A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

INTRODUCTION: Benign prostatic hyperplasia (BPH) is associated with bothersome lower urinary tract symptoms (LUTS) and reduced patient quality of life (QoL). Phosphodiesterase (type) 5 (PDE5) inhibitors such as vardenafil are commonly used for the treatment of erectile dysfunction (ED), but have also been shown to improve the symptoms of BPH. This randomised, double-blind, placebo-controlled study investigated the effects of vardenafil on LUTS and QoL in men with BPH/LUTS, with or without concomitant ED. METHODS: Men aged 45-64 yr with BPH/LUTS and an International Prostate Symptom Score (IPSS) > or =12 were randomised to receive either 10mg vardenafil or placebo twice daily. LUTS were assessed with the use of two primary efficacy parameters, IPSS score and maximum urinary flow rate (Qmax), as well as postvoid residual (PVR) urine volume; ED was measured with the use of the erectile function (EF) domain score of the International Index of Erectile Function (IIEF-EF); and QoL was assessed with the Urolifetrade mark QoL-9 questionnaire. RESULTS: After 8 wk of treatment, there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (-5.9 and -3.6, respectively; p=0.0013). Nominally significant improvements in irritative and obstructive IPSS subscores (p=0.0017 and p=0.0081, respectively), EF (p=0.0001), and Urolife QoL-9 (p<0.0001) were also associated with vardenafil treatment. Qmax and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. Vardenafil was generally well tolerated, with most adverse events considered mild or moderate in severity. CONCLUSIONS: Vardenafil treatment significantly improved LUTS, EF, and QoL in men with BPH/LUTS. Vardenafil may be considered a promising treatment option for men with symptoms secondary to BPH.     

The Prognostic Value of Prothrombin Time in Predicting Survival after Major Trauma: a Prospective Analysis of 1,351 Patients from the German Trauma Registry

Background: Early assessment of the individual trauma load in major trauma patients is difficult. A simple and reliable prognostic factor already available in the emergency room would help the emergency physician to make appropriate therapeutic decisions, e. g., when and how to operate on major fractures. The aim of the study was to evaluate the prognostic value of prothrombin time (PT). Patients and Methods: The German Trauma Registry is a prospective, standardized and anonymous documentation of severely injured patients. 3,814 patients were included in the registry. 1,351 patients with an Injury Severity Score (ISS) h 16 and complete data for specific variables (PT, Trauma Score + Injury Severity Score [TRISS], survival until discharge) were included in the study. The PT was measured on the patient's arrival in the emergeny room. Three different analyses were performed. 1. According to clinical judgment, three groups of patients were compared (PT S 60%, PT 40-59%, PT < 40%). A univariate analysis compared therapeutic interventions and outcome variables between the three groups. 2. A receiver-operator-characteristic (ROC) curve analysis compared the performance of PT with the prognostic standard TRISS. 3. A multivariate logistic regression was performed in order to evaluate PT as an independent prognostic variable. Results: PT values showed a good inverse correlation with the severity of injury and the level of therapeutic interventions. The ROC analysis as well as the regression revealed PT as a significant prognostic factor although it showed a slightly worse performance compared to TRISS. Conclusions: As PT, in contrast to TRISS, is readily available already in the emergency room, it can be used as a screening variable for the assessment of a patient's trauma load and thereby help in the decision-making for further operative treatment of major trauma patients.     

The diagnostic value of multimodal intraoperative monitoring (MIOM) during spine surgery: a prospective study of 1,017 patients

A prospective study of 1,017 patients who received MIOM during spine surgery procedures between March 2000 and December 2005. To determine the sensitivity and specificity of MIOM techniques used to monitor spinal cord and nerve roots function during spine surgery. MIOM has become a widely used method of monitoring neural function during spine surgery. Several techniques only monitor either ascending or descending pathways and thus may not provide sensitive or specific results. MIOM aims to monitor both ascending and descending pathways therefore giving immediate feedback information regarding any neurological deficits during the operation. Intraoperative sensory spinal and cortical evoked potentials, combined with monitoring of EMG and motor evoked potentials recorded from the spinal cord and muscles elicited by electrical motor cortex, spinal cord, cauda equina and nerve root stimulation, was evaluated and compared with post-operative clinical neurological changes. One thousand and seventeen consecutive patients underwent a total of 4,731 h of MIOM to evaluate any neural deficits that may have occurred during spine surgery. Of these, 935 were true negative cases, 8 were false negative cases, 66 were true positive cases and 8 were false positive cases, resulting in a sensitivity of 89% and a specificity of 99%. Based on the results of this study, MIOM is an effective method of monitoring the spinal cord functional integrity during spine surgery and therefore can lead to reduction of neurological deficit and consequently improve postoperative results.

     

Severe pyomyositis caused by Panton–Valentine leucocidin-positive methicillin-sensitive <Emphasis Type="Italic">Staphylococcus aureus</Emphasis> complicating a pilonidal cyst

Background To our best knowledge, Panton–Valentine leucocidin (PVL)-positive methicillin-sensitive Staphylococcus aureus (MSSA) has not been described yet as cause for severe pyomyositis. Case report We present a 23-year-old apparently healthy male patient without any typical predisposing findings who developed severe pyomyositis secondary to an operated pilonidal cyst. In the follow-up, the patient showed signs of immunocompromisation. The causative agent for purulent infection of multiple muscles was a MSSA strain harbouring PVL toxin. Results In the reported case, aggressive antibiotic and surgical treatment with additional application of immunoglobulins has lead to recovery from the disease without relapse. Conclusions PVL-positive S. aureus are associated with skin diseases, multiple abscesses and often complicated by severe sepsis and necrotising pneumonia. Under such circumstances, the mortality rate can reach up to 75%. In addition, the PVL toxin can cause immunocompromisation and might be therefore involved in the aetiology of pyomyositis. Aggressive antibiotic and surgical treatment with additional application of immunoglobulins is recommended for treatment.     

The first two cases of living donor liver transplantation using dual grafts in Europe.

The major limitation in adult-to-adult living donor liver transplantation (LDLT) is an adequate graft size with special regard to the safety of the donor. Only 20% of the evaluated donors are suitable to donate the right liver, depending mainly on the critical remnant liver volume. We report 2 cases of adult-to-adult LDLT using dual grafts. In the first case we implanted a left lateral lobe together with a left lobe; in the second case we used a left lateral and a right lobe. Dual graft LDLT solves the problem of graft-size insufficiency and avoids critical right lobectomy in the donor. This procedure can be safely performed and opens up the possibility of LDLT to even more families in the Western world.     

Prevalence and predictors of epoetin hyporesponsiveness in chronic kidney disease patients.

BACKGROUND: The required erythropoiesis-stimulating agent (ESA) dose varies when correcting anaemia in chronic kidney disease (CKD) patients. This analysis was performed to identify the prevalence of and factors associated with ESA hyporesponsiveness. METHODS: This analysis was a post hoc evaluation of epoetin alfa dosage requirements in a subgroup of patients from the Effect of early Correction of Anemia on the Progression of CKD study. The patients in this subgroup were randomly assigned to the high haemoglobin target group (14-15 g/dl for men and 13-14 g/dl for women) and completed a 4-month haemoglobin stabilization phase with complete epoetin dosage data. The relationship of demographics, disease characteristics and laboratory measures with epoetin dosage were evaluated using Pearson's correlation, association measures and analysis of covariance (ANCOVA) models. RESULTS: Of the 93 patients evaluated in this subgroup analysis, 14 (15%) were hyporesponsive to epoetin (maximum dosage >100 IU/kg/week during stabilization). An ANCOVA analysis showed that 52% of the observed variability in epoetin dosage at completion of the stabilization phase could be accounted for by diabetes as the primary cause of kidney disease, angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) use, proteinuria, transferrin saturation, age, pre-treatment haemoglobin, geographical region, serum iron and body mass index (BMI). Unidentified patient characteristics accounted for an additional 16% of the dosage variance. CONCLUSIONS: Older age, higher BMI, anaemia, ACE inhibitor/ARB use and diabetes as the primary cause of kidney disease are associated with increased epoetin requirements when normalizing haemoglobin in anaemic CKD patients.     

Liver transplantation for acute liver failure: are there thresholds not to be crossed?

Factors predicting survival after liver transplantation (LT) for irreversible acute liver failure (ALF) are rare. The aim of this study was to identify prognostic preoperative factors of patients with ALF that predict mortality after LT to avoid futile transplantation. From chart review, we identified 57 patients receiving transplants for ALF from 12/2000 to 09/2010. Recipient and donor data were analyzed and correlated with in‐hospital mortality and patient survival by univariable/multivariable logistic regression and Cox proportional hazards. The survival rates at 30 days and 12 months were 77.2% and 64.9%, respectively. The in‐hospital mortality rate was 29.8%. Follow‐up of patients discharged from the hospital alive showed 30‐day and 12‐month survivals of 100% and 92.5%, respectively. Multivariable analysis of factors known preoperatively showed that the lowest pH of the recipient before LT (P = 0.03) was independently associated with in‐hospital mortality, and the recipient's BMI (P = 0.03) and the lowest pH before LT (P = 0.03) were independently associated with patient survival. A pH of 7.26 was the calculated cutoff (ROC) for increased in‐hospital mortality. Donor factors did not affect patient survival. Patients with ALF and a pH ≤ 7.26 have the worst outcome after liver transplantation. Therefore, emergency liver transplantation should be critically discussed for each individual.     

Treatment for displaced proximal humerus fractures: comparison of interlocking plate fixation versus minimal invasive techniques

Background and purpose

The functional results and the complications following interlocking plate fixation of displaced proximal humerus fractures should be evaluated and compared with those following minimal invasive fixation techniques.

Patients and methods

Fifty patients (30 women, 20 men, mean age 62.7 (18–91) years) were treated for a displaced proximal humerus fracture using an interlocking plate fixation (PHILOS^®) between 2003 and 2004. The mean follow-up time was 12 (9–36) months. Functional and radiographic results (Constant-Murley and Neer scores) were analyzed and compared with an equivalent historical control group of 53 patients operated for the same fracture types using minimal invasive techniques (K-wires and/or cannulated screws) between 1995 and 1997. According to the OTA/AO classification, there were 15 type A, 18 type B, and 17 type C fractures in the plate fixation group, and 23, 25, and 5 of these types in the control group, respectively.

Results

The mean Neer score was 85.9, the mean Constant-Murley score 84, whereas 82.4 and 75.4 for the control group, respectively. Good and excellent results were seen in 78 %, whereas in 70 % in the control group. The results were dependent upon the fracture’s type, sex, and patient’s age. Complications were seen in 9 patients, whereas in 16 patients in the control group.

Interpretation

Using an interlocking plate, the indication of fixation of displaced proximal humerus fractures had been expanded to type C fractures. The implant failure rate can be reduced. The functional results achieved are better compared with those following minimal invasive techniques.     

Enhanced Recovery Pathway for Urgent Colectomy

Background

Enhanced recovery protocols have been proven to decrease complications and hospital stay following elective colorectal surgery. However, these principles have not yet been reported for urgent surgery procedures. We aimed to assess our initial experience with urgent colectomies performed within an established enhanced recovery pathway.

Methods

In a prospective cohort study, all patients undergoing colonic resection between April 2012 and March 2013 were treated according to a standardized enhanced recovery protocol. Urgent surgeries were compared with the elective procedures with regards to baseline characteristics, compliance with enhanced recovery items, and clinical outcome.

Results

Patients (N = 28) requiring urgent colonic resection were included and compared with patients undergoing elective colectomy (N = 63). Overall compliance with the protocol was 57 % for the urgent compared with 77 % for the elective procedures (p = 0.006). The pre-operative compliance was 64 versus 96 % (p < 0.001), the intra-operative compliance was 77 versus 86 % (p = 0.145), and the post-operative compliance was 49 versus 67 % (p = 0.015), for the urgent and elective resections, respectively. Overall, 18 urgent patients (64 %) and 32 elective patients (51 %) developed postoperative complications (p = 0.261). Median postoperative length of stay was 8 days in the urgent setting compared with 5 days in the elective setting (p = 0.006).

Conclusions

Many of the intra-operative and post-operative enhanced recovery items can also be applied to urgent colectomy, entailing outcomes that approach the results achieved in the elective setting.     

Short- and long-term results of liver transplantation in infants aged less than 6 months

BACKGROUND: Despite major surgical and medical advances, it is still a challenge to perform transplantation in small infants. This study, focusing on short- and long-term outcomes, summarizes our 10-year experience with liver transplantation (LTx) in infants aged less than 6 months. PATIENTS AND METHODS: We analyzed 43 patients aged 6 months or less (range: 12-184 days, median: 136 days) whose median weight at the time of LTx was 5.8 kg (range: 2.8-8.0 kg). The reasons for LTx were biliary atresia (n=27; 62.8%), neonatal hepatitis (n=6; 14%), neonatal cholestasis (n=4; 9.3%), and miscellaneous (n=6; 14%). The patients were followed up for a median time of 3 years and evaluated with respect to graft function, physical, and neurodevelopmental outcome. RESULTS: The patient survival was 90.7% after 1 year and 87.2% after 2 years. The graft survival was 86% after 1 year and 82.1% after 2 years. Twelve patients (27.9%) experienced 15 surgical complications requiring intervention, two of whom demonstrated vascular thrombosis (4.7%). Acute early rejection occurred in 15 patients (34.9%), and chronic rejection occurred in 3 patients (7%); 83.3% of the patients had normal liver function test results at the time of evaluation. Complications such as posttransplant lymphoproliferative disease (4.7%) and persistent arterial hypertension (4.7%) were rarely seen. The physical and neurodevelopmental outcomes were good. CONCLUSIONS: LTx in infants aged less than 6 months provides excellent short- and long-term results. Low weight or young age of infants awaiting LTx should not be exclusion criteria for LTx.