key: cord-0758951-fnf24gpf authors: Freund, Michael R.; Kent, Ilan; Horesh, Nir; Smith, Timothy; Zamis, Marcella; Meyer, Ryan; Yellinek, Shlomo; Wexner, Steven D. title: The effect of the first year of the COVID-19 pandemic on sphincter preserving surgery for rectal cancer: A single referral center experience date: 2022-02-17 journal: Surgery DOI: 10.1016/j.surg.2022.02.006 sha: 8037f290c2e7ef200d05c8db3b37f9834623a522 doc_id: 758951 cord_uid: fnf24gpf BACKGROUND: COVID-19 has significantly impacted healthcare worldwide. Lack of screening and limited access to healthcare has delayed diagnosis and treatment of various malignancies. The purpose of this study was to determine the effect of the COVID-19 pandemic on sphincter preserving surgery in rectal cancer patients. METHODS: A single-center retrospective study of patients undergoing surgery for newly diagnosed rectal cancer. Patients operated during the first year of the COVID-19 pandemic (March 2020-February 2021) compiled the study group (COVID-19 era); while patients operated earlier (March 2016-February 2020) served as the control group (pre-COVID-19). RESULTS: 234 rectal cancer patients were included, 180 (77 %) patients in the pre-COVID-19 group, and 54 patients (23%) in the COVID-19 era group. There were no differences between the groups in terms of mean patient age, sex or BMI. The COVID-19 era group presented with a significantly higher rate of locally advanced disease (stage T3/T4 79% vs 58%; p=0.02) and metastatic disease (9% vs. 3%; p=0.05). The COVID-19 era group also had a much higher percentage of patients treated with total neoadjuvant therapy (TNT) (52% vs 15%, p=0.001) and showed a significantly lower rate of sphincter preserving surgery (73% vs. 86%; p=0.028). Time from diagnosis to surgery in this group was also significantly longer (median 272 vs. 146 days; p<0.0001). CONCLUSIONS: Patients undergoing surgery for rectal cancer during the first year of the COVID-19 pandemic presented later and at a more advanced stage, they were more likely to be treated with TNT and were less likely candidates for sphincter preserving surgery. . In an attempt to contain the spread of the virus and to preserve medical resources including mechanical ventilators, intensive care unit beds and designated healthcare personnel, many surgical societies, institutions and government officials recommended postponing non-emergent operations [2] [3] [4] . Consequently, surgical care in the USA was limited to emergency and urgent oncological cases. In addition, social distancing and other restrictions contributed to a significant decrease in elective colorectal operations and screening colonoscopies around the globe 5, 6, 7 . Treatment of rectal cancer has significantly evolved in recent decades with the introduction of pre-operative neoadjuvant treatment and surgical techniques designed to enable anal sphincter preserving surgical procedures and local excision (rectal preserving surgery) for low lying rectal tumors. The current paradigm of rectal cancer treatment takes into consideration not only optimal cure rates, but also functional outcomes in addition to morbidity and mortality considerations. The widespread implementation of neoadjuvant chemoradiotherapy (CRT) has led to tumor shrinkage, allowing for a higher rate of sphincter preserving operations with increased rates of negative margins and reduction in lymphovascular invasion as seen in the surgical specimen. [8] [9] [10] [11] Total neoadjuvant therapy (TNT), a promising treatment strategy that incorporates chemotherapy with CRT prior to surgery, was originally described for poor-risk rectal cancers. 12 It has recently been added to the National Comprehensive Cancer Network (NCCN) clinical guidelines as an alternate treatment strategy for locally advanced rectal cancer. 13 It theoretically offers several surgical advantages, such as increasing the possibility of preforming a sphincter-sparing operation and potentially lowering the odds of requiring an ileostomy. Nonetheless, neither of J o u r n a l P r e -p r o o f these theoretical advantages were upheld in a recent meta-analysis, suggesting that the benefit remains mainly in disease control and decreased recurrence rates. 14 Overall, 234 rectal cancer patients were included in the study, the distribution of rectal cancer operations throughout the study period including both APR and sphincter preserving surgery is depicted in Figure 1 . Figure 2 . Time to treatment (from diagnosis to initiation of any treatment modality) was significantly prolonged in the COVID-19 era group (11.1 vs 8.7 weeks, p=0.006). In addition, the median time from diagnosis to surgery in the COVID-19 era group was significantly longer compared to the pre-COVID-19 group (9.5 vs. 5 months; p<0.0001). After stratifying patients who underwent total neoadjuvant therapy (TNT) protocol treatment, the median time from diagnosis to surgery for patients treated with TNT in the COVID-19 era group was also significantly longer compared to patients treated with TNT in the pre-COVID-19 group (10.5 vs. 9 months; p=0.0118), while the time from diagnosis to surgery for patients without TNT in the COVID-19 era group was also longer but not statistically significant (median months: 5.5 vs. 4.5; p=0.3614). Surprisingly, no significant differences were seen in the abdominal surgical approach techniques used between the two groups or in the rate of patients who underwent transanal total mesorectal excision J o u r n a l P r e -p r o o f (taTME) surgery. Review of the pathology specimens demonstrated no significant differences in pathologic TNM staging, the number of harvested lymph nodes, or TME quality (Table 2) . Rectal cancer, along with colon cancer, is the second leading cause of cancer death in the USA. In 2021, it is estimated that there will be 149,500 new cases of colorectal cancer with more than 50,000 related deaths 18 . Current treatment of rectal cancer is characterized by a multidisciplinary approach; the successful management of this malignancy relies greatly on early screening and diagnosis as it directly affects prognosis. These unprecedented times, brought upon by the COVID-19 pandemic, had a dramatic effect on healthcare. Resources have been abridged and social distancing has been widely implemented to try and minimize exposure for both patients and surgeons, resulting in delaying surgery and a massive decrease in case volume 19, 20 . It appears that despite our best efforts, the intricate network of multidisciplinary care for rectal cancer has been substantially affected by the COVID-19 pandemic, as seen by the statistically significant decrease in sphincter preserving operations during the first year of the pandemic. We believe this to be a sensitive parameter of delayed diagnosis and treatment. These findings are further supported by the fact that the patients operated on during the pandemic presented with more advanced disease and worse findings on their initial imaging evaluation. This may be attributed to the lack of timely screening colonoscopies performed during the pandemic 21 . Conversely, these findings cannot only be explained by delayed diagnosis as patients operated and even though this two-week difference represents a true delay in the initiation of treatment, it is unlikely to explain the significant difference seen in sphincter preserving operations between the two groups. Furthermore, a multicenter study published recently reviewing over 1000 rectal cancer patients has shown that delay in the initiation of treatment beyond the NAPRC's recommended 60 days from diagnosis, does not significantly affect oncologic outcomes. 22, 23 The proportion of patients who received TNT in the COVID-19 era group was significantly higher than in the control group. This finding may not be surprising given the fact these patients other factors that may have potentially contributed to this delay. Whether surgeons' fear of poor results, complications, and anastomotic leaks has also played some role in delaying surgery is yet to be determined 26 . We do however wish to emphasize, in that aspect, that the decision regarding the appropriate oncological operation, including whether to perform a sphincter preserving operation or an APR, was based solely on oncological considerations as discussed during the presentation of every patient with rectal cancer during our weekly institutional MDT meeting. In any event, a longer process of diagnosis and treatment is associated with significantly increased healthcare costs and utilization 27 . Further studies are needed to determine to what extent, if any, this delay may affect oncological outcomes. During the outbreak of the pandemic, there was concern about COVID-19 transmission during laparoscopic surgery 28, 29 . This concern was substantiated in a recent study from China wherein the rate of laparoscopic surgery dropped by nearly 20% in patients operated during the COVID-19 era 30 . However, we saw no significant differences between the rate of minimally invasive and open surgery in our study. It seems that the initial concern of COVID-19 transmission did not patients. However, this scenario was not germane to this study. Our study has several limitations, mainly its nonrandomized retrospective single center nature and the lack of long-term oncological outcome follow-up. Although our cohort is relatively small, it is mainly due to the dramatic decrease in case volume during the COVID-19 pandemic. Despite these limitations, we believe our findings indicate a concerning trend that should be considered when mobilizing healthcare resources. 32 . In relation to delaying treatment, bed and staff availability should be maintained as much as possible by having local transfer programs set in place and employing models for predicting hospital admissions and bed occupancy during the next waves of this or future pandemic 33 . In addition, prioritizing oncologic procedures and treatments, over procedures performed for non-malignant indications should allow for prompt and timely surgical intervention. This task will become harder as there is a backlog of rectal cancer patients whose care will further strain an already burdened healthcare system still dealing with the pandemic 34 . Long-term oncological outcomes will need to be reviewed in the future to further elucidate the impact of the COVID-19 pandemic on rectal cancer treatment. J o u r n a l P r e -p r o o f : Table 1 . Comparison of characteristics between control and study group Table 2 . 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