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Trial registered on ANZCTR


Registration number
ACTRN12613000664741
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
19/06/2013
Date last updated
4/03/2019
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
LIPPSMAck POP trial - Lung Infection Prevention Post Surgery (Major Abdominal) with Pre-Operative Physiotherapy education.
Scientific title
In Adults awaiting elective major upper abdominal surgery, does the provision of pre-operative education from a Physiotherapist reduce the risk of the patient developing a post-operative pulmonary complication, compared to receiving an information booklet alone?
Secondary ID [1] 282652 0
Nil
Universal Trial Number (UTN)
U1111-1144-2282
Trial acronym
LIPPSMAck POP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pulmonary complications 289354 0
Condition category
Condition code
Surgery 289689 289689 0 0
Other surgery
Physical Medicine / Rehabilitation 289690 289690 0 0
Physiotherapy
Respiratory 289731 289731 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One (1) 20-30 minute pre-operative education session delivered by a Physiotherapist at the standard outpatient Pre-Admission Clinic appointment. The education is to be provided within 6 weeks of the schedued operation date and will be performed in person, however, if this is not possible, the patient will be contacted by phone and provided with the education and training via telephone and the booklet sent via mail. The pre-operative physiotherapy session will consist of education on the prevention of post-operative pulmonary complications stressing the importance of early post-operative ambulation and the performance of self-directed deep breathing and coughing (DB&C) exercises immediately from waking from the operation. Patients will be informed that the further they walk and the more often they walk away from the bedside each day following their operation the better their chance of avoiding serious post-operative complications (chest infection or deep vein thrombosis). They will be informed that a Physiotherapist will see them on the first post-operative day and assist them out of bed to walk as far as possible. They will be told that they will be walking at a pace that gets them a bit breathless and will be familiarised with the 0-10 Borg scale Rating of Perceived Exertion (RPE). They will be told that each time they walk it should feel like a 3-4/10 in exertion. After the first post-operative day session with the Physiotherapist they will be encouraged strongly to walk or exercise by their bedside as often as they can by themselves or with the assistance of a nurse or carer.
As it is frequently not possible to ambulate as early and as often as recommended, participants will be encouraged (during the pre-operative intervention) to perform self-directed breathing exercises to protect their lungs during this time in bed. They will be instructed to perform the DB&C exercises immediately from waking from the anaesthetic and then every hour during daytime waking hours until their first ambulation session, and then at any time when they are not ambulant. The physiotherapist will then coach each participant in at least three repetitions, and as many as required to master technique, of two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath stacking manoeuvres. Each breath is held for three to five seconds. Each set of 10 breaths are followed by three coughs, or a forced expiratory technique with an open glottis called a “huff”, with a small firm pillow pressed over on the abdominal incision to support the wound and to encourage greater expiratory force. Participants will be encouraged to practice these exercises prior to their operation to develop familiarity. Each patient in the intervention group will be given an estimate of their likelihood of getting a PPC based on available pre-operative information (type of procedure proposed, booked post-operative admission to ICU, usual length of procedure, respiratory co-morbidity, self rated fitness levels, current smoker). Patients will be informed that aggressive early self directed DB & C exercises and ambulation is effective in reducing this known risk of a PPC. Participants will be provided with an accompanying education booklet outlining what was presented on prevention of PPC, post-operative physiotherapy, early ambulation, self directed DB&C (2 sets of 10 DB followed by 3 coughs every hour during daytime) and the expected recovery process. Post-operatively participants will be provided with a standardised physiotherapy assisted early mobilisation program and reminded to do the DB&C exercises as per the booklet provided. No further coached respiratory physiotherapy is provided.
Intervention code [1] 287318 0
Prevention
Comparator / control treatment
Provision of an education booklet (indentical to the intervention group) outlining prevention of post-operative pulmonary complications, post-operative physiotherapy, early ambulation, self directed DB&C (2 sets of 10 DB followed by 3 coughs every hour during daytime) and the expected recovery process.
Control group
Active

Outcomes
Primary outcome [1] 289784 0
% who develop a Post-operative Pulmonary Complication as diagnosed with the following criteria: When four (4) or more of the following criteria are present 1. Chest radiograph report of collapse/consolidation 2. Raised maximum tympanic temperature greater than 38.0 C on more than one consecutive post-operative day 3. Pulse oximetry oxygen saturation (Sp02) less than 90% on room air on more than one consecutive post-operative day 4. Production of yellow or green sputum different to pre-operative assessment 5. Presence of infection on sputum culture report 6. An otherwise unexplained white cell count greater than 11 7. New abnormal breath sounds on auscultation different to preoperative assessment 8. Physician’s diagnosis of postoperative pulmonary complication OR prescription of an antibiotic specific for respiratory infection
Timepoint [1] 289784 0
Daily measure until post-operative day 7 or discharge from hospital whichever occurs first. From day 7 and up until Day 14, if there are any documented reasons i,n the daily medical record that indicate a deterioration in respiratory status a full respiratory complication diagnostic screen using the defined tool will be enacted.
Secondary outcome [1] 303232 0
Length of hospital stay in days
Timepoint [1] 303232 0
Total days in hospital from admission to discharge.
Secondary outcome [2] 316402 0
ICU length of stay
Timepoint [2] 316402 0
Anytime during the acute hospital stay
Secondary outcome [3] 316403 0
ICU readmission
Timepoint [3] 316403 0
Any time during acute hospital stay
Secondary outcome [4] 316404 0
Pneumonia, defined as the presence of new CXR infiltrates along with at least 2 of the following criteria; temperature >38C, dyspnoea, cough and purulent sputum, altered respiratory auscultation, and WCC >14,000/ml or leukopenia <3000/ml on any day within the first 14 post-operative hospital days;
Timepoint [4] 316404 0
Post-operative day 1 to post-operative day 14.
Secondary outcome [5] 316405 0
Hospital costs for the UAS admission episode of care. This will be supplied by the participating centres’, or health departments’, costing data for each participant’s admission episode.
Timepoint [5] 316405 0
On completion of the participants episode of care regarding the abdominal surgery.
Secondary outcome [6] 316406 0
Patient reported complications using a semi-structured phone interview. Complications are defined as any new health issue requiring medical management/review. Specific questions about wound complications (infection, breakdown), surgical complications (ileus, anastamosis leak, DVT, haemorrage etc), physical complications (fatigue, weakness, nausea, vomiting), respiratory complications (pneumonia, PE, pulm odema etc), cardiac complications (ami, NSTEMI etc)
Timepoint [6] 316406 0
6 - 8 weeks following day of surgery
Secondary outcome [7] 316407 0
health related quality of life using the SF36 questionnaire
Timepoint [7] 316407 0
6-8 weeks following day of surgery
Secondary outcome [8] 316408 0
Self reported functional capacity using the self-administered physical activity questionnaire (SAQ)
Timepoint [8] 316408 0
6-8 weeks following day of surgery
Secondary outcome [9] 330886 0
All-cause mortality as measured from each hospital's/health department's database.
Timepoint [9] 330886 0
up to 12-months post-surgery
Secondary outcome [10] 367743 0
In-hospital pathology and imaging testing. Type of test and units of daily consumption were extracted from pathology and radiology electronic databases for each participant for the relevant episode of care.
Timepoint [10] 367743 0
Prospectively and daily for the first 21 hospital days or until day of hospital discharge whichever occurred first
Secondary outcome [11] 367744 0
Clinical coding (ICD-10) of selected surgical and postoperative complications, including intraoperative surgical laceration, haemorrhage, anastomosis leak, wound infection, wound dehiscence, urinary tract infection, delirium, fall, all-cause cardiac complication, pressure ulcer, volume depletion, fluid overload, and sepsis. The codes will be extracted from the electronic hospital database for each participant's relevant episode of care by blinded assessors.
Timepoint [11] 367744 0
Hospital episode of care database will be accessed at the six-week follow up time point. If clinical coding not available at the first time point, databases will be checked fortnightly up until one year from surgery,
Secondary outcome [12] 367745 0
Clinical coding (ICD-10) of respiratory complications. Including unplanned reintubation, acute respiratory failure, pneumonia, pulmonary collapse, pneumothorax, pulmonary emboli, pleural effusion, and non-specified pulmonary problem. The codes will be extracted from the electronic hospital database for each participant's relevant episode of care by blinded assessors.
Timepoint [12] 367745 0
Hospital episode of care database will be accessed at the six-week follow up time point. If clinical coding not available at the first time point, databases will be checked fortnightly up until one year from surgery,
Secondary outcome [13] 367746 0
Quality adjusted life year (QALY) as determined by the SF-36 conversion to SF-6D health utility score. QALY calculated using linear change under the curve from baseline to six-weeks; six-weeks to 1-year. One-year health utility will be extrapolated using the baseline utility.
Timepoint [13] 367746 0
One-year from day of surgery
Secondary outcome [14] 367747 0
Hospital costs using a targeted resource use model. This includes units of use and attributed unit costs for bed days in ICU, surgical ward, and sub-acute care, ventilation and oxygen therapy use, CXRs, chest CTs, sputum cultures, blood cultures, all other types of diagnostic testing, all-cause antibiotic prescription, respiratory specific antibiotic prescription, extraordinary out of round physician call-outs, MET calls, preoperative physiotherapy use.
Timepoint [14] 367747 0
Measured prospectively and daily for first 21 postoperative days or until day of hospital discharge whichever occurred first

Eligibility
Key inclusion criteria
All patients awaiting elective major upper abdominal surgery at the Launceston General Hospital AND North West Regional Hospital, Tasmania, Australia, AND North Shore Hospital, Auckland, New Zealand. UAS is defined as any type of open incision above, or extending above, the umbilicus
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing condition that would limit their ability to participate in the standardised mobilisation protocol post-operatively. This is defined as any person who is unable to stand upright and ambulate for a maximum of 6 minutes without a seated rest. eg paraplegics, hoist transfer nursing home and disability patients, severely cognitively disabled patients who would not reliably participate in the post-operative ambulation program. 2. Unable to understand verbal or written instructions in English 3. Unable to attend a pre-admission assessment and education session with a Physiotherapist. 4. Open hernia repairs

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients who are listed for elective major upper abdominal surgery will be identified from the hospital's elective gastrointestinal, urology, and general surgery waiting lists. Written information about the clinical trial and consent form will be sent to the patient in the mail. The information and consent form will be re-presented to patient, or next of kin, at presentation to hospital for their pre-admission appointment.
Allocation: Patients will be randomly allocated by the Pre-operative Physiotherapist by opening a pre-prepared sealed opaque envelope containing a card with the nominated group allocation . After allocation patient details will be written on envelope once opened to ensure that patients were randomised in the same order as they were recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An administration assistant (who then takes no further part in the study) will prepare sequentially numbered opaque envelopes, each containing a card with allocation group determined by computer generated random number (odd=intervention).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Recent published Australian studies (Scholes 2009, Browning 2007) in this patient population have measured the rate of post-operative pulmonary complications at 15-20% in context of providing pre-operative physiotherapy education and a once only post-operative physiotherapy session.
Sample size was calculated using inference for proportions comparing two independent samples with a 0.05 two-sided significance level and will have 80% power to detect a 10% absolute difference in PPC between Pre-Op (estimated at 10%) and an education booklet (estimated at 20%) when the sample size is 398. This is further increased by 11% to account for attrition, resulting in a final sample size of 441.
The effectiveness of the randomisation process will be tested by simple logistic regression for binomial categorical variables; general linear modelling for normally distributed continuous data; and ordered logistic regression for non-normal continuous data or for rank-ordered categorical variables. In order to minimise the effect on outcome estimates of potential confounding variables due to minor variation in distribution of those variables between the trial groups, multivariate adjustment for those variables will be performed. Adjustment covariates will be selected from covariates that may have the potential for clinically significant alterations in effect sizes by backward stepwise regression. These include: history of a respiratory comorbidity, smoking history, self-reported physical activity levels, age, BMI, length in time of operation, operation category (upper gastrointestinal, colorectal, urological, other), ICU admission immediately following the procedure, incision type and location, intraoperative ventilation strategies, fluid delivery, blood transfusions, mode of post-operative analgesia, and use of prophylactic antibiotics.
All outcomes are to be analysed using intention-to-treat. The absolute and relative rates of PPC in the trial groups will be estimated using multivariate robust random effects Poisson generalised linear regression to allow assessment of binary outcomes with or without adjustment for potential confounding variables (incidence rates and rate ratios, 95% confidence intervals, p-values). Treatment centre will be treated as a fixed variable in the multi-level models. In addition, the effect of time from the end of surgery/anaesthesia to commencement of symptoms of PPC will be compared using Cox proportional hazards regression with and without covariate adjustment (hazards ratio, 95% confidence intervals, p-values). Graphic representation of this analysis will be performed using the Kaplan-Meier method.
Binomial secondary outcomes, including pneumonia, unplanned ICU admission and patient reported complications, will be analysed using mixed effects Poisson regression. Secondary outcomes with irregular distributions, including length of time periods (ICU and total post-operative LOS, time to ambulation for 1 minute and 10 minutes, and time to discharge from assisted ambulation physiotherapy service) and HRQoL and functional capacity, group differences will be evaluated using mixed effects ordered logistic regression, with mean time (95% CI) estimated for descriptive purposes using mixed effects linear regression, with or without log transformation depending on distribution. Hospital costs associated with the interventions will be compared using mixed effects linear regression. Log transformation of highly skewed cost data will be performed.
The sensitivity of the outcome estimates to missing data will be evaluated using multiple imputation (Stata command syntax mi). All analyses will be performed using Stata version 13 or later (StataCorp, College Station, Texas USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 1118 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 4133 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 6956 0
7250 - Launceston
Recruitment postcode(s) [2] 10064 0
7320 - Burnie
Recruitment outside Australia
Country [1] 7079 0
New Zealand
State/province [1] 7079 0
Auckland

Funding & Sponsors
Funding source category [1] 287436 0
Charities/Societies/Foundations
Name [1] 287436 0
Clifford Craig Medical Research Trust
Address [1] 287436 0
W.D. Booth Centre
5th Floor
Launceston General Hospital
274-280 Charles Street
Launceston Tas 7250
Country [1] 287436 0
Australia
Funding source category [2] 291787 0
University
Name [2] 291787 0
University of Tasmania
virtual Tasmanian Academic Health Science Precinct project
Address [2] 291787 0
Churchill Avenue
Sandy Bay
Tasmania
7005
Country [2] 291787 0
Australia
Funding source category [3] 291788 0
Other Collaborative groups
Name [3] 291788 0
Awhina Health Campus
Awhina Research & Knowledge Centre
Address [3] 291788 0
Lower Ground Floor
North Shore Hospital
124 Shakespeare Road
Takapuna
AUCKLAND CITY 0622
Country [3] 291788 0
New Zealand
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 286179 0
None
Name [1] 286179 0
Address [1] 286179 0
Country [1] 286179 0
Other collaborator category [1] 277448 0
University
Name [1] 277448 0
Department of Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Address [1] 277448 0
Physiotherapy
Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building
161 Barry Street, Carlton
Victoria 3053
Country [1] 277448 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289412 0
Human Research Ethics committee (Tasmania) network
Ethics committee address [1] 289412 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, Tasmania, 7001
Ethics committee country [1] 289412 0
Australia
Date submitted for ethics approval [1] 289412 0
Approval date [1] 289412 0
06/09/2011
Ethics approval number [1] 289412 0
H0011911
Ethics committee name [2] 293306 0
Northern A Health and Disability Ethics Committee
Ethics committee address [2] 293306 0
Freyberg House
20 Aitken St
PO BOX 5013
Wellington 6011
Ethics committee country [2] 293306 0
New Zealand
Date submitted for ethics approval [2] 293306 0
Approval date [2] 293306 0
23/01/2015
Ethics approval number [2] 293306 0
14/NTA/233

Summary
Brief summary
Chest infections can occur in as many as 1 out of every 2 patients after they have had major bowel, stomach, liver or kidney surgery. This is serious and costly. Chest infections dramatically increase the risk of death following surgery, and the average length of time spent in hospital is doubled.

Studies have shown that getting up, and out of bed, and walking as early as possible after surgery with a Physiotherapist reduces this chance of getting a chest infection down to as low as 1 in 20. Unfortunately, these studies have also included time spent with a Physiotherapist before the operation on learning how to do breathing exercises and how to get going again soon after the operation.

So, it is really hard to say for certain if this significant reduction in chest infections is down, not just to the amount of walking a patient does after the operation, but also to the level of education they received before the operation.

No clinical trial to this point has specifically looked at how effective this type of pre-operative education is, in its own right, in reducing the risk of a chest infection after an operation.

The LIPPSMAck POP trial will provide education and training from a Physiotherapist to half of the patients about to undergo major abdominal surgery. The other half will get a pamphlet covering the same sort of information. All patients will get a follow up session with a physiotherapist on the first day after their surgery.

The trial will compare these two groups and see if there is any difference in rates of chest infections and how long they stay in hospital.

The result of this trial will assist in determining the wisest and most cost effective way to allocate Physiotherapy services to people having a major abdominal operation and assist them in recovering from their operation as quickly as possible.
Trial website
Trial related presentations / publications
Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. The BMJ. 2018 Jan 24;360:j5916.

Boden I, El-Ansary D, Zalucki N, Robertson IK, Browning L, Skinner EH, Denehy L. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2017 Sep 1.

Boden I, Browning L, Skinner EH, et al. The LIPPSMAck POP (Lung Infection Prevention Post Surgery-Major Abdominal-with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial. Trials 2015; 16(1): 1-15.

Boden I, Skinner EH, Browning L, Denehy L. The LIPPSMAck POP (Lung Infection Prevention Post Surgery-Major Abdominal-with Pre-Operative Physiotherapy) trial: a multi-centre randomised controlled trial. Australian and New Zealand College of Anaesthetists Annual Scientific Meeting. Auckland; 2016.

Boden I, Skinner EH, Browning L, Denehy L. Hospital costs of respiratory complications following abdominal surgery: Implications for service provision and interpretation of clinical trials. Australian and New Zealand College of Anaesthetists Annual Scientific Meeting. Auckland; 2016.
Public notes

Contacts
Principal investigator
Name 40666 0
Ms Ianthe Boden
Address 40666 0
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania 7250
Country 40666 0
Australia
Phone 40666 0
+61 3 6777 6216
Fax 40666 0
Email 40666 0
ianthe.boden@dhhs.tas.gov.au
Contact person for public queries
Name 40667 0
Ms Ianthe Boden
Address 40667 0
Physiotherapy Department
Launceston General Hospital
PO BOX 1963
Launceston, Tasmania 7250
Country 40667 0
Australia
Phone 40667 0
+61 3 6777 6216
Fax 40667 0
Email 40667 0
ianthe.boden@dhhs.tas.gov.au
Contact person for scientific queries
Name 40668 0
Ms Ianthe Boden
Address 40668 0
Physiotherapy Department
Launceston General Hospital
PO BOX 1963
Launceston, Tasmania 7250
Country 40668 0
Australia
Phone 40668 0
+61 3 6777 6216
Fax 40668 0
Email 40668 0
ianthe.boden@dhhs.tas.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 794 0
Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, et al. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018;360:j5916.
Attachments [1] 794 0
Publication date and citation/details [2] 795 0
Boden I, El-Ansary D, Zalucki N, Robertson IK, Browning L, Skinner EH, 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;104:194–202.
Attachments [2] 795 0
Publication date and citation/details [3] 796 0
Boden I, Browning L, Skinner EH, Reeve J, El-Ansary D, Robertson IK, et al. The LIPPSMAck POP (lung infection prevention post surgery-major abdominal-with pre-operative physiotherapy) trial: study protocol for a multi-centre randomised controlled trial. Trials. 2015;16:1–15.
Attachments [3] 796 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary