Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer (COVID-CRC)

February 10, 2022 updated by: Matteo Rottoli, University of Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021
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)
Control group
Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Matteo Rottoli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Anticipated)

February 15, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 854/2020/Oss/AOUBo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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