Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study.

BACKGROUND: Postoperative ileus after colorectal surgery is a frequent problem that significantly prolongs hospital stay and increases perioperative costs. OBJECTIVE: The aim was to evaluate the effect of standardized coffee intake on postoperative bowel movement after elective laparoscopic colorectal resection. DESIGN: This is a prospective randomized controlled trial that was conducted between September 2014 and December 2016. SETTINGS: This study was performed in a public cantonal hospital in Switzerland with accreditation for colon and rectum cancer surgery. PATIENTS: Patients who underwent elective colorectal surgery were included. INTERVENTIONS: Patients were randomly assigned either to the intervention group receiving coffee or the control group receiving tea. A total of 150 mL of the respective beverage was drunk 3 times per day every postoperative day until discharge. MAIN OUTCOME MEASURES: The primary end point was time to first bowel movement. Secondary end points included the use of laxative, insertion of a nasogastric tube, length of hospital stay, and postoperative complications. RESULTS: A total of 115 patients were randomly assigned: 56 were allocated to the coffee group and 59 to the tea group. After coffee intake, the first bowel movement occurred after a median of 65.2 hours versus 74.1 hours in the control group (intention-to-treat analysis; p = 0.008). The HR for earlier first bowel movement after coffee intake was 1.67 (p = 0.009). In the per-protocol analysis, hospital stay was shorter in the coffee group (6 d in the coffee group vs 7 d in the tea group; p = 0.043). LIMITATIONS: The rate of protocol violation, mostly coffee consumption in the tea arm, was relatively high, even if patients were clearly instructed not to consume coffee if they were in the tea arm. CONCLUSIONS: Coffee intake after elective laparoscopic colorectal resection leads to faster recovery of bowel function. Therefore, coffee intake represents a simple and effective strategy to prevent postoperative ileus. See Video Abstract at http://links.lww.com/DCR/A955. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02469441.

Is rivaroxaban associated with higher morbidity and mortality in patients with traumatic head injuries? A retrospective cohort study comparing rivaroxaban, no anticoagulation, and phenprocoumon.

OBJECTIVES: The use of new anticoagulants potentially carries the risk of increased intracranial bleeding, but there is a lack of evidence. The aim of this study was to investigate whether the morbidity and mortality differs in head trauma patients depending on the type of anticoagulation. PATIENTS AND METHODS: A retrospective cohort study was conducted in 2009-2014. Based on sex, age, and Glasgow-Coma Scale (GCS), patients that received rivaroxaban were matched to two control groups, one that received no anticoagulant and another one that received phenprocoumon. The primary outcome was mortality. Among others, secondary outcome variables were the length of stay (LOS) at the hospital and presence of an intracranial injury. RESULTS: Sixty-nine patients (23 patients per group) were analyzed. The characteristics of patients did not differ significantly across groups. There were no significant differences between groups for the primary and secondary outcomes. Two patients died in the rivaroxaban group (one of them likely due to head trauma), while one patient died in the phenprocoumon group (likely not due to head trauma), and no patient died in the no anticoagulatoin group (p = 0.36). The LOS at the hospital was similar (5.0, 4.0, and 5.0 days; p = 0.94). An intracranial injury was observed in a similar number of patients in all groups (n = 11, n = 10, and n = 8; p = 0.75). CONCLUSION: Although limited in size, this study did not observe significant outcome differences in patients with traumatic head injuries, who received rivaroxaban, no anticoagulant or phenprocoumon. Although not significant, the only death likely due to head trauma in the study occurred in the rivaroxaban group. Larger studies are needed before clinical application of these findings.

Diet, medication use and drug intake during pregnancy: data from the consecutive Swiss Health Surveys of 2007 and 2012.

OBJECTIVE: The aim of this work was to gain knowledge on the health status of pregnant women in Switzerland, especially their attitude to and decisions about diet, use of medication and consumption of drugs, including alcohol and tobacco. METHODS: Data collected by the consecutive Swiss Health Surveys of 2007 and 2012 on sociodemographic and lifestyle characteristics (including nutrition), type and intake of medication, use of alcohol, tobacco and illicit drugs of the female population were analysed. To compare pregnant with non-pregnant women, a group of 10 times as many non-pregnant women (reference group, n = 3090) was matched with all the participating women who said they were pregnant at the time of the survey (pregnant group, n = 309). The two groups were then compared. RESULTS: The pregnant and non-pregnant participant groups were comparable with respect to most sociodemographic characteristics and both showed a high awareness of health-related issues. Significantly more pregnant than non-pregnant women revealed a high nutritional awareness, claiming to pay attention to what they ate (78.3 vs 73.0%). Frequent consumption of milk products and fish, and moderate consumption of meat were found more often in the pregnant group. Use of medication was comparable between the two groups, except that pregnant women took pain killers less frequently than did non-pregnant women (30.0 vs 61.5%) and relied more often on prescribed medication. Pregnant women were more restrictive in their alcohol consumption than non-pregnant women. Nevertheless, 10.0 and 1.9% of the pregnant women declared consumption of wine and beer, respectively, in the previous 7 days. Regular smoking was less frequent in the pregnant group than in the reference group (11.7 vs 30.3%) and less intensive (pregnant smokers smoked 3.6 cigarettes fewer per day). A few pregnant women (1.9%) said they consumed marijuana; no other illicit drugs were mentioned. CONCLUSIONS: In Switzerland, women of child-bearing age revealed high general health-awareness. During pregnancy, a considerable proportion of the women adapted their diet and seemed to refrain from using pain killers and from consuming alcohol, tobacco and illicit drugs. However, since a fairly large minority of the pregnant women mentioned drinking alcohol and/or smoking tobacco, further preventive work is needed.

Isolation of Stenotrophomonas maltophilia in asymptomatic lung transplant recipients: effects of treatment on eradication and outcome.

In this retrospective, single-center data analysis, we audited our clinical practice to treat Stenotrophomonas maltophilia in asymptomatic lung transplant recipients (LTRs). Eighteen LTRs with confirmed isolation of S. maltophilia were identified. Twelve of these LTRs have been treated with antibiotics, while 6 were managed without treatment. Treatment was based on antibiograms (trimethoprim/sulfamethoxazole [TMP/SMX] (8/12), levofloxacin (1/12), or both (3/12). Clearance (12/12 vs 6/6), eradication (10/12 vs 3/6, P=.27), and freedom from S. maltophilia recurrence (83%±11% vs 40%±22% after one year, log-rank P=.09) were not found to differ significantly between treated and untreated patients. None of the patient groups showed significant changes in lung function or biochemical variables. Creatinine levels at the end of the study period were found to be higher in treated patients compared to the untreated group (P=.049). De novo acquired TMP/SMX resistance in S. maltophilia strains was not observed. These results indicate no evidence that antibiotic treatment for S. maltophilia in asymptomatic LTRs alters lung function or the clinical outcome.

CT Angiography of the Aorta: Prospective Evaluation of Individualized Low-Volume Contrast Media Protocols.

Purpose To prospectively develop individualized low-volume contrast media (CM) protocols adapted to tube voltage in patients undergoing computed tomographic (CT) angiography of the aorta. Materials and Methods The study was approved by the institutional review board and local ethics committee. All patients provided written informed consent. CT angiography was performed by using automated attenuation-based tube voltage selection (ATVS) (range, 70-150 kVp; 10-kVp increments). Iodine attenuation curves from an ex vivo experiment in a phantom were used to design CM protocols for CT angiography of the thoracoabdominal aorta in 129 consecutive patients (hereafter, cohort A). Further modified CM protocols based on results in cohort A were designed with the aim of homogeneous vascular attenuation of 300-350 HU across tube voltages and were applied to another 61 consecutive patients (cohort B). Three independent blinded radiologists assessed subjective image quality, and one reader determined objective image quality. The Kruskal-Wallis test was performed to test for differences in subjective image quality, and linear regression was performed to test for differences in objective image quality between the automatically selected tube voltages. Results Experiments revealed tube voltage-dependent iodine attenuation curves, which were used to determine the CM protocols in cohort A; these ranged from 68 mL at 110 kVp to 45 mL at 80 kVp. In both cohorts, ATVS selected 80 kVp in 62 patients, 90 kVp in 84, 100 kVp in 33, and 110 kVp in 11. In cohort A, image quality that was satisfactory or better was attained in 126 (98%) of 129 patients who had no significant differences in subjective image quality between tube voltages (P = .106) but who did have significant differences in attenuation and contrast-to-noise ratio (CNR) (P < .001 for both). In cohort B, the further-modified CM protocol (from 33 mL at 80 kVp to 68 mL at 110 kVp) yielded image quality that was satisfactory or better in all 61 (100%) patients, without significant differences in subjective image quality (P = .178), and without significant differences between tube voltage and attenuation (P = .108), noise (P = .250), or CNR (P = .698). Conclusion Individualized low-volume CM protocols based on automatically selected tube voltages are feasible and yield diagnostic image quality for CT angiography of the aorta. (©) RSNA, 2016 Online supplemental material is available for this article.

The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial.

BACKGROUND: Iron deficiency (ID) and malaria co-exist in tropical regions and both contribute to high rates of anaemia in young children. It is unclear whether iron fortification combined with intermittent preventive treatment (IPT) of malaria would be an efficacious strategy for reducing anaemia in young children. METHODS: A 9-month cluster-randomised, single-blinded, placebo-controlled intervention trial was carried out in children aged 12-36 months in south-central Côte d'Ivoire, an area of intense and perennial malaria transmission. The study groups were: group 1: normal diet and IPT-placebo (n = 125); group 2: consumption of porridge, an iron-fortified complementary food (CF) with optimised composition providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferrous fumarate 6 days per week (CF-FeFum) and IPT-placebo (n = 126); group 3: IPT of malaria at 3-month intervals, using sulfadoxine-pyrimethamine and amodiaquine and no dietary intervention (n = 127); group 4: both CF-FeFum and IPT (n = 124); and group 5: consumption of porridge, an iron-fortified CF with the composition currently on the Ivorian market providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferric pyrophosphate 6 days per week (CF-FePP) and IPT-placebo (n = 127). The primary outcome was haemoglobin (Hb) concentration. Linear and logistic regression mixed-effect models were used for the comparison of the five study groups, and a 2 × 2 factorial analysis was used to assess treatment interactions of CF-FeFum and IPT (study groups 1-4). RESULTS: After 9 months, the Hb concentration increased in all groups to a similar extent with no statistically significant difference between groups. In the 2 × 2 factorial analysis after 9 months, no treatment interaction was found on Hb (P = 0.89). The adjusted differences in Hb were 0.24 g/dl (95 % CI -0.10 to 0.59; P = 0.16) in children receiving IPT and -0.08 g/dl (95 % CI -0.42 to 0.26; P = 0.65) in children receiving CF-FeFum. At baseline, anaemia (Hb <11.0 g/dl) was 82.1 %. After 9 months, IPT decreased the odds of anaemia (odds ratio [OR], 0.46 [95 % CI 0.23-0.91]; P = 0.023), whereas iron-fortified CF did not (OR, 0.85 [95 % CI 0.43-1.68]; P = 0.68), although ID (plasma ferritin <30 µg/l) was decreased markedly in children receiving iron fortified CF (OR, 0.19 [95 % CI 0.09-0.40]; P < 0.001). CONCLUSIONS: IPT alone only modestly decreased anaemia, but neither IPT nor iron fortified CF significantly improved Hb concentration after 9 months. Additionally, IPT did not augment the effect of the iron fortified CF. CF fortified with highly bioavailable iron improved iron status but not Hb concentration, despite three-monthly IPT of malaria. Thus, further research is necessary to develop effective combination strategies to prevent and treat anaemia in malaria endemic regions. TRIAL REGISTRATION: http://www.clinicaltrials.gov ; identifier NCT01634945; registered on July 3, 2012.

Positive effects of the progestin desogestrel 75 µg on migraine frequency and use of acute medication are sustained over a treatment period of 180 days.

BACKGROUND: Premenopausal migraines frequently are associated with fluctuations of estrogen levels. Both, migraine and combined hormonal contraceptives (CHC) increase the risk of vascular events. Therefore progestagen-only contraceptives (POC) are a safer alternative. A previous short-term study demonstrated a positive impact of the oral POC desogestrel on migraine frequency. To study the effect of the POC desogestrel 75 µg on migraine frequency, intensity, use of acute medication and quality of life in a clinical setting over the period of 180 days. METHODS: Patients' charts were screened for women with migraine, who had decided to use desogestrel for contraception. Charts were included, if routinely conducted headache diaries were complete for 90 days before treatment (baseline) and over a treatment period of 180 days. We also report about starters who stopped treatment early, because of adverse events. Baseline data (day 1-90 before treatment) were compared with first and second treatment period (treatment days 1-90 and days 91-180). Quality of life was evaluated using MIDAS questionnaires. RESULTS: Days with migraine (5.8 vs 3.6), with any kind of headache (9.4 vs 6.6), headache intensity (15.7 vs 10.7), days with severe headache (5.4 vs 2.4) and use of triptans (12.3 vs7.8) were significantly reduced after 180 days. MIDAS score and grade improved significantly. CONCLUSION: Contraception with desogestrel 75 µg resulted in a significantly improved quality of life and a reduction of migraine days over the observation period of 180 days. A clinically meaningful 30% reduction in pain was observed in 25/42 (60%) participants. For counselling reasons it is of importance, that the major reduction in migraine frequency occured during the initial 90 days, however further improvement occurs with longer duration of use. Prospective studies are needed to confirm these results.

Importance of excision repair cross-complementation group 1 and ribonucleotide reductase M1 as prognostic biomarkers in malignant pleural mesothelioma treated with platinum-based induction chemotherapy followed by surgery.

OBJECTIVES: Survival and response to platinum-based induction chemotherapy are heterogeneous among patients with malignant pleural mesothelioma. The aim of the present study was to assess the prognostic role of DNA repair markers, such as excision repair cross-complementation group 1 and ribonucleotide reductase M1, in multimodally treated patients with malