To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial.

BACKGROUND: Major adverse cardiac events (MACEs) are a common cause of death after non-cardiac surgery. Despite evidence for the benefit of aspirin for secondary prevention, it is often discontinued in the perioperative period due to the risk of bleeding. METHODS: We conducted a randomized, double-blind, placebo-controlled trial in order to compare the effect of low-dose aspirin with that of placebo on myocardial damage, cardiovascular, and bleeding complications in high-risk patients undergoing non-cardiac surgery. Aspirin (75 mg) or placebo was given 7 days before surgery and continued until the third postoperative day. Patients were followed up for 30 days after surgery. RESULTS: A total of 220 patients were enrolled, 109 patients received aspirin and 111 received placebo. Four patients (3.7%) in the aspirin group and 10 patients (9.0%) in the placebo group had elevated troponin T levels in the postoperative period (P=0.10). Twelve patients (5.4%) had an MACE during the first 30 postoperative days. Two of these patients (1.8%) were in the aspirin group and 10 patients (9.0%) were in the placebo group (P=0.02). Treatment with aspirin resulted in a 7.2% absolute risk reduction [95% confidence interval (CI), 1.3-13%] for postoperative MACE. The relative risk reduction was 80% (95% CI, 9.2-95%). Numbers needed to treat were 14 (95% CI, 7.6-78). No significant differences in bleeding complications were seen between the two groups. CONCLUSIONS: In high-risk patients undergoing non-cardiac surgery, perioperative aspirin reduced the risk of MACE without increasing bleeding complications. However, the study was not powered to evaluate bleeding complications.

Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study.

OBJECTIVE: To analyze outcomes after open small-incision surgery (minilaparotomy) and laparoscopic surgery for gallstone disease in general surgical practice. METHODS: This study was a randomized, single-blind, multicenter trial comparing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC). Both elective and acute patients were eligible for inclusion. All surgeons normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure at participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of trial results. The randomization period was from March 1, 1997, to April 30, 1999. RESULTS: Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were randomized to each of the procedures. The groups were well matched for age and sex, but there were fewer acute operations in the LC group than the MC group. In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operating times were 100 and 85 minutes for LC and MC, respectively. Median hospital stay was 2 days in each group, but in a nonparametric test it was significantly shorter after LC. Median sick leave and time for return to normal recreational activities were shorter after LC than MC. Intraoperative complications were less frequent in the MC group, but there was no difference in the postoperative complication rate between the groups. There was one serious bile duct injury in each group, but no deaths. CONCLUSIONS: Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy.

Expression profiling across many samples via manifold-assisted mRNA processing.

Analysis of mRNA provides a condensed view of gene structure, and quantitative analyses can reveal induction of physiological or pathological gene expression programs. One of the main hurdles for routine mRNA analyses is the need to prepare large sets of samples in a rapid and standardized manner. We describe here a procedure for mRNA isolation and cDNA synthesis using manifold devices, consisting of a set of prongs that project into individual reaction wells. The prongs have a high binding capacity for the polyA-tails of mRNA and the captured mRNA is directly used to synthesize cDNA on the supports, followed by amplification. The convenience and reproducibility of the procedure allows profiling of gene expression over time, by comparing many different samples. Using the device mRNA was simultaneously isolated and accurately measured from up to 96 different samples of anywhere between 10 and 200 000 cells. The amounts of a leukemia-specific transcript could be measured when the malignant cells represented

Closed vs. open hemorrhoidectomy--is there any difference?

PURPOSE: The aim of this study was to compare closed (Ferguson) hemorrhoidectomy to open (Milligan-Morgan) hemorrhoidectomy regarding postoperative conditions, complications, and long-term results. METHOD: This was a randomized study of 77 patients with second-degree or third-degree hemorrhoids suitable for hemorrhoidectomy. In 39 patients the Milligan-Morgan procedure was used, and in 38 patients the Ferguson procedure was used. Details of operations, postoperative complications, and length of postoperative stay were recorded. Pain was assessed from a visual analog scale and by registration of postoperative analgesic medication. Follow-up was done at three weeks, six weeks, and by visit or telephone interview after at least a year. RESULTS: No statistically significant differences were found between the two methods regarding complications, pain, or postoperative stay. There were four reoperations for bleeding, all after Milligan-Morgan operations. At follow-up after three weeks 86 percent of the Ferguson patients had completely healed wounds, and none had signs of infection. Of the Milligan-Morgan patients, only 18 percent had completely healed wounds, and symptoms of delayed wound healing were significantly more frequent. One patient had a superficial wound infection. After one year more than 10 percent in each group had recurrent hemorrhoids with symptoms. CONCLUSION: Both methods are fairly efficient treatment for hemorrhoids, without serious drawbacks. The closed method has no advantage in postoperative pain reduction, but wounds heal faster, and the risk of wound dehiscence seems exaggerated.

Function of rat pancreatic islets exposed to interleukin-18 in vitro.

The recently cloned cytokine interleukin-18 (IL-18) has been shown to promote a Th1-cell immune response, which may be a prerequisite for development of Type 1 diabetes. In this study we examined the effects of IL-18 on the function of isolated rat pancreatic islets. The islets were cultured in medium RPMI 1640 + 10% fetal calf serum and exposed for 48 h to recombinant human IL-18 (0, 0.1, 1 and 10 nM). In some experiments IL-18 (l0 nM) was combined with interleukin-12 (10 ng/ml), since these cytokines may act synergistically. IL-18 alone, or in combination, with IL-12 did not affect the islet DNA content suggesting absence of cytotoxicity. However, both cytokines induced an increased islet insulin content compared to non-cytokine exposed control islets. A slight increase in the medium insulin accumulation was observed when 1.0 nM IL-18 was added, but not in other experimental groups. Glucose-stimulated insulin release, glucose oxidation and (pro)insulin biosynthesis rates were not affected by the cytokines after culture. In acute experiments IL-18 had a small stimulatory effect on glucose-stimulated insulin secretion. It was also tested if IL-18 (10 nM) could affect IL-1beta (25 U/ml) induced suppression of the glucose oxidation rate, but this was not the case. We conclude that IL-18 has minor stimulatory effects on beta-cell function, and no clear synergistic effect is observed when IL-12 is added together with IL-18. If IL-18 is involved in beta-cell destruction in Type 1 diabetes, it is likely that this effect is secondary to an influence on the action of other cytokines.

Quality through metrics.

The Quality Assurance Unit analyzed 18 months of departmental data regarding the report-audit cycle. Process mapping was utilized to identify milestones in the cycle for measurement. Five milestones were identified in the audit cycle, as follows: (1) time from report receipt in quality assurance to start of audit, (2) total calendar days to audit a report, (3) actual person-hours to perform a report audit, (4) time from completion of audit to issuance of report, and (5) total time a report is in quality assurance. An interrelationship diagraph is a quality tool that is used to identify what activities impact the overall report-auditing process. Once the data collection procedure is defined, a spreadsheet is constructed that captures the data. The resulting information is presented in time charts and bar graphs to visually aid in interpretation and analysis. Using these quality tools and statistical analyses, the Quality Assurance Unit identified areas needing improvement and confirmed or dispelled previous assumptions regarding the report-auditing process. By mapping, measuring, analyzing, and displaying the data, the overall process was examined critically. This resulted in the identification of areas needing improvement and a greater understanding of the report-audit cycle. A further benefit from our increased knowledge was the ability to explain our findings objectively to our client groups. This sharing of information gave impetus to our clients to examine their report-generation process and to make improvements.

Anticoagulant vs anti-platelet therapy as prophylactic against cerebral infarction in transient ischemic attacks.

156 patients with transient ischemic attacks (TIA) or reversible ischemic neurological deficit (RIND) were given prophylactic anticoagulant (AC) treatment against cerebral infarction in a prospective multicenter study from 5 hospitals in southern Sweden. After 2 months of AC treatment, 135 patients remained in the study and were randomized into 2 groups; one continued with AC treatment and one changed to anti-platelet therapy. The patients were followed for 12 months. No significant difference was seen between the 2 groups but 3 completed cerebral infarctions occurred during anti-platelet therapy against one during AC treatment. One cerebral hemorrhage was seen during AC treatment. All completed strokes occurred in men who initially had carotid symptoms. The number of patients with TIA/RIND was somewhat higher in the anti-platelet group whereas myocardial infarctions occurred more often during AC treatment. Compared to the natural history of untreated TIA/RIND both treatments were found to have a prophylactic effect against cerebral infarction.