ANZCTR search results

To find out the efficacy of vaginal vault prolapse repair with uterosacral ligament suspension via vaginal approach to those of the current gold standard surgery of sacrocolpopexy

Failure to immobilise the neck during tracheal intubation in patients with cervical spine injuries (CSI) can result in a devastating neurologic outcome. One method to immobilise the neck during laryngoscopy and tracheal intubation is manual in-line neck stabilisation (MILNS). With MILNS, however, it is often more difficult to visualise the larynx using conventional laryngoscopy. Consequently, the application of MILNS may result in failure to secure the airway, which may result in substantial morbidity or even mortality. These issues highlight the need to develop alternative approaches to securing the airway in patients with CSI. The purpose of the proposed study is to compare the performance of the Airway Scope and GlideScope laryngoscopes for tracheal intubation in patients with cervical spine immobilisation using MILNS. The GlideScope laryngoscope, is a modification of the standard Macintosh blade, with a high-resolution camera and with a light source for illumination embedded within the blade. Endotracheal intubation is performed based on an image on a screen. Its use is well described in the airway management of patients with immobilised cervical spines. The Airway Scope, in contrast, is a novel intubation device. It is a video laryngoscope with a reusable handle and desposible blade. A number of design features that suggest its utility in the setting of cervical spine immobilisation. A limited amount of research to date has generally supported this proposition. We intend to conducting a randomised, single-blind, controlled clinical trial. All patients will receive a standardised general anaesthetic with routine non-invasive monitoring. The neck will be immobilised using MILNS applied by an experienced assistant. Participants will be randomly assigned to tracheal intubation with either the Airway Scope or the GlideScope. All intubations will be performed by one anaesthetist experienced in the use of both laryngoscopes. The primary outcome measures will be intubation time and the Intubation Difficulty Scale score. Any complications or difficulties will be recorded.

The aim of the study is to to determine whether land- or water-based rehabilitation is the more effective mode of delivery following primary total knee replacement (TKR) in the sub-acute period.

Inflammatory markers have been found to be raised in hip fracture patients. It is plausible that fish oils will counteract production of these chemicals and reduce weight and muscle loss which is experienced in many of these patients. This study will investigate proof of this concept, feasibility of recruitment and adherence to fish oil liquid or capsules.

In infants with gastrointestinal complications, constructing an ileostomy is a common temporising surgical intervention whilst waiting for future definitive surgery. An ileostomy is a surgically created opening into the ileum (the final part of the small intestine) which connects the healthy end of the ileum to an artifical bag on the surface of the skin; allowing the distal and diseased bowel to be bypassed and heal. Intestinal waste passes out of the ileostomy, bypassing the colon. Intestinal waste which has bypassed the colon usually has a higher content of water and electrolytes because the small intestine does not conserve electrolytes, in particular sodium as well as the colon. It is known that infants with high ileostomy fluid losses are at risk of dehydration, sodium deficit and failure to thrive. To prevent this, clinicians at the Royal Children's Hospital (RCH) Neonatal Unit (NNU) have traditionally replaced ileostomy fluid losses with intravenous saline when those losses are above 20ml/kg/day. This method requires recurrent insertion of intravenous cannulae, or insertion of central venous lines because the median duration between fashioning and closing an ileostomy is 44 days (Range 16-107 days). Central lines are important risk factors for sepsis in infants. Moreover, some infants have very difficult intravenous access. Therefore in these situations, clinicians at RCH NNU have been replacing high volume ileostomy fluid losses with oral rehydration solution. The aim of this pilot study is to determine sample size calculations, data variability and feasibility for a future study with the specific aim to determine whether oral rehydration solution replacement is as effective as intravenous saline for replacement of ileostomy fluid losses in infants. In this study consented infants with ileostomy fluid losses of 20-40ml/kg/day who are tolerating full enteral feeds and additional salt supplementation will be allocated to receive both intravenous saline and oral rehydration solution for two weeks each. The order of which will be randomly assigned. They will receive each type of rehydration fluid for 14 days; a total of 28 days. Irrespective of the method of fluid replacement, the ileal fluid volume will be replaced over the following 24 hours if over 20ml/kg/day. During the study, information including third daily weight; weekly urine sodium, ileostomy sodium and sodium supplementation dose; daily total fluid balance (total fluid input and output), ileostomy losses and replacement, and any complications that may occur will be recorded on a standardised data sheet. No additional blood tests are required, therefore discomfort should be no greater than currently associated with being an inpatient in the NNU. Descriptive statistics will be generated for all outcome measures to determine population variability and sample size for a larger study.

