Guidelines Update to Laparoscopy in the Era of COVID-19

Authors

Sunjay S. Kumar¹, Elisa C. Calabrese^2,3,4, Bethany J. Slater⁵, Chelsea Lin⁶, Julie Hong⁷, Jonathan Dort¹⁸, Robert Lim⁹, Shawn Tsuda¹⁰, Ziad Awad¹¹, Wendy Babidge^3,4, Guy Maddern^3,4, Pramod Nepal¹², R. Wesley Vosburg¹³, Romeo Ignacio¹¹, Devi Bavishi¹⁵, Ali Kchaou¹⁶, Subhashini Ayloo¹⁷, Nader M. Hanna^18,19, Geoffrey P. Kohn⁶

Abstract

Background: Patients requiring cholecystectomy or appendectomy may present with concomitant COVID infection in both the inpatient and outpatient scenarios. It is unclear whether these patients benefit more from operative or nonoperative management in the setting of active COVID infection. These guidelines seek to address urgent and elective clinical scenarios.

Methods: A systematic review was conducted to address these questions. These results were then presented to an interdisciplinary panel who formulated recommendations based on the best available evidence or utilized expert opinion when the evidence base was lacking.

Results: Conditional recommendations were made in favor of 1) either operative or nonoperative management of patients with appendicitis or cholecystitis and active COVID infection and 2) delaying elective operations by more than six weeks in patients who test positive for COVID.

Conclusions: These recommendations should provide guidance regarding management of surgical patients with concomitant COVID infection. This guideline also identifies important areas where the future research should focus to strengthen the evidence base.

Keywords: COVID-19 · COVID · Guidelines · Surgery · Guideline update · Appendicitis · Cholecystitis

ABBREVIATIONS & ACRONYMS

COVID: Coronavirus disease 2019
EtD: Evidence to Decision
GRADE: Grading of Recommendation, Assessment, Development, and Evaluation
KQ: Key question
OR: Operating room
PICO: Population, intervention, comparison, outcome
PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
SAGES: The Society of American Gastrointestinal and Endoscopic Surgeons
RCT: Randomized controlled trial

Introduction

Aim of these guidelines and specific objectives

The purpose of these guidelines is to provide evidence-based recommendations for the management of patients with concomitant coronavirus disease 2019 (COVID) infection and surgical pathology. COVID-positive varied depending on the
study between rapid antigen test, polymerase chain reaction
(molecular), or antibody testing. We specifically investigated outcomes of operative and nonoperative management for appendicitis and cholecystitis as well as optimal delay of elective operations. The target audience for these guidelines includes patients, surgeons, anesthesiologists, and all physicians who care for patients with surgical pathologies in clinical practice. A patient-physician perspective was taken so cost-effectiveness, resources requirements, and availability of said resources were not evaluated.

Description of the health problems

The COVID pandemic permanently altered the practice of medicine in the United States. The initial virulence appears to have cooled but the virus now appears to be endemic [1]. Practices such as initial nonoperative management of surgical diseases and routine preoperative screening for COVID were without a doubt necessary during the initial phases of the pandemic but it is unclear what role they should continue to play as the healthcare system returns to a “new normal.”

Several studies evaluated the feasibility and safety of nonoperative management of surgical emergencies including appendicitis and cholecystitis [2-15]. There was strong reluctance toward these patients to the operating room, given the uncertainty over the potential for increased perioperative morbidity as well the increased risk of spreading the virus to OR staff during laparoscopic cases. The first version of these guidelines suggested that laparoscopic cases in this population did not place staff and increased risk of contracting COVID as long as standard precautions were taken [16]. At this time, it is unclear whether the operative treatment of patients with active COVID infection truly does place the patients at higher risk of morbidity.

How to use these guidelines

The aim of these guidelines is to assist surgeons, anesthesiologists, and all physicians who care for patients with surgical pathologies to make management decisions when their patient has concomitant COVID. These guidelines are also intended to provide education, inform advocacy, and describe future areas for research. While these guidelines are meant to highlight the optimal approach in a generalized patient population, distinct patient needs, comorbidities, and specific situations will require tailoring the treatment to each individual for optimal outcomes. In addition, these guidelines can serve as a resource for patients to promote discussion with their physicians. The paper is not intended to establish a local, regional, or national standard of care. The paper will be revised in the future as additional evidence becomes available.

Methods

Guideline Panel Organization

A panel was selected from within the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines committee, including members of the prior COVID guideline, to create a systematic review. The systematic review was overseen by a methodologist with systematic review expertise (A.A.). The panel was composed of practicing surgeons from the SAGES and individuals with backgrounds in nursing, infectious disease, and epidemiology. The guideline committee fellow (S.S.K.) facilitated guideline panel meetings as a non-voting member of the panel. The panel used the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology to assess the evidence from the systematic review and judge the certainty of evidence [17, 18].

