Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial

Abstract

Objective: To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.

Design: Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.

Setting: Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.

Participants: 441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial.

Interventions: Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided.

Main outcome measures: The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months.

Results: The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected.

Conclusion: In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.

Trial registration: Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Conflict of interest statement

Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare that IB received grants from the Clifford Craig Foundation (CCF), University of Tasmania, and Waitemata District Health Board to fund participating sites for physiotherapists to provide preoperative interventions outside of current standard care and for research assistants to acquire data. JR, LA, and CH were also supported by these grants to coordinate the project at their respective sites. IKR receives a salary from the CCF to perform statistical analysis and provide study design advice for studies receiving grants from the CCF. IKR also receives information technology and library services from the University of Tasmania. Neither CCF nor the University of Tasmania have managerial authority over IKR’s work.

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Figures

Fig 1

Flow of patients through trial. UAS=upper abdominal surgery. PAC=preadmission clinic

Fig 2

Time to diagnosis of a postoperative pulmonary complication after surgery. Data are on an intention-to-treat basis and adjusted for age, previous respiratory disease, and surgical category. PPC=postoperative pulmonary complication

Fig 3

(a) 12 month mortality between groups; (b) 12 month mortality between groups in subgroup treated by experienced physiotherapists. Data are per protocol and adjusted for age, previous respiratory disease, and surgical category

Fig 4

Sensitivity analysis of subgroup effects on incidence of postoperative pulmonary complications (PPCs). Data are adjusted for age, respiratory comorbidity, and upper gastrointestinal surgery

Fig 5

Sensitivity analysis of subgroup effects on hospital length of stay. Data are adjusted for age, respiratory comorbidity, and upper gastrointestinal surgery. PPC=postoperative pulmonary complication

Fig 6

Sensitivity analysis of subgroup effects on 12 month all cause mortality. Data are adjusted for age, respiratory comorbidity, and upper gastrointestinal surgery. PPC=postoperative pulmonary complication