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

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ClinicalTrials.gov Identifier: NCT04712292
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Matteo Rottoli, University of Bologna

Study Description
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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.


Condition or disease Intervention/treatment
Colorectal Neoplasms Malignant Procedure: Surgical procedure for confirmed or suspected colorectal cancer

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 Design
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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Oncologic stage [ Time Frame: 30 days from the surgery ]
    The stage will be reported at the histological examination according to TNM classification

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Liver metastases [ Time Frame: At the preoperative staging or at surgery (time 0) ]
    Rate of single/multiple liver metastases

  4. Lung metastases [ Time Frame: At the preoperative staging or at surgery (time 0) ]
    Rate of single/multiple lung metastases

  5. 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

  6. Emergency surgery [ Time Frame: surgery (time 0) ]
    rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital

  7. Postoperative complications [ Time Frame: 30 days from surgery ]
    Rate of 30-day complications graded according to the Clavien-Dindo Classification

  8. Mortality [ Time Frame: 30 days from surgery ]
    Rate of 30-day deaths


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712292


Contacts
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Contact: Matteo Rottoli, MD, PhD +390512145262 matteo.rottoli2@unibo.it

Locations
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Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Matteo Rottoli, MD IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
More Information
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Publications of Results:

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Responsible Party: Matteo Rottoli, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT04712292    
Other Study ID Numbers: 854/2020/Oss/AOUBo
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matteo Rottoli, University of Bologna:
colorectal cancer
diagnosis
screening
 COVID-19
surgery
outcomes
Additional relevant MeSH terms:
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COVID-19
Colorectal Neoplasms
Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases