Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000722291
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A retrospective evaluation of patients with acute appendicitis who have been managed conservatively at a metropolitan health network in Melbourne, Australia from 2011 to 2016
Scientific title
A retrospective evaluation of patients with acute appendicitis who have been managed conservatively at a metropolitan health network in Melbourne, Australia from 2011 to 2016
Secondary ID [1] 294723 0
Nil Known
Universal Trial Number (UTN)
U1111-1212-9559
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
appendicitis 307603 0
Condition category
Condition code
Surgery 306660 306660 0 0
Other surgery
Oral and Gastrointestinal 306676 306676 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of patients admitted to hospital from 1st July 2011 to 31st December 2016. Observed interventions include:

Laparoscopic appendicectomy
Open appendicectomy
Colonoscopy
Right hemicolectomy
Intravenous Antibiotics (Ceftriaxone, Metronidazole, Tazocin, Meropenem)
Intervention code [1] 301016 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305668 0
The prevalence of conservative management (intravenous antibiotics and/or radiologically guided drainage) of acute appendicitis within the study period. Data are collected via medical records
Timepoint [1] 305668 0
From July 2011 to December 2016
Secondary outcome [1] 346105 0
Percentage of patients who have required radiologically guided drainage of intra-abdominal collection or abscess during their primary admission. Data are collected via medical records
Timepoint [1] 346105 0
from admission to 6-24 months post primary admission episode
Secondary outcome [2] 346159 0
Percentage of patients who required outpatient colonoscopy as a follow-up. Data are collected via medical records
Timepoint [2] 346159 0
from admission to 6-24 months post primary admission episode
Secondary outcome [3] 346161 0
Percentage of patients who required an interval appendicectomy during the follow-up period. Data are collected via medical records
Timepoint [3] 346161 0
from admission to 6-24 months post primary admission episode

Eligibility
Key inclusion criteria
Patients who were diagnosed with the primary diagnosis of acute appendicitis with evidence on imaging, who had complete treatment within Eastern Health, Melbourne
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No imaging confirmation of diagnosis
Patients transferred to another health network
Patients who received operative management of appendicitis within the same primary admission

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Observational data only
No statistical analysis needed

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/04/2017
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
31/07/2017
Sample size
Target
50
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10791 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 10792 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 10793 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 22530 0
3128 - Box Hill
Recruitment postcode(s) [2] 22531 0
3135 - Ringwood East
Recruitment postcode(s) [3] 22532 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 299332 0
Hospital
Name [1] 299332 0
Eastern Health
Country [1] 299332 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 arnold st, Box Hill VIC 3128, Australia
Country
Australia
Secondary sponsor category [1] 298616 0
None
Name [1] 298616 0
Address [1] 298616 0
Country [1] 298616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300237 0
Office of research and ethics
Ethics committee address [1] 300237 0
Ethics committee country [1] 300237 0
Australia
Date submitted for ethics approval [1] 300237 0
Approval date [1] 300237 0
04/04/2017
Ethics approval number [1] 300237 0
QA30-2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83010 0
Dr Zexi Allan
Address 83010 0
department of general surgery
Box Hill Hospital
5 arnold st, Box Hill VIC 3128, Australia
Country 83010 0
Australia
Phone 83010 0
+61420853245
Fax 83010 0
Email 83010 0
[email protected]
Contact person for public queries
Name 83011 0
Zexi Allan
Address 83011 0
department of general surgery
Box Hill Hospital
5 arnold st, Box Hill VIC 3128, Australia
Country 83011 0
Australia
Phone 83011 0
+61420853245
Fax 83011 0
Email 83011 0
[email protected]
Contact person for scientific queries
Name 83012 0
Zexi Allan
Address 83012 0
department of general surgery
Box Hill Hospital
5 arnold st, Box Hill VIC 3128, Australia
Country 83012 0
Australia
Phone 83012 0
+61420853245
Fax 83012 0
Email 83012 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.