The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study (CO-OLDER)

May 22, 2023 updated by: Belinda De Simone, Poissy-Saint Germain Hospital

This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer.

The final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the COVID pandemic outbreak (11th March 2020) and after the 11th March, during the ongoing pandemic.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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

  • France
      • Paris, France, 75016
        • Recruiting
        • World Society of Emergency Surgery
        • Contact:
        • Principal Investigator:
          • Belinda De Simone, MD

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All older (aged 75 years old and over) patients who were admitted to the surgical department with acute abdominal pain due to a complication of colorectal cancer.

Description

Inclusion Criteria:

  • Patients aged 75 years old and over;
  • Admission to the emergency department with acute abdominal pain;
  • Diagnosis of obstructed and/or perforated colorectal cancer.

Exclusion Criteria:

  • Patients aged< 75 years old;
  • Patients aged >=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Poissy-Saint Germain Hospital

Collaborators

Fausto Catena
World Society of Emergency Surgery

Investigators

  • Principal Investigator: Belinda De Simone, MD, World Society of Emergency Surgery

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)

May 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

January 2, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDS02

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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