Quality assurance in bariatric surgery in Germany--results of the German multicentre trial 2005 and 2006

BACKGROUND: Since January 1st 2005, the situation of bariatric surgery in Germany has been examined. The data are registered in cooperation with the Institute of Quality Assurance in Surgery at the Otto-von-Guericke-University Magdeburg. METHODS: The data registration took place prospectively in an internet online data base. All primary bariatric procedures performed since January 1st 2005 were detected as well as re-operations in patients who had been operated before. RESULTS: 629 patients underwent bariatric surgery in 21 hospitals in 2005 and 828 patients were operated in 32 hospitals in 2006. The mostly performed operation was gastric banding with 46.8 %, followed by Roux-Y gastric bypass with 38.5 %. 74.4 % of the patients were female. The medium BMI of all patients was 48.5 kg/m2 in 2005 and 48.4 kg/m2 in 2006. Follow-up data were available for 71.2 % of the patients operated in 2005. These data show a higher reduction of BMI after malabsorptive than after restrictive bariatric procedures. CONCLUSION: A trend from restrictive bariatric procedures to a malabsorptive approach could be observed. In Germany the BMI of patients undergoing bariatric surgery is higher than in most countries world-wide. No differences could be detected in intraoperative and short-term complications as well in the complication rate in the first year of follow-up in comparison with the literature.     

Surgical therapy for malignant pleural effusions

Symptomatic malignant pleural effusions are common in patients with neoplastic disease (50 %). Frequently, they are a sign of advanced disease. These patients have an average life expectancy of 3 to 12 months. The therapeutic aim should be an efficient treatment with a short hospital stay. Chest tube drainage gives rapid relief of symptoms and information on the expansion of the lungs. When complete expansion of the lung is possible, VATS insufflation of talc is recommended. Talc is the most effective sclerosant (80 %) followed by doxycycline (70 %). VATS pleurodesis has a higher complication rate but is more effective than a talc slurry instilled through the chest tube. When the lung is trapped, long-term indwelling pleural drainage and pleuroperitoneal shunts are alternatives.     

Population Pharmacokinetics of Risperidone and 9-Hydroxyrisperidone in Patients with Acute Episodes Associated with Bipolar I Disorder

A population model was developed with the aim to simultaneously describe risperidone and 9-hydroxyrisperidone pharmacokinetics; to obtain estimates for pharmacokinetic parameters and associated inter- and intra-individual variability of risperidone and 9-hydroxyrisperidone; and to evaluate the influence of patient demographic characteristics and other factors on risperidone, 9-hydroxyrisperidone, and active moiety pharmacokinetics. Data were obtained from 407 patients enrolled in four Phase 1 (serial blood sampling) and three Phase 3 trials (sparse sampling), representing dosage regimens ranging from 4 mg single dose to flexible 1–6 mg once daily. A pharmacokinetic model with two-compartment submodels for risperidone and 9-hydroxyrisperidone disposition and a sequential zero- and first-order absorption pathway was selected based on prior knowledge. A mixture model was incorporated due to CYP2D6 polymorphism of risperidone conversion to 9-hydroxyrisperidone. Patient characteristics tested as potential covariates were: age, sex, race, body weight, lean body mass, body mass index, creatinine clearance, liver function laboratory parameters, study, and carbamazepine comedication. The quasi-clearance of active moiety (the sum of risperidone and 9-hydroxyrisperidone) was simulated and linear regression performed to identify significant covariates. The selected pharmacokinetic model described the plasma concentration-time profiles for risperidone and 9-hydroxyrisperidone quite well and was able to determine each patient’s phenotype. Covariates significantly affecting the pharmacokinetics were carbamazepine comedication, and study because the proportion of patients assigned to the intermediate metabolizer status decreased from single to multiple dosing while the proportion assigned to extensive metabolizer status increased. Covariates with limited and clinically irrelevant effects on active moiety concentrations were patient phenotype, race, and total protein. Carbamazepine also decreased active moiety concentrations.     

Isolation, structure, and coccidiostat activity of coccidiostatin A

Coccidiosis is one of the more common and costly diseases in poultry that is caused by various Eimeria species. In our quest to discover coccidiostats from natural products, we discovered a microbial fermentation extract that exhibited in vivo anticoccidial activity. Fractionation of this extract led to the discovery of two potent antiprotozoals, emecorrugatin A (1) and coccidiostatin A (2). The former compound exhibited only in vitro activity, whereas the latter new compound exhibited in vivo activity against Eimeria species in chickens at 150 ppm dosed in chicken feed. The isolation, structure elucidation, relative configuration, and activity of coccidiostatin A (2) are described.     

Efficacy of gene therapy-delivered cytosine deaminase is determined by enzymatic activity but not expression

The potential utility of tumour-selective 5-fluorouracil treatment using attenuated Salmonella serovar typhimurium recombinant for cytosine deaminase (TAPET-CD) has been documented in experimental settings. The present data demonstrate that in vivo (19)F-magnetic resonance spectroscopy measurements allow the outcome prediction of this prokaryotic-based therapy, demonstrating the necessity of non-invasive real-time imaging techniques for treatment monitoring.     

The Vascular Join: a new sutureless anastomotic device to perform end-to-end anastomosis. Preliminary results in an animal model

Standard vascular techniques don't meet new surgeons' needs for the more complex vascular reconstructions, minimal invasive approaches and robotic surgery. Therefore, alternative ways to perform vascular anastomosis are always welcome. We present a new sutureless vascular connector and the first animal study. The Vascular Join consists of two metallic rings fixed to the extremity of two conduits being joined together, connected with a snap-on system. The key element that makes this device different from all other sutureless devices is that there is no foreign material inside the vessel lumen. In 10 adult sheep, both carotid arteries were prepared and severed after heparinisation. Twenty end-to-end vascular anastomoses were performed and controlled with intravascular ultrasound and colour-Doppler. Animals were sacrificed and a histopathological analysis was carried out. All anastomoses were successfully completed without bleedings, stenosis or occlusions. The histological results confirmed the perfect vessel edges apposition and absence of foreign material in the vessel lumen. The intimal layer was intact. Vascular Join can easily perform sutureless end-to-end anastomoses and it can be used either with biological or prosthetic materials. Further animal studies are underway to assess the long-term results. Following the same technical criteria, we are developing an end-to-side anastomotic device.     

Cost of dialysis in France

The provision of care for patients with end-stage chronic renal failure is an important medical and economic challenge for the Health Insurance. Previous studies have shown a lower cost for home dialysis. More recently, studies have confirmed identical short-term survival rates between haemodialysis and peritoneal dialysis. Notwithstanding, home dialysis techniques utilization remains weak in France. This work aims at: determining the average annual cost of dialysis, per patient and per technique of dialysis, and assessing the global annual cost of dialysis in France, from the Health Insurance perspective. Methodologically, this article provides a static estimation of the cost of dialysis. Costs related to co-morbidities of end-stage chronic renal failure have not been considered. Standard patient care schemes have been outlined by a multidisciplinary expert committee, for each dialysis technique, and have been valorised using publicly available data and tariffs recorded in 2005. Our result show that home dialysis techniques are the less costly, with an average annual cost per patient of 49.9, 49.7 and 50.0 k euro respectively for home haemodialysis, automated peritoneal dialysis, and continuous ambulatory peritoneal dialysis. Autodialysis, autonomous in-center haemodialysis and in-center haemodialysis respectively cost 59.5, 62.3 and 81.5 k euro per patient and per annum. The total 2005 cost of dialysis for the Health Insurance is estimated at 2.1 billion euro. Therefore, the development of alternative techniques to in-center haemodialysis, such as home dialysis or autonomous in-center haemodialysis, autodialysis being already well developed, could generate savings for the Health Insurance. From the patient's perspective, it could also allow the enlightened choice of the best customized technique, less guided by local offer than by medical or social criteria, as well as by the patient's own opinion.