Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer

Study Overview
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Brief Summary
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov_2 infection requiring admission.

Detailed Description
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Italy witnessed a rapid and uncontrolled spread of the infection after March 2020, and a worrisome increasing number of related deaths. The need for increased capacity for COVID-19 patients required elective activities to be drastically reduced or canceled. The unprecedented stress on the healthcare system has caused the reduction of the elective surgery and the cancer screening programs during the last 2 years. Studies predicting harmful impact of the COVID-19 pandemic on cancer care have been already published. However, it has not been proved whether the potential delay of screening, diagnosis and treatment could have a measurable effect on patients undergoing surgery for colorectal cancer in the COVID-19 era. The aim of the study is therefore to compare the 30-day perioperative and oncologic outcomes between patients undergoing surgery for cancer of the colon and rectum between January 2020 and December 2021 (study group) and those who had surgery for colorectal cancer between January 2018 and December 2019 (Control Group), in order to identify: any change in the distribution of the histological stage (primary aim) any change in the rate of palliative surgery (primary aim) any change in the rate of non-radical surgery (R1 or R2 resection) ( primary aim) any change in the rate of 30-day postoperative complications (secondary outcome) Anonimyzed data will be retrospectively collected on a RedCap platform hosted on the servers of the Alma Mater Studiorum University of Bologna. The variables included demographic characteristics, comorbidities, details of the disease at the diagnosis, details of the neoadjuvant therapy, perioperative variables and 30-day postoperative follow-up variables.

Official Title
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Effects of the COVID-19 Pandemic on the Diagnosis, Treatment and Outcomes of Patients Affected by Colorectal Cancer Requiring Surgery: Results From a National Multicentre Cohort Study

Conditions
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Colorectal Neoplasms Malignant

Intervention / Treatment
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* Procedure: Surgical procedure for confirmed or suspected colorectal cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient undergoing radical surgery for histologically confirmed diagnosis of cancer located in the colon, the rectum or the anus; or any patient undergoing surgery with oncologic intents, for instance: radicalization of endoscopically removed cancerous polyp; radical surgery to remove large, at-risk polyp which are not removable by endoscopy; or any patient undergoing planned or unpredicted palliative surgery for a primary cancer localized in the colon, rectum or anus; or any patient undergoing a staging procedure (i.e. staging laparoscopy, surgical exploration), which did not result in any radical surgery due to advanced disease, metastasis, etc. and age > 18 years elective or urgent surgery Exclusion Criteria: Colorectal cancer recurring after previous surgery; Cancer originating from other organs than the colon, the rectum and the anus; Lack of significant histological details (expect when the cancer was not removed) lack of 30-day follow-up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021 | Procedure: Surgical procedure for confirmed or suspected colorectal cancer<br>* Surgical procedure for cancer may include: any radical surgery (right or left hemicolectomy, rectal resection, abdomino-perineal resection, total colectomy, proctocolectomy, and others depending on the tumor site and other tumor characteristics), surgery for radicalization of cancer polyps previously removed endoscopically surgery for excision of large polyps which are not removable endoscopically staging surgery (laparoscopy or laparotomy), in case of advanced-non operable cancer palliative surgery (defined as any surgery with no curative intent)<br>|
| Control group<br>Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019 | Procedure: Surgical procedure for confirmed or suspected colorectal cancer<br>* Surgical procedure for cancer may include: any radical surgery (right or left hemicolectomy, rectal resection, abdomino-perineal resection, total colectomy, proctocolectomy, and others depending on the tumor site and other tumor characteristics), surgery for radicalization of cancer polyps previously removed endoscopically surgery for excision of large polyps which are not removable endoscopically staging surgery (laparoscopy or laparotomy), in case of advanced-non operable cancer palliative surgery (defined as any surgery with no curative intent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncologic stage | The stage will be reported at the histological examination according to TNM classification | 30 days from the surgery | 
| Palliative surgery | Rate of palliative surgery (defined as any procedure which did not have the aim of radically removing the primary cancer, either planned preoperatively in order to reduce the symptoms, or which became necessary during surgery due to unexpected findings | at time 0 (surgery) | 
| Rate of radical surgery | Surgery is defined radical according to the absence of cancer (R0) at the surgical margins on the histological specimen | 30 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggressive cancer biology | Biology was considered aggressive if any of the following characteristics were found at the histological examination: signet ring cells, mucinous tumor, tumor budding, lymphovascular invasion, perineurial invasion, lymphangitis. | 30 days from the surgery | 
| Rate of clinical T4 cancer at the preoperative staging | Clinical T4 cancer are defined as those with high suspicious of local invasion of adjacent organs or structures, not necessary confirmed as T4 at the histological examination | At time 0 (surgery) | 
| Liver metastases | Rate of single/multiple liver metastases | At the preoperative staging or at surgery (time 0) | 
| Lung metastases | Rate of single/multiple lung metastases | At the preoperative staging or at surgery (time 0) | 
| Associated symptoms | Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening | Before surgery | 
| Emergency surgery | rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital | surgery (time 0) | 
| Postoperative complications | Rate of 30-day complications graded according to the Clavien-Dindo Classification | 30 days from surgery | 
| Mortality | Rate of 30-day deaths | 30 days from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, diagnosis, screening, COVID-19, surgery, outcomes