ANZCTR search results

Pelvic organ prolapse (POP) is a common gynaecological condition with an incidence of 40-60%, and 12-19% of women undergo surgical correction. Standard technique of native tissue repair (NTR) relying on damaged tissue is associated with variable success and recurrence rate up to 30-50% initiating the exploration of innovative surgical techniques and grafts to improve long-term outcomes. Surgery is preferential for younger women with more severe symptoms related to quality of life, if also affecting bladder, bowel, and sexual function. Use of transvaginal polypropylene mesh is no longer accepted in most of the global market due to unfavourable complications of increased reoperation rates, mesh erosion, dyspareunia, and chronic pelvic pain. Surgical techniques using biological grafts or absorbable mesh to augment POP have been trialled, with systematic reviews based on low quality evidence demonstrating minimal advantage compared with NTR regarding rates of awareness of prolapse or reoperation. Low to moderate quality evidence suggests higher recurrence rates for anterior prolapse after NTR than with biological grafts. This is a randomised controlled trial comparing two surgical approaches for pelvic organ prolapse treatment: Intervention Group with autologous graft augmentation and Control Group with conventional prolapse repair surgery. In Group 1, patients undergo native tissue repair surgery for vaginal prolapse, with an autologous graft prepared from 40mls of the patient's own blood during surgery. The graft is then sutured or glued to the underlying connective tissue. In Group 2, patients undergo the same surgery as Group 1 but without the creation of a graft. Postoperative care is identical for both groups, including routine instructions on physical activity, bowel habits, and abstinence from intercourse for six weeks. Patients are followed up teleconsult at one week and face-to-face at 6 weeks, 6 months, and 12 months. Participants are invited to the study after being diagnosed with pelvic organ prolapse that requires pelvic floor repair surgery, having tried medications and non-surgical alternatives with persistent symptoms. The study includes an initial assessment consultation, surgery, and three follow-up assessments at 6 weeks, 6 months, and 12 months after the treatment. No medical expenses are incurred during these consultations or treatments, and both specialists involved in patient care will be responsible for administering the study treatment and performing the assessments. The assessment consultations involve evaluating the pelvic organ prolapse, bowel, bladder, and sexual function to determine the treatment's effectiveness. This study aims to provide valuable insights into the efficacy of autologous graft augmentation compared to conventional prolapse repair surgery, contributing to improved treatment options for patients suffering from pelvic organ prolapse.

This is a phase I, feasibility, prospective, multi-centre, double-blinded randomised placebo-controlled trial in ICU patients with septic shock to test whether the intravenous administration of mega-dose sodium ascorbate is safe and feasible, shortens the time to weaning from vasopressor support and leads to an improvement in biomarkers of sepsis compared to placebo. The study hypothesis is that the mega-dose sodium ascorbate in early septic shock will be safe and feasible.

This study aims to investigate the maintenance or de-training effect of the participants following discharge from the RHM CTS balance programs. It also aims to identify whether or not patients are continuing with physical activity behaviours following discharge and if this has a difference on de-training effects. We hypothesize that the patients who do continue with regular physical activity will have less of a de-training effect then those who do not continue to be active. We hope to identify how we might better encourage a higher rate of continued physical activity.

Peer Workers have lived experience of mental ill-health and are intentionally employed to support individuals with mental ill-health as well as their family and carers. These Peer Workers are inaccessible to many in need, especially for those whose main or only support is through general practice. Our aim is to trial the implementation of a co-designed lived experience peer support intervention for mental health consumers in primary care.

Research has revealed that 50% - 60% of individuals do not seek help prior to a suicide attempt, thus it is imperative we find new ways to reach them. One way to reach them is to use a Google Ads campaign, in which a person visiting the website is asked if they have previously sought help before, with the intention of providing more relevant offerings. In this study, we assess the impact of reducing the effort needed by individuals to seek help on help seeking.

Heart failure with preserved ejection fraction (HFpEF) is the most prevalent phenotype of heart failure. However, the treatment options for these patients remain limited. Permanent pacemakers are commonly used in the management of bradycardia (low heart rate), with many pacemaker patients also presenting with early HFpEF. This study is a prospective, two-arm randomised controlled trial including 160 participants with pacemakers and early HFpEF from Adelaide, South Australia. Participants will be randomised to an accelerated pacing rate (75bpm) or usual care (60bpm), performing follow-up at 4-weeks and 52-weeks post randomisation. It is hypothesised that increasing the heart rate settings compared to standard permanent pacemaker settings, will improve exercise tolerance, defined using peak oxygen consumption, at 12-months post-randomisation.

OM002 is a synthetic oligosaccharide that is identical to the human milk oligosaccharide (HMO) 2’ fucosyllactose (2'FL) and has the potential to address the underlying pathophysiology of Parkinson’s Disease (PD) constipation and address unmet clinical needs in these patients. This study is being conducted to assess the safety and efficacy of OM002 relating to reduced severity of constipation and disease progression in patients with PD. This double-blind, randomized, placebo-controlled study trial will consist of two groups (n=80/each) who will receive either OM002 or placebo for 13 weeks in addition to the standard of care. Following this period both groups will receive an open-label for an additional 13 weeks. Biological samples and surveys will be sampled at 5 time points (baseline, mid-treatment, completion of first arm (13 weeks), mid-open-label treatment, and at the end of the open-label treatment period (13 weeks)). Trial data will be used in combination with available open-label data to guide the late-stage development of OM002 in participants with PD. We hypothesise that ingestion of 10 grams of OM002 daily will improve cognitive function and reduce GI symptom severity in patients diagnosed with PD.

This study is aiming to evaluate the efficacy of an interactive online portal, iCare, in improving the health and wellbeing of people living with complex cancers, and their informal carers. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with an upper gastrointestinal (GI) cancer in the past 3 months, or a carer who is looking after someone who has been diagnosed with an upper GI cancer. Study details Patients and carers will be provided access to the online iCare platform as often as they would like over a three month period. The platform will provide information on the patient journey, support and resources with a facility to identify and record medical symptoms. All participants will be asked to complete surveys at baseline, 3-months and 6-months post-recruitment. It is hoped that findings from this study will help determine the utility of the iCare platform in supporting the emotional needs of complex cancer patients and their carers.

Glucose-dependent insulinotropic polypeptide (GIP) is a natural hormone released from the intestines after meals. It regulates blood sugar levels by controlling insulin secretion. Our recent studies suggest it may also regulate glucose excretion in the urine. We want to find out whether giving an intravenous infusion of GIP can affect urinary glucose excretion in people with type 2 diabetes.

This study aims to assess the effectiveness, cost-effectiveness, and implementation context of an integrated liver fibrosis detection pathway in detecting unrecognized advanced liver fibrosis in at-risk patients in primary care. Who is it for? You may be eligible to participate in this trial if you are between 45-75 years and are at risk of chronic liver disease and are under the care of a GP at a participating general practice clinic, Study details GP clinics will be randomised to one of two cluster groups. One group will receive usual care provided by their GP. The other group will have a liver fibrosis detection pathway implemented through the Future Health Today (FHT) clinical decision support system (CDSS). GPs will be alerted by the CDSS from the electronic patient medical record if their patient is at-risk for advanced liver fibrosis and warrant further investigation. Further investigation will be prompted by way of a screening blood test for liver fibrosis and then a diagnostic special liver ultrasound, known as a liver elastogram. It is hoped that this research will demonstrate if this clinical decision support system is effective in improving detection of liver disease and liver cancer, thus improving patient outcomes.