Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.
Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. ⋯ The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection.
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Randomized Controlled Trial Multicenter Study
Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: study protocol for a randomised controlled trial.
Smoking rates, and associated negative health outcomes, are disproportionately high among people with mental illness compared to the general population. Smoke-free policies within mental health hospitals can positively impact on patients' motivation and self-efficacy to address their smoking. However, without post-discharge support, preadmission smoking behaviours typically resume. This protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence. ⋯ If shown to be effective, the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities.
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Randomized Controlled Trial Multicenter Study
The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol.
Insertion of a ventriculoperitoneal shunt (VPS) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK, but failures caused by infection occur in approximately 8% of primary cases. VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service. Antibiotic-impregnated (rifampicin and clindamycin) and silver-impregnated VPS have been developed to reduce infection rates. Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection, there are no randomised controlled trials (RCTs) to support their routine use. ⋯ The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS. The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future.
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Randomized Controlled Trial Multicenter Study
The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.
Ageing populations may demand more blood transfusions, but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors. One approach to increase blood supply is to collect blood more frequently from existing donors. If more donations could be safely collected in this manner at marginal cost, then it would be of considerable benefit to blood services. National Health Service (NHS) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks. In contrast, some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women. The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors. ⋯ The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply, acceptability, and donors' physical and mental well-being. The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere.
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Randomized Controlled Trial Multicenter Study
Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial.
About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care. ⋯ This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP.