ANZCTR search results

Placental delivery is accelerated by placental cord drainage at vaginal delivery. Hypothesis: This effect may extrapolate to caesarean section, where the blood loss from the vascular uterine incision may make time to delivery of placenta particularly important. Aim: To determine if drainage of the placental cord at caesarean section accelerates delivery of the placenta, compared to delayed clamping of the placental cord. Methods: Randomised Controlled Trial with Intention to Treat Analysis. Women at elective caesarean section without antenatal evidence of placental disease or fetal compromise, randomised to Intervention (Placental Cord Drainage) or Control (Delayed Cord Clamping).

The present study will evaluate the relative efficacy of two digital interventions for recurrent binge eating: a smartphone app and an Internet-based program. The relative efficacy of different technology mediums has yet to be explored. Findings will shed light towards possible technologies that afford an added benefit. The following hypotheses are derived: 1. Participants randomized to the two digital intervention groups will experience greater reductions in primary and secondary outcomes than participants randomized to the waitlist. 2. There will be no differences in outcome variables between those randomized to one of the two digital interventions (app versus web program).

This is a prospective randomised controlled trial (RCT) comparing the outcomes for patients undergoing proximal hamstring tendon avulsion repair with two different post-operative rehabilitation regimes. The first regime includes a period of brace immobilisation and limited weight-bearing with a gradual progression of physiotherapy. The second regime allows immediate full-weight bearing with an accelerated rehabilitation program of physiotherapy. Patient outcomes will be collected and compared between the two rehabilitation regime cohorts over a 24-month post-operative period. This will include validated Patient Reported Outcome Measures (PROMs) investigating pain, symptoms and patient satisfaction, and objective measures of hip range of motion (ROM), muscle girth, peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength. Overall satisfaction and assessment of complications will be assessed throughout.

Phase 1 of the study will obtain safety data for the investigational automated insulin delivery EOPatch pump. We hypothesize that the EOPatch pump is as safe and is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes who under-bolus mealtime insulin.

Burnout is a common problem among medical doctors, with difficulties emerging as early as undergraduate medical training. The current study will deliver a psychological flexibility skills training intervention (Acceptance and Commitment Training) to medical students via an online App, which aims to provide early intervention to improve burnout and wellbeing outcomes. The App-based delivery format aims to make the intervention accessible among a time-poor group that tends not to seek out support due to perceived stigma, as well as facilitate the delivery of an intervention that can be adapted to suit individual skill-building needs (individualised). We will compare the efficacy of an individualised version of the App with a non-individualised version. We expect that medical students who complete either version of the intervention will demonstrate better burnout and wellbeing outcomes than students who have not completed the intervention. We also expect that students who receive the individualised version will benefit more from the intervention than those who receive the non-individualised version.

This study comprises two sections. o Section 1: Co-design section: The aim of this section is to co-design an infographic with the assistance of consumers (in this instance, people who have had a knee replacement). The aim of the infographic is to increase people’s knowledge of physical activity after knee joint replacement surgery. o Section 2: Randomised controlled trial: The aim of this section is to measure how effective the infographic is at increasing people’s knowledge of physical activity after total knee joint replacement with a randomised controlled trial. Outcome measures will be based on previously published questionnaires that evaluate knowledge of physical activity, self-efficacy for exercise and the participant's engagement with the infographic. Measures will take place at baseline, 1 and 6 week after study commencement. Participants for both sections will be recruited from the SMART registry (HREC A 100/14) of total joint replacement surgery maintained by St Vincent’s Hospital, Melbourne, including public and private patients. It is anticipated that 10-15 participants will take part in co-designing the infographic, and 44 participants will take part in the randomised controlled trial. Study hypothesis: We expect that people who receive the co-designed infographic will demonstrate an increase in knowledge of physical activity and an increase in self-efficacy for exercise.

Currently at our institution (Mercy Hospital for Women), approximately 12 women are referred each week for postmenopausal bleeding, or 600 per annum. These women are then seen in the outpatient gynaecology department in any one of four clinics. Pelvic ultrasonography is used as a binary differentiator, as a risk predictor for endometrial cancer. If the endometrial thickness (lining of the womb) is below a certain level (4mm as per national and international guidelines), the risk of endometrial cancer is less than 1%, and thus endometrial sampling is not indicated, in the absence of recurrent episodes or high-risk features. Unfortunately, the time from referral to our clinics, to the time of notification of the histological diagnosis (and thus options for definitive management) is usually 12 weeks at best. The effect of this delay is 2-fold; 1) we believe patients may experience anxiety and frustration at the delay to review and diagnosis, particularly when concerns regarding endometrial cancer have been raised, and 2) seeing women in the outpatient clinic with a normal endometrial thickness (<4mm) is unnecessary, when sampling is not required. We believe these women can be safely managed in the community by their local general practitioner. We thus plan to randomise patients referred to the Endosurgery B unit to either routine care (with outpatient ‘in-person’ clinic review) or a ‘virtual clinic’ utilising telephone consultation with a gynaecologist after pelvic ultrasound results are known. We suspect outcomes to indicate: 1. more efficient throughput of patients with postmenopausal bleeding 2. a change in patient satisfaction impacted by faster contact and review, and individual acceptance of the telephone clinic model 3. clinician satisfaction upon seeing improved efficiency in the management of this common problem 4. shorter outpatient clinic wait times

The health economic impact of epilepsy is well-studied, but similar data is lacking for first seizures. First seizures are a common and important neurological disorder, with unprovoked seizures affecting up to 10% of people and acute symptomatic seizures affecting over 3% of people during a lifetime. Establishing the true cost of first seizures is important to fully appreciate their substantial impact on patients, care-givers and society. Some data exists on the direct medical costs of first seizures, that is, the cost of health care utilisation, including hospitalisation, outpatient appointments, investigations and antiepileptic drugs. Far less studied is the indirect costs of seizures and the effect of seizures on patients’ quality of life. We propose to do this by measuring work productivity activity index (WPAI) through absenteeism, presenteeism and early retirement, and informal care needs. Additionally, patient reported outcome measures (PROMS) through validated quality of life surveys including EQ-5D, QoLIE-31 will be collected. In applicable cases, we will consider the reasons guiding initiation of antiepileptic drugs, both from clinicians’ and patients’ perspectives. People with epilepsy have a far higher prevalence of mood disorders compared to the general population. Screening for depression and anxiety via the Hospital Anxiety and Depression Scale (HADS) will help determine the onset of these disorders relative to the onset of the first seizure, and if the patients later develop epilepsy, provide a baseline measure of mood disorders to compare with subsequent evaluations. Flagging mood disorders as early as First Seizure Clinic will also promote earlier diagnosis and management, and this is an important part of providing holistic and comprehensive care. By adding indirect cost data and quality of life data to the literature, we hope to more comprehensively capture the true societal burden of first seizures, as well as to prospectively study the reasons behind decision to initiate or defer antiepileptic drug therapy.

This project will test the effectiveness of a community intervention designed to increase the proportion of Aboriginal people who receive a timely diagnosis of dementia and receive best practice care. It will address community, healthcare system, and patient and family level barriers to care, and determine the impact of these strategies on quality of life and depression for Aboriginal people living with dementia and other chronic disease and their carers. ACCHSs allocated to the intervention condition will receive a 3 year multi-component community-based intervention designed to address barriers to the timely diagnosis of dementia and other chronic conditions and the provision of best practice care. If found to be effective, the community-based ACCHS focus will allow the adoption of the strategies by Aboriginal communities across Australia. Study Hypothesis: A three-year community support strategy implemented at ACCHSs will increase the proportion of Aboriginal people who receive a timely diagnosis of dementia and receive best practice care.

Each year, over 1000 children with congenital heart disease (CHD) in Australia require heart surgery. The short and long-term outcomes of these children are primarily determined by pre-existing comorbidities and genetic factors, direct impact of the surgical intervention, the response to cardiopulmonary bypass (CPB), and the consequences thereof during their intensive care stay. Neurodevelopmental disabilities remain amongst the most common, and the most damaging, outcomes in children undergoing surgery for CHD. Large longitudinal population-based studies assessing long-term outcome are lacking. One out of four infants undergoing heart surgery develop a harmful response to CPB, which leads to low cardiac output syndrome (LCOS). LCOS results in prolonged (multi-) organ dysfunction related to hypotension, organ hypoperfusion, renal failure, and brain ischemia. LCOS translates into adverse short-term outcomes (LCOS, need for extracorporeal life support (ECLS), and death), and determines adverse long-term outcomes manifesting into school age and beyond. Currently, there are no reliable, sensitive, and rapid predictors for LCOS or adverse early and long-term outcomes. In addition, the concept of LCOS remains poorly understood, and clinical evidence indicated highly variable presentations, suggestive of variability of host response. Preventive strategies to reduce LCOS remain of limited effectiveness. Thanks to rapid sequencing technology, discriminative patterns of the individual response to CPB can now be tested in real-time. Transcriptomics therefore has huge potential to unravel the mechanisms underlying adverse outcomes after CPB surgery, to reveal biological phenotypes, and to identify novel interventional strategies.