Validity and Utility Testing of a Criteria-led Discharge Checklist to Determine Post-operative Recovery after Abdominal Surgery: an International Multicentre Prospective Cohort Trial.

BACKGROUND: Criteria-led discharge (CLD) has promising potential to reduce unnecessary hospital stay after abdominal surgery; however, the validity and utility of CLD is uncertain as studies are limited to small single-centre studies involving predominantly elective colorectal surgery. METHODS: This prospective international multicentre cohort study explored the relationship between a CLD checklist, post-operative recovery, and hospital length of stay using patient-level data from four clinical trials involving 1071 adults undergoing all types of emergency and elective abdominal surgery at five hospitals across Australia and New Zealand. Patients were assessed daily for 21 post-operative days using a standardised CLD checklist. Surgeons and hospital clinicians were masked to findings. Criterion, construct, and content validity of the checklist to accurately reflect discharge decisions by surgical teams, assess physiological recovery, and encompass parameters signalling physiological readiness to discharge were tested. Potential utility of CLD to minimise unnecessary hospital stay was assessed by comparing day of readiness to discharge to actual day of discharge. RESULTS: The CLD checklist had concordance with existing discharge planning practices and accurately measured a longer post-operative recovery in more complex clinical situations. The CLD checklist in its current format did not detect all legitimate medical and surgical reasons necessitating a continued stay in hospital. Day of readiness to discharge was 0.8 days (95% CI 0.7 to 0.9, p < 0.001) less than actual day of discharge. CONCLUSION: A CLD checklist has excellent criterion and construct validity in measuring physiological recovery following all types of major elective and emergency abdominal surgery. Content validity could be improved. The use of CLD has the potential to reduce unnecessary hospital stay although the safety of discharging patients according to the criteria requires investigation prior to implementation. TRIAL REGISTRATION: Trials were prospectively registered at the Australian New Zealand Clinical Trials Registry (LIPPSMAck POP 12613000664741, ICEAGE 12615000318583, PLASTIC 12619001344189, NIPPER PLUS 12617000269336).

PHYSIO+++: protocol for a pilot randomised controlled trial assessing the feasibility of physiotherapist-led non-invasive ventilation for patients with hypoxaemia following abdominal surgery.

INTRODUCTION: Few clinical trials have investigated physiotherapy interventions to treat hypoxaemia following abdominal surgery. The objective of this study is to determine the feasibility and safety of conducting a clinical trial of physiotherapist-led non-invasive ventilation (NIV). METHODS AND ANALYSIS: This single-centre, 50-patient, parallel-group, assessor blinded, pilot feasibility randomised controlled trial with concealed allocation will enrol spontaneously ventilating adults with hypoxaemia within 72 hours of major abdominal surgery. Participants will receive either (1) usual care physiotherapy of a single education session (talk), daily walking of 10-15 min (walk) and four sessions of coached deep breathing and coughing (breathe) or (2) usual care physiotherapy plus four 30 min sessions of physiotherapist-led NIV delivered over 2 postoperative days. Primary feasibility and safety outcome measures are; number of eligible patients recruited per week, total time of NIV treatment delivered, acceptability of treatments to patients and clinicians and incidence of adverse events. Secondary feasibility outcomes include measures of recruitment and treatment adherence. Exploratory outcome measures include change in respiratory parameters, postoperative pulmonary complications, length of hospital stay, health-related quality of life, postoperative activity levels and mortality. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the relevant institution. Results will be published to inform future research. TRIAL REGISTRATION NUMBER: ACTRN12622000839707.

Intensive physical therapy after emergency laparotomy: Pilot phase of the Incidence of Complications following Emergency Abdominal surgery Get Exercising randomized controlled trial.

