ANZCTR search results

This is a prospective randomized controlled trial (RCT) comparing outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction (ACLR) with or without concomitant iliotibial band tenodesis. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period. This will include a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength, and single limb hop capacity.

There is currently no gold-standard fistula-in-ano management that consistently achieves healing while avoiding faecal incontinence. Reported success varies in the literature. This study is a prospective, multicentre, randomised control trial to compare the safety and efficacy of cutting seton with ligation of the intersphincteric tract (LIFT) for complex cryptoglandular (primary) fistula-in-ano. Other outcomes examined will include development of faecal incontinence, and patient satisfaction. We aim to determine whether these procedures are equivalent in terms of ability to achieve complete fistula healing without developing significant faecal incontinence

High-Intensity Multimodal Training (HIMT) has recently gained interest as a proposed time-efficient method of meeting physical activity guidelines. Previous studies have demonstrated positive effects of HIMT on physical health and perceptual outcomes. However, the magnitude of these effects in HIMT remains unclear when compared to other methods of combined aerobic and resistance training (i.e., inter-session concurrent training [CT]). This may be due to a lack of standardisation in the prescription and reporting of training variables in HIMT. Therefore, the purpose of this study is to compare the effects of 7-weeks of HIMT and inter-session CT (on separate days to match physical activity guidelines) on physical and perceptual responses. This study will also compare physical activity behaviours prior, during and following the intervention.

Research has identified that over one third of young people with Type 1 Diabetes (T1D) experience disordered eating behaviours or at risk for an eating disorder (ED), which can impact T1D management and lead to diabetes-related complications and death. The current study aims to determine whether participating in the ADBP will reduce ED risk factors, depression, anxiety, and distress, and improve body acceptance, T1D management, and quality of life. This Randomised controlled trial will recruit 80 females with T1D between the ages of 15 and 25. Participants will be randomly assigned to an active control (educational videos) or the ADBP, which includes attending 6 weekly, hour-long, online group sessions that discuss body ideals and diabetes concerns. Validated surveys measuring body dissatisfaction, body ideals, disordered eating, quality of life, and diabetes distress, along with biometric data to assess diabetes management, will be collected at baseline (immediately prior to ADBP), immediately post-ADBP, and at 3 months follow-up. We expect that participation in the ADBP will lead to improvements in disordered eating, body acceptance, quality of life, and diabetes management

The aim of the study is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal liposarcoma undergoing curative intent treatment. Who is it for? You may be eligible for this study if you are aged 18 or older presenting with first recurrent liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection. Study details Patients enrolled in this study will form a validation cohort of the TARPSWG recurrent RPS nomogram. The treatment decision (surgery alone +/- post operative treatments, or surgery with preoperative RT +/- post operative chemotherapy) is per the institutional multidisciplinary team recommendation. There are no additional tests above standard of care tests involved in this project. There will be a quality of life questionnaire that will be administered at 4-5 different timepoints throughout the study. It is hoped that findings from this study will further medical knowledge about the treatment for this type of sarcoma and hence improve outcomes for patients with recurrent retroperitoneal liposarcomas in the future.

Every year, nearly 250,000 Australian university students report suicidal thoughts and behaviours, but are reluctant to seek support. We have developed a novel screening tool that accurately identifies students at increased suicide risk, and proactively reach out to offer safety planning and support. Our initial work shows this is associated with a 41.7% reduction in suicidal behaviour one year later (this work was not pre-registered). In this project, we will extend this program to support university students across the country. We anticipate that a similar effect will be observed in the larger study.

We seek to evaluate the effectiveness of a pilot adaptation of Mother-Infant Dialectical Behaviour Therapy (MI-DBT), an evidence-based therapy for mothers with Borderline Personality Disorder. We will collect measures related to sense of parenting confidence, severity of borderline personality and depression amongst other measures, and interview participants about their experience of participating in the group.

The aim of this research project is to evaluate proof of concept - change in mechanistic and clinical outcomes, and feasibility and acceptability of a newly developed online FODMAP (LFD) diet intervention. The FODMAP diet is an evidence-based therapy and first-line intervention for the management of IBS. The specific aims of this research are: To evaluate if the online FODMAP diet program can achieve a pre-specified minimally clinically important change (MCIC) in: i. Total FODMAP intake; and ii. Gastrointestinal IBS symptoms. To evaluate if the online FODMAP diet program can be implemented as designed specifically addressing: i. recruitment, ii. trial processes and procedures including completion of primary outcome measures, participant engagement with the program, and therapist intervention; and ii. program acceptability. We hypothesise that the online FODMAP diet program will achieve a clinically meaningful change in total FODMAP intake and gastrointestinal IBS symptom improvement; and that the online FODMAP diet program will be feasible and acceptable to participants as indicated by meeting a priori identified benchmarks. We anticipate that the post treatment qualitative interviews will facilitate further refinement and optimisation of the online treatment prior to conducting the proposed randomised controlled trial.

The trial is to test a new device and determine if scrotal cooling improves semen quality. We expect to observe an improvement in all measured semen parameters (morphology, motility, concentration, DNA damage) with the use of the scrotal cooling device.

The purpose of this study is to evaluate the extent of scar formation and to provide safety information for a new approach to scar formation after s surgical procedure. TetraDERM device uses the natural heat from the body to form an elastic hydrogel scaffold, the controls moisture within the wound bed whilst providing a cushioning effect physically to reduce the tension of the wound. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed, to reduce wound tension and support healing work to reduce scar formation. Up to 8 subjects will be enrolled at one clinical site in Australia in cohort 1. There will be a total of 11 subject visits occurring over 12 months.