Clinical trial NCT05641129: Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot
Official title: Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot-An International, Multi-centre Study of Emergency Presentations of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal surgery
colorectal cancer
colonic stenting
emergency surgery
Lead sponsor: European Student Research Network
Sponsor class: NETWORK
First posted: 2022-12-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome
timeFrame: 90-day
Secondary outcomes:
measure: Secondary outcome 1
timeFrame: 30-day
measure: Secondary outcome 2
timeFrame: 30- and 90-day
measure: Secondary outcome 3
timeFrame: 30- and 90-day
measure: Secondary outcome 4
timeFrame: 30- and 90-day
measure: Secondary outcome 5
timeFrame: 90-day
measure: Secondary outcome 6
timeFrame: 30- and 90-day
measure: Secondary outcome 7
timeFrame: 30- and 90-day
measure: Secondary outcome8
timeFrame: 30- and 90-day
measure: Secondary outcome 9
timeFrame: 30- and 90-day
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Ireland
Study officials:
References: