Trials
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Randomized Controlled Trial Comparative Study
Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial.
Excision of the pit of the sinus with phenolisation of the sinus tract and surgical excision are two treatment modalities for patients with sacrococcygeal pilonidal sinus disease. Phenolisation seems to have advantages over local sinus excision as it is performed under local anaesthesia with a relatively small surgical procedure, less postoperative pain, minor risk of surgical site infection (8.7%), and only a few days being unable to perform normal activity (mean of 2.3 days). The disadvantage may be the higher risk of recurrence (13%) and the necessity to perform a second phenolisation in a subgroup of patients. Wide surgical excision of sacrococcygeal pilonidal sinus disease has a recurrence rate of 4 to 11%. The disadvantages, however, are postoperative pain, high risk of surgical site infection, and a longer period being unable to perform normal activity (mean of 10 days). The objective of this study is to show that excision of the pit of the sinus of sacrococcygeal pilonidal sinus disease with phenolisation of the sinus tract is a successful first-time treatment modality for sacrococcygeal pilonidal sinus disease accompanied by a quicker return to normal daily activity compared to local excision of the sinus. ⋯ This study is a randomised controlled trial to provide evidence that phenolisation of the sinus tract compared to radical excision reduces the total number of days unable to perform normal activity.
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Randomized Controlled Trial
Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial.
As people live longer, their risk of disability increases. Disability affects quality of life and increases health and social care costs. Preventing or delaying disability is therefore an important objective, and identifying an effective intervention could improve the lives of many older people. Observational and interventional evidence suggests that physical activity may reduce the risk of age-related disability, as assessed by physical performance measures. However it is unclear what approach is the most cost-effective intervention in changing long-term physical activity behaviour in older adults. A new theory-driven behavioural intervention has been developed, with the aim of increasing physical activity in the everyday lives of older adults at risk of disability. This pilot study tests the feasibility and acceptability of delivering this intervention to older adults. ⋯ The intervention, if effective, has the potential to reduce disability and improve quality of life in older adults. Before proceeding to a full-scale trial a pilot trial is necessary to ensure intervention feasibility and acceptability, and that the intervention shows evidence of promise.
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Randomized Controlled Trial Multicenter Study
Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study.
Enhanced recovery programmes in total knee arthroplasty are well established. Post-operative knee swelling is common and impairs early post-operative function. The use of a short-stretch, inelastic compression bandage is hypothesised to reduce knee swelling and improve pain and early function. A study was designed to test feasibility with a view to informing a larger, future trial and to provide preliminary data. ⋯ Enhanced recovery programmes have revolutionized the management of total knee arthroplasty. There is a paucity of clinical data regarding the efficacy of compression bandages. Large, randomised controlled trials are uncommon in orthopaedic surgery. The results of this study will provide feasibility and preliminary data prior to the construction of a larger, multicentre study.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparing different dosing regimens of bevacizumab in the treatment of neovascular macular degeneration: study protocol for a randomised controlled trial.
Bevacizumab (Avastin®) is as effective as ranibizumab (Lucentis®) in the treatment of neovascular age-related macular degeneration (nAMD). However it has two important structural differences. First, it has two active sites instead of one; second, it retains the Fc portion of the antibody which would be expected to confer a significantly longer half-life. These agents have been associated with systemic complications including strokes, so it is desirable to use the smallest effective dose. Furthermore, the standard dosing regimen requires monthly hospital visits, which present a significant challenge both to the hospital services and to the patients (who are elderly). ⋯ This randomised control trial will show if half dose and two monthly as required is as effective as full dose and monthly regimes. A two monthly as required regimen of Bevacizumab would significantly reduce both the cost and the service delivery burden for the treatment of nAMD while a reduced dose would be expected to enhance the safety profile of this treatment regime.
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Randomized Controlled Trial Comparative Study
Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial.
Laparoscopic liver resection is used in specialized centers all over the world. However, laparoscopic liver resection has never been compared with open liver resection in a prospective, randomized trial. ⋯ After 35 months of recruitment, 200 patients have been included in the trial. Molecular and immunology data are being analyzed. Results for primary and secondary outcome measures will be presented following the conclusion of the study (late 2015). The Oslo-CoMet Study will provide the first level 1 evidence on the benefits of laparoscopic liver resection for colorectal liver metastases.