Journal Article

ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery

Winzer, Brooke, Boden, Ianthe, Hackett, Claire, Lane, Rebecca, Robertson, Iain, Sullivan, Kate, McKinnon, Melissa

2018

Overview

Background Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard care alone. Methods The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient- and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15 min) or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum 2 days, and 30 min of daily supervised early rehabilitation for minimum five postoperative days). The primary outcome is a respiratory complication within the first 14 postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30 days and at 1 year following surgery. Discussion The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, minimal harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial. Trial registration ACTRN 12615000318583 . Registered 8 April 2015

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / Abdominal surgery / Australia / Breathing exercises / Clinical trials / Complications / Complications and side effects / Costs / Digestive System Surgical Procedures - methods / Digestive System Surgical Procedures - rehabilitation / Early Ambulation / Emergency Medicine / Emergency surgery / Exercise Therapy - methods / Gynecological surgery / Humans / Incidence / Intensive care / Intraoperative Complications - prevention & control / Length of Stay / Medicine / Medicine & Public Health / Morbidity / Mortality / Ostomy / Patients / Physical therapy / Physical Therapy Modalities - nursing / Physiotherapy / Pneumonia / Postoperative complications / Postoperative period / Postoperative pulmonary complication / Prevention / Quality of life / Quality of Life - psychology / Rehabilitation / Risk factors / Sepsis / Study Protocol / Systematic review / Traumatic Surgery / Treatment Outcome