BACKGROUND: Postoperative pneumonia and delayed physical recovery are significant problems after emergency laparotomy. No randomized controlled trial has assessed the feasibility, safety, or effectiveness of intensive postoperative physical therapy in this high-risk acute population. METHODS: The internal pilot phase of the Incidence of Complications after Emergency Abdominal Surgery: Get Exercising (ICEAGE) trial was a prospective, randomized controlled trial that evaluated the feasibility, safety, and clinical trial processes of providing intensive physical therapy immediately following emergency laparotomy. Fifty consecutive patients were recruited at the principal participating hospital and randomly assigned to standard-care or intensive physical therapy of twice daily coached breathing exercises for 2 days and 30 minutes of daily supervised rehabilitation over the first 5 postoperative days. RESULTS: Interventions were provided exactly as per protocol in 35% (78 of 221 patients) of planned treatment sessions. Main barriers to protocol delivery were physical therapist unavailability on weekends (59 of 221 patients [27%]), awaiting patient consent (18 of 99 patients [18%]), and patient fatigue (26 of 221 patients [12%]). Despite inhibitors to treatment delivery, the intervention group still received twice as many breathing exercise sessions and four times the amount of physical therapy over the first 5 postoperative days (23 minutes [interquartile range, 12-29 minutes] vs. 86 minutes [interquartile range, 53-121 minutes]; p < 0.001). One adverse event was reported from 78 rehabilitation sessions (1.3%), which resolved fully on cessation of activity without escalation of medical care. CONCLUSION: Intensive postoperative physical therapy can be delivered safely and successfully to patients in the first week after emergency laparotomy. The ICEAGE trial protocol resulted in intervention group participants receiving more coached breathing exercises and spending significantly more time physically active over the first 5 days after surgery compared with standard care. It was therefore recommended to progress into the multicenter phase of ICEAGE to definitively test the effect of intensive physical therapy to prevent pneumonia and improve physical recovery after emergency laparotomy. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

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.

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.

A modified inflammatory bowel disease questionnaire and the Vaizey Incontinence questionnaire are more sensitive measures of acute gastrointestinal toxicity during pelvic radiotherapy than RTOG grading.

PURPOSE: Simple scales with greater sensitivity than Radiation Therapy Oncology Group (RTOG) grading to detect acute gastrointestinal toxicity during pelvic radiotherapy, could be clinically useful. METHODS AND MATERIALS: Do questionnaires used in benign gastrointestinal diseases detect toxicity in patients undergoing radiotherapy? The patient-completed Inflammatory Bowel Disease (IBDQ) and Vaizey Incontinence questionnaires were compared prospectively at baseline and at Week 5 to physician-completed RTOG grading. RESULTS: A total of 107 patients, median age 63 years, were recruited. After 5 weeks of treatment, patients with gynecologic and gastrointestinal cancer were more symptomatic than urologic patients (p = 0.012; p = 0.014). Overall, 94% had altered bowel habits, 80% loose stool, 74% frequency, 65% difficult gas, 60% pain, >48% distress, 44% tenesmus, >40% restrictions in daily activity, 39% urgency, 37% fecal incontinence, and 40% required antidiarrheal medication. The median RTOG score was 1 (range, 0-2), median IBDQ score 204.5 (range, 74-224), and median Vaizey score 5 (range, 0-20). Chemotherapy preceding radiotherapy increased fecal incontinence (p = 0.002). RTOG scores stabilized after 3 weeks, IBDQ scores peaked at Week 4, and Vaizey scores worsened throughout treatment. IBDQ and Vaizey scores distinguished between groups with different RTOG scores. CONCLUSION: The IBDQ and Vaizey questionnaires are reliable and sensitive, offering greater insight into the severity and range of symptoms compared with RTOG grading.

Taste preferences for oral nutrition supplements in patients before and after pelvic radiotherapy: a double-blind controlled study.

BACKGROUND & AIMS: No data exists about the effect of pelvic radiotherapy on taste preference for oral nutrition supplements, including elemental diet, which may prevent gastrointestinal symptoms if taken during pelvic radiotherapy. This double blind study aimed to: (1) examine the palatability of elemental, peptide and polymeric oral nutrition supplements in patients with pelvic malignancies compared with healthy controls (2) assess changes in taste preference following pelvic radiotherapy (3) develop a reliable scale to measure taste preference. METHODS: Subjects blind tasted six 30ml oral nutrition supplement samples, one duplicated, before and after 5 weeks of treatment (or the same time interval for controls). A Likert scale was used to score preference. RESULTS: Fifty patients and 50 controls were recruited. Before radiotherapy, patients had a lower mean preference for the peptide formulation than the other oral nutrition supplements (P<0.001). There were no significant differences in preferences between patients and controls (P>0.2 all supplements). Radiotherapy did not affect supplement preference. CONCLUSIONS: Patients with pelvic malignancy and healthy controls rate elemental nutritional supplements as highly as polymeric supplements and significantly better than peptide supplements. This trend continues even after pelvic radiotherapy. A Likert scale is a reliable tool in this scenario.