providing post-surgery respiratory therapy, in favour of early ambulation, through .... **For ventilated patients, if FiO2 ⥠0.5 or PEEP ⥠8, assume criterion 3 is ...
ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising BACKGROUND AND RELEVANCE OF THE PROPOSED RESEARCH
Emergency abdominal surgery is conducted for common conditions like a small bowel obstruction, perforation of a stomach ulcer, invasive cancerous tumours, haemorrhage from ulcerative colitis/inflammatory bowel disease, blunt force/penetrative trauma injuries, and infections within the abdominal cavity (peritonitis). Surgery for these problems are time critical and tens of thousands of Australians are treated for these conditions every year with an emergency operation under the care of General Surgeons operating within the range of hospital types; from small rural surgical centres to large teaching metropolitan hospitals; both public and private. After emergency abdominal surgery the most common cause of morbidity and mortality is a post-operative pulmonary complication (PPC)1,2 with an incidence rate of 30-40%3,4. A PPC is an umbrella term for conditions such as pneumonia, severe atelectasis, and postsurgical exacerbation of chronic pulmonary disease. For patients who get a PPC, health costs are doubled5,6, hospital stay is longer by a minimum of 4 days7-9, mortality is higher10,11, and there is an overall poorer outcome and delayed rate of recovery when compared to elective abdominal surgery.
Post-operative physiotherapy (traditionally, a combination of respiratory exercises, assisted early ambulation and physical rehabilitation) is routinely provided in Intensive Care Units and surgical wards across Australia in an effort to prevent respiratory complications12-14 and to enhance physical recovery after this major surgery type. Despite ubiquitous provision of this service the effectiveness of postoperative physiotherapy is uncertain15,16. Conclusive evidence is lacking in part due to methodological design weaknesses, multiple confounders, small sample sizes, and heterogeneous populations. Potentially due to uncertainty over respiratory physiotherapy to prevent PPC, physiotherapy service provision has moved more towards early ambulation as a prime modality for preventing PPC although there is only a very small body of observational evidence4,17,18 that delayed ambulation may be associated with PPC development. The only known randomised controlled trial of enforced bed rest following abdominal surgery found no difference in PPC rates between patients provided with an early ambulation program and those forced to rest in bed for 2 days, although the early ambulation group had a significantly shorter length of hospital stay and required less physiotherapy interventions19. From the available evidence it could be interpreted that early ambulation following major upper abdominal surgery is an effective treatment to improve functional recovery, but does not reduce respiratory complications. These results should be viewed with caution due to the limited sample size and methodological weaknesses. It is possible that physiotherapists around Australia have erroneously strayed away from providing post-surgery respiratory therapy, in favour of early ambulation, through the interpretation of a Type 2 research error. The clinical costs of a PPC are too high to risk this possible error and a clinical trial investigating the use of breathing exercises in this cohort is urgently needed to determine this.
It is also difficult to compare the literature for the effects of ambulation on PPCs and physical recovery rate as the definition and delivery of early ambulation varies considerably; from sitting out of bed once a day through to intense walking programs for more than 3 hours a day. There is also variability between and within countries on who is Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising responsible for assisting the patient to mobilise around the ward. Physiotherapists, registered and enrolled nurses, allied health assistants, and ward orderlies, or a combination of these, can provide assistance in ambulating patients following abdominal surgery18,20. The intensity and duration of an early ambulation program is significantly greater when delivered by a physiotherapist when compared to nurse or a physiotherapy assistant18. A majority of early ambulation in Australian hospitals is provided by a physiotherapist18 with great variation to the amount of physiotherapy provided with some hospitals providing physiotherapy daily for the first 5-7 days4,21,22, whilst in others, provided on the first post-operative day only8,23. There is no current evidence that determines the intensity, frequency, or duration of early ambulation that is necessary to successfully reduce the incidence of a respiratory complication and improve physical recovery following surgery.
