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NCT ID: NCT00934388 Not yet recruiting - Chronic Groin Pain Clinical Trials

A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain

Start date: January 2011
Phase: Phase 3
Study type: Interventional

Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this pain may be due to the presence of a hernia. However, if on clinical examination there is no palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these patients may have the diagnosis of sportsman's groin. Other names which have been attached to this condition include Gilmores groin and sportsmans hernia. These conditions are more commonly associated with sportsmen and women but those who do not play sport may also receive this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior inguinal wall without a clinically recognisable hernia. Differing explanations for sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening of the transversalis fascia, tears in the internal or external oblique, superficial inguinal ring dilatation and abnormalities of the rectus abdominus insertion. There is some evidence that pre peritoneal mesh placement in these patients may be beneficial. The theory being that the mesh prevents pressure transmission to the damages structures, allowing them to heal more rapidly. Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP technique in patients with chronic groin pain.

NCT ID: NCT00731107 Not yet recruiting - Clinical trials for Laparoscopic Surgery

XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

Start date: September 2008
Phase: N/A
Study type: Interventional

The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted, usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a sharp trocar is then inserted to hold the operating telescope. The XCEL bladeless trocar is another method of inserting the operating telescope whereby you don't need to first introduce gas before the trocar. This trocar is widely used in laparoscopic surgery but it is uncommon to the field of gynecology. This study will compare the two methods with regard to: 1. Time taken to enter the abdomen 2. The number of attempts taken to enter the abdomen 3. The impact of the time taken to enter compared to the whole operating time 4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of 1 to 5. Patients will be recruited into the trial through the Monash Medical Centre Gynecology department and the Mercy Hospital for Women Gynecology department. Patients that are having laparoscopic surgery and would usually have a Veress Needle entry are suitable for this trial. A patient information sheet will be provided and written consent will then be obtained. Patients who give written consent will be randomised into one of two arms of the trial, either the control (Veress Needle) or the XCEL bladeless trocar arm. Information will be entered on a proforma by a researcher for each patient during their operation. All patient information will be strictly confidential and only be available to researchers directly involved in the study. Surgeons operating as part of the project are the consultants and fellow of the gynecology department of Monash Medical Centre and Mercy Hospital for Women and are competent in both techniques. 200 women will be recruited over a one year period and the data will then be analysed with the help of a statistician.

NCT ID: NCT00484835 Not yet recruiting - Clinical trials for Total Abdominal Hysterectomy

Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial

Start date: September 2007
Phase: Phase 1
Study type: Interventional

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp & suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

NCT ID: NCT00456170 Not yet recruiting - Clinical trials for Vaginal Hysterectomy

Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

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Start date: April 2007
Phase: Phase 1
Study type: Interventional

The hypotheses of this study is that the use of the instrument “Harmonic Scalpel” (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

NCT ID: NCT00448318 Not yet recruiting - Dementia Clinical Trials

Evaluating the Effects of Music Interventions on Hospitalised People With Dementia

Start date: March 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities. Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success. Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention. The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do. In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.

NCT ID: NCT00421616 Not yet recruiting - Overweight Clinical Trials

Effectiveness of High Protein Diets in Promoting Weight Loss in Overweight and Obese Subjects.

Start date: February 2007
Phase: N/A
Study type: Interventional

Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. In addition, we aim to develop dietary intervention strategies that are realistic and sustainable.

NCT ID: NCT00322426 Not yet recruiting - Parkinson's Disease Clinical Trials

Sensory Cues for Freezing in Parkinson's Disease

Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones.

NCT ID: NCT00310570 Not yet recruiting - Mallet Finger Clinical Trials

Comparison of Splinting Interventions for Treating Mallet Finger Injuries

Start date: May 2006
Phase: N/A
Study type: Interventional

Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball, cricket and football. This can result in a Mallet finger deformity, where the end joint of a finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred, the skin remains intact, and the impairment results from a tear of the extensor tendon or an avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved. This study aims to compare two different types of splintage (the commonly used thermoplastic thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will include patient compliance with the splint, degree of extensor lag, active movement of the joint, and any complications. The null hypothesis is that there are no differences in outcome between different methods of conservative splinting treatment for mallet finger.

NCT ID: NCT00310349 Not yet recruiting - Clinical trials for Pneumococcal Infections

PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease

Start date: March 2006
Phase: Phase 3
Study type: Interventional

PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control vaccine for the birth dose. The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups. Each mother and infant will be followed from pregnancy until the baby is seven months of age. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule. The primary outcome will be prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.

NCT ID: NCT00164086 Not yet recruiting - Myeloma Clinical Trials

Atorvastatin in Myeloma

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.