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Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial
The BMJ ( IF 105.7 ) Pub Date : 2018-01-24 , DOI: 10.1136/bmj.j5916
Ianthe Boden , Elizabeth H Skinner , Laura Browning , Julie Reeve , Lesley Anderson , Cat Hill , Iain K Robertson , David Story , Linda Denehy

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.


中文翻译:

术前物理疗法预防上腹部手术后呼吸系统并发症:实用,双盲,多中心随机对照试验

目的评估单个术前理疗疗程减少上腹部手术后术后肺部并发症(PPC)的疗效。
设计前瞻性,务实,多中心,患者和评估者不知情,平行组,安慰剂对照的随机对照试验。在澳大利亚和新西兰的三所三级公立医院
设立多学科的入院前诊所。
参加者441例年龄在18岁或以上的成年人在进行选择性大开口上腹部手术的六周之内被随机分配,以隐蔽方式分配,以接受信息手册(n = 219;对照组)或术前物理治疗(n = 222;干预)和随后的12个月。432完成了审判。
干预术前,参与者收到一本信息手册(对照)或另外的30分钟理疗教育和呼吸运动训练课(干预)。教育着重于PPC及其预防,方法是通过早期移动和自主呼吸练习,在术后恢复意识后立即开始。术后,所有参与者均接受了标准化的早期步行,并且未提供其他呼吸物理治疗。
主要观察指标主要结局是每天使用墨尔本组评分评估的术后14天内的PPC。次要结局为医院获得性肺炎,住院时间长短,使用重症监护病房服务以及医院费用。患者报告了与健康相关的生活质量,身体机能和出院后并发症,在第6周进行了测量,所有病因死亡率均在12个月以内。
结果与对照组相比,干预组在术后14天内(包括医院获得性肺炎)的PPC发生率降低了一半(调整后的危险比0.48,95%置信区间0.30至0.75,P = 0.001),绝对风险降低15%(95%置信区间7%至22%)和7(95%置信区间5至14)需要治疗。在其他次要结局方面未发现明显差异。
结论在需要进行上腹部手术的一般患者中,现有医院多学科入院前诊所提供的30分钟术前物理治疗时间将PPC的发生率降低了一半,尤其是医院获得性肺炎的发生率。需要进行进一步的研究以调查对死亡率和住院时间的益处。
试验注册澳大利亚新西兰临床试验注册中心ANZCTR 12613000664741。
更新日期:2018-01-25
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