Another significant gap in the literature is that physiotherapy has not been specifically tested in the emergency abdominal surgery population24. This is despite the risk of respiratory complications being greater and physical recovery slower following emergency surgery when compared to elective surgery. Additionally, patients having emergency surgery tend to be more acutely unwell, more likely to require an intensive care unit (ICU) admission, and have a higher degree of surgical trauma and systemic inflammation when compared to elective surgery candidates25,26. There are no clinical trials that have investigated the effect of ambulation, rehabilitation, and/or respiratory exercises on PPCs and overall recovery in patients following emergency abdominal surgery over and above standard ward care. There are also no clinical trials on the medium term recovery and level of disability of patients following emergency surgery specifically. RESEARCH PLAN, METHODS AND TECHNIQUES
Research questions: 1. Following emergency abdominal surgery does additional chest physiotherapy (twice daily, 10x2 sets of DB&C) in the first two days and ongoing as necessary reduce the odds of a PPC when compared to a single postoperative chest physiotherapy session on post-operative day one only? 2. Does an enhanced physiotherapy early rehabilitation program of a minimum 30 minutes a day for the first 5 postoperative days, improve rate of recovery, prevent a prolonged postoperative ileus, reduce requirements for dedicated rehabilitation services, and reduce length of stay when compared to standard physiotherapy care of approximately 10-minutes of assisted ambulation per day.
Aims: 1. To determine the effectiveness of an enhanced daily physiotherapy program (daily physiotherapy assisted ambulation, rehabilitation, and respiratory exercises) on the incidence of post-operative pulmonary complications (PPC), hospital length of stay (LOS), prolonged post-operative ileus (PPOI), and requirement for
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising extra rehabilitation services in adult patients following emergency abdominal surgery via an open incision when compared to standard ward care. 2. To investigate if enhanced daily physiotherapy is effective in improving the rate of physical recovery following emergency abdominal surgery (handgrip strength, functional performance, level of independence, and subjective quality of recovery) when compared to standard ward care. 3. To ascertain the medium term (3 month) self-reported physical and psychosocial status of patients following emergency abdominal surgery. 4. To develop a preliminary multivariate risk prediction model for the development of a respiratory complication following emergency abdominal surgery 5. To develop a preliminary multivariate risk prediction model for delayed recovery following emergency abdominal surgery
Trial design: Phase two, prospective, multi-centre, parallel-group, randomised, controlled, double blinded (assessor and patient) clinical trial.
Sample Size: PPC rates previously reported following emergency abdominal surgery are between 30-40%3,4. Analysis of a prospective audit of the PPC rate at the primary participating centre, Launceston General Hospital, in this patient population found a lower rate of 20% (95%CI 15-25%). There are no publications specifying the minimum absolute risk reduction (ARR) to achieve clinical significance of PPC reduction. We have hypothesised that an ARR of 12% would be clinically significant in this population i.e 20% down to 8%.
The sample size for the study was calculated using Inference for Proportions, comparing two independent samples method (Type 1 error () 0.05, power () 80%, one sided, PPC rate 20%, ARR 12%). A total sample size of 262 participants (131 per group) was calculated as being required to measure a significant difference between groups. This number is further increased to compensate for a potential 10% drop out/withdrawal rate. Recruitment of a total of 288 participants is required.
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Eligible participants: Adults over 18yrs admitted for emergency abdominal surgery with an incision greater than or equal to 5 cm and requiring at least an overnight stay. Exclusions: 1.
Inguinal hernia repairs, open appendectomy or gynaecological procedures. This is due to the generally lower risk and faster recovery rates following these procedure types.
2.
Patients diagnosed with a PPC prior to recruitment
3.
Pre-existing condition that would limit participation in a standardised post-operative mobilisation protocol. For example, any person unable to stand upright and ambulate for 1 minute without a seated rest, paraplegics, hoist transfer nursing home and disability patients, severely cognitively disabled patients
4.
Unable to understand spoken English without the assistance of an interpreter as determined by the research assistant, site investigator or ward Physiotherapist performing eligibility screening.
5.
Within 7 days of elective abdominal surgery.
6.
Patients who have undergone emergency thoracic surgery only.
7.
Patients who have undergone emergency laparoscopic surgery.
8.
Patients who were assessed by senior medical staff as approaching imminent death or withdrawal of medical treatment within 48 hours of their surgical procedure.
9.
Patients who have medical orders not to participate in an early, active rehabilitation program.
10.
Patients who are unable to be recruited by the research team within 48 hours of the completion of the surgical procedure.
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Primary outcome: PPC within the first 14 post-operative hospital days. PPC’s will be diagnosed with the Melbourne Group Score (MGS; Figure 1), a reliable and valid diagnostic scoring tool for respiratory complications following abdominal and thoracic surgery4,8 which has high inter-rater reliability33. This tool has eight clinical criteria; four factors relating to symptoms and four to diagnostic markers. A PPC will be diagnosed when four or more factors are present at any time from midnight to midnight during a single post-operative day. The factors do not have to occur concurrently. Figure 1: PPC diagnostic criteria – Melbourne Group Score Version 3 When four (4) or more of the following criteria* are present anytime in the 24hour period 00:01 to 24:00 on a single postoperative day: 1. New abnormal breath sounds on auscultation different to preoperative assessment+ 2. Production of yellow, green, or brown sputum different to pre-morbid status+ 3. Pulse oximetry oxygen saturation (Sp02) 11 or < 3 8. Physician’s diagnosis of postoperative pulmonary complication (e.g. atelectasis, pneumonia, AECOPD, respiratory failure, upper respiratory tract infection) OR prescription of an antibiotic specific for respiratory infection *If a blinded physiotherapist, nurse, or physician documents in the medical record the occurrence of a criterion the by a can be taken as a positive finding. If no documentation present, a blinded assessor is required to assess this directly. +
If no preoperative assessment or documentation assume normal at baseline
**For ventilated patients, if FiO2 0.5 or PEEP 8, assume criterion 3 is present (do not alter FiO2), for all other patients set FiO2 to 0.21 and observe SpO2 for two minutes. If SpO2 drops below 90% immediately reinstate previous FiO2. If not permissible to alter ventilation parameters assume +ve. #
If no written report for a CXR is available and a patient has 3 other +ve signs, a masked Senior Physiotherapist or ward Medical Officer is to be contacted to report verbally on the available CXR. *** When there are no daily measures of CXR or sputum sampling, carry over a +ve finding to the next consecutive postoperative day.
Participants will be assessed prospectively and daily for a PPC by a blinded assessor until the seventh post-operative day. Thereafter, additional PPC assessments are performed only as clinically suspected till day 14 when there are signs or symptoms of respiratory system deterioration reported within the medical record. Retrospective collection of PPC data from the daily medical record will be permitted when a patient or assessor is unavailable for prospective PPC assessment. Components will be collected via the patient’s medical record and pathology/radiology databases. Diagnostic components (Chest X-ray (CXR), white cell count (WCC), sputum microbiology) are recorded only if results are available. All medical officers are masked to group allocation and these diagnostic tests are ordered only as Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising clinically indicated, and will not need to be routinely requested for the purposes of the ICEAGE trial. For this trial, the following modifications have been made to the MGS diagnostic criteria to ensure that respiratory therapy will not be withheld longer than necessary from patients who may have developed a PPC. 1. A CXR can be verbally reported by a blinded senior respiratory physiotherapist or ward physician, rather than awaiting a radiologist report, 2.When three factors (out of a possible eight) in the MGS PPC tool are present, the blinded assessor or ward physiotherapist will contact the surgical ward doctor and discuss the option of further diagnostic testing to rule in or out a PPC and these patients will be assessed twice daily to monitor clinical criteria for any deterioration. A positive diagnosis for a PPC will be confirmed by a blinded senior respiratory physiotherapist and the participant will then receive respiratory treatment as determined by the ward physiotherapist. Secondary/exploratory trial outcomes 1) Surgical team request for residential rehabilitation or discharge to home with home-based rehabilitation services. Request to be made within the first 14 postoperative days whilst on the acute surgical ward. On the 14th postoperative day if participant is still a hospital inpatient a blinded Senior Physiotherapist will review the participant’s progress notes within the medical record and adjudicate for the requirement for ward based or residential rehabilitation services. 2) Discharge destination from the acute ward (home, rehabilitation facility, nursing home or other hospital) 3) Days of hospital length of stay (LOS). This is defined as the continuous time spent in any type of inpatient hospital service (i.e acute care, sub-acute rehabilitation, and time at another hospital) from the day of admission to the day of discharge to a community dwelling Hospital days will be sub-categorised into acute, sub-acute, and overall length of stay. 4) Prolonged postoperative ileus (PPOI) within the first 14 post-operative hospital days defined if two or more of the following five criteria are met on or after day 4 postoperatively: (i) Nausea or vomiting, (ii) Inability to tolerate an oral diet over last 24, (iii) Absence of flatus over last 24 h, (iv) Abdominal distension, (v) Radiologic confirmation27 5) Physical and Quality of Life recovery i)
Rate of change of the Modified Iowa Level of Assistance (mILOA) score from Day 1 to day of acute ward discharge. The mILOA consists of four mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step), which are graded according to the level of assistance required, use of gait aid, and the distance that can be walked.
ii)
Rate of change in handgrip strength (kg) measured using a handheld dynamometer over four postoperative measures within the first 14 hospital days. Measures will be taken at least two days apart.
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising iii)
Rate in change of the EuroQual (EQ-5D, Appendix) quality of life score over two consecutive measures within the first 5 postoperative days; measures to be taken at least two days apart, and then at 90 days following surgery.
iv)
Health related quality of life using World Health Organisation Disability Assessment Schedule V2 (WHODAS; Appendix) change from preoperative, to day of discharge from acute care, and then at 90 days post-surgery.
v)
Physical capacity using Self-Assessment of Physical Activity Questionnaire (SAQ)28,29 at 90 days (+/- 14 days) following day of surgery.
vi)
Time in hours from end of operation to time able to achieve ambulation greater than one minute;
vii)
Time in days from end of operation to post-operative day able to achieve ambulation greater than 10 minutes;
6) ICU LOS in days; 7) Unplanned ICU admission at any time point during the acute stay; 8) Pneumonia, defined as the presence of new CXR infiltrates along with at least two of the following criteria; temperature >38C, dyspnoea, cough and purulent sputum, altered respiratory auscultation, and WCC >14,000/ml or leukopenia 15mins if able 2. Lower limb: sit to stand – raised bed progressed to ward chair - Low resistance, 20 reps, 3-4 sets, 2 min rest between sets. Can include step ups. 3. Upper limb or Lower limb exercises in sitting – against gravity progressed to theraband resisted - Low resistance, 20 reps, 3-4 sets, 2 min rest between sets. Can include seated pedals 4. Sit over edge of bed – patient to sit supporting themselves as much as able 5. Bed exercises – bridging, hip flexion/extension/abduction, knee flexion/extension, ankle plantar/dorsiflexion; either active or active-assisted. 6. Deep breathing and coughing exercises 7. Passive mobilisation – passive cycling, functional electrical stimulation, passive limb movements The exercises are to be attempted in sequence, starting with mobilising the patient in accordance with the ambulation protocol detailed for control patients. If the patient can ambulate they do this for as long as able. If that time is less than 30 minutes they will then attempt lower limb exercises for the remaining time. If they are unable to ambulate they attempt the lower limb exercises for as long as able, if that time is less than 30 minutes then they attempt upper limb/lower limb exercises in sitting for as long as able. This process continues, attempting each exercise type in sequence until a total treatment time of 30 minutes has been reached. Resting is permitted, however, the rest time cannot exceed the preceding active period. Once the rest time becomes greater than the preceding work time, the exercise session is considered completed. Sedated and ventilated patients will be passively mobilised for a minimum of 30 minutes if they are unable to perform any DB&C or bed exercises32. The decision regarding the initial exercise type appropriate for each patient will be made by the treating physiotherapist and will be dependent on the patient’s status. If the patient is unable to complete 30 minute session the reason will be documented by the treating physiotherapist. Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Patients will be treated daily by a Physiotherapist until at least POD5. After POD5 daily treatment with a physiotherapist or allied health assistant will continue until discharge from Physiotherapy as determined with a standardised tool30, or discharge from hospital, whichever occurs first. If the patient fulfils the physiotherapy discharge criteria before POD5, daily treatment will continue until POD5 but cease thereafter.
