Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
- Conditions
- Colorectal Neoplasms Malignant
- Interventions
- Procedure: Surgical procedure for confirmed or suspected colorectal cancer
- Registration Number
- NCT04712292
- Lead Sponsor
- University of Bologna
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group Surgical procedure for confirmed or suspected colorectal cancer Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021 Control group Surgical procedure for confirmed or suspected colorectal cancer Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019
- Primary Outcome Measures
Name Time Method Palliative surgery 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
Oncologic stage 30 days from the surgery The stage will be reported at the histological examination according to TNM classification
Rate of radical surgery 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
Name Time Method Mortality 30 days from surgery Rate of 30-day deaths
Aggressive cancer biology 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.
Rate of clinical T4 cancer at the preoperative staging 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
Liver metastases At the preoperative staging or at surgery (time 0) Rate of single/multiple liver metastases
Lung metastases At the preoperative staging or at surgery (time 0) Rate of single/multiple lung metastases
Associated symptoms Before surgery Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening
Emergency surgery surgery (time 0) rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital
Postoperative complications 30 days from surgery Rate of 30-day complications graded according to the Clavien-Dindo Classification
Trial Locations
- Locations (44)
Santissima Trinità Hospital
🇮🇹Cagliari, Italy
San Paolo Hospital
🇮🇹Civitavecchia, Italy
AUSL Romagna Ravenna-Faenza
🇮🇹Faenza, Italy
ASST Santi Paolo e Carlo Hospital
🇮🇹Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano
🇮🇹Milan, Italy
San Giovanni di Dio Hospital
🇮🇹Firenze, Italy
ASST FBF Sacco Hospital
🇮🇹Milan, Italy
San Raffaele Hospital
🇮🇹Milan, Italy
Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
AORN Cardarelli
🇮🇹Napoli, Italy
San Matteo Hospital
🇮🇹Pavia, Italy
Università della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Veneto Institute of Oncology IOV-IRCCS
🇮🇹Padova, Italy
Padova University Hospital
🇮🇹Padova, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Italy
AOU Parma
🇮🇹Parma, 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
University Hospital of Trieste
🇮🇹Trieste, Italy
UOSD Tor Vergata
🇮🇹Roma, Italy
AOU Città della Salute e della Scienza
🇮🇹Turin, Italy
Mauriziano Hospital
🇮🇹Turin, Italy
Humanitas Research Center
🇮🇹Rozzano, Milan, Italy
AOU Policlinico di Bari "M. Rubino"
🇮🇹Bari, Italy
Fondazione Poliambulanza
🇮🇹Brescia, Italy
Rho Memorial Hospital
🇮🇹Rho, Milan, Italy
Policlinico di Bari
🇮🇹Bari, Italy
Maggiore Hospital
🇮🇹Bologna, Italy
Humanitas Gavazzeni Hospital
🇮🇹Bergamo, Italy
Policlinico San Marco
🇮🇹Bergamo, Italy
Spedali Civili
🇮🇹Brescia, Italy
Vittorio Emanuele III Hospital
🇮🇹Carate Brianza, Italy
Mirano Hospital
🇮🇹Mirano, Italy
Pederzoli Hospital
🇮🇹Peschiera Del Garda, Italy
Sant'Eugenio Hospital
🇮🇹Roma, Italy
Regional Hospital Treviso
🇮🇹Treviso, Italy
AOU Sassari
🇮🇹Sassari, Italy
ASST Vimercate
🇮🇹Vimercate, Italy
Gardone Val Trompia Hospital
🇮🇹Gardone Val Trompia, Italy