NCT05788224

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

March 14, 2023

Last Update Submit

May 22, 2023

Conditions

Keywords

elderly; oldest; colorectal cancer; perforation; bleeding; obstruction; emergency; surgery; laparotomy; laparoscopy; futility; frailty

Outcome Measures

Primary Outcomes (1)

  • mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer

    through study completion, an average of 1 year

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Society of Emergency Surgery

Paris, 75016, France

RECRUITING

Related Publications (1)

  • DE Simone B, Abu-Zidan FM, Podda M, Pellino G, Sartelli M, Coccolini F, DI Saverio S, Biffl WL, Kaafarani HM, Moore EE, Dhesi JK, Moug S, Ansaloni L, Avenia N, Catena F; CO-OLDER Collaborators. The management of complicated colorectal cancer in older patients in a global perspective after COVID-19: the CO-OLDER WSES project. Minerva Surg. 2024 Jun;79(3):273-285. doi: 10.23736/S2724-5691.23.10165-1.

MeSH Terms

Conditions

Colorectal NeoplasmsHemorrhageBites and StingsEmergenciesFrailty

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and InjuriesDisease Attributes

Study Officials

  • Belinda De Simone, MD

    World Society of Emergency Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Belinda De Simone, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 28, 2023

Study Start

May 1, 2022

Primary Completion

September 30, 2023

Study Completion

January 2, 2024

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations