Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study.
Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy. ⋯ This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures.
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Randomized Controlled Trial Multicenter Study Observational Study
Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial.
Proximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, multipart fractures. There is no clear benefit from surgical fracture fixation compared to nonoperative treatment. Replacement of the fractured humeral head with a hemiarthroplasty is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or internal fixation. Recently, reverse total shoulder arthroplasty has been used to treat these fractures, particularly in the older population with several case series demonstrating good outcomes. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against nonoperative treatment. ⋯ The study will assess the effectiveness of reverse shoulder arthroplasty for complex proximal humeral fractures and thereby guide treatment of a common injury in the older population.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial.
Long-acting bronchodilator monotherapy (long-acting β2-agonist [LABA] or long-acting muscarinic antagonist [LAMA]) is extensively used for treatment of patients with chronic obstructive pulmonary disease (COPD) with mild-to-moderate airflow limitation. However, a substantial number of patients remain symptomatic despite treatment with a single bronchodilator, necessitating a change in therapy. ⋯ This study intends to establish the use of LABA/LAMA combination therapy in symptomatic patients with mild-to-moderate COPD by demonstrating the superiority of IND/GLY over tiotropium monotherapy.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial.
Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges. This paper presents a protocol for a two-armed, multisite, pragmatic, mixed-methods RCT examining the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP), a new 6-month interprofessional, nurse-led program to promote self-management in older adults (aged 65 years or older) with T2DM and MCC and support their caregivers (including family and friends). ⋯ This study will provide evidence of the effectiveness of a community-based self-management program for a complex target population. By studying both implementation and effectiveness, we hope to improve the uptake of the program within the existing community-based structures, and reduce the research-to-practice gap.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial.
Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the 'culture' of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health. ⋯ SCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health.