title: The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.
authors.affiliation: Physiotherapy Department, Launceston General Hospital, Charles St, Launceston, Tasmania, 7250, Australia. ianthe.boden@ths.tas.gov.au.|Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, Parkville, Victoria, 3010, Australia. ianthe.boden@ths.tas.gov.au.
authors.forename: Ianthe
authors.initials: I
authors.lastname: Boden
authors.affiliation: Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, Parkville, Victoria, 3010, Australia. laura.browning@wh.org.au.|Division of Allied Health, Western Health, Furlong Road, St Albans, Victoria, 3021, Australia. laura.browning@wh.org.au.
authors.forename: Laura
authors.initials: L
authors.lastname: Browning
authors.affiliation: Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, Parkville, Victoria, 3010, Australia. elizabeth.skinner@wh.org.au.|Department of Physiotherapy, Western Health, 160 Gordon St, Footscray, Victoria, 3011, Australia. elizabeth.skinner@wh.org.au.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Skinner
authors.affiliation: Department of Physiotherapy, School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Private Bag 92006, Auckland, 1142, New Zealand. julie.reeve@aut.ac.nz.|Physiotherapy Department, North Shore Hospital, Waitemata District Health Board, North Shore City, Auckland, 0622, New Zealand. julie.reeve@aut.ac.nz.
authors.forename: Julie
authors.initials: J
authors.lastname: Reeve
authors.affiliation: Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, Parkville, Victoria, 3010, Australia. d.el-ansary@unimelb.edu.au.
authors.forename: Doa
authors.initials: D
authors.lastname: El-Ansary
authors.affiliation: School of Health Sciences, University of Tasmania, Locked Bag 1320, Launceston, Tasmania, 7250, Australia. iain.robertson@utas.edu.au.|Clifford Craig Medical Research Trust, Launceston General Hospital, Charles Street, Launceston, Tasmania, 7250, Australia. iain.robertson@utas.edu.au.
authors.forename: Iain K
authors.initials: IK
authors.lastname: Robertson
authors.affiliation: Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, Parkville, Victoria, 3010, Australia. l.denehy@unimelb.edu.au.
authors.forename: Linda
authors.initials: L
authors.lastname: Denehy
mesh_terms: D000005:Abdomen / Q000601:surgery*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D017721:Hospital Costs; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects* / Q000191:economics; D007902:Length of Stay; D008297:Male; D009520:New Zealand; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods; D026741:Physical Therapy Modalities / Q000191:economics; D011300:Preoperative Care / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000191:economics / Q000382:microbiology / Q000517:prevention & control*; D012307:Risk Factors; D013648:Tasmania; D013997:Time Factors; D016896:Treatment Outcome