Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001162202
Ethics application status
Approved
Date submitted
4/06/2018
Date registered
13/07/2018
Date last updated
13/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term survival outcomes of colorectal cancer in the elderly
Scientific title
Colorectal cancer long term survival outcomes in the elderly populaton: a retrospective cohort study
Secondary ID [1] 295089 0
Nil known
Universal Trial Number (UTN)
U1111-1215-1975
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 308151 0
Condition category
Condition code
Cancer 307636 307636 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 307637 307637 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Colorectal cancer is the condition observed. Patients are observed from the time of diagnosis (histological or radiological) until 10th July 2017, which was when data collection finished)
Intervention code [1] 301425 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306143 0
Overall survival.. This will be collected from Alfred Health medical records, Cabrini Monash Colorectal Neoplasia Database (CMCND) and the Victorian Births Deaths and Marriages (BDM) Registry
Timepoint [1] 306143 0
5-year post diagnosis
Secondary outcome [1] 347729 0
complications will be obtained from Alfred Health medical records and the CMCND. Surgical complications are: anastomotic leak, prolonged ileus, wound dehiscence, wound infection, bleeding, stoma problem, hernia, deep collection, return to theatre
Medical complications are: pneumonia, pleural effusion, cardiac related, stroke, VTE, UTI, acute kidney impairment
Timepoint [1] 347729 0
30-day post surgery
Secondary outcome [2] 347730 0
recurrence is measured at 1 year and 3 years. This information will be obtained from medical records and CMCND.
Timepoint [2] 347730 0
Less than 1 year and between 1-3 years post surgery

Eligibility
Key inclusion criteria
diagnosis of colorectal cancer between January 2011 and December 2015, and admitted to Alfred Health
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No dates of diagnosis or surgery documented
No long term outcomes documented
No form of management documented

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Pearson Chi-Square or Fisher’s exact test was performed for categorical data to identify the significant differences between the three age groups. All survival analysis was performed using Kaplan-Meier and multivariate Cox Regression analysis was performed to identify significant independent predictors of 5-year cancer specific survival.. Statistical analysis was performed using SPSS version 22.0.0.0, and a p-value <0.05 was considered significant.
As this was not a prospective trial, there was no sample size calculations performed in this retrospective study. All patients who meet the inclusion criteria are included in the data analyses. From experience of colorectal surgeons are Alfred Health, it was estimated 150 patients would meet the criteria

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/09/2016
Date of last participant enrolment
Anticipated
Actual
8/07/2017
Date of last data collection
Anticipated
Actual
10/07/2017
Sample size
Target
150
Accrual to date
Final
330
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11068 0
The Alfred - Prahran
Recruitment postcode(s) [1] 22871 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 299672 0
Self funded/Unfunded
Name [1] 299672 0
Brianne Lauritz
Country [1] 299672 0
Australia
Funding source category [2] 300131 0
Hospital
Name [2] 300131 0
Department of colorectal surgery, Alfred Hospital
Country [2] 300131 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Alfred Health
55 Commercial Rd, Prahran Vic 3004
Country
Australia
Secondary sponsor category [1] 299005 0
None
Name [1] 299005 0
Address [1] 299005 0
Country [1] 299005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300572 0
Alfred Health Ethics Committee
Ethics committee address [1] 300572 0
Alfred Health
55 Commercial Rd, Prahran, Victoria 3004
Ethics committee country [1] 300572 0
Australia
Date submitted for ethics approval [1] 300572 0
25/02/2016
Approval date [1] 300572 0
26/03/2016
Ethics approval number [1] 300572 0

Summary
Brief summary
As the ageing population increases, so has the number of colorectal cancer surgeries performed. Despite clear consensus on the treatment, the elderly are known to be undertreated. This study aims to interrogate age-related morbidity, mortality and long-term survival in elderly colorectal cancer patients.
Trial website
Trial related presentations / publications
Verbal presentation at the RACS Victorian ASM 2017
Public notes

Contacts
Principal investigator
Name 84090 0
Dr Brianne Lauritz
Address 84090 0
Melbourne Health
300 Grattan St, Parkville Vic 3050
Country 84090 0
Australia
Phone 84090 0
+61402852246
Fax 84090 0
Email 84090 0
[email protected]
Contact person for public queries
Name 84091 0
Brianne Lauritz
Address 84091 0
Melbourne Health
300 Grattan St, Parkville Vic 3050
Country 84091 0
Australia
Phone 84091 0
+61402852246
Fax 84091 0
Email 84091 0
[email protected]
Contact person for scientific queries
Name 84092 0
Brianne Lauritz
Address 84092 0
Melbourne Health
300 Grattan St, Parkville Vic 3050
Country 84092 0
Australia
Phone 84092 0
+61402852246
Fax 84092 0
Email 84092 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.