exposure in very high incidence areas like Wuhan, China [47]. The rapid global increase in the number of infected patients resulted in a shortage of PPE even in developed countries, while the health care systems in LMICs were put under severe logistics and economic pressure. As the end of this pandemic is still not in sight, a strategy has to be formulated for rational and appropriate utilization of PPEs to conserve resources for this long haul. This scoping review was conducted to evaluate the quality of current guidelines that emerged during the COVID-19 pandemic and how this crucial issue of PPE recommendations was addressed in a surgical setting.

A scoping review is an ideal approach to assess the nature and extent of research evidence and identify knowledge gaps promptly, especially for an on-going pandemic where knowledge, attitude, and practice are still evolving and are diverse. When evaluated by GRADE assessment, the level of the evidence was uniformly rated “low” in all guidelines (Table 1) [4]. As seen in the summary of their guidance on PPE in Table 2, a major knowledge gap was lack of recommendations for optimizing the PPE use, conservation of resources, and advice on its donning/ doffing and disposal (Table 3).

Table 3 The identified gaps in the existing knowledge on the use of PPE and the practice recommendations based on scoping review
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Transmission of COVID-19 is believed to be predominantly via inhalation of droplets (10–100  μm) which are aero-produced during an expiratory event (breathing, talking, coughing, and sneezing) and gravitationally settle quickly. Some surgical procedures are high aerosol-generating procedures (HAGP); these are defined by WHO as medical procedures that are aerosol-generating and are consistently associated with an increased risk of pathogen transmission. Other equally important determinants of this risk are the duration of exposure, the proximity of HCP to aerosol, manipulation of high viral load tissue, and infectivity of organisms generated from the use of energy devices (laser, cautery, drills, micro-debriders, saws, and ultrasonic devices) [48]. This complex issue is further compounded by the debatable labeling of laparoscopy as high HAGPs for the risk of virus transmission [2]. Therefore, there is an urgent need to stratify HAGPs based not only on the type of surgery but also on incorporating other compounding factors too in the risk assessment [49].

“Mask” is the primary prophylaxis against droplet infection. Interestingly, the evolution of the “mask” has its roots in surgery, having been developed by Polish Surgeon Professor Jan Mikulicz-Radecki in 1897; who realized the importance of German bacteriologist Carl Flügge’s discovery of droplets as a mode of transmission of disease. The generic term “mask” includes various specific types with different qualities: ordinary home-made cloth mask, 3-layer surgical mask, respirator variants with/ without valve (tight-fitting design to protect the wearer, with a safety rating; the letters N and FFP/ P denote standardization by US Center for Disease Control and European Committee for Standardization respectively; the numbers after N/FFP/P denote filter capacity, i.e., removes x% of all particles that are 0.3 microns in diameter or larger) and powered air-purifying respirator (PAPR; headgear-and-fan assembly that actively filters pollutant/pathogen from ambient air then delivers the clean air to the user). Since surgical face masks filter particles larger than 0.1 to 5.0  μm, it has been shown to provide adequate protection from transmission of COVID-19 in low-risk circumstances during previous respiratory virus epidemics [50]. However, a recent systemic review suggests that N95 respirators might offer better protection from viral transmission than surgical masks [51]. Similarly, a large variation exists in components of PPE with undefined classification/degree of protection by different types/best ways of its donning and doffing (to avoid any breach in bio-safety) and how to train HCWs to use PPE [52]. Such heterogeneity in classification and practice shows a lack of clear evidence.

Any decision making process for resource optimization (and thereby resource conservation) needs broad consensus on three issues: classification of surgical procedure into high or low risk (based on the degree of aerosol generation and HCP’s exposure), classification of PPE into “universal” respiratory precaution (for normal AGPs) or “specific” respiratory precautions (for high AGPs), and classification of a patient into COVID positive or negative (based on symptoms and best diagnostic modalities: RT-PCR and chest CT scan) [1, 51, 53,54,55,56]. Theoretically, universal preoperative testing helps to categorize the surgical patients into COVID positive or negative, but the two most commonly used diagnostic modalities: RT-PCR and CT scan Thorax do not have 100% accuracy [57, 58]. Surprisingly, none of the 41 guidelines for surgery during this COVID pandemic addressed the crucial issue of optimization of PPE use; routine versus emergency settings, consideration of clinical surveillance, and none of the guidelines even from LMICs have any advice for temporary measures in the context of PPE shortage or reusability of PPEs.

To sum up, this scoping review of guidelines for surgery has brought out certain gaps in available research evidence:

  1. 1.

    When assessed by GRADE, the level of evidence was uniformly rated “low” in all guidelines.

  2. 2.

    The crucial issue of optimization of PPE has not been addressed at all and is conspicuously missing.

This can serve as a richly informed starting point for further conceptual work in the field of research, practice, and policy. This pandemic has caused major disruption to the health economics of all countries, barring none. This alone calls for the optimization of PPE and the conservation of resources. Surgeons are considering rebooting elective surgery wherever the pandemic has plateaued [59]. Much needed research on such an important topic should be part of the continuation and rebooting of surgical services. A simple decision-making algorithm can be constructed, based upon this scoping review which can allow HCWs to walk the tightrope between safeguarding themselves and optimizing/conserving resources (Fig. 2). This algorithm addresses all the limitations of guidelines observed in this scoping review.

Fig. 2
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A simple decision-making algorithm for use of PPE in different surgical settings during COVID-19, based on the knowledge gaps found in the scoping review

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Results of our scoping review are not meant as a critique of these guidelines; however, only a rigorous evidence base will make these guidelines more reliable. Additionally, easy understanding, resource availability, geographical implications and economic implications part of any recommendation has to be addressed, especially for LMIC which is facing the major brunt of the pandemic [3, 60]. The Association of Surgeons of India has led from the front in this war against the COVID-19 pandemic. Formulation and timely revision of guidelines on this contemporary and vitally important topic, incorporating the economic needs of LMICs, will further enhance ASI’s eminence and will be of immense help for all the surgeons working in LMICs. This scoping review can provide interim guidance and act as the stepping stone for the development of such a guideline.