Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001124820
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Date results information initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cost effectiveness of routine histology for haemorrhoidectomy specimens
Scientific title
Cost effectiveness of routine histology for haemorrhoidectomy specimens - retrospective cohort study
Secondary ID [1] 304794 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemorrhoids 322860 0
Anal cancer 322861 0
Condition category
Condition code
Oral and Gastrointestinal 320437 320437 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 320670 320670 0 0
Bowel - Anal

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective cohort study of patients who received haemorrhoidectomies at Hervey Bay Hospital between March 2012 and May 2020. The proportion sent for histology is determined by consulting the medical records. The histology results of those shows the proportion of haemorrhoidectomy specimens showing incidental anal cancers. Cost effectiveness of routine histology was investigated by weighing the number of incidental anal cancers detected against the cost of analysis.
Intervention code [1] 321169 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328277 0
Cost of histological analysis per case of incidental anal cancer. This will be done by accessing medical records of all patients receiving haemorrhoidectomy to determine histological diagnosis, and comparing to the cost of histological analysis as stated by the pathology provider.
Timepoint [1] 328277 0
At time of haemorrhoidectomy
Secondary outcome [1] 398322 0
Proportion of haemorrhoidectomy specimens sent for histology. This will be done by accessing medical records of all patients receiving haemorrhoidectomy.
Timepoint [1] 398322 0
At time of haemorrhoidectomy

Eligibility
Key inclusion criteria
Patients who underwent haemorrhoidectomies at Hervey Bay Hospital between 1st March 2012 and 18th May 2020
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Those who had preoperative or intraoperative suspicion of a pathology other than haemorrhoids

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/08/2020
Date of last participant enrolment
Anticipated
Actual
28/08/2020
Date of last data collection
Anticipated
Actual
9/07/2021
Sample size
Target
100
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309166 0
Self funded/Unfunded
Name [1] 309166 0
N/A
Country [1] 309166 0
Primary sponsor type
Individual
Name
Henry Watter
Address
Hervey Bay Hospital
Corner Nissen St and Urraween Rd
Urraween 4655 QLD
Country
Australia
Secondary sponsor category [1] 310124 0
None
Name [1] 310124 0
N/A
Address [1] 310124 0
N/A
Country [1] 310124 0
Other collaborator category [1] 281914 0
Individual
Name [1] 281914 0
Guat Shi Ng
Address [1] 281914 0
Hervey Bay Hospital
Corner Nissen St and Urraween Rd
Urraween 4655 QLD
Country [1] 281914 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309028 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 309028 0
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Australia
Ethics committee country [1] 309028 0
Australia
Date submitted for ethics approval [1] 309028 0
Approval date [1] 309028 0
20/08/2020
Ethics approval number [1] 309028 0

Summary
Brief summary
This study aimed to determine the cost-effectiveness of routine histology for haemorrhoidectomy specimens in a regional Australian hospital, as a way of detecting incidental anal cancer. The secondary aim was to determine the proportion of specimens that were sent for histology over the study period and whether individual surgeons had a significant preference for whether to send for histology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112702 0
Dr Henry Watter
Address 112702 0
Hervey Bay Hospital
Corner Urraween Rd and Nissen St
Urraween QLD 4655
Country 112702 0
Australia
Phone 112702 0
+61408421104
Fax 112702 0
Email 112702 0
[email protected]
Contact person for public queries
Name 112703 0
Dr Henry Watter
Address 112703 0
Hervey Bay Hospital
Corner Urraween Rd and Nissen St
Urraween QLD 4655
Country 112703 0
Australia
Phone 112703 0
+61743256666
Fax 112703 0
Email 112703 0
[email protected]
Contact person for scientific queries
Name 112704 0
Dr Henry Watter
Address 112704 0
Hervey Bay Hospital
Corner Urraween Rd and Nissen St
Urraween QLD 4655
Country 112704 0
Australia
Phone 112704 0
+61743256666
Fax 112704 0
Email 112704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.