Guideline funding & declaration and management of competing interests

SAGES provided funding for the librarian who assisted with the systematic review, the methodologists, and the Guidelines Committee Fellow. Industry did not provide any financial support nor any input into the conception or development of this guideline. A standard SAGES conflict of interest form was collected from all guideline contributors by the guideline lead.

Selection of questions and outcomes of interest

The guideline panelists formulated key questions relevant to COVID infection in surgical patients according to the Population, Intervention, Comparison, Outcome (PICO) format, in consultation with the methodologist, guideline lead, and committee Chair (B.S.) Key questions were approved by a SAGES Guidelines committee working group.

The panel members used their clinical experience to identify patient-centered outcomes they believed most surgeon-patient dyads would consider important to decision-making. These outcomes were chosen based on panel consensus by simple majority and then further designated as critical or important to decision-making on the basis of their relative importance to patients. This designation was confirmed by panel members during the formulation of recommendations after reviewing the evidence from the systematic review.

Evidence review and synthesis

A systematic review addressing the key questions (KQs) was conducted according to the SAGES Guidelines Committee’s standard operating procedure [19]. The Cochrane Library, Clinicaltrials.gov, Embase, PubMed, and the International Clinical Trials Registry Platform were searched from their inception to January 2023 for evidence, ultimately only yielding observational studies. When no direct comparative studies were available, non-comparative evidence was considered. Search strategies can be found in Appendix A.

Each record was screened by two independent reviewers at both the abstract and full text review phases. Screening criteria and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) can be found in Appendix B. As there was no randomized controlled trial (RCT) data found for any question, study quality was assessed using the Newcastle Ottawa scale. Random effects meta-analysis was performed on the extracted data. Forest plots can be found in Appendix C.

Assessment of Certainty of Evidence

As per the Guidelines Committee’s standard operating procedure, the GRADE approach was utilized to judge the certainty of evidence available for each outcome [20]. The highest level of evidence identified was imported into GRADEPro evidence tables [21]. The certainty of this evidence was evaluated on the basis of its risk of bias, inconsistency, indirectness, and imprecision. The certainty was downgraded based on the number of domains across which there were concerns. This data was then imported into an Evidence to Decision (EtD) table for each KQ which provided the framework through which the expert panel developed its recommendations. Evidence tables and Evidence to Decision tables can be found in Appendices E and F, respectively.

Assumed Values and preferences

The panel members used clinical experience to inform judgment on the valuation of different outcomes on behalf of patients. This expertise was deemed likely sufficient to anticipate the variation in values by patients informed by the same evidence. Empirical evidence of how patients value these outcomes was not searched, so the panel’s judgment was used as a proxy for patient values and preferences.

Development of recommendations

The panel convened virtually to review the evidence and make recommendations. The results of the systematic review and the articles utilized were available for independent review prior to the meetings. During the meetings, the panel members reviewed the evidence and completed the Evidence to Decision tables to generate recommendations. This process entailed deliberating the magnitude of desirable and undesirable effects, the certainty of evidence, and variation in how patients may value outcomes. This format was not followed for the pediatric population due to the lack of evidence, but an expert opinion was still formed on the basis of the data presented to the panel. After this, the panel voted on whether the overall balance of these considerations favored the intervention or comparison. The panel then discussed the acceptability and feasibility of this judgment. For each decision, both the available evidence was discussed as well as pertinent additional considerations taken either from panel expert experience or interpretation of evidence. Based on the balance of effects and the acceptability and feasibility of a favored option, the panel voted on the final recommendation for that key question. While serial voting was used to come to a consensus on individual components of the EtD table, 80% agreement was mandatory for all final recommendations.

When the panel determined that the available evidence was too low quality to call the recommendation “evidence-based,” expert opinion was utilized instead.

Guideline Document review

This guideline was drafted based on the evidence to decision tables and panel discussion and was edited by all panel members. In accordance with SAGES Guidelines Committee policies, the final draft was distributed to the committee for approval or suggested changes. After incorporating these edits, the Guideline was then submitted to SAGES Executive board for approval and published online for public comment for 2 weeks.

Key Questions

• KQ1: Should nonoperative management vs. operative management be used for patients with disease processes amenable to either approach and active COVID infection?
• KQ2: Is delayed elective operations for six weeks or greater superior to a relatively shorter delay of elective operations in patients with COVID infection?

RECOMMENDATIONS

KQ1: Should nonoperative management vs. operative management be used for patients with disease processes amenable to either approach and active COVID infection?

Recommendation: The panel suggests that either nonoperative or operative management may be used for patients with active COVID infection and disease processes amenable to either management strategy. This conditional recommendation applies to both adult and pediatric patients. Greater consideration for operative management may be given in situations that are higher risk for failure of nonoperative management, e.g., fecalith in appendicitis, or in cases of persistent symptoms despite maximal medical therapy. Greater consideration for nonoperative management may be given in cases where the patient severely symptomatic from COVID infection, including situations where the patient requires supplemental oxygen or even intubation. (Expert opinion due to low quality of the evidence.)

Introduction

The initial phase of the pandemic coincided with increasing literature supporting the nonoperative management of surgical emergencies [22-24]. Given the initial uncertainty surrounding the safety of general anesthesia and intubation for COVID positive patients as well as the safety of laparoscopy for operating room staff, many patients with surgical intraabdominal infections were initially managed nonoperatively. Multiple large series published outcomes of nonoperative management in patients with appendicitis, however few of the included patients were actually COVID positive [2-15]. This question sought to provide greater clarity on the safety of operative or nonoperative management in such patients. Appendicitis and cholecystitis were the disease processes considered for this question as both the decision of surgical compared to nonsurgical management is considered safe under most circumstances.

Summary of the evidence

As noted above, the vast majority of publications on this subject are about the nonoperative management of patients during the initial phase of the COVID pandemic, but not necessarily in COVID positive patients. In the adult population, four such studies did actually report outcomes for the small number of COVID positive patients in their cohorts [2-5]. All looked at patient encounters between March 2020 and May 2020, therefore all patients were unvaccinated. Two studies were based on patients in the United Kingdom and two were based in Spain. Three studies addressed appendicitis while one addressed cholecystitis. All four were found to be at high risk of bias given the small patient populations, retrospective nature, and presumed limited comparability of the two groups.

In the pediatric population, one study on appendicitis in the US was identified [6]. Operative management in this study included the use of percutaneous drainage of peri-appendiceal abscesses. This study was also deemed high risk of bias.

While the panel did not follow the GRADE process for this conditional recommendation, the evidence revealed in the literature is still presented below for the sake of transparency.

 Adult

Benefits

The review found one benefit of nonoperative management: mortality. Across three studies with a total of 35 patients, there was one mortality in a patient who was severely ill with their COVID infection.

Harms

One harm of nonoperative management was identified: conversion to operative management/reoperation. The one study of cholecystitis found seven conversions to operative management in the 39 patients in the nonoperative arm and zero reoperations in the three patients in the operative arm. This gives an odds ratio (OR) of 1.62 (95% CI 0.08 – 34.72).

Certainty of evidence

The certainty of this evidence was deemed to be too low to utilize for an evidence-based recommendation given the small patient populations, multiple confounders that the studies were not designed to address, wide confidence intervals, and lack of data on other outcomes deemed critical by the panel, such as intensive care unit (ICU) admission.

Pediatric

Benefits

One benefit of nonoperative management was identified: ICU admission. In one study of 581 pediatric patients with appendicitis, the OR for ICU admission was 0.84 (95% CI 0.22 – 3.13) for nonoperative as opposed to operative management.

Harms

There were no harms identified in the comparative literature available.

Certainty of evidence

The certainty of this evidence was deemed to be too low to utilize for an evidence-based recommendation given the small patient populations, multiple confounders that the studies were not designed to address, wide confidence intervals, and lack of data on other outcomes deemed critical by the panel, such as mortality.

Decision criteria and additional considerations

Overall, there is no evidence of significant harm to operating on COVID positive patients with cholecystitis or appendicitis, except in situations where patients are severely symptomatic from COVID. Such patients and even borderline patients should be managed in a multidisciplinary fashion with input from infectious disease and pulmonary specialists, depending on local practice patterns and access to these resources.

The evidence for this question is severely limited but it is worth noting that evidence for the adult population all came from unvaccinated patients in the first wave of COVID.

Conclusions and research needs

In conclusion, the panel suggests either nonoperative or operative management for these disease processes. Patients severely symptomatic from acute COVID infection will likely derive greater benefit from initial nonoperative management. Patients with persistent symptoms in spite of maximal medical therapy may need to proceed to operative intervention.

There are multiple avenues for future research relating to this question. COVID positive patients with appendicitis or cholecystitis should be analyzed by vaccination status, viral strain, time between positive test and presentation, and degree of symptoms. More data is needed in the pediatric population as well.

