ANZCTR search results

Stress incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Midurethral slings (MUS) have become the operation of choice for treatment of female stress urinary incontinence. MUS are synthetic tapes that are implanted transvaginally to support the urethra. The urethra is a tube that connects the bladder to the outside of the body and removes urine from the body. Midurethral slings can be deployed in a retropubic or transobturator fashion. A retropubic approach involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. In contrast, the transobturator approach involves the passage of a sling through the obturator membrane which is further away from the bladder. This approach has been shown to have a reduced rate of intra-operative bladder perforation. Recent systematic reviews of retropubic or transobturator midurethral tapes suggest equivalent efficacy, at least in the medium term. Long term success rates of the retropubic approach are up to 91%. Both midurethral systems continue to have clinically significant complications such as bladder injuries, vagina mesh exposures, voiding difficulty, denovo (new onset) urgency and groin/thigh pain reported. Retropubic slings have more hematoma, bladder perforations, whereas transobturator slings have less over active bladder symptoms and less voiding difficulties. The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route. Randomised trials of minislings against transobturator slings have shown similar results, with the added advantage of less overactive bladder symptoms and voiding difficulties. The self-fixating tips of the minislings allow them to be placed under more tension, whilst retaining the advantages of the transobturator sling. There have been no studies comparing the efficacy of the retropubic sling with the minisling. Minislings may provide equivalent results as the retropubic sling with lower complication rates. We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and compare their clinical outcomes.

The primary purpose of this trial is to evaluate whether early referral for palliative care can improve quality of life, cost effectiveness and quality of end of life care for adults who are newly diagnosed with advanced lung cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced non-small cell lung cancer, extensive small cell lung cancer or advanced malignant pleural mesothelioma within the last 60 days. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care referral to palliative care at the discretion of the treating oncologist, or to receive early referral to palliative care within 7 days of enrolling in this trial. With the exception of the timing of the referral, the palliative care received by each group will be as per standard care, with information and care provided by the palliative care team as required for each participant. Participants will be asked to complete a number of questionnaires relating to quality of life and cancer symptoms at regular time points until their death. Carers will be asked to complete quality of life and death questionnaires and an interview at regular intervals up to six months following participant death. It is anticipated that the findings from this trial will provide information on whether early referral to palliative care following diagnosis of advanced lung cancer is beneficial for patient quality of life and end of life, and cost-effectiveness of care.

The purpose of the present study is to quantify, measure and investigate the effects of time-restricted feeding of a high-fat diet on circadian metabolomics, blood glucose, insulin, lipids and hormones with regulatory roles in satiety/appetite compared to unrestricted feeding of the same high-fat diet. We hypothesize that in the face of a high-fat diet (HFD), time-restricted feeding will ‘rescue’ the disruptions to circadian metabolomics observed with unrestricted intake of a HFD (previously demonstrated in animal models).

The primary purpose of this trial is to evaluate the effectiveness of Ex-Med Cancer, a community-based exercise medicine program designed to improve physical and psychosocial wellbeing in cancer survivors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have completed cancer treatment (surgery, chemotherapy and/or radiotherapy) within the previous one year (Note: participants are eligible if they are currently receiving/scheduled to receive hormone therapy). Study details All participants enrolled in this trial will complete a 12 week group-based, supervised exercise program delivered 3 times per week in community fitness centres/gyms in Victoria. Participants will receive an individualised exercise plan developed by an up-skilled exercise physiologist. Exercise sessions will last approximately one hour and comprise of a combination of aerobic, strength and flexibility training. This trial will provide information on whether Ex-Med Cancer is an acceptable, efficacious and sustainable model of care that has the potential to be translated into cancer care.

Heart disease is a major cause of death and disability in Australia. We have already shown that diet has a key role to play in maintaining blood vessel health. A low magnesium diet is emerging as a risk factor for heart disease and is associated with an increased risk of fatal and nonfatal ischaemic heart disease. Few studies have examined the effect of Mg on endothelial function in healthy adults. The hypothesis is that an improvement blood vessel function measured by flow mediated dilatation after a high magnesium diet achieved using dietary supplements.

A prospective randomised controlled trial comparing skin closure of surgical incisions in children using either a wound dressing only, adhesive tape (SteriStrips) or adhesive glue (Dermabond). The choice of which of these techniques is used is usually dependent upon the surgeon’s preference and there is little evidence to show which of the three is better. This study will help to determine which of these three techniques, if any, is better and will help paediatric surgeons choose the best skin closure technique for their patients. Parents of children presenting for elective surgical procedures will be approached for enrolment. Participating children will then be randomised to have surgical incision skin closure with sutures and then either adhesive tape, adhesive glue or a simple wound dressing. Postoperatively, children will be followed up at 2 weeks via telephone survey where a parental satisfaction survey in terms of the wounds will be performed. Parents will also be asked questions related to: 1. Wound healing 2. The presence of any complications such as wound infection 3. Requirement to see a doctor regarding the wound postoperatively, 4. Time taken for each skin closure type to come off 5. Any parental concerns regarding the type of skin closure used. Parents will also be asked to fill out an online survey in which they will rate the cosmetic outcome of the wound. Parents unable to be reached via telephone will have a link emailed to their email address to complete the entire survey online. There will be a second followup at 6 weeks postoperatively where children will be reviewed by a paediatric surgeon in the Outpatients Clinic to assess the cosmetic outcome of the surgical wound and parents will be asked to complete a survey in hard-copy or on an iPad about the cosmetic outcome of the wound and overall parental satisfaction with the skin closure technique. Data collected will then be used to assess for differences between the three patient groups including blinded photographic assessment of the surgical wounds. This project will aim to look for differences between the three groups in terms of cosmetic outcome (as rated by the parents and a blinded paediatric surgeon assessor), differences in wound infection and wound breakdown rates and a comparison of parental satisfaction with the skin closure technique. It is hypothesised that, as all three wound closure techniques are used in clinical practice, it is likely that there will be minimal difference between the three groups. However these techniques have not been compared in a controlled trial.

It is well recognised that wellbeing has close links with learning (NSW Department of Education and Communities, 2015b); where improvements in wellbeing have the potential to bring about positive change in self -concept and a lack thereof, can negatively affect a student’s engagement and success in learning (NSW Department of Education and Communities, 2015b). Consequently, there has been increased attention given to the study of wellbeing over the past decade, particularly in educational or school settings. The wellbeing of adolescents has become a recent focus in public health due to the prevalence and rise in mental health disorders in this age group in recent times (with approximately 20% of adolescents worldwide having a diagnosed mental health illness) (Patton et al., 2012); and with the negative health consequences associated with physical inactivity trends in this age group (World Health Organisation, 2014). In Australia, the proportion of young people aged 16–24 years having high or very high levels of psychological distress is approximately 9%, the prevalence of mental disorders is approximately 26% (Australian Institute of Health and Welfare, 2011), and almost 80% of adolescents are not meeting physical activity guidelines (Hallal et al., 2012). Mental disorders and physical inactivity are now considered leading causes of ill-health in this age group, often with lasting effects throughout adulthood (Kieling et al., 2011; Kohl III et al., 2012; World Health Organisation, 2014). Of note, there is a distinct gender pattern in physical and mental health after the age of 13 years, with adolescent girls generally reporting more mental health problems than boys and exhibit lower levels of physical activity (Beets, Bornstein, Beighle, B.J., & Morgan, 2010; Myrin & Lagerstrom, 2008; Nitzko & Seiffge-Krenke, 2009) When combined with inadequate coping strategies, increased stress levels in the adolescent years can have profound and negative health consequences (including anxiety and depression) (Chrousos, 2009; Dougall, Hyman, Hayward, McFeeley, & Baum, 2001; K. A. McLaughlin & Hatzenbuehler, 2009a, 2009b; K. J. McLaughlin, Baran, & Conrad, 2009; Seiffge-Krenke, Aunola, & Nurmi, 2009)

This is a double-blind, placebo-controlled, crossover study assessing the therapeutic effects of curcumin in 60 youth suffering from attentional problems. Each participant receives both treatments (8 weeks of curcumin and placebo) and randomisation is used to determine the order in which the participant receives each treatment,( i.e. curcumin followed by placebo, or placebo followed by curcumin). The curcumin dosage is 500mg of BCM-95 'Registered Trademark' twice daily. Changes in attentional symptoms will be assessed via a computerised test for attention and the completion of several questionnaires.

This is a double-blind, placebo-controlled study assessing the therapeutic effects of saffron in 80 youth suffering from depressive and/ anxiety symptoms. Participants will be randomly allocated into either a saffron (affron 'Registered Trademark' - 14mg twice daily) or placebo group and changes in symptoms will be measured over an 8-week period.

The aim of this study is to examine whether very early dietetic intervention for people with newly diagnosed upper gastrointestinal cancer will enhance quality adjusted life years lived compared with usual dietetic care. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have primary new diagnosis of oesophageal or stomach or pancreatic cancer. Study details Participants will be randomised (allocated by chance) to one of three treatment groups (usual care, early intervention telephone or early intervention electronic messages via mobile application). For those randomised to intervention groups, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. Personalised nutrition support/ advice will be provided. Outcomes will be measured at baseline and at follow up at 3, 6 and 12 months. It is hoped that this study will demonstrate effectiveness of early and frequent dietetic intervention in enhancing quality of life and that intervention will be cost-effective while also minimising nutritional decline (weight loss).