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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021 |
| |
| Control group | Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical procedure for confirmed or suspected colorectal cancer | Procedure | Surgical procedure for cancer may include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Oncologic stage | The stage will be reported at the histological examination according to TNM classification | 30 days from the surgery |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of clinical T4 cancer at the preoperative staging |
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Inclusion Criteria:
and
Exclusion Criteria:
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The study will include all adult patients undergoing elective or urgent surgery for proven or suspected colorectal within the study periods
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Rottoli, MD, PhD | Contact | +390512145262 | matteo.rottoli2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Matteo Rottoli, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rho Memorial Hospital | Recruiting | Rho | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33097915 | Result | 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. | |
| 32986516 | Result | 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. |
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|
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 | Rate of single/multiple liver metastases | At the preoperative staging or at surgery (time 0) |
| Lung metastases | Rate of single/multiple lung metastases | At the preoperative staging or at surgery (time 0) |
| Associated symptoms | Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening | Before surgery |
| Emergency surgery | rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital | surgery (time 0) |
| Postoperative complications | Rate of 30-day complications graded according to the Clavien-Dindo Classification | 30 days from surgery |
| Mortality | Rate of 30-day deaths | 30 days from surgery |
| Humanitas Research Center | Recruiting | Rozzano | Milan | 40100 | Italy |
|
| AOU Policlinico di Bari "M. Rubino" | Recruiting | Bari | Italy |
|
| Policlinico di Bari | Recruiting | Bari | Italy |
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| Humanitas Gavazzeni Hospital | Recruiting | Bergamo | Italy |
|
| Policlinico San Marco | Recruiting | Bergamo | Italy |
|
| Maggiore Hospital | Recruiting | Bologna | 40100 | Italy |
|
| Fondazione Poliambulanza | Recruiting | Brescia | Italy |
|
| Spedali Civili | Recruiting | Brescia | Italy |
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| Spedali Civili | Recruiting | Brescia | Italy |
|
| Santissima TrinitĂ Hospital | Recruiting | Cagliari | Italy |
|
| Vittorio Emanuele III Hospital | Recruiting | Carate Brianza | Italy |
|
| San Paolo Hospital | Recruiting | Civitavecchia | Italy |
|
| AUSL Romagna Ravenna-Faenza | Recruiting | Faenza | Italy |
|
| San Giovanni di Dio Hospital | Recruiting | Florence | Italy |
|
| Gardone Val Trompia Hospital | Recruiting | Gardone Val Trompia | Italy |
|
| ASST FBF Sacco Hospital | Recruiting | Milan | 20100 | Italy |
|
| San Raffaele Hospital | Recruiting | Milan | 20100 | Italy |
|
| ASST Santi Paolo e Carlo Hospital | Recruiting | Milan | Italy |
|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano | Recruiting | Milan | Italy |
|
| Istituto Nazionale dei Tumori | Recruiting | Milan | Italy |
|
| Mirano Hospital | Recruiting | Mirano | Italy |
|
| AORN Cardarelli | Recruiting | Naples | Italy |
|
| UniversitĂ della Campania Luigi Vanvitelli | Recruiting | Naples | Italy |
|
| Padova University Hospital | Recruiting | Padova | Italy |
|
| Veneto Institute of Oncology IOV-IRCCS | Recruiting | Padova | Italy |
|
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello | Recruiting | Palermo | Italy |
|
| AOU Parma | Recruiting | Parma | Italy |
|
| San Matteo Hospital | Recruiting | Pavia | Italy |
|
| Pederzoli Hospital | Recruiting | Peschiera del Garda | Italy |
|
| Azienda Sanitaria Fiuli Occidentale | Recruiting | Pordenone | Italy |
|
| Ceccarini Hospital | Recruiting | Riccione | Italy |
|
| Infermi Hospital | Recruiting | Rimini | Italy |
|
| Campus Biomedico | Recruiting | Roma | Italy |
|
| Fondazione Policlinico Roma Tor Vergata | Recruiting | Roma | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | Italy |
|
| San Filippo Neri Hospital | Recruiting | Roma | Italy |
|
| Sant'Eugenio Hospital | Recruiting | Roma | Italy |
|
| UOSD Tor Vergata | Recruiting | Roma | Italy |
|
| AOU Sassari | Recruiting | Sassari | Italy |
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| Regional Hospital Treviso | Recruiting | Treviso | Italy |
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| University Hospital of Trieste | Recruiting | Trieste | Italy |
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| AOU CittĂ della Salute e della Scienza | Recruiting | Turin | Italy |
|
| Mauriziano Hospital | Recruiting | Turin | Italy |
|
| ASST Vimercate | Recruiting | Vimercate | Italy |
|
| 32675512 | Result | 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. |
| 33339569 | Result | 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. |
| 32203977 | Result | 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004194 | Disease |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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