This study is designed to compare how safe and effective zonisamide is compared to placebo in people with myoclonic seizures associated with idiopathic generalised epilepsy who are already being treated with one or two other anti-epileptic drugs. Zonisamide is an investigational drug. RESEARCH OBJECTIVES To assess the efficacy of adjunctive zonisamide in idiopathic generalised epilepsy (IGE) in reducing the frequency of myoclonic seizures in subjects with continuing seizures despite treatment with 1 or 2 other anti epileptic drugs (AEDs). To assess the safety and tolerability of zonisamide and explore further efficacy in other seizure types. STUDY DESIGN This is a double blind, randomised, placebo controlled study comparing zonisamide and placebo in 110 subjects (1:1ratio). The study consists fo Baseline, Titration and Maintenance periods. Baseline Period once the Screening Visit has been performed, a seizure diary will be maintained to document the baseline seizure frequency in the eight weeks before the Randomisation Visit. Titration Period zonisamide/placebo dose will commence at at 50 mg. Further dose increases will occur at one week intervals until at dose of 300 mg is reached by Week 4. If adverse events (AEs) occur, one titration step will be omitted during Weeks 0 3, in which case the dose reached at Week 4 will be 250 mg. Subjects who require further down titration during this period will be withdrawn. Maintenance Period subjects will be treated with their Week 4 dose. In the event of seizures occurring in the first two weeks of the Maintenance Period, the dose will be increased to 400 mg (or 350 mg, if the subject omitted one dose in the Titration Period and the AE that led to this dose increase omission has subsided). The dose can be reduced to 200 mg in the case of dose-limiting AEs. Subjects who require further down titration or dose increases will be withdrawn (with the exception of those who had temporary dose decreases for not more that 4 days when necessitated by intercurrent illness). During the remainder of the Maintenance Period, the dose of study medication must remain unchanged. During the entire study the patient will keep a seizure diary to ascertain seizure frequency and type. Adverse events (AEs) will be reviewed at every visit, also physical and neurological exams and orthostatic vitals will be collected at every visit.

This study is designed to compare how safe and effective zonisamide is compared to placebo in people with primary generalised tonic clonic seizures who are already being treated with one or two other anti-epileptic drugs. Zonisamide is an investigational drug. Primary Research Objective: To assess the efficacy of adjunctive zonisamide in IGE in reducing the frequency of tonic-clonic seizures in subjects with continuing continuing primary generalised tonic-clonic seizures Secondary Research Objective: To assess the safety and tolerability of adjunctive zonisamide. Exploratory Research Objective: To further explore the efficacy of zonisamide on other seizure types expected to occur in a significant proportion of subjects (myoclonic seizures, absence seizures). This is a double-blind, randomised, placebo-controlled study comparing zonisamide and placebo in 154 subjects (1:1 ratio). The study consists of Baseline, Titration and Maintenance periods. Baseline Period - once the Screening Visit has been performed, a seizure diary will be maintained to document the baseline seizure frequency in the eight weeks before the Randomisation Visit. Titration Period - zonisamide/placebo dose will commence at 1 mg/kg in subjects <12 years of age or at 50 mg for subjects 12 years of age. Further dose increases will occur at one week intervals until at dose of 5 mg/kg or 300 mg is reached by Week 4. If adverse events (AEs) occur, one titration step will be omitted during Weeks 0-3, in which case the dose reached at Week 4 will be 4 mg/kg or 250 mg. Subject's who require further down titration will be withdrawn from the study. Maintenance Period - subjects will be treated with their Week 4 dose. In the event of seizures occurring in the first two weeks of the Maintenance Period, the dose will be increased to 6 mg/kg or 400 mg (or 5 mg/kg or 350 mg, if the subject omitted one dose in the Titration Period and the AE that led to this dose increase omission has subsided). The dose will be reduced to 4 mg/kg or 200 mg in dose-limiting AEs. Subjects who require further down titration or dose increases will be withdrawn (with the exception of those who had temporary dose decreases for not more that 4 days when necessitated by intercurrent illness). During the remainder of the Maintenance Period, the dose of study medication must remain unchanged. During the entire study the patient will keep a seizure diary to ascertain seizure frequency and type. Adverse events (AEs) will be reviewed at every visit, also physical and neurological exams, orthostatic vitals, 12 lead ECGs and clinical labs will be collected at every visit.

The Person-Centred Care (PCC) is consistent with nursing philosophy & is distinguished by care staff making genuine efforts to understand and meet the person's individual needs. PCC improves the person's Quality of Life (QOL) helping them to feel valued for who they are. Person-Centred Environment Design (PCD) - there is a direct link between QOL for person's with dementia & physical space, whereby the physical environment serves as non-pharmacological supportive element in retaining memory, stimulating the remaining senses enabling communication with carers, assisting the person retain self control and reducing levels of anxiety, aggression, depression & psychotic behaviour through built "cues". The physical environment can therefore exercise dramatic psychological impact on QOL for the person with dementia. This randomised controlled trial will evaluate whether PCC and/or PCD improves the QOL and Quality of Care (QOC) of persons with dementia. Another major aspect of the study is to assess the efficiency (Cost Effectiveness) of such measures. The study will be conducted over 3years with 600 person with dementia with 400 care staff in 38 care units in NSW.

Unemployment is the most significant non-illness disability that people with mental illness face. Despite much effort being put into employment systems in the community, they remain the single most unemployed disability group despite being able to, and wanting to work. In this study we will trial a form of employment intervention known as Individual Placement and Support with a group of young people with first episode psychosis who are interested in finding work. Our primary aim is to see if this intervention is superior to currently normal treatment. Secondly we are interested in seeing if employment has positive effects on symptoms and medication management. Finally we will be examining the economics of this intervention to establish if the benefit (if there is one) exceeds the cost of providing this type of intervention.

This project will assess the success (cure rate) of two types of suburethral sling procedures in the treatment of women with urodynamic stress incontinence and intrinsic sphincter deficiency. This group of patients has a low urethral closure pressure and is a challenging subgroup of patients that has shown less success in their treatment with other surgical methods (e.g. Burch colposuspension). The suburethral sling procedures (e.g. TVT) have shown better results in this group. The Monarc sling is a new procedure that places the tape in a different way (through the obturator foramen) as the TVT, which has been established for some time in the treatment of intrinsic sphincter deficiency. Therefore we will assess and compare the success and other outcomes (complication rate, hospital stay, etc) of both procedures.