Clinical trial NCT04712292: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms Malignant
Keywords: colorectal cancer
diagnosis
screening
COVID-19
surgery
outcomes
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all adult patients undergoing elective or urgent surgery for proven or suspected colorectal within the study periods

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 criteria: 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

Primary outcomes:
measure: Oncologic stage
timeFrame: 30 days from the surgery
measure: Palliative surgery
timeFrame: at time 0 (surgery)
measure: Rate of radical surgery
timeFrame: 30 days from surgery
Secondary outcomes:
measure: Aggressive cancer biology
timeFrame: 30 days from the surgery
measure: Rate of clinical T4 cancer at the preoperative staging
timeFrame: At time 0 (surgery)
measure: Liver metastases
timeFrame: At the preoperative staging or at surgery (time 0)
measure: Lung metastases
timeFrame: At the preoperative staging or at surgery (time 0)
measure: Associated symptoms
timeFrame: Before surgery
measure: Emergency surgery
timeFrame: surgery (time 0)
measure: Postoperative complications
timeFrame: 30 days from surgery
measure: Mortality
timeFrame: 30 days from surgery
Other outcomes:
Locations:
city: Rho
country: Italy
facility: Rho Memorial Hospital
state: Milan
city: Rozzano
country: Italy
facility: Humanitas Research Center
state: Milan
city: Bari
country: Italy
facility: AOU Policlinico di Bari "M. Rubino"
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni Hospital
city: Bergamo
country: Italy
facility: Policlinico San Marco
city: Bologna
country: Italy
facility: Maggiore Hospital
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Brescia
country: Italy
facility: Spedali Civili
city: Brescia
country: Italy
facility: Spedali Civili
city: Cagliari
country: Italy
facility: Santissima Trinità Hospital
city: Carate Brianza
country: Italy
facility: Vittorio Emanuele III Hospital
city: Civitavecchia
country: Italy
facility: San Paolo Hospital
city: Faenza
country: Italy
facility: AUSL Romagna Ravenna-Faenza
city: Firenze
country: Italy
facility: San Giovanni di Dio Hospital
city: Gardone Val Trompia
country: Italy
facility: Gardone Val Trompia Hospital
city: Milan
country: Italy
facility: ASST FBF Sacco Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori
city: Mirano
country: Italy
facility: Mirano Hospital
city: Napoli
country: Italy
facility: AORN Cardarelli
city: Napoli
country: Italy
facility: Università della Campania Luigi Vanvitelli
city: Padova
country: Italy
facility: Padova University Hospital
city: Padova
country: Italy
facility: Veneto Institute of Oncology IOV-IRCCS
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
city: Parma
country: Italy
facility: AOU Parma
city: Pavia
country: Italy
facility: San Matteo Hospital
city: Peschiera Del Garda
country: Italy
facility: Pederzoli Hospital
city: Pordenone
country: Italy
facility: Azienda Sanitaria Fiuli Occidentale
city: Riccione
country: Italy
facility: Ceccarini Hospital
city: Rimini
country: Italy
facility: Infermi Hospital
city: Roma
country: Italy
facility: Campus Biomedico
city: Roma
country: Italy
facility: Fondazione Policlinico Roma Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Roma
country: Italy
facility: San Filippo Neri Hospital
city: Roma
country: Italy
facility: Sant'Eugenio Hospital
city: Roma
country: Italy
facility: UOSD Tor Vergata
city: Sassari
country: Italy
facility: AOU Sassari
city: Treviso
country: Italy
facility: Regional Hospital Treviso
city: Trieste
country: Italy
facility: University Hospital of Trieste
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza
city: Turin
country: Italy
facility: Mauriziano Hospital
city: Vimercate
country: Italy
facility: ASST Vimercate
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
name: Matteo Rottoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenwood E, Swanton C. Consequences of COVID-19 for cancer care - a CRUK perspective. Nat Rev Clin Oncol. 2021 Jan;18(1):3-4. doi: 10.1038/s41571-020-00446-0.
citation: Jazieh AR, Akbulut H, Curigliano G, Rogado A, Alsharm AA, Razis ED, Mula-Hussain L, Errihani H, Khattak A, De Guzman RB, Mathias C, Alkaiyat MOF, Jradi H, Rolfo C; International Research Network on COVID-19 Impact on Cancer Care. Impact of the COVID-19 Pandemic on Cancer Care: A Global Collaborative Study. JCO Glob Oncol. 2020 Sep;6:1428-1438. doi: 10.1200/GO.20.00351.
citation: Torzilli G, Vigano L, Galvanin J, Castoro C, Quagliuolo V, Spinelli A, Zerbi A, Donadon M, Montorsi M; COVID-SURGE-ITA group. A Snapshot of Elective Oncological Surgery in Italy During COVID-19 Emergency: Pearls, Pitfalls, and Perspectives. Ann Surg. 2020 Aug;272(2):e112-e117. doi: 10.1097/SLA.0000000000004081.
citation: Mitchell EP. Declines in Cancer Screening During COVID-19 Pandemic. J Natl Med Assoc. 2020 Dec;112(6):563-564. doi: 10.1016/j.jnma.2020.12.004. No abstract available.
citation: Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.