NCT04712292

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (estimated)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colorectal Neoplasms Malignant

Interventions

Type	Name	Description
PROCEDURE	Surgical procedure for confirmed or suspected colorectal cancer	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)

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-02-15
• Completion: 2022-04-01
• First posted: 2021-01-15
• Last updated: 2022-02-28

Locations

45 sites across 1 country: Italy