ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12622001182785

Ethics application status

Approved

Date submitted

30/08/2022

Date registered

2/09/2022

Date last updated

2/09/2022

Date data sharing statement initially provided

2/09/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

What is the effect of preoperative education on postoperative pulmonary complications following upper abdominal surgery

Scientific title

Investigating the effect of preoperative education, on the incidence of postoperative pulmonary complications following upper abdominal surgery at John Hunter Hospital

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Postoperative pulmonary complications following upper abdominal surgery

Upper abdominal surgery

Condition category

Condition code

Oral and Gastrointestinal

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

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This intervention is identical to that provided by Boden I, El-Ansary D, Zalucki N, et al. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2018;104(2):194-202. (ACTRN12613000664741)

This study is examining the pragmatic delivery of the intervention (within a NSW health district and utilising telehealth for delivery) used in this study - effect on postoperative pulmonary complications and the feasibility of its delivery in a tertiary hospital.

The intervention comprises 2 components. These are:
1. A 20-minute education session that is delivered 1:1 with a physiotherapist trained specifically in delivery of the relevant information. This information delivered in this education session is related to the effects of anaesthesia and surgery on the lungs, what to expect after surgery, and education regarding deep breathing breathing exercises that can be practiced before the surgery and that should be commenced immediately after surgery (ie. prior to the physiotherapist seeing the patient).
2. A handout with this information included in both text and graphical representations.

The intervention will be provided either via face-to-face or via teleconference with audio only, whichever mode of delivery is preferable to the patient. It will be provided within 6 weeks prior to surgery. A physiotherapist who is with more than 1 year clinical experience, will provide the intervention.

The handout is identical to that developed by Boden et al (2018) with details pertaining to JHH included. Exercises within the handout mirror that presented by the physiotherapist including deep breathing exercises, supported cough and early mobility.

All physiotherapists delivering the intervention will undergo training in the delivery of the education session. This will comprise a single 2 hour workshop delivered by a senior physiotherapist with more than 10 years clinical experience in cardiorespiratory physiotherapy. These physiotherapists will also perform their first session in pairs (with permission from the participant), where formative feedback from the second physiotherapist (also a trainee in the intervention) will be provided to ensure the session is delivered appropriately. Training will occur at least 1 month prior to recruitment of the first participant.

Intervention code [1]

Prevention

Comparator / control treatment

The comparator group comprises 48 patients who underwent upper abdominal surgery at John Hunter Hospital between November 2021 and June 2022. These patients did not receive any preoperative education ie. usual care, and underwent their surgery prior to commencement of the intervention.

Control group

Historical

Outcomes

Primary outcome [1]

Postoperative pulmonary complication as measured by the Melbourne Group Score

Timepoint [1]

Daily in the 7 days following surgery

Primary outcome [2]

Feasibility of delivering peroperative education prior to surgery as measured by proportion of patients who receive the education compared with those who are eligible. The proportion of patients who receive the education will be determined by an audit of the study database and the proportion of patients who are eligible will be determined by an audit of the study screening and enrollment logs.

Timepoint [2]

Assessed at the conclusion of the study

Secondary outcome [1]

Hospital length of stay as measured by data-linkage to medical records

Timepoint [1]

Until acute care hospital discharge

Secondary outcome [2]

Other non-pulmonary complications including cardiac complications, wound or urinary infections, falls etc. identified via medical records

Timepoint [2]

Daily in the 7 days following surgery

Eligibility

Key inclusion criteria

All patients 18 years and older, assessed and consented by the John Hunter Hospital Perioperative service for planned upper abdominal surgery,
At least one abdominal incision above the umbilicus and below the diaphragm that is greater than 5cm in length.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

SAMPLE SIZE
The sample size has been calculated for the outcome of rate of postoperative pulmonary complications (PPC).

An examination of data for John Hunter Hospital (JHH) PPC rates in June 2022 identified the rate of PPCs in a sample of 48 patients is 25%.

In previously published data, the intervention led to a 50% relative risk reduction (RRR). Therefore, in the first instance we propose that the intervention be powered for a PPC rate of 25% down to 12%. However, we have decided to factor an 'uncertainty’ buffer into our calculations that the effect won’t be as strong compared with the published data (given the published data was an ‘ideal’ face-to-face process, and our process is pragmatic and including telehealth options) or the current baseline sample is not representative of the broader population. Therefore, we have powered for 40% RRR equating to an absolute risk reduction of 10% ie. Rate of PPC s from 25% to 15% following implementation of the intervention.

Based on inference for a single proportion comparing to a known proportion with a=0.05 and power at 80% a post-cohort sample of 133 is required if the baseline PPC rate is 0.25 and a reduction to 0.15 is detected.

