Spots Global Cancer Trial Database for Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
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Trial Identification
Brief Title: Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
Official Title: 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
Study ID: NCT04712292
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rho Memorial Hospital, Rho, Milan, Italy
Humanitas Research Center, Rozzano, Milan, Italy
AOU Policlinico di Bari "M. Rubino", Bari, , Italy
Policlinico di Bari, Bari, , Italy
Humanitas Gavazzeni Hospital, Bergamo, , Italy
Policlinico San Marco, Bergamo, , Italy
Maggiore Hospital, Bologna, , Italy
Fondazione Poliambulanza, Brescia, , Italy
Spedali Civili, Brescia, , Italy
Spedali Civili, Brescia, , Italy
Santissima Trinità Hospital, Cagliari, , Italy
Vittorio Emanuele III Hospital, Carate Brianza, , Italy
San Paolo Hospital, Civitavecchia, , Italy
AUSL Romagna Ravenna-Faenza, Faenza, , Italy
San Giovanni di Dio Hospital, Firenze, , Italy
Gardone Val Trompia Hospital, Gardone Val Trompia, , Italy
ASST FBF Sacco Hospital, Milan, , Italy
San Raffaele Hospital, Milan, , Italy
ASST Santi Paolo e Carlo Hospital, Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano, Milan, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Mirano Hospital, Mirano, , Italy
AORN Cardarelli, Napoli, , Italy
Università della Campania Luigi Vanvitelli, Napoli, , Italy
Padova University Hospital, Padova, , Italy
Veneto Institute of Oncology IOV-IRCCS, Padova, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, , Italy
AOU Parma, Parma, , Italy
San Matteo Hospital, Pavia, , Italy
Pederzoli Hospital, Peschiera Del Garda, , Italy
Azienda Sanitaria Fiuli Occidentale, Pordenone, , Italy
Ceccarini Hospital, Riccione, , Italy
Infermi Hospital, Rimini, , Italy
Campus Biomedico, Roma, , Italy
Fondazione Policlinico Roma Tor Vergata, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
San Filippo Neri Hospital, Roma, , Italy
Sant'Eugenio Hospital, Roma, , Italy
UOSD Tor Vergata, Roma, , Italy
AOU Sassari, Sassari, , Italy
Regional Hospital Treviso, Treviso, , Italy
University Hospital of Trieste, Trieste, , Italy
AOU Città della Salute e della Scienza, Turin, , Italy
Mauriziano Hospital, Turin, , Italy
ASST Vimercate, Vimercate, , Italy
Contact Details
Name: Matteo Rottoli, MD
Affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
Role: PRINCIPAL_INVESTIGATOR
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