Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot (APOLLO)

Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot-An International, Multi-centre Study of Emergency Presentations of Colorectal Cancer

APOLLO (Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal snapshot) is an international, multi-centre, prospective observational study which will address this need and aims to describe the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

Detailed Description

Primary aim: Describe the variation in the operative and non-operative management of emergency presentations of colon and rectal cancer in an international cohort.

Secondary aims:

• Identify risk factors for mortality (intraoperatively, at 30-days and at 90-days) and ostomy rates (at 30- and 90-days) in patients deemed for active management (i.e., not for palliative management) to develop a risk prediction model
• Validate risk criteria of large bowel obstruction in patients with previously known colorectal cancer undergoing neoadjuvant chemotherapy or awaiting elective surgery

Who?

• Patients aged 18 years and above presenting to the hospital acutely with colorectal cancer (CRC) for malignant large bowel obstruction (LBO), perforation, CRC-related haemorrhage or other reasons within the data collection periods. Both those managed with and without surgery will be included
• Patients with localised and metastatic disease will be included
• Patients with known colorectal cancer diagnoses will be included if they present acutely (e.g., with disease progression)
• Patients presenting acutely for the side effects of chemotherapy/radiotherapy of known cancers will be excluded

What? Data will be collected on patients' presenting status and symptoms, patient management strategies, and intraoperative and postoperative outcomes.

When? Prospectively over 2023 in consecutive 6-week data collection blocks between January and June with 90-day follow-up till September.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• United Kingdom
  • Ireland
    • Aberdeen, Ireland, United Kingdom
      • Aberdeen Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent.

Description

Inclusion Criteria:

• Patient pathology: Patients admitted to the hospital acutely with primary colon AND/OR rectal adenocarcinoma and referred to general/colorectal surgical departments:
• Patients who are operated on for curative/palliative treatment of colorectal cancer
• Patients who are referred to general surgery for assessment (irrespective of if they proceed to surgery)
• New diagnoses of colorectal cancer
• Extent of cancer: All patients including extra-abdominal metastatic, intra-abdominal metastatic and non-metastatic disease
• Known cancer: Patients presenting for the first time with colorectal cancer AND/OR known colorectal cancer diagnosis with progression of disease. i.e. obstruction of known colorectal cancer
• Patient presentation: Symptomatic presentation of colorectal cancer i.e. large bowel obstruction, haemorrhage, perforation

Exclusion Criteria:

• Presenting for side effects of cancer treatment
• Patients with secondary cancers
• Previously included in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Main Cohort; Consecutive adult patients (≥18 years of age) presenting acutely (i.e. unplanned and non-elective presentation to hospital for urgent or emergency reasons) for symptoms of known or unknown colorectal cancer assessed by hospital surgical teams. Patients should be included regardless of operative or non-operative management, and curative or palliative intent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Mortality since day of presentation	90-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome 1	Inpatient mortality, mortality since day of presentation	30-day
Secondary outcome 2	Operative mortality rates	30- and 90-day
Secondary outcome 3	Rates of primary anastomosis	30- and 90-day
Secondary outcome 4	Stoma formation and reversal rates	30- and 90-day
Secondary outcome 5	Rate and grade of surgical complications	90-day
Secondary outcome 6	Rates of stenting in those with left-sided LBO, rates of stenting in those treated with palliative intent, rate of colonic stenting complications	30- and 90-day
Secondary outcome 7	Rate of representation for patients managed nonoperatively	30- and 90-day
Secondary outcome8	Rates of radiological assessment on admission	30- and 90-day
Secondary outcome 9	Proportion of patients presenting acutely with large bowel obstruction with known colorectal cancer who had high risk criteria for obstruction (as defined by the FOXTroT obstruction criteria) at index assessment	30- and 90-day

Collaborators and Investigators

• Sponsor: European Student Research Network

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; colorectal surgery; colonic stenting; emergency surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: APOLLO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Centre-summaries will be made available to respective centres for audit purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No