The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) Trial: Study Protocol for a Multi-centre Randomised Controlled Trial

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aut.relation.issue1en_NZ
aut.relation.journalTrialsen_NZ
aut.relation.volume16en_NZ
aut.researcherReeve, Julie
dc.contributor.authorBoden, Ien_NZ
dc.contributor.authorBrowning, Len_NZ
dc.contributor.authorSkinner, EHen_NZ
dc.contributor.authorReeve, Jen_NZ
dc.contributor.authorEl-Ansary, Den_NZ
dc.contributor.authorRobertson, IKen_NZ
dc.contributor.authorDenehy, Len_NZ
dc.date.accessioned2019-01-23T02:58:43Z
dc.date.available2019-01-23T02:58:43Z
dc.date.copyright2015en_NZ
dc.date.issued2015en_NZ
dc.description.abstractBackground: Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. Methods/design: The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. Discussion: The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting. Trial registration: Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.en_NZ
dc.identifier.citationTrials, 2015, 16:573, doi: 10.1186/s13063-015-1090-6
dc.identifier.doi10.1186/s13063-015-1090-6en_NZ
dc.identifier.issn1745-6215en_NZ
dc.identifier.urihttps://hdl.handle.net/10292/12181
dc.languageengen_NZ
dc.publisherBioMed Central Ltd.en_NZ
dc.relation.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1090-6
dc.rights© 2015 Boden et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.accessrightsOpenAccessen_NZ
dc.subjectAbdominal surgeryen_NZ
dc.subjectBreathing exercisesen_NZ
dc.subjectPhysiotherapyen_NZ
dc.subjectPost-operative pulmonary complicationen_NZ
dc.subjectPre-operative educationen_NZ
dc.subjectPreventionen_NZ
dc.subjectRandomised controlled trialen_NZ
dc.titleThe LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) Trial: Study Protocol for a Multi-centre Randomised Controlled Trialen_NZ
dc.typeJournal Article
pubs.elements-id195529
pubs.organisational-data/AUT
pubs.organisational-data/AUT/Health & Environmental Science
pubs.organisational-data/AUT/Health & Environmental Science/Clinical Sciences
pubs.organisational-data/AUT/PBRF
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences/HH Clinical Sciences 2018 PBRF
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