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NCT Number: NCT05641129

Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aberdeen Royal Infirmary

Aberdeen, Ireland, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary outcome

    Time frame: 90-day

    Mortality since day of presentation

Secondary outcomes

  1. Secondary outcome 1

    Time frame: 30-day

    Inpatient mortality, mortality since day of presentation

  2. Secondary outcome 2

    Time frame: 30- and 90-day

    Operative mortality rates

  3. Secondary outcome 3

    Time frame: 30- and 90-day

    Rates of primary anastomosis

  4. Secondary outcome 4

    Time frame: 30- and 90-day

    Stoma formation and reversal rates

  5. Secondary outcome 5

    Time frame: 90-day

    Rate and grade of surgical complications

  6. Secondary outcome 6

    Time frame: 30- and 90-day

    Rates of stenting in those with left-sided LBO, rates of stenting in those treated with palliative intent, rate of colonic stenting complications

  7. Secondary outcome 7

    Time frame: 30- and 90-day

    Rate of representation for patients managed nonoperatively

  8. Secondary outcome8

    Time frame: 30- and 90-day

    Rates of radiological assessment on admission

  9. Secondary outcome 9

    Time frame: 30- and 90-day

    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

Sponsors and collaborators

Lead sponsor

European Student Research Network

Network

Registry information

Official study title

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

Acronym: APOLLO

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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