New generation cut-and-seal devices in oral and oropharyngeal cancer resection: clinical and cost-effectiveness study.

OBJECTIVES: To evaluate the clinical efficacy and cost-effectiveness of ultrasonic shears and the electrothermal bipolar vessel sealing system, in comparison to the traditional cold knife and bipolar forceps, in oral and oropharyngeal cancer surgery. METHODS: Patients who underwent oral or oropharyngeal cancer resection and neck dissection with either ultrasonic shears (n = 36) or electrothermal bipolar vessel sealing (n = 32) were enrolled. Surgical time, intra-operative bleeding, blood drainage, post-operative pain, neck oedema, complications and hospitalisation duration were compared to those of an historical cohort of 36 patients treated using a cold knife and bipolar forceps. Additionally, a cost-effectiveness evaluation was performed. RESULTS: Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, were advantageous compared to the traditional techniques. The cost of ultrasonic shears and electrothermal bipolar vessel sealing was completely offset by declining time-driven costs for the surgical team and operating theatre. CONCLUSION: Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, are more advantageous compared to the traditional techniques, from both a clinical and economic point of view.

Informed consent in high-risk renal transplant recipients.

Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words--informed and consent--are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

Health effects assessment for environmental perchlorate contamination: the dose response for inhibition of thyroidal radioiodine uptake in humans.

Application of a sensitive new detection method has revealed widespread perchlorate contamination of groundwater in the southwestern United States, typically at 0.005-0.020 mg/L (5-20 ppb). Perchlorate is a competitive inhibitor of the process by which iodide is actively transported from the bloodstream into the thyroid. This inhibitory action of perchlorate is the basis of its pharmaceutical use (in the treatment of hyperthyroidism) as well as its potential toxicity. To establish the dose response in humans for perchlorate inhibition of thyroidal iodide uptake and any short-term effects on thyroid hormones, we gave perchlorate in drinking water at 0.007, 0.02, 0.1, or 0.5 mg/kg-day to 37 male and female volunteers for 14 days. In 24 subjects we performed 8- and 24-hr measurements of thyroidal (123)I uptake (RAIU) before exposure, on exposure days 2 (E2) and 14 (E14), and 15 days postexposure (P15). In another 13 subjects we omitted both E2 studies and the 8-hr P15 study. We observed a strong correlation between the 8- and 24-hr RAIU over all dose groups and measurement days. We found no difference between E2 and E14 in the inhibition of RAIU produced by a given perchlorate dose. We also found no sex difference. On both E2 and E14, the dose response was a negative linear function of the logarithm of dose. Based on the dose response for inhibition of the 8- and 24-hr RAIU on E14 in all subjects, we derived estimates of the true no-effect level: 5.2 and 6.4 micro g/kg-day, respectively. Given default body weight and exposure assumptions, these doses would be ingested by an adult if the drinking-water supply contained perchlorate at concentrations of approximately 180 and 220 micro g/L (ppb), respectively. On P15, RAIU was not significantly different from baseline. In 24 subjects we measured serum levels of thyroxine (total and free), triiodothyronine, and thyrotropin in blood sampled 16 times throughout the study. Only the 0.5 mg/kg-day dose group showed any effect on serum hormones: a slight downward trend in thyrotropin levels in morning blood draws during perchlorate exposure, with recovery by P15.

An ecological risk assessment for spinosad use on cotton.

Spinosad is a reduced-risk insecticide with a novel mode of action that provides an alternative to older classes of insecticides such as organophosphates, carbamates and pyrethroids. A comprehensive ecological risk assessment for spinosad use in US cotton crops is presented within a framework of tiered levels of refinement following the guidelines of the US EPA for ecological risk assessments. Toxicity information for a variety of species is documented and utilized, environmental concentrations estimated, and risk characterizations in the form of risk quotients are quantified. Results indicate that spinosad use in cotton does not exceed the most conservative Tier I levels of concern (LOC) values for groundwater, mammals and birds or acute risk to aquatic organisms. Use of very conservative Tier I screening methods resulted in exceeding LOC values for chronic exposure for some aquatic organisms, thus prompting further refinement. When the exposure prediction was refined using less conservative, Tier II mechanistic environmental fate transport models to predict offsite transport and environmental concentrations, chronic risk was not predicted for these species. Spinosad is acutely toxic to bees under laboratory conditions, but toxicity of residue studies and field studies indicate that under actual use conditions the impact on bees is minimal.

Reduction in gram-positive pneumonia and antibiotic consumption following the use of a SDD protocol including nasal and oral mupirocin.

The objective of this prospective, randomized, double-blind study was to evaluate the effect of the addition of mupirocin to the 'classical' topical SDD regimen (tobramycin 80 mg, polymyxin E 100 mg, amphotericin B 500 mg) on the development of ICU-acquired infections due to gram-positive bacteria. The study was carried out in an intensive care unit (ICU) of a 1400-bed community hospital. All patients admitted to the ICU during a 16-month period, who were expected to require mechanical ventilation for more than 24 hours, were randomized to receive either the 'classical' SDD regimen (Group A) or a modified regimen with mupirocin (Group B). Data from 223 patients requiring mechanical ventilation for at least 48 hours, who were neither infected nor receiving antibiotics on ICU admission, was analysed. A 2% paste containing tobramycin, polymyxin E and amphotericin B was applied every 6 hours in the oropharynx to the patients in Group A, while in Group B this formula was modified with the addition of 2% mupirocin. In Group B 0.2 ml of a 2% mupirocin ointment was also applied four times daily in both nostrils. Patients in Group A received a soft paraffin ointment as a placebo indistinguishable from mupirocin. Patients in both groups received the classic SDD regimen through the nasogastric tube. Systemic antibiotic prophylaxis was not used. Data on lower airway infection, and blood infection, infections of intravascular catheters, antibiotic consumption and expenditures for antibiotics were analysed. The diagnosis of ventilator-associated pneumonia (VAP) was based on quantitative cultures of protected specimen brush samples (PSB) or on the results of distal broncho-alveolar lavage (BAL). One hundred and four patients received the 'classical' SDD and 119 the modified regimen. Overall 29 patients, 20 in Group A and nine in Group B (p < 0.02) had a total of 33 cases of pneumonia. There were 23 episodes of pneumonia in Group A and 10 in Group B (p < 0.02). Gram-positive bacteria were isolated from samples in 17 episodes in Group A and six in Group B (p < 0.02). Staphylococcus aureus was isolated in nine cases of pneumonia in Group A and once in the 'mupirocin' group (p < 0.05). MRSA were isolated in seven out of nine cases in Group A and in the only case in Group B. There were no differences in the isolation of gram-negative bacilli. Antibiotic consumption and cost were lower in Group B. In conclusion, our data show that the topical use of a modified formula of SDD, with the addition of mupirocin to the oral paste and in the anterior nares, is associated with a reduction in lung infections caused by gram-positives and in a reduction in antibiotic consumption and in the overall expenditure for antibiotics.

[The clinico-instrumental assessment of the vascular status of the uremic patient for the making of a vascular access for hemodialysis]. / Valutazione clinico-strumentale del patrimonio vascolare del paziente uremico per la confezione di accesso vascolare per emodialisi.

For almost twenty years the Institute of General Surgery and Organ Transplant at Palermo Polyclinic has dealt with vascular problems arising during the preparation, monitoring and search for vascular access in uremic patients. For a number of years advantage has been taken of the vascular status in uremic patients; in fact, the possibility of creating a long-lasting and efficient vascular access also depends on the optimal use of the patient's vascular resources. The authors briefly describe the clinical and instrumental diagnostic strategy for the approach to a vascular access in uremic patients which must be correct and must respect the vascular resources of a "chronic" patient by definition, for whom hemodialysis is often the only prospect of therapy.

Calibration of the delayed-gamma neutron activation facility.

The delayed-gamma neutron activation facility at Brookhaven National Laboratory was originally calibrated using an anthropomorphic hollow phantom filled with solutions containing predetermined amounts of Ca. However, 99% of the total Ca in the human body is not homogeneously distributed but contained within the skeleton. Recently, an artificial skeleton was designed, constructed, and placed in a bottle phantom to better represent the Ca distribution in the human body. Neutron activation measurements of an anthropomorphic and a bottle (with no skeleton) phantom demonstrate that the difference in size and shape between the two phantoms changes the total body calcium results by less than 1%. To test the artificial skeleton, two small polyethylene jerry-can phantoms were made, one with a femur from a cadaver and one with an artificial bone in exactly the same geometry. The femur was ashed following the neutron activation measurements for chemical analysis of Ca. Results indicate that the artificial bone closely simulates the real bone in neutron activation analysis and provides accurate calibration for Ca measurements. Therefore, the calibration of the delayed-gamma neutron activation system is now based on the new bottle phantom containing an artificial skeleton. This change has improved the accuracy of measurement for total body calcium. Also, the simple geometry of this phantom and the artificial skeleton allows us to simulate the neutron activation process using a Monte Carlo code, which enables us to calibrate the system for human subjects larger and smaller than the phantoms used as standards.

[The thermodilution determination of right ventricular volumes and ejection fraction in the critical patient. Volumetric vs pressure measurement assessment]. / Determinazione mediante termodiluizione dei volumi e della frazione di eiezione del ventricolo destro nel paziente critico. Valutazione volumetrica vs pressumetrica.

The widespread use of hemodynamic investigation techniques, allowed a better understanding of the right ventricle (RV) pathophysiology and led to progressive reevaluation of its role. A modification of the classical Swan-Ganz catheter, made possible the measurement of the ejection fraction (EF) and of the end-systolic and end-diastolic volumes of RV just by the simple application of the thermodilution technique. In this paper, we first refreshed the basic theoretical principles of the technique and then presented our preliminary results of one-year experience in ICU. A non-homogeneous group of 36 critically ill patients (septic shock 17, COPD 13 and ARDS 6) was studied. Specifically we found that neither the data of central venous pressure nor those of RV end diastolic pressure, were able to estimate the real preload, i.e. RV end diastolic volume (r = 0.01 and r = 0.03 respectively with "p" not significant). We compared the data of RV EF with that of the end systolic pressure/volume (P/V) ratio in a group of patients before and during the administration of dobutamine to evaluate their sensitivity to identify changes of contractility. The results obtained support the superiority of RV end systolic P/V ratio over RV EF to detect variations of contractile status. We conclude that the use of the thermodilution technique to measure the volumes of RV, allows a real evaluation of the preload. At the same time it avoids all the problems associated with the measurement of transmural pressure and with the changes produced by shifting of intrapleural pressure. Finally the end systolic volume may be combined with the pressure data to estimate the contractile status and, in our experience, this parameter has proved more sensitive than EF in order to detect changes of contractility of the right ventricle.