Study protocol
Does physiotherapy reduce the incidence of postoperative complications in patients following pulmonary resection via thoracotomy? a protocol for a randomised controlled trial
1 Division of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, AUT University, Auckland, New Zealand
2 Allied Health, Auckland City Hospital, Auckland, New Zealand
3 Physiotherapy, Royal Adelaide Hospital, Adelaide, South Australia, Australia
4 School of Physiotherapy, Faculty of Medicine, Dentistry and Health, University of Melbourne, Melbourne, Victoria, Australia
Journal of Cardiothoracic Surgery 2008, 3:48 doi:10.1186/1749-8090-3-48
Published: 18 July 2008Abstract
Background
Postoperative pulmonary and shoulder complications are important causes of postoperative morbidity following thoracotomy. While physiotherapy aims to prevent or minimise these complications, currently there are no randomised controlled trials to support or refute effectiveness of physiotherapy in this setting.
Methods/Design
This single blind randomised controlled trial aims to recruit 184 patients following lung resection via open thoracotomy. All subjects will receive a preoperative physiotherapy information booklet and following surgery will be randomly allocated to a Treatment Group receiving postoperative physiotherapy or a Control Group receiving standard care nursing and medical interventions but no physiotherapy. The Treatment Group will receive a standardised daily physiotherapy programme to prevent respiratory and musculoskeletal complications. On discharge Treatment Group subjects will receive an exercise programme and exercise diary to complete. The primary outcome measure is the incidence of postoperative pulmonary complications, which will be determined on a daily basis whilst the patient is in hospital by a blinded assessor. Secondary outcome measures are the length of postoperative hospital stay, severity of pain, shoulder function as measured by the self-reported shoulder pain and disability index, and quality of life measured by the Medical Outcomes Study Short Form 36 v2 New Zealand standard version. Pain, shoulder function and quality of life will be measured at baseline, on discharge from hospital, one month and three months postoperatively. Additionally a subgroup of subjects will have measurement of shoulder range of movement and muscle strength by a blinded assessor.
Discussion
Results from this study will contribute to the increasing volume of evidence regarding the effectiveness of physiotherapy following major surgery and will guide physiotherapists in their interventions for patients following thoracotomy.
Trial registration
The study protocol is registered with the Australian and New Zealand Clinical Trials registry (ANZCTRN12605000201673).
