ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Patients undergoing appendicectomy

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

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]

Within three months of operation

Primary outcome [2]

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]

Within three months of operation

Primary outcome [3]

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]

Within six months of operation

Secondary outcome [1]

Observed incidental appendiceal pathologies (descriptive report).
This will be assessed by interrogation of patient medical records, both electronic and hard copy.

Timepoint [1]

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?

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)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke Street, Canberra City ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Hospital Research Foundation

Address [2]

60 Woodville Rd, Woodville SA 5011

Country [2]

Australia

Funding source category [3]

University

Name [3]

The University of Adelaide

Address [3]

Adelaide SA 5005, Australia

Country [3]

Australia

Primary sponsor type

Individual

Name

Dr Ned Kinnear

Address

Western Health, 160 Gordon St, Footscray VIC 3011

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Mr James Moore

Address [1]

Royal Adelaide Hospital, Port Road. Adelaide, SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
   Clinical Trial Centre
   Wayfinder 3D460.02   Level 3 
Port Road
ADELAIDE   SA   5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/11/2015

Ethics approval number [1]

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

Dr Ned Kinnear

Address

Western Health
160 Gordon St
Footscray VIC 3011

Country

Australia

Phone

+61 3 8345 6666

Fax

ned.kinnear@gmail.com

Contact person for public queries

Name

Ned Kinnear

Address

Western Health
160 Gordon St
Footscray VIC 3011

Country

Australia

Phone

+61 3 8345 6666

Fax

ned.kinnear@gmail.com

Contact person for scientific queries

Name

Ned Kinnear

Address

Western Health
160 Gordon St
Footscray VIC 3011

Country

Australia

Phone

+61 3 8345 6666

Fax

ned.kinnear@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Communication and management of incidental pathology in 1,214 consecutive appendicectomies; a cohort study.	2019	https://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.

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Documents added automatically