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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05641129
Other study ID # APOLLO Study
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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