ANZCTR search results

Who is it for? This study is intended for patients undergoing an endoscopic resection procedure (Endosocpic Mucosal Resection, EMR or Endoscopic Submucosal Dissection, ESD) for dysplasia or early cancer in the oesophagus. When a resection involves >/= 75% of the oesophageal lumen, the chance of a stricture and difficulty swallowing can approach 100% Study details: The aim is to assess whether the injection of this fat helps prevent the extent of these strictures Eligible patients undergoing this procedure have a portion of fat removed by liposuction from another part of their body and this fat is then injected into the defect after the resection takes place. There is no randomisation involved and the study is open (non-blinded). Follow up involves checking on swallowing and endoscopies to assess stricture rates (this is part of routine care) There are several things we do to try and prevent strictures after these procedures, including repeated gastroscopies and stretching of the narrowed portion of the oesophagus (food pipe), known as dilation, as well as using steroids either injected directly into the oesophagus (food pipe) at the site where the abnormal tissue was removed or in tablet form, to reduce the inflammation that leads to the narrowing forming. We would like to find a safer, more effective way to prevent the narrowing in the oesophagus (food pipe) from forming after this procedure, or to reduce the severity of the narrowing that develops. Recent studies have shown that injecting a small amount of your own fat into areas of inflammation and scarring in the body may improve healing. This has been looked at in healing tissue openings around the anus, and in healing after patients undergo plastic surgery. It has not been looked at in the oesophagus before and we hope we can develop strategies to help our patients by reducing the amount of stricture formation after oeosphageal endoscopic resection.

This study will use a single-case experimental design to investigate how pain-related outcomes and stress change during participation in the StressModex intervention for individuals with acute or sub-acute whiplash-associated disorders. Daily assessments of pain interference and stress (primary outcomes), along with pain intensity and pain bothersomeness (secondary outcomes), will be used to determine when changes occur across different phases of the intervention. Cross-lagged correlation analyses will be conducted on daily data to investigate whether stress operates as a mechanism of change in pain-related outcomes. Qualitative interviews will explore changes in pain-related beliefs, perceived pain controllability, and associated behavioural and emotional responses. The study will also evaluate whether stress, pain, neck disability, perceived recovery and related psychological factors improve from pre- to post-treatment and whether any observed improvements are maintained at six-month follow-up. The feasibility of using a wrist-based heart-rate monitor for daily HRV collection will also be assessed both qualitatively and quantitatively. Physiological stress, indexed by daily heart rate variability (HRV), will be examined to characterise its trajectory during treatment and assess its potential role as a mechanism underlying changes in pain-related outcomes.

Infants born preterm are at high risk of developing cognitive, behavioural and emotional deficits later in life. One in three infants born before 32 weeks of pregnancy exhibits a language delay, with communication difficulties persisting into adulthood. While advances in neonatal medicine have resulted in decreased mortality for preterm infants, neurodevelopmental problems in survivors have remained unchanged. We propose a parent driven intervention focused on increased exposure to parents’ speech to promote language development in the preterm infant, giving those most vulnerable the greatest chance to thrive.

The FLUDRO-SHOCK trial is a large international randomised controlled double-blinded study aiming to improve treatment for people with septic shock—a life-threatening condition caused by severe infection. Patients with septic shock receive a steroid called hydrocortisone, but it is unclear whether adding another steroid, fludrocortisone, improves their chances of recovery and survival. This study will test two doses of fludrocortisone (50 mcg and 100 mcg) against a placebo to see which works best. It will also explore whether a person’s unique immune response, based on their genes, affects how well the treatment works. The trial will involve up to 2,200 critically ill adults in intensive care units across Australia and other countries. Researchers will track survival, organ recovery, and quality of life for up to a year. The goal is to find the most effective and personalised way to use steroids in septic shock, potentially saving lives and improving long-term outcomes.

Headache is a common reason for seeking emergency care in Australia. The sphenopalatine ganglion represents a promising anatomical target for analgesic intervention among patients with headache. Findings from the seven studies conducted to date support that a sphenopalatine ganglion block may be effective among emergency department patients with headache. This multicentre (Angliss Hospital, Box Hill Hospital, and Maroondah Hospital), individually randomised, double-blind, placebo-controlled, two-group parallel (1:1), superiority trial will examine the effectiveness of an adjunct sphenopalatine ganglion block in adult emergency department patients with headache. We hypothesise that an adjunct sphenopalatine ganglion block will be superior to placebo for all outcomes.

Critically ill patients in the ICU are commonly observed to have low serum electrolyte concentration of magnesium and/or phosphate. Prompt treatment must be administered to avoid serious harm. The intravenous (IV) route is most commonly administered in the ICU. This is important for very unwell patients in the ICU where electrolyte levels are dangerously low. However, most patients in the ICU have electrolyte levels that are only slightly or moderately low and we are exploring if the enteral route could be used more often. The enteral route has potential benefits - it costs less and produces less waste, therefore producing less carbon which makes it a more environmentally friendly alternative. There is little information known about how effective the enteral route is compared to IV for patients in the ICU, and whether the enteral route would be acceptable to staff and patients to use more often. This study is extending the work from two small clinical trials comparing enteral to IV route of magnesium and phosphate in the ICU. Both studies showed that enteral route didn’t cause harm, cost significantly less than the IV route and had less waste. However, there were mixed results on clinical effectiveness and wider testing in other ICUs is needed. In particular, staff perceptions of effectiveness, attitudes toward cost and environmental impact in decision making and beliefs on which route is “easier” to give have not been explored. The aim of this study is to test effectiveness of the enteral route compared to the IV route in a larger group of patients across multiple ICU settings. Each ICU will first use the IV route for all patients in the ICU that require electrolyte replacement for mild and moderately low electrolyte levels. We will then gradually ‘switch’ the ICUs across to using the enteral route. We will conduct staff surveys and group discussions to explore the factors that may influence staff in use of enteral or IV route.

The VIBE study aims to investigate the effect of Voyant Versus Diathermy for Haemostasis on post-surgical drainage and seroma in Breast Cancer Surgery Who is it for? You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer and undergoing unilateral or bilateral mastectomy Study details Participants in this study will randomly be allocated (by chance) to one of two groups: one group will be allocated the Voyant™ Intelligent Energy System for tissue dissection and vessel sealing during surgery while the other group will be allocated standard surgical care with conventional diathermy for tissue dissection and vessel sealing during surgery. Outcomes assessed up to 30 days post-surgery include time to drain removal, total drain output, seroma, and other recovery measures such as pain, complications, and quality of life. This research may help identify the most effective surgical device for reducing post-operative drainage and seroma after breast cancer surgery, with the potential to improve recovery and patient outcomes.

Body dysmorphic disorder (BDD) is a disorder that is characterized by a significantly disturbed perception of one’s own appearance. We propose to conduct a randomised within-group mixed-methods study on individuals with BDD to determine the feasibility and acceptability of VR-based mindfulness training. This study will be conducted at Swinburne University of Technology, Melbourne, Australia. The feasibility and acceptability of VR-based mindfulness training will be achieved in a number of ways: 1) qualitative semi-structured interviews; 2) self-report measures; 3) physiological measures (i.e. heart rate variability and galvanic skin response). This comprehensive, multimodal assessment of these experiences will be integral in refining our mindfulness training for this complex disorder. The effects of receiving VR-based mindfulness training will be assessed through comparing pre- and post-intervention state mindfulness, body image concerns and emotional regulation variables.

International guidelines now recommend screening for primary aldosteronism (PA) in people with chronic hypertension, however this is often not done. Unlike essential hypertension, PA has specific treatments, some of which can even provide a cure. Pregnancy and the postpartum provides a window of opportunity to screen women and improve their longterm health outcomes. However we don't know the prevalence of PA in this population. We aim to determine the prevalence of PA in women who have chronic hypertension after pregnancy. With a pragmatic design, we also aim to provide both quantitative and qualitative data on performing initial screening on medications commonly used in the postpartum period.

The CogCoach Brain project aims to evaluate an online, evidence-based lifestyle intervention designed to promote healthy brain ageing and reduce dementia risk in older adults with subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Building on the CogCoach-Health framework, the program delivers a 12-week multidomain intervention targeting physical activity, cognitive engagement, diet, social connection, sleep, and mood through interactive e-learning modules and personalised behavioural support. The randomised controlled trial follows participants for 12 and 24 months to assess long-term changes in cognitive function, lifestyle behaviours, and wellbeing. Optional biomarker testing will explore how lifestyle modification may influence biological indicators of brain health. The overarching goal is to provide an accessible, scalable program that supports healthy brain ageing and reduces dementia risk in older Australians