KQ2: Is a longer delay of elective operations superior to a shorter delay of elective operations in patients with recent COVID infection?

Recommendation: The panel suggests delaying elective operations by greater than six weeks in patients with recent COVID infection (low quality of evidence in adults, expert opinion in pediatrics).

 Introduction

Now that the COVID pandemic appears to have become endemic, positive COVID tests prior to elective operations are becoming increasingly frequent [25]. Some institutions maintain policies for mandatory, routine COVID testing prior to elective operations. Given that both surgery and COVID can place patients at increased risk for deep venous thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI), these operations are often delayed [26]. However, the optimal, minimal amount of delay from COVID testing remains unclear.

A “short,” delay was loosely defined as less than six weeks while a “long” delay was greater than six weeks. If a study’s author defined it differently, we utilized their definition, so there is some heterogeneity in what actually constitutes a shorter or longer delay.

While the panel did not follow the GRADE process for this conditional recommendation, the evidence revealed in the literature is still presented below for the sake of transparency.

Summary of the evidence

The literature search in the adult population identified five studies with comparative data investigating this question [27-31]. Three utilized six-week time cutoffs while one utilized four and the last utilized eight. The type of elective case varied greatly. The patient populations were mixed symptomatic and asymptomatic. The vast majority were unvaccinated. Four of these studies were deemed to be at low risk of bias while one was rated high risk of bias.

In the pediatric population, only one study was identified [32]. This was a case series of 13 cardiac surgery patients. It is debatable whether this paper truly meets the criteria for being “elective” operations but it was the only comparative data identified and thus is presented nonetheless. This study was found to be at high risk of bias.

 Adult

Benefits

There were three benefits to a longer delay identified in the comparative literature: mortality, MI, and DVT/PE.

• Mortality: estimated 26 fewer per 1,000 patients (95%CI 30 fewer to 19 fewer) based on five observational studies with 41,015 patients.
• MI: estimated 8 fewer per 1,000 patients (95%CI 11 fewer to 4 fewer) based on one observational study with 37,354 patients.
• DVT/PE: estimated 9 fewer per 1,000 patients (95%CI 12 fewer to 6 fewer) based on three observational studies with 40,265 patients.

Harms

There were no harms to a longer delay of elective operations identified in the literature. Logically, the main harm will be related to the disease process the patient is seeking surgical treatment for; waiting longer with their underlying condition may have a small, temporary impact on their quality of life.

Certainty of evidence

The certainty of evidence was graded as low on the basis of their retrospective nature.

Pediatric

Benefits

There were no benefits to a longer delay of elective operations in the one study identified in the pediatric population.

Harms

Harms associated with a longer delay included mortality, DVT/PE, and ventilation time. However, this is such a small cohort that is so heterogeneous, it is difficult to try to apply this to the elective, pediatric population.

Certainty of evidence

The panel judged this evidence too poor to be utilized for an evidence-based decision.

Decision criteria and additional considerations

There seems to be a benefit to a longer delay of elective operations after a recent COVID infection. Especially given that these are elective operations, every effort should be made to optimize the patient preoperatively. A deeper analysis of the OR for death by week can be found in table 1. This shows that the OR for death is lowest after a 13-week delay.

Table 1 Mortality rate by number of weeks delayed

Patients who remain very symptomatic with COVID or who have significant underlying pulmonary issues may benefit from an even longer delay. Another factor worth considering is that this data comes from a majority unvaccinated population and earlier waves of COVID. As COVID continues to evolve, this data may not accurately represent optimal management.

Conclusions and research needs

In conclusion, the panel suggests delaying elective operations by six weeks or more for patients with COVID infection. The quality of evidence in the adult population is low and in the pediatric population this conditional recommendation was based on expert opinion alone.

Research needs include analysis of vaccinated versus unvaccinated patients and by specific COVID variant.

DISCUSSION

Dissemination

This guideline will be published in Surgical Endoscopy and available for review at http://sages.org.

Limitations of these guidelines

These guidelines are certainly limited by the low level of evidence available for review. It is well known that infection and its impact on a host is dependent on several factors including the virality of the strain, viral load, stability in the environment, potential for spread in a closed environment and immune status of the potential host [33]. The mutating potential of the COVID virus creates varying viral characteristics that may influence the aforementioned factors in spread and could create viral strains that invalidate these guidelines.

Implementation

Outcomes in COVID positive patients should continue to be monitored as these recommendations are implemented. This is particularly true in the case of any new outbreaks or surges of COVID.

Health equity statement

The COVID-19 pandemic had a starkly disproportionate impact on racial and ethnic minority groups, with African American, Native American, and LatinX communities experiencing higher rates of death [33-37]. This was driven by and highlights existing inequities in healthcare access and the higher prevalence of chronic disease among minority populations. When deliberating the delay of operative care, it is crucial to consider the diverse needs of our patient populations. This includes recognizing the potential implications for healthcare outcomes and access to follow-up care, particularly among marginalized communities. Delaying an operation, having a longer hospitalization, or suffering a complication can also lead to devastating economic consequences, both from the hospital bill and from loss of wages; this type of economic burden is least tolerated by the most financially vulnerable patients. The pandemic has underscored the interconnectedness between COVID-19 and preexisting health inequalities, emphasizing the urgency for comprehensive, community-centered strategies for surgical care.

Updating these guidelines

​​After publication of these guidelines, the SAGES Living Guidelines Taskforce will plan to repeat the literature search at a 3-year interval to identify new evidence. If the updated literature search detects high-quality, new literature, a formal update of these guidelines will be performed. Particular attention will be given to future studies that address the research recommendations proposed in this guideline.

Acknowledgments

The authors would like to thank Sarah Colón, the SAGES senior program coordinator, Holly Burt, the SAGES librarian for their assistance in creating this guideline.

Funding SERF.

APPENDICES

Appendix A: Search strategies
Appendix B: PRISMA diagrams
Appendix C: Forest plot
Appendix D: Evidence tables
Appendix E: Evidence-to-Decision Tables

Declarations
Disclosures Bethany J. Slater is a Hologic consultant, SAGES guideline chair and SAGES board member. Elisa C. Calabrese is a SAGES ASERNIPS Evidence Guidance Research Scholarship recipient. Geoffrey Kohn gives expert opinion for Avant Law. Julie Hong has T32 funding for Columbia center for transplant immunology. Robert Lim has received payment from Up to Date, Inc, travel and lodging for a presentation from ASGBI and is the SAGES treasurer. Shawn Tsuda is a member of the SAGES Board of Governors member and the Surgical Data Science Committee, he also holds stock in Doximity. Ziad Awad, Ali Kchaou, Chelsea Lin, Devi Bavishi, Jonathan Dort, Nader Hanna, Pramod Nepal, Guy Maddern, Romeo Ignacio, Subhashini Ayloo, Sunjay Kumar, Wendy Babidge, and Wesley Vosburg had no conflict of interest or financial ties to disclose.

Funding SERF.

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Author Affiliations

Sunjay S. Kumar¹, Elisa C. Calabrese^2,3,4, Bethany J. Slater⁵, Chelsea Lin⁶, Julie Hong⁷, Jonathan Dort¹⁸, Robert Lim⁹, Shawn Tsuda¹⁰, Ziad Awad¹¹, Wendy Babidge^3,4, Guy Maddern^3,4, Pramod Nepal¹², R. Wesley Vosburg¹³, Romeo Ignacio¹¹, Devi Bavishi¹⁵, Ali Kchaou¹⁶, Subhashini Ayloo¹⁷, Nader M. Hanna^18,19, Geoffrey P. Kohn⁶

Corresponding Authors: Elisa C. Calabrese, Ziad Awad

1. Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA
2. Department of Surgery, University of California-East Bay, Oakland, CA, USA
3. Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, SA, Australia
4. Research, Audit & Academic Surgery, Royal Australasian College of Surgeons, Adelaide, SA, Australia
5. Department of Surgery, University of Chicago, Chicago, IL, USA
6. Monash University, Clayton, VIC, Australia
7. Department of Surgery, New York Presbyterian-Queens, Flushing, NY, USA
8. Department of Surgery, Inova Fairfax Medical Campus, Falls Church, VA, USA
9. Wake Forest University School of Medicine Charlotte, Charlotte, NC, USA
10. The Valley Health System GME Consortium, Las Vegas, NV, USA
11. Department of Surgery, University of Florida College of Medicine, Jacksonville, FL, USA
12. Department of Surgery, Maimonides Medical Center, Brooklyn, NY, USA
13. Department of Surgery, Grand Strand Medical Center, Myrtle Beach, SC, USA
14. Department of Surgery, Division of Pediatric Surgery, University of California San Diego School of Medicine, La Jolla, CA, USA
15. Department of Surgery, University of Texas Health Science Center at Houston, Houston, TX, USA
16. Department of Surgery, Sfax Medical School, University of Sfax, Sfax, Tunisia
17. Department of Surgery, Saginaw Veterans Healthcare System, Saginaw, MI, USA
18. Department of Surgery, Queen’s University, Kingston, ON,
    Canada
19. Department of Surgery, McMaster University, Hamilton, ON,
    Canada