Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Cohort<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, colorectal cancer, colonic stenting, emergency surgery