Clinical trials : journal of the Society for Clinical Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy - study rationale and design.
Surgery is of increasing importance in the treatment and outcome of diseases of the pancreas worldwide. The incidence of pancreatic cancer (7-11/ 100,000 per year) has risen over the last years and surgical resection remains the only option for definite cure. Twenty-five percent of all resections are left of the superior mesenteric vein (distal pancreatectomy) and the appropriate closure technique for the pancreatic remnant remains unclear. Pancreatic fistulas are the most common (0-40%) and relevant postoperative complication. The optimal surgical strategy for pancreatic resection needs to be identified from the large number of surgical procedures available today. ⋯ A group-sequential study design accounts for the uncertainty of pre-existing evidence. Also, standardization of surgical and postoperative care and blinded outcome assessment as well as adjustment for varying surgical expertise will contribute to a high validity and generalizability of the results.
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Randomized Controlled Trial Multicenter Study
A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial.
Since the late 1960s, coronary artery bypass graft (CABG-only) procedures were traditionally performed using a heart-lung machine on an arrested heart (on-pump). Over the past decade, an increasing number CABG-only procedures were performed on a beating heart (off-pump). Advocates of the off-pump approach expect to reduce many of the adverse side effects related to using the heart-lung machine, while advocates for the on-pump procedure raise concerns related to graft patency rates and long-term event-free survival for the off-pump technique. ⋯ The study design presented allows for a balanced and fair assessment of the on-pump and off-pump CABG procedures across a diversity of clinical outcomes and resource use metrics. Its results have the potential to influence clinical cardiac surgical practice in the future.
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Randomized Controlled Trial
Quality assurance questionnaire for professionals fails to improve the quality of informed consent.
The informed consent process for research warrants improvement but approaches designed to enhance informed consent need testing in the context of actual clinical research. ⋯ Despite prior beliefs, a standardized quality assurance tool do not enhance informed consent in actual clinical trials. Future research is needed to rigorously evaluate proposed methods to enhance informed consent prior to widespread introduction.