A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

<p>Abstract</p> <p>Background</p> <p>The development of suture hole bleeding at peripheral arterial bypass anastomoses using PTFE graft prostheses is a common problem in peripheral vascular surgery. Traditionally the problem is managed by compression with surgical swabs and reversal heparin or by using several haemostatic device (e.g. different forms of collagen, oxidized cellulose, gelatine sponge, ethylcyanoacrylate glue or fibrin) with various success. Preclinical data suggest that the haemostatic effect of collagen is stronger than that of oxidized cellulose, but no direct clinical comparison of their hemostatic performance has been published so far.</p> <p>Design</p> <p>This randomized, controlled, prospective trial evaluates the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis. 28 patients undergoing an elective peripheral vascular reconstruction due to peripheral vascular disease will be included. Suture hole bleeding occurring at the arterial bypass anastomosis using a PTFE prostheses will be stopped by the application of Lyostypt and/or Surgicel. The proximal anastomoses will be randomized intraoperatively. The patients will be allocated into 4 different treatment groups. Group1 Lyostypt distal/Surgicel proximal; Group 2: Lyostypt proximal/Surgicel distal; Group 3: Surgicel distal and proximal; Group 4: Lyostypt distal and proximal. Primary endpoint of the study is time to haemostasis. Secondary endpoints are the number of intraoperatively used haemostatic devices, postoperative mortality within 30 days as well as the intraoperative efficacy rating of the two devices evaluated by the surgeon. As a safety secondary parameter, the local and general complication occurring till 30 ± 10 days postoperatively will also be analysed. After hospital discharge the investigator will examine the enrolled patients again at 30 days after surgery.</p> <p>Discussion</p> <p>The COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings of arterial bypass anastomoses.</p> <p>Trial registration</p> <p>NCT00837954</p

The contribution of RCTs to quality management and their feasibility in practice

The randomized controlled trial (RCT) is generally accepted as the most reliable method of conducting clinical research. To obtain an unbiased evaluation of the effectiveness of spine surgery, patients should be randomly assigned to either new or standard treatment. The aim of the present article is to provide a short overview of the advantages and challenges of RCTs and to present a summary of the conclusions of the Cochrane Reviews in spine surgery and later published trials in order to evaluate their contribution to quality management and feasibility in practice. From the searches, 130 RCTs were included, 95 from Cochrane Reviews and systematic reviews, and 35 from additional search. No study comparing surgery with sham surgery was identified. The first RCT in spine surgery was published in 1974 and compared debridement and ambulatory treatment in tuberculosis of the spine. The contribution of RCTs in spinal surgery has markedly increased over the last 10 years, which indicates that RCTs are feasible in this field. The results demonstrate missing quality specifications. Despite the number of published trials there is conflicting or limited evidence to support various techniques of instrumentation. The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica. For future trials, authors, referees, and editors are recommended to follow the CONSORT statement. RCTs provide evidence to support clinical opinions before implementation of new techniques, but the individual clinical experience is still important for the doctor who has to face the patient

Trauma of the spine and spinal cord: imaging strategies

Traumatic injuries of the spine and spinal cord are common and potentially devastating lesions. We present a comprehensive overview of the classification of vertebral fractures, based on morphology (e.g., wedge, (bi)concave, or crush fractures) or on the mechanism of injury (flexion-compression, axial compression, flexion-distraction, or rotational fracture-dislocation lesions). The merits and limitations of different imaging techniques are discussed, including plain X-ray films, multi-detector computed tomography (MDCT), and magnetic resonance imaging (MRI) for the detection. There is growing evidence that state-of-the-art imaging techniques provide answers to some of the key questions in the management of patients with spine and spinal cord trauma: is the fracture stable or unstable? Is the fracture recent or old? Is the fracture benign or malignant? In summary, we show that high-quality radiological investigations are essential in the diagnosis and management of patients with spinal trauma

The role of phosphate in kidney disease

The importance of phosphate homeostasis in chronic kidney disease (CKD) has been recognized for decades, but novel insights-which are frequently relevant to everyday clinical practice-continue to emerge. Epidemiological data consistently indicate an association between hyperphosphataemia and poor clinical outcomes. Moreover, compelling evidence suggests direct toxicity of increased phosphate concentrations. Importantly, serum phosphate concentration has a circadian rhythm that must be considered when interpreting patient phosphate levels. Detailed understanding of dietary sources of phosphate, including food additives, can enable phosphate restriction without risking protein malnutrition. Dietary counselling provides an often underestimated opportunity to target the increasing exposure to dietary phosphate of both the general population and patients with CKD. In patients with secondary hyperparathyroidism, bone can be an important source of serum phosphate, and adequate appreciation of this fact should impact treatment. Dietary and pharmotherapeutic interventions are efficacious strategies to lower phosphate intake and serum concentration. However, strong evidence that targeting serum phosphate improves patient outcomes is currently lacking. Future studies are, therefore, required to investigate the effects of modern dietary and pharmacological interventions on clinically meaningful end points