Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
NCT ID: NCT04712292
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15000 participants
OBSERVATIONAL
2020-09-08
2022-04-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Study group
Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021
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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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Matteo Rottoli
Professor
Principal Investigators
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Matteo Rottoli, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
Locations
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Rho Memorial Hospital
Rho, Milan, Italy
Humanitas Research Center
Rozzano, Milan, 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
Florence, , Italy
Gardone Val Trompia Hospital
Gardone Val Trompia, , Italy
ASST FBF Sacco Hospital
Milan, , Italy
San Raffaele 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
Mirano Hospital
Mirano, , Italy
AORN Cardarelli
Napoli, , Italy
Università della Campania Luigi Vanvitelli
Napoli, , Italy
Padova University Hospital
Padua, , Italy
Veneto Institute of Oncology IOV-IRCCS
Padua, , 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
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
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, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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854/2020/Oss/AOUBo
Identifier Type: -
Identifier Source: org_study_id
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