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

Colorectal Neoplasms Malignant Clinical Trial

— COVID-CRC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712292
• Other study ID #: 854/2020/Oss/AOUBo
• Status: Recruiting
• Start date: September 8, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2022
• Source: University of Bologna
• Contact: Matteo Rottoli, MD, PhD
• Phone: +390512145262
• Email: matteo.rottoli2[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: April 1, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• COVID-19
• Neoplasms

Intervention

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)

Locations

Country	Name	City	State
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	ASST Santi Paolo e Carlo Hospital	Milan
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano	Milan
Italy	Istituto Nazionale dei Tumori	Milan
Italy	San Raffaele Hospital	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	Rho Memorial Hospital	Rho	Milan
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	Humanitas Research Center	Rozzano	Milan
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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 Pa — View 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. — View 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. Erratum in: JAMA. 2020 Apr 28;323(16):1619. — View Citation

Torzilli G, Viganò 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncologic stage	The stage will be reported at the histological examination according to TNM classification	30 days from the surgery
Primary	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)
Primary	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	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
Secondary	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)
Secondary	Liver metastases	Rate of single/multiple liver metastases	At the preoperative staging or at surgery (time 0)
Secondary	Lung metastases	Rate of single/multiple lung metastases	At the preoperative staging or at surgery (time 0)
Secondary	Associated symptoms	Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening	Before surgery
Secondary	Emergency surgery	rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital	surgery (time 0)
Secondary	Postoperative complications	Rate of 30-day complications graded according to the Clavien-Dindo Classification	30 days from surgery
Secondary	Mortality	Rate of 30-day deaths	30 days from surgery