Acute PresentatiOn of CoLorectaL Cancer: an internatiOnal Snapshot

Colorectal Cancer Clinical Trial

— APOLLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641129
• Other study ID #: APOLLO Study
• Status: Completed
• Start date: January 16, 2023
• Est. completion date: November 11, 2023

Study information

• Verified date: February 2023
• Source: European Student Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: November 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Ireland

Sponsors (1)

Lead Sponsor	Collaborator
European Student Research Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	Mortality since day of presentation	90-day
Secondary	Secondary outcome 1	Inpatient mortality, mortality since day of presentation	30-day
Secondary	Secondary outcome 2	Operative mortality rates	30- and 90-day
Secondary	Secondary outcome 3	Rates of primary anastomosis	30- and 90-day
Secondary	Secondary outcome 4	Stoma formation and reversal rates	30- and 90-day
Secondary	Secondary outcome 5	Rate and grade of surgical complications	90-day
Secondary	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	Secondary outcome 7	Rate of representation for patients managed nonoperatively	30- and 90-day
Secondary	Secondary outcome8	Rates of radiological assessment on admission	30- and 90-day
Secondary	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