STATISTICAL METHODS
The feasibility of delivery of this intervention within the patient cohort at JHH will be determined by the proportion of patients who agree to participate and are provided the education session through either face-to-face or telehealth delivery.

The rate of PPCs following implementation of education session will be examined and compared with the rate of PPCs measured in a group who had their surgery prior to implementation of the intervention. The absolute and relative rates of PPCs will be estimated using multivariate robust random effects Poisson generalised linear regression.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

15/08/2022

Date of last participant enrolment

Anticipated

28/02/2023

Actual

Date of last data collection

Anticipated

31/03/2023

Actual

Sample size

Target

183

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hunter New England Local Health District

Address [1]

John Hunter Hospital
Lookout Road,
New Lambton Heights. NSW. 2305

Country [1]

Australia

Primary sponsor type

Hospital

Name

John Hunter Hospital

Address

John Hunter Hospital
Lookout Road
New Lambton Heights. NSW. 2305

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

HMRI, Level 3 POD
Lot 1, Kookaburra Circuit
New Lambton Heights. NSW. 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2022

Approval date [1]

31/05/2022

Ethics approval number [1]

2022/ETH0551

Summary

Brief summary

A postoperative pulmonary complication (PPC) is more than 15 times more common following upper abdominal surgery (UAS) than a cardiac complication. A PPC more than doubles the baseline cost of abdominal surgery.1,2 A single PPC costs the hospital approximately $AUD 45 000 to treat.1 

John Hunter Hospital is a major centre in NSW for UAS such as open gastro-oesophageal cancer resections, performing 384 UAS procedures in 2019. Due to the pathophysiological impact that these higher risk procedures have, PPCs are more likely to occur when compared to lower abdominal and non-thoracic surgeries.2,3 Prospective collection of PPCs in a group of patients undergoing UAS at JHH (n=48) between November 2021 and June 2022 demonstrated a rate of PPCs of 25%. 

An Australian/New Zealand multicentre randomized control trial (RCT) and economic analysis evaluated the impact of a simple 30-minute preoperative Physiotherapy education intervention for those undergoing high risk abdominal surgery.3 (ACTRN12613000664741) This intervention involved education related to postoperative pulmonary complications, their causes and implications, and the importance of deep breathing, coughing and early mobility in their prevention.  This intervention resulted in  a reduction in the incidence of PPC by half and an absolute risk reduction of PPC of 15%. 3

It is unclear how this research translates into clinical practice, particularly when preoperative flow may differ between health services and also when many perioperative appointments are now conducted via telehealth. 

This research aims to evaluate the feasibility of the pragmatic delivery of a 20 minute 1:1 physiotherapy preoperative education session (Boden et al 3) for people undergoing UAS at JHH and the impact on PPCs . We hypothesise, that more than 90% of patients eligible for this study will be delivered the preoperative education, and that a reduction in PPCs, similar to that reported by Boden et al 3, will be observed. 

1.	Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014;3:7.
2.	Serpa Neto A, Hemmes SN, Barbas CS, et al. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014;2(12):1007-1015.
3.	Boden I, El-Ansary D, Zalucki N, et al. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2018;104(2):194-

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jennifer Mackney

Address

Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305

Country

Australia

Phone

+61 2 49217879

Fax

Jennifer.Mackney@health.nsw.gov.au

Contact person for public queries

Name

Jennifer Mackney

Address

Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305

Country

Australia

Phone

+61 2 49217879

Fax

Jennifer.Mackney@health.nsw.gov.au

Contact person for scientific queries

Name

Jennifer Mackney

Address

Department of Physiotherapy
John Hunter Hospital
Lookout Road, New Lambton Heights. NSW. 2305

Country

Australia

Phone

+61 2 49217879

Fax

Jennifer.Mackney@health.nsw.gov.au

Data sharing statement

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

Yes

What data in particular will be shared?

Non-identifiable data collected as part of this study will be shared

When will data be available (start and end dates)?

Beginning immediately following publication and ending 5years following publication.

Available to whom?

Genuine researchers who agree to keep the information confidential and who are provided approval from the original research team.

Available for what types of analyses?

Any analyses as deemed suitable by the original researchers.

How or where can data be obtained?

Access subject to approval by Principal Investigator: Dr Jennifer Mackney, Jennifer.Mackney@health.nsw.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Email
17068	Study protocol	Jennifer.mackney@health.nsw.gov.au
17069	Statistical analysis plan	Jennifer.mackney@health.nsw.gov.au
17070	Informed consent form	Jennifer.mackney@health.nsw.gov.au
17071	Ethical approval	Jennifer.mackney@health.nsw.gov.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically