Trial Review

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
ACTRN12619000857101
Ethics application status
Approved
Date submitted
26/05/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Date results information initially provided
17/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of staffing structures on communication and management of unexpected findings in patients with a suspected inflamed appendix
Scientific title
Communication and management of incidental pathology in 1,214 consecutive appendicectomies; a cohort study.
Secondary ID [1] 298325 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing appendicectomy 312965 0
Condition category
Condition code
Surgery 311478 311478 0 0
Other surgery
Oral and Gastrointestinal 311521 311521 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 311522 311522 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Introduction of an acute surgical unit model (ASU).
Traditionally, general surgery departments allocated their surgeons and trainees to elective duties. Emergency general surgery (EGS) patients were managed ad-hoc, either after long delays, or through the interruption of elective patients. An alternative ASU model was introduced at our hospital on 01/08/2012. Compared with the Traditional model of managing emergency general surgical referrals, the ASU provides resources solely for EGS patients. This includes an on-site registrar, on-call consultant and ready emergency theatre, all available 24 hours a day and without elective duties.
The study will compare patient outcomes between the period 2.5 years before and after ASU implementation; that is, from 01/02/2010 to 01/02/2015. Eligible patients will be aged >=18 years at time of admission, and undergo appendicectomy at our institution in the enrolment period 01/02/2010 to 01/02/2015.
Patients will be followed from hospital admission until 6months post surgery.

Data collected will comprise basic demographic data (age, gender, date/ time of presentation, date/ time of referral to general surgery, date/ time of procedure, open or laparoscopic appendicectomy performed), and outcome data (appendiceal pathology result, date/ existence of documentation of communication of important incidental pathology result surgeon-patient and surgeon-general practitioner, and date/ existence of documentation of appropriate treatment of important incidental pathology).
Intervention code [1] 314562 0
Not applicable
Comparator / control treatment
Patients undergoing appendicectomy at our institution in the 2.5 years before introduction of the ASU. This period is between 01/02/2010 and 31/07/2012.
Control group
Historical

Outcomes
Primary outcome [1] 320177 0
Rates of documentation of communication of important incidental findings to the patient . This will be assessed by interrogation of patient medical records, both electronic and hard copy.
Timepoint [1] 320177 0
Within three months of operation
Primary outcome [2] 320178 0
Rates of documentation of communication of important incidental findings to the patient's general practitioner This will be assessed by interrogation of patient medical records, both electronic and hard copy.
Timepoint [2] 320178 0
Within three months of operation
Primary outcome [3] 320179 0
Rates of documentation of appropriate management or follow-up.
The authors will pre-define management standards for common and uncommon important incidental appendiceal pathology, through reference to specialist guidelines and the literature. If rare important pathologies are found that were not pre-defined, then standards will be defined for these also, in the same manner.
Whether patient management met these pre-defined standards will be assessed by interrogation of patient medical records, both electronic and hard copy.
Timepoint [3] 320179 0
Within six months of operation
Secondary outcome [1] 370778 0
Observed incidental appendiceal pathologies (descriptive report).
This will be assessed by interrogation of patient medical records, both electronic and hard copy.
Timepoint [1] 370778 0
At time of surgery

Eligibility
Key inclusion criteria
Patients with important incidental pathology on their appendicectomy specimen at our institution between 01/02/2010 and 31/01/2015.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with incomplete data.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Pearson's chi-squared test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
31/01/2019
Date of last data collection
Anticipated
Actual
31/01/2019
Sample size
Target
1200
Accrual to date
Final
1214
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13820 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 26577 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 302864 0
Government body
Name [1] 302864 0
National Health and Medical Research Council
Country [1] 302864 0
Australia
Funding source category [2] 302867 0
Charities/Societies/Foundations
Name [2] 302867 0
The Hospital Research Foundation
Country [2] 302867 0
Australia
Funding source category [3] 302868 0
University
Name [3] 302868 0
The University of Adelaide
Country [3] 302868 0
Australia
Primary sponsor type
Individual
Name
Dr Ned Kinnear
Address
Western Health, 160 Gordon St, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 302820 0
Individual
Name [1] 302820 0
Mr James Moore
Address [1] 302820 0
Royal Adelaide Hospital, Port Road. Adelaide, SA 5000
Country [1] 302820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303440 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 303440 0
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02 Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 303440 0
Australia
Date submitted for ethics approval [1] 303440 0
Approval date [1] 303440 0
12/11/2015
Ethics approval number [1] 303440 0
Q20151120

Summary
Brief summary
Lay summary
When a patient has their appendix removed (appendicectomy), the specimen is then examined under a microscope in a laboratory. Most show an inflamed appendix (appendicitis), as expected, a few are normal (negative), and approximately 10% show important unexpected findings (pathology). These include cancer, pre-cancerous growths (polyps), abnormally located cells from the womb (endometriosis) or parasites.
In 2005, a new structure of care for patients with appendicitis and other emergency general surgery (EGS) conditions. Unlike the previous Traditional arrangements, this acute surgical unit (ASU) model allocated separate teams to elective and emergency patients. Many studies have shown that the ASU model reduces the time spent waiting for the operating theatre, the overall time spent in hospital and complications. However, it is unclear whether this dedicated team for EGS patients leads to better care or communication when unexpected findings occur.
Therefore, amongst appendicectomy patients with important incidental findings, we aimed to assess whether introducing an ASU led to better surgeon-to-patient and surgeon-to-general practitioner communication, and better management.
Trial website
Trial related presentations / publications
Public notes
Explanation why ethics approved post-dated the enrolment period;
This is a retrospective observational study. Hence, ethics approval was sought to examine patient outcomes during two periods in the past; 01/02/2010 - 01/08/2012 (Traditional model), and 01/08/2012 - 01/02/2015 (acute surgical unit model).

Contacts
Principal investigator
Name 93674 0
Dr Ned Kinnear
Address 93674 0
Western Health
160 Gordon St
Footscray VIC 3011
Country 93674 0
Australia
Phone 93674 0
+61 3 8345 6666
Fax 93674 0
Email 93674 0
[email protected]
Contact person for public queries
Name 93675 0
Dr Ned Kinnear
Address 93675 0
Western Health
160 Gordon St
Footscray VIC 3011
Country 93675 0
Australia
Phone 93675 0
+61 3 8345 6666
Fax 93675 0
Email 93675 0
[email protected]
Contact person for scientific queries
Name 93676 0
Dr Ned Kinnear
Address 93676 0
Western Health
160 Gordon St
Footscray VIC 3011
Country 93676 0
Australia
Phone 93676 0
+61 3 8345 6666
Fax 93676 0
Email 93676 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
The authors do not have permission to share confidential patient data.


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
SourceTitleYear of PublicationDOI
EmbaseCommunication and management of incidental pathology in 1,214 consecutive appendicectomies; a cohort study.2019https://dx.doi.org/10.1016/j.ijsu.2019.10.025
N.B. These documents automatically identified may not have been verified by the study sponsor.