Impact of delay due to the first wave of COVID-19 pandemic on elective surgical patients in a tertiary care center: An observational study.

Abstract

Background: To cope with the stress on the health care system caused by Coronavirus disease 2019 (COVID-19), elective services were withheld in most parts of the world for a variable duration. However, delaying elective services for more than a particular duration adversely affects outcomes of the underly disease. This study was conducted to assess the outcome on elective surgical patients due to delay due to withholding elective surgical services caused by the first wave of the COVID-19 pandemic at our institute.   

Methodology: This prospective observational study included all the patients planned and waiting for elective surgery till the day elective services were withheld at our institution (24^th March 2020) due to the COVID-19 pandemic. All benign and malignant patients were followed until the patients were operated on or three months until elective operative services were resumed at our institution to determine the proportion of patients with worsening symptoms, stage progression, and needing emergency procedures or palliative surgery.

Results: Breast cancer was the most common cancer among malignancy patients awaiting surgery. Compared to breast cancer, gastrointestinal cancers had a significantly higher proportion of patients with stage progression (61.3% vs 90%, p = 0.016) and mortality (6.5% vs 53.3%, p < 0.001). In benign patients, symptom progression was seen in 45.9% and emergency surgery/procedure was needed in 5.4 % of patients.

Conclusion: Even though the so-called elective surgery, postponing these surgeries, particularly cancer surgeries, can compromise the outcomes of the patients if delayed for more than a certain point. Hence the decision to postpone an elective surgery should be cautioned, even during pandemics.

Introduction

Coronavirus disease 2019 (COVID-19) has a high rate of human-to-human transmission compared to influenza, with a case fatality rate of 3.5% [1,2]. World Health Organization (WHO) declared COVID-19 a global pandemic on 11th March 2020 [3]. Subsequently, an exponential increase in emergency department visits and inpatient admissions, and healthcare workforce shortage due to viral exposure and respiratory illness have adversely affected the effectiveness and sustainability of the healthcare system worldwide [4]. 

The term “elective surgery” (ES) implies that the procedure is not immediately indicated in response to a limb or life-threatening emergency. However, 50% of all elective surgeries can inflict harm if delayed or canceled [5]. Therefore, the adverse impact of the blanket suspension of ES facilities has to be weighed against the morbidity and mortality inflicted by COVID-19 itself [3]. However, there is a lack of data on the impact due to the COVID pandemic-induced delay in elective surgeries on the patients’ outcomes.

Ours is a tertiary care center designated as a COVID-care center, and all elective surgeries were withheld from 24th March 2020. The present study evaluated the impact of the delay due to the suspension of elective surgeries at our institution on patients’ outcomes during the first wave of the COVID-19 pandemic.

Methodology

Study design

This prospective observational study was done in the Department of Surgery of a tertiary teaching hospital in India from March 2020 to April 2021. The study’s necessary ethical approval was obtained from the Jawaharlal Institute of Postgraduate Medical Education & Research, Institute Ethics Committee (approval number JIP/IEC/2020/0182).

Study Population 

All planned ES services under the Department of Surgery were withdrawn (24th March 2020) at our institute because of the COVID-19 pandemic, and such patients scheduled for ES were included in the study. In addition, the patients who were receiving neoadjuvant therapy and would have been generally included for surgery or operated if elective operative services would not have been withdrawn at our institute were also included.

Exclusion criteria

1. Patients below 18 years of age. 

2. Patients who expired before the surgery due to causes unrelated to their diagnosis.

Study duration

From the time all elective surgeries were withheld at our institute, from 24th March 2020, all patients were followed up till the time they were operated on or a maximum period of three months after the elective operative services were resumed to pre COVID-19 capacity at our institute.

Objectives

The primary objective was to estimate the proportion of malignant patients who had stage progression and were waiting for surgery. The secondary objectives were to assess the proportion of patients with worsening symptoms in malignant and benign cases and the proportion of patients needing emergency surgery or procedure in malignant and benign cases.

Procedure

The study included all the patients from the departmental database as per the inclusion criteria. The patients were communicated using telecommunication services, and informed verbal consent was taken from all the participants. The patients were followed up for worsening of previous symptoms, development of new symptoms, any emergency procedures done, or if operated outside. After resuming the ES services at our institute, the non-operated patients were followed up in the outpatient department. Informed written consent was taken from all the participants. The patients were assessed by a clinician other than the principal investigator to worsen the existing symptoms or develop any new symptoms. Pain episodes were evaluated in severity using the visual analog scale (VAS) and frequency of pain episodes by the number of attacks per day or week; if the patient had suffered continuous pain, it was considered daily pain. Vomiting was categorized by the number of attacks per week and after taking a solid or liquid diet. Laboratory tests for parameters like bilirubin or hemoglobin were repeated. Swelling size progression was assessed by clinical examination or an imaging modality based on the disease. Depending on the type of malignancy, stage progression was evaluated by clinical examination and imaging as required.

Statistical analysis

Data were assessed using a statistical package for the social sciences 2019 software. Continuous data were represented as mean with standard deviation (SD) or median with an interquartile range based on normality of distribution. The categorical variables were expressed as percentages and compared using the Chi-Square or Fischer Exact test.  A p-value < 0.05 was considered significant for all the statistical analyses conducted.

Results

Our elective operative services were withheld on 24^th March 2020 and were fully resumed on 25^th January 2021. Therefore, non-operated patients were followed up till 25^th April 2021. Of 88 malignancy patients enrolled in the study, 19 patients were lost to follow-up, and 69 were assessed (Fig. 1). Demographic profile and outcome variables are tabulated in Table 1. The mean age of the patients was 52.1 SD11.5 years.   Carcinoma breast accounted for the major bulk of waiting cases (44.9%). The median delay in surgery for operated cases was 135 days (interquartile range 89-223), whereas 55.1% (n=38) of patients were not operated till the end of the study. Out of these patients, 71% (n=49) patients had symptom progression and 68.1% (n=47) had stage progression. In 4.3% (n=3) of patients, the treatment plan was changed to palliative based on disease progression, and 26% (n=18) expired awaiting surgery. 

On comparing the patients’ outcomes based on their malignancy site, there was a statistically significant difference in stage progression (p < 0.001) and mortality (p < 0.001), whereas in symptom progression, no statistically significant difference (p = 0.056) was seen irrespective of the site (Table 2).

 As breast and gastrointestinal (GI) cancers (esophagus, gastric, colorectal, and hepatopancreatobiliary cancers) formed the significant bulk of the patients (88.4%), on comparing breast malignancy patients with GI cancers, higher stage progression rate (61.3% vs 90.0%, p = 0.016) and mortality (6.5% vs 53.3%, p < 0.001) was seen in GI malignancies. Symptom progression was also higher in GI cancers (86.7% vs 64.5%), but this difference was not statistically significant (p=0.073) (Table 3).

A change in definitive curative surgical plan (25.8% vs 10%) or down gradation to palliative treatment (20.0% vs 6.5%) was seen in a higher proportion of patients with GI malignancy as compared to breast malignancy at follow-up, which was statistically significant (Table 4). 

Among 168 patients awaiting surgery for benign conditions who were enrolled, 22 patients lost to follow-up, and a total of 146 patients were assessed (Fig. 1). Demographic profile and other variables are tabulated in Table 5. The mean age of patients was 45.8 SD14.1 years. The median delay in surgery for operated cases was 332 days (interquartile range 194-396), whereas 100 patients were not operated till the end of the study. 46% (n=67) patients had symptom progression, whereas 8.2% (n=12) had improvement in their symptoms due to conservative measures.

Discussion

In this study, we prospectively followed the patients planned for ES when elective surgeries were withheld at our institution due to the first wave of the COVID-19 pandemic. Malignant patients had poor outcomes. In malignancy cases, when compared to carcinoma breast, GI malignancies had a significantly higher percentage of patients with stage progression, mortality, and underwent palliative surgeries. While in benign patients, even though symptomatic progression was noted in 45.9% of patients, their surgical plan remained the same in almost all patients. None of the patients expired due to underlying disease during the follow-up.

It is estimated that around 28 million elective surgeries were postponed or canceled globally during the peak of the pandemic, and 90% of these are benign diseases [6]. In our study also, benign cases formed the significant bulk of patients (66%) waiting for surgery by the time elective surgeries were withheld in our institution. Reasons for such extreme measures were limiting in-hospital transmission of verse postoperative pulmonary complications and optimizing and diverting health care infrastructure, workforce, and medical supplies for COVID-19 management.

Elective surgeries were categorized into elective essential and elective discretionary. Elective essential (cancer surgery, hernia repair, subacute cardiac valve prolapse, hysterectomy, and reconstructive surgery) being time-sensitive, are at an increased risk of adverse outcomes if such surgeries are delayed for an indeterminate period (more than one to three months) [3]. Moreover, surgical management remains the mainstay of curative treatment in managing many cancers. Even though the exact delay for malignancy patients following which the outcomes will be compromised is unknown. Systematically reviewed the literature between 2005 and 2020 concluded that a delay of more than 30–40 days would adversely affect patients with GI malignancies [7]. In our cohort, the median delay in patients operated on for malignancy was 135 days; therefore, a significant number of malignant patients had their surgical plan changed to palliative (11.6%) or expired due to delay in surgery (26%). Moreover, many patients were still awaiting (55.1%) surgery when this study was concluded.

According to cancer statistics 2020, breast cancer is the most common malignancy and the fifth most common cause of overall cancer deaths after lung, colorectal, liver, and stomach cancer [8]. In our study, breast cancer comprises the major bulk of the cancer patients (44.9%) awaiting surgery. Although it is difficult to compare the aggressiveness of different malignancies, survival statistics can be used to determine cancer prognosis [9]. Based on five-year survival rates, breast cancer (86%) has a better prognosis when compared to aggressive GI tumors [10]. Similarly, due to the delay caused by the first wave of COVID-19, stage progression and mortality were significantly more in GI cancers when compared to breast cancer.

Perioperative COVID-19 infection has deleterious postoperative outcomes in increased pulmonary complications and mortality [11]. But, the delay in curative surgery will lead to poor results. Recent studies showed that, by taking appropriate perioperative precautions, the COVID-19 free pathway, even the surgeries with a high risk of transmission could be performed safely with minimal cross infection and post-operative outcomes similar to the pre-COVID-19 period [12–14]. Moreover, any delay in curative surgery led to poor outcomes in the form of symptom worsening, stage progression, and at the worst, mortality, as seen in our study. Therefore, a balanced approach is required to manage the COVID-19 pandemic and patients seeking treatment for non-COVID illnesses by following the COVID-19 free pathway.

Closure of elective services to optimize health resources utilization and fear of poor perioperative outcomes for elective surgeries are only some of the factors responsible for the delay. Certain factors like lockdown induced travel restrictions, accommodation, and food availability made it difficult for patients to reach healthcare facilities. Economic constraints caused by the loss of livelihood by the COVID-19 pandemic also affected healthcare access and spending. Finally, patients’ apprehension due to fear of COVID-19 cross-infection played a significant role as a hindrance to seeking health care [15].

Our center’s delay in resuming elective services was much more than the global average of 12 weeks [6]. Our tertiary COVID-19 care center caters to a large population of sicker COVID-19 patients referred from other centers. Therefore, even after the peak had passed, we had a sizeable number of COVID-19 patients in our hospital, leading to a slow escalation of regular services. Complete services were resumed only on 25th January 2021. But, due to the surge of COVID-19 cases in March 2021, elective surgeries were again withheld from 10th April 2021. As the pandemic continues to evolve, to avert the poor outcomes caused by delaying essential elective surgeries, instead of blanket suspension of elective services, surgery decisions should be made on a case-by-case basis, and by following the COVID-19 free pathway, a balance should be reached to minimize the cross-infection and optimize surgical outcomes.

The main strength of our study is that we, in reality, noted the impact on patient outcomes caused by delay due to the first wave of the COVID-19 pandemic on both malignant and benign patients. In contrast, the previous studies could only envisage the poor outcome caused by the delay.

Our study has some limitations; firstly, the study design is observational and descriptive without a control group; hence the conclusion of poor outcomes on delay due to the first wave of COVID-19 cannot be made. Secondly, the wait was considerably more than that noted internationally, an average of 12 weeks during the pandemic’s peak. Thirdly, our study included a smaller study sample size. To know the real impact caused by delaying elective services on elective surgical patients, a multicentric study including broader surgical diseases can be done with the historical data as a control group.

Conclusion

The Coronavirus disease 2019 pandemic has drastically changed almost all individuals and organizations' usual way of life and work. Health care systems, both public and private, are the worst affected. Some elective surgeries (elective essential) are time-sensitive, delaying of which resulted in poor outcomes as could be noted more in malignancy patients than in benign. Even in malignancy patients, aggressive gastrointestinal cancers had deleterious consequences compared to breast cancer. With appropriate precautions, elective surgeries can be continued even during the pandemic. Priority should be given to cancer surgeries, especially gastrointestinal cancers, for better outcomes.

Declarations

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.

Acknowledgments: I would like to acknowledge Dr, Ankit Jain for his support in methodology, data curation, and writing- original draft preparation. I would also like to acknowledge Dr. M. Rajeswari for her help in the analysis of the data.

Funding: The author(s) received no financial support with respect to the research, authorship, and/or publication of this article.

Conflicts of interests/competing interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethics approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of Jawaharlal Institute of Postgraduate Medical Education & Research, Institute. Ethics Committee (approval number JIP/IEC/2020/0182).

Consent to participate: Informed consent was obtained from all individual participants included in the study.

Consent to publish: Additional informed consent was obtained from all individual participants for whom identifying information is included in this article.

Availability of data and material: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code availability: Not applicable

Authors' contributions: The first author Dr. Abhinaya Reddy involved in conceptualization, data curation, formal analysis, investigation, methodology, resources, supervision, validation, visualization, writing original draft preparation, writing review & editing. The corresponding author Ramakrishnaiah N Vishnu Prasad involved in conceptualization, formal analysis, methodology, project administration, resources, supervision, validation, visualization, writing review & editing.

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Tables

Table 1. Baseline demographic variables and follow-up data of malignancy patients.

Table 2. Comparison of patient outcomes based on site of malignancy.  

Table 3. Comparison of patient outcomes of breast cancer and gastrointestinal malignancies.

Table 4. Comparison of surgical plan in patients with breast cancer and gastrointestinal malignancies.

Table 5. Baseline demographic variables and follow-up data of benign patients.