Respiratory Exercises: (minimum twice daily for first two postoperative days and then as necessary) Patients will receive an initial treatment and education session with a physiotherapist on the first available occasion within the first two post-operative days as per the control group. On the first two post-operative days there will be an additional coached respiratory exercise session with the Physiotherapist in the afternoon with the same reps and sets and procedure as detailed above for the Control Group. Minimum dosage of respiratory exercises will be four (4) sessions in the first two postoperative days. Additional to this is allowable and at the discretion of the treating physiotherapist based on their clinical judgement of the risk of a PPC. Physiotherapy treatment sessions for the following 5 postoperative days will also include a daily reminder to continue with DB&C exercises including a check to ensure they are being performed as initially instructed. If necessary, additional coached DB&C exercises can be provided to ensure compliance and based on clinical judgement of the individualised risk of a PPC.
Availability of Physiotherapy on Weekends The three sites participating in ICEAGE have limited Physiotherapy service on weekends, with strict criteria for referral. If protocol is unable to be delivered due to weekend service capacity limitations this will be recorded. At the completion of the trial an a-priori sensitivity analysis will be performed to determine if the absence of weekend physiotherapy affected any outcomes.
Safety: Many studies undertaken in the critically ill or ICU patient population demonstrate that that mobilisation 1-2 times per day for 15-30mins is not only safe but recommended in critically ill patients provided it is done under controlled circumstances and the decision is made depending on the patients individual status and haemodynamic stability, with adverse events occurring in a very small number of patients (1%)33,34. In a systematic review conducted in 2012 14 of 15 trials reported no serious adverse medical consequences mobilising critically ill patients in ICU35. It is expected that the emergency abdominal surgery patient population will be less acute and consequently more stable than the majority of patients included in these studies. Every day, each patient will be assessed by the ward physiotherapist for safety to participate in the rehabilitation program and before delegating ambulation therapy to an Allied Health Assistant, if appropriate. If an adverse event occurs (i.e. pain) this will be reported to the patient’s nurse, the treating physiotherapist, the principal investigator and either the surgical or pain team depending on the nature of the event. Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Assessments: A physiotherapist, research assistant or project co-ordinator, not involved in the patient’s care, will perform the role of outcome assessor. The outcome assessor will be blinded to group allocation for the first 7 days. The outcome assessor will assess patients for a PPC, assess grip strength, interview patient for self-reported quality of life measures, and determine daily functional status as graded with the modified Iowa Level of Assistance score (mILOA – see appendix) using existing entries contained with the patient medical record for that day. If a patient is diagnosed with a PPC by the blinded assessor, this diagnosis will be confirmed by an independent Senior Physiotherapist blinded to group allocation. This confirmation can occur via phone or face to face. Following the confirmation of a PPC, the patient will receive respiratory physiotherapy treatment as determined by the treating physiotherapist. Assisted ambulation/exercise therapy will continue as per group allocation. Patients will be assessed daily by the ward physiotherapist using the Post-Operative Physiotherapy Discharge Scoring Tool (POP DST – see appendix). If the patient is in the control group, patients will be discharged from physiotherapy when they achieve a score of 14 or 15 out of a possible 15. Patients in the intervention group will be considered for physiotherapy discharge only after the 5th postoperative day. If a patient remains an inpatient by the 14th postoperative day and has not yet been referred for ward based or residential rehabilitation services, a blinded Senior Physiotherapist will review the patient’s progress notes and medical record to adjudicate for the requirement of rehabilitation services to improve a patient’s functional recovery following surgery. Data collection: A standardised Case Report Form will collect data for each participant in the trial (Appendix). Measurements will be taken either by the research assistant, physiotherapists, or project co-ordinators directly from the patient, from the medical record, ward charts or from the patient’s progress notes. Protocol end points 1. Discharge from hospital 2. A PPC diagnosis ceases the chest physiotherapy protocol component and respiratory therapy is then provided at the discretion of the ward physiotherapist. Participants remain being treated as per the rehabilitation treatment allocation. 3. If a member of the Surgical team requests a rehabilitation referral or further physiotherapy input prior to Day 14 due to mobility dysfunction or slow progress, or if a blinded Senior Physiotherapist adjudicates for this need on Day 14. At this point the rehabilitation protocol component of ICEAGE will be ceased and the patient provided with rehabilitation services at the discretion of the treating therapists. 4. Patient is transferred to another hospital 5. Patient becomes deceased Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Adverse event definitions and reporting The following changes are considered to be adverse events that can be directly related to therapy e.g. during or after the therapy session. (Adapted from Zeppos et al 2007) 1. BP change 20% from resting 2. HR change 20% from resting 3. New arrhythmia 4. Drop in SpO2 >10% 5. Pneumothorax following intervention 6. Line detachment 7. Patient requires increased sedation 8. Patient requires increased inotropic support 9. Fall 10. Severe nausea Adverse events will be reported appropriately using the following process: 1. The treating physiotherapists will record adverse events on the data collection sheet provided by the research team. 2. The treating physiotherapist will include all details in the patient progress notes to ensure the medical and nursing teams are aware of the event. 3. The Chief Investigator will also be informed so that further investigation of the event is timely, if required.
Breaks to protocol reporting If the physiotherapist provides the incorrect treatment protocol, this will be documented and data analysed intention to treat.
Withdrawal from trial Patients will be withdrawn from the trial if they: - withdraw self from the trial - do not consent after having been randomised - returned to theatre for further surgery within 5 post-operative days of initial surgery
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Blinding and separation of physiotherapy assessment and treatment documentation The recruiting physiotherapist will be aware of group allocation. The Site Investigator will securely maintain the data base of group allocation within a password protected file. Assessors and data analysts will be blinded to group allocation until the clinical trial and data analysis are completed. Post-operative patient measurements for PPC, PPOI, MILOA scores, grip strength for the first 7 days will be collected by independent blinded assessors. Daily physiotherapy interventions specific for the intervention or control group will be recorded on dedicated data sheets by the treating physiotherapist or physiotherapy assistant and kept in a secure environment to ensure that the blinded assessor is not made aware of group allocation. As blinded assessors will need to have access to patient progress notes, the treating physiotherapist will record standardised structured subjective and objective assessment details in the medical record and for the treatment component will record “Treatment provided as per ICEAGE protocol”. If an adverse event occurs during treatment the event will be documented in full within the medical record. The specific treatment provided for each patient will be recorded on separate progress note pages. These notes will be stored securely with the Site Investigator and reinserted into the patient’s medical record upon discharge. This process has been approved by Patient Information Services at all three sites and complies with legal requirements of reporting and communication. If a treatment group participant inadvertently informs the assessors of their post-operative ambulation activities, this will be noted, and a new assessor will be found for ongoing assessments.
Statistical analysis: The rate of PPCs between groups will be measured using Fisher’s exact test and time-to-event analysis using Cox proportional analysis adjusted for imbalances at baseline between groups. ARR and 95% confidence intervals (CIs) for the primary outcome of PPCs will be calculated. Nominal and interval data from the patient profiles will be analysed using the chi-square test, Mann—Whitney U test, Fisher’s exact test and independent samples t-test. The CI for the difference between two means used the method that assumes equal variances for the two populations. The Wilson score method without continuity correction will be used to calculate a CI for a proportion. Postoperative LOS data if not normally distributed will be analysed using a Mann—Whitney U test. The associations between the incidence of PPCs and preoperative risk factors will be analysed using Fisher’s exact test. The associations of risk factors with the number of PPC criteria met will be analysed using ordinal logistic regression. Analyses will be performed on an intention-to-treat basis.
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Mortality associated with emergency abdominal surgery in the elderly. Canadian journal of surgery. 2003;46(2):111. Martínez-Serrano MÁ, Pereira JA, Sancho JJ, López-Cano M, Bombuy E, Hidalgo J. Risk of death after emergency repair of abdominal wall hernias. Still waiting for improvement. Langenbeck's Archives of Surgery. 2010;395(5):551-556. Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidisciplinary Respiratory Medicine. 2013;8(1):1-6. Smetana GW. Postoperative pulmonary complications: an update on risk assessment and reduction. Cleveland Clinic Journal of Medicine. 2009;76(Suppl 4):S60-S65. Hanekom SD. Reaching consensus on the physiotherapeutic management of patients following upper abdominal surgery: a pragmatic approach to interpret equivocal evidence. BMC medical informatics and decision making. 2012;12(1):5. Lawrence VA, Cornell JE, Smetana GW. 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Mackay MR, Ellis E, Johnston C. Randomised clinical trial of physiotherapy after open abdominal surgery in high risk patients. Australian Journal of Physiotherapy. 2005;51(3):151-159. MacKay MR. Physiotherapy outcomes and staffing resources in open abdominal surgery patients. Physiotherapy theory and practice. 2002;18(2):75-93. Browning L, Denehy L, Scholes RL. The quantity of early upright mobilisation performed following upper abdominal surgery is low: an observational study. Australian Journal of Physiotherapy. 2007;53(1):47-52. Sullivan K, Reeve J, Boden I, Lane R. Physiotherapy for patients undergoing emergency abdominal surgery. In: Garbuzenko DV, ed. Actual problems of emergency abdominal surgery: Intech; 2016. Griffith DM, Lewis S, Rossi AG, et al. Systemic inflammation after critical illness: relationship with physical recovery and exploration of potential mechanisms. Thorax. 2016:thoraxjnl-2015-208114. Rettig T, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde E, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Annals of surgery. 2015. Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. Journal of Gastrointestinal Surgery. 2013;17(5):962-972. Rankin SL, Briffa TG, Morton AR, Hung J. A specific activity questionnaire to measure the functional capacity of cardiac patients. . American Journal of Cardiology. 1996;77:1220-1223.
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising APPENDIX 1. 2. 3. 4. 5. 6.
Case Report Forms (a – blinded assessors, b – ward physiotherapists) EuroQuol 5 domain quality of life questionnaire (EQ-5D) Post-Operative Physiotherapy Discharge Scoring Tool (POP DST) Modified Iowa Level of Assistance Scale (MiLOA) Self-administered physical Activity Questionnaire (SAQ) World Health Organisation Disability Assessment Schedule (WHODAS)
DATAPOINTS Baseline Characteristics Parameter Gender Age Body Mass Index Surgical category
Method Male or Female Age in years weight (kg) / height (m) squared 1. Hepatobiliary and Upper Gastrointestinal 2. Colorectal and lower Gastrointestinal 3. Renal & Urology 4. Other
Group comparison/PPC risk analysis/general data points Co-morbidities Functional Co morbidity Index (0-18 scale) Including respiratory disease, cancer, diabetes, cardiovascular disease, peripheral vascular disease, musculoskeletal, neuromuscular disease Smoking history 1. Non smoker 2. Current smoker 3. Ex smoker (ceased >8weeks pre-operatively) Pack years 1 pack year = 20 cigarettes per day for 1 year Pre-op health status ASA from anaesthetic record Anaesthesia duration Time in minutes Incision type 1. Midline laparotomy 2. Bilateral subcostal (Chevron) 3. Subcostal (Kocher) 4. Transverse 5. Abdominal incision 6. Other 7. Mini-laparotomy Type of post-operative analgesia 1. Epidural 2. Constant opioid infusion 3. Patient controlled analgesia 4. Patient controlled epidural analgesia 5. Oral 6. Other Length of analgesia Number of post-op days ICU admission Yes/no Length of ICU stay Length in days Mechanical ventilation Hours POD of diagnosed PPC POD Incidence of death Yes/no Reason for withdrawal from trial 1. Withdrew self from trial 2. Does not consent after having been randomised
Protocol V8 June 2017
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ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Post-operative measurements PPC detection CXR report of collapse/consolidation Minimum daily SpO2 on room air Maximum daily tympanic temperature WCC > 11 OR AB for chest infection Sputum presence
Bacteria growth shown in sputum sample Auscultation abnormal findings
Dr diagnosis of PPC
PPOI detection Nausea or vomiting Inability to tolerate oral diet last 24hrs Absence of flatus last 24hrs Abdominal distention Radiologic confirmation Doctors diagnosis of ileus Outcome measures Hospital length of stay Time to readiness to discharge POP DST
Time to discharge from physio Incidence of pulmonary complications Incidence of prolonged post-op ileus Recovery of strength
Functional ability
Medium term recovery
Complications – self report at 3 months post-surgery
Protocol V8 June 2017
Yes/no/not available One measure daily from observation chart One measure daily from observation chart Yes/no/not available Daily measure, yes/no Defined as production of green or yellow sputum different to pre-operative assessment or reported by the patient. Yes/no/not available Daily measure yes/no Defined as new abnormal breath sounds different to pre-operative auscultation as documented by Dr or assessing physiotherapist Yes/no
Yes/no Yes/no Yes/no Yes/no Yes/no/not available Yes/no Days Day post-op, using Fiore tool or modified version for surgical categories other than colorectal Score out of 15 assessed POD 1,2,3,4,5. If discharge from physiotherapy not achieved by POD 5, continue daily assessment until discharged from Physiotherapy. Day post-op, using POP DST Yes/no (using defined diagnostic criteria) Yes/no (using defined diagnostic criteria) Grip strength in kgs taken POD 1, 3, 5, 7, Day of d/c. This measurement should ideally be performed within the same time period within +/- 3 hours of the baseline measurement. Score on the Modified Iowa Level of Assistance (MILOA) Scale (See Appendix D) taken between 1 and 4pm on POD 1, 3, 5, 7, and on d/c Quality of Recovery (QoR-15) (See Appendix E) assessed POD 1 & 3 and at 3 months from surgery WHODAS-12 disability questionnaire (See Appendix F) assessed day of discharge and at 3 months. Hospitalisation following discharge, hospital visit or GP visit for complications including 1. PE/DVT 2. Respiratory 3. Cardiac 4. Surgical/wound complication 5. Ileus/constipation/nausea 6. Fatigue/tiredness/weakness Page 19 of 20
ICEAGE Incidence of Complications following Emergency Abdominal surgery: Get Exercising Discharge destination
Cost analysis/health care utilisation Days of supplemental oxygen usage Hours of mech vent/NIV usage Occasions of service by a physio Occasions of service by a PTA Extra-ordinary attendance by MO Incidence of non-respiratory complications Intra and post-operative fluid delivery Intra and post-operative blood products Daily ambulation sessions Time of day Mobility level achieved each POD
Max Borg scale per physio session Barriers to mobilisation Symptomatic hypotension limiting ambulation
Incidence of vomiting limiting mobilisation Pain score prior to physio ambulation
Protocol V8 June 2017
7. Death 1. Home 2. Rehab facility 3. Nursing home 4. Other hospital Days Hours Number of treatment sessions Number treatment sessions Number of occasions For example, sepsis, DVT, PE, surgical failure, cardiovascular event. Event reason documented and POD occurred Type and amount Type and amount Time 1. SOEOB 0-2 minutes 2. MOS 0-1 minute 3. MOS/walk 1-3 minutes 4. MOS/Walk 3-6 minutes 5. Walk 6-10 minutes 6. Walk 10-15 minutes 7. Walk > 15 mins 1-10 scale Yes/no daily Defined: sitting BP
