The risks and benefits of surgery for colorectal cancer in old patients have not been unequivocally defined. The present investigation was carried out in 309 hospitals as a prospective multicenter study. In the period between 1 January 2000 and 31 December 2001, a total of 19,080 patients were recruited for the study; 16,142 (84.6%) patients were younger than 80 years (<80) and 2932 (15.4%) were 80 years and older (> or =80). Significant differences between the age groups were observed for general postoperative complications (22.3% for <80 years; 33.9% for > or =80). Specific postoperative complications were identical in both groups. Overall, significantly elevated morbidity and mortality rates were found with increasing age (morbidity: 33.9% vs. 43.5%; mortality: 2.6% vs. 8.0%). The distribution of tumor stages revealed a significantly higher percentage of locally advanced tumors in the older age group (stage II: 28.0% vs. 34.4%). In contrast, no increase in metastasizing tumors was found in the older age group (stage IV: 17.4% vs. 14.1%). Logistic regression showed that, in concert with a number of other parameters, age is a significant influencing factor on postoperative morbidity and mortality. The increase in postoperative morbidity and mortality rates associated with aging is a result of the increase in general postoperative complications, in particular, pneumonia and cardiovascular complications. Age as such does not represent a contraindication for surgical treatment. The short-term outcome and quality of life are of overriding importance for the geriatric patient.
A single-blind, randomized, five-way cross-over, safety and tolerability trial was conducted to determine whether intravenous (i.v.) dolasetron mesylate at varying single doses induces changes in ECG intervals in healthy volunteers and to compare these changes with a single intravenous dose of ondansetron or placebo. Thirty healthy male volunteers received 1.2, 1.8, and 2.4 mg/kg i.v. dolasetron mesylate, 32 mg i.v. ondansetron, and placebo on 5 separate days. ECGs were recorded at intervals during the 24 h after study drug administration. The changes in ECG intervals observed after dolasetron mesylate or ondansetron were acute, transient, and asymptomatic. Dolasetron mesylate resulted in slight but statistically significant dose-related increases in heart rate (HR) and PR and QRS intervals (between h 0 and 4). A statistically significant increase in QTc interval was detected with both dolasetron mesylate (2.4 mg/kg) and ondansetron. Ondansetron also produced a slight but statistically significant increase in JT interval and a decrease in HR. These changes in ECG intervals were usually observed between h 0 and 4; all parameters returned to baseline within 8 h of treatment. The results demonstrate that both dolasetron mesylate and ondansetron prolong the QTc interval. However, dolasetron mesylate predominantly altered ECG parameters indicative of ventricular depolarization (QRS duration), whereas ondansetron predominantly affected ventricular repolarization as measured by a prolongation in the JT interval. Both dolasetron and ondansetron were well tolerated. The adverse event (AE) rate was 13.3% (4 of 30); all AE were of mild or moderate severity and were distributed across all dose arms.
The systolic time intervals have been measured in 76 normal children, aged 1 month to 15 years, from simultaneous recordings of the electrocardiogram, phonocardiogram and carotid arterial pulse or apexcardiogram (left or right). Four different statistical methods were applied to study the separate influence of heart rate (HR) and age on these intervals. Left ventricular ejection time (LVET) had a highly significant correlation with HR but none with age. Age alone had a slight but significant influence on pre-ejection period (PEP) and isometric contraction time (ICT). Electromechanical systole (Q-II) varied directly with age and inversely with HR. Right and left total mechanical systole (TMS
R
, TMS
L
) and left isometric relaxation time (IRT
L
) were inversely related to HR, while right electromechanical delay varied only with age. Q to first sound interval (Q-I), interval from onset of contraction to first sound on left and right apexcardiogram (Cl
L
, Cl
R
) and left electromechanical delay (EMD
L
) were found to be constant values. PEP/LVET (0.313,
sd
0.05) and TMS
L
/LVET (1.546,
sd
0.128) were not significantly correlated with HR nor age. Regression equations and mean values are presented to permit rapid estimation of predicted normal values in children. The ratios TMS
L
/LVET and PEP/LVET being unaffected by age or HR, are suggested as practical indices of myocardial function in children.
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