Trials
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Randomized Controlled Trial
RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial.
On-pump cardiac surgery triggers a significant postoperative systemic inflammatory response, sometimes resulting in multiple-organ dysfunction associated with poor clinical outcome. Extracorporeal cytokine elimination with a novel haemoadsorption (HA) device (CytoSorb®) promises to attenuate inflammatory response. This study primarily assesses the efficacy of intraoperative HA during cardiopulmonary bypass (CPB) to reduce the proinflammatory cytokine burden during and after on-pump cardiac surgery, and secondarily, we aim to evaluate effects on postoperative organ dysfunction and outcomes in patients at high risk. ⋯ In this pilot trial we try to assess whether intraoperative HA with CytoSorb® can relevantly reduce postoperative IL-6 levels in patients undergoing on-pump cardiac surgery. Differences in secondary outcome variables between the study groups may give rise to further studies and may lead to a better understanding of the mechanisms of haemoadsorption.
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Randomized Controlled Trial
The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.
To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in the Trendelenburg position. This position results in hemodynamic changes that may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as an alternative to the Trendelenburg position during laparoscopic surgery. The objective of this trial is to study the impact of the use of an intraoperative retractor sponge on the duration of the hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer. ⋯ This study is the first randomized controlled trial to evaluate the effect of sponge-assisted laparoscopic colorectal surgery in comparison with standard Trendelenburg position on hospital stay and peri- and postoperative complications. Results of this study will also be relevant for other surgical procedures in the pelvic region. The present study is the second randomized controlled trial according to the cmRCT design, which is embedded within our colorectal cancer cohort.
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Randomized Controlled Trial Multicenter Study Comparative Study
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial.
Pancreatic cancer is the fourth largest cause of cancer death in the United States and Europe with over 100,000 deaths per year in Europe alone. The overall 5-year survival ranges from 2-7 % and has hardly improved over the last two decades. Approximately 15 % of all patients have resectable disease at diagnosis, and of those, only a subgroup has a resectable tumour at surgical exploration. Data from cohort studies have suggested that outcome can be improved by preoperative radiochemotherapy, but data from well-designed randomized studies are lacking. Our PREOPANC phase III trial aims to test the hypothesis that median overall survival of patients with resectable or borderline resectable pancreatic cancer can be improved with preoperative radiochemotherapy. ⋯ The PREOPANC trial is designed to investigate whether preoperative radiochemotherapy improves overall survival by means of increased (R0) resection rates in patients with resectable or borderline resectable pancreatic cancer.
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Randomized Controlled Trial
Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial.
Blepharospasm and hemifacial spasm are debilitating conditions that significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief, but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed-time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others, if symptoms return before the scheduled follow-up period. ⋯ This trial will assess the effectiveness and cost-effectiveness of a patient-led care model for botulinum toxin therapy. If the new model is shown to be effective in reducing distress and disability in these populations and is found to be acceptable to patients, whilst being cost-effective, this will have significant implications for service organisation across the NHS.
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Randomized Controlled Trial Multicenter Study
A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial.
With the aging of the global population, an increasing number of elderly are diagnosed with advanced non-small cell lung cancer. Although systematic chemotherapy has been one of the primary treatments for advanced non-small cell lung cancer worldwide, the elderly cannot always tolerate standard platinum-based doublet chemotherapy, thus resulting in treatment failure. To reduce toxicity, single-agent chemotherapy is often used to treat the elderly with non-small cell lung cancer; however, this may increase the risk of treatment failure due to an inadequate dose. It has been shown that compound kushen injection in combination with chemotherapy can enhance the efficacy and reduce the toxicity. The aim of this trial is to assess the clinical effectiveness and safety of compound kushen injection in combination with single-agent chemotherapy versus platinum-based doublet chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer. ⋯ Before the trial was designed, compound kushen injection was shown to be effective for lung cancer through basic experiments and clinical trials. This study will determine whether or not the efficacy of compound kushen injection in combination with single-agent chemotherapy is comparable to that of platinum-based doublet chemotherapy, and whether or not the toxicity of compound kushen injection in combination with single-agent chemotherapy is lower than that of platinum-based doublet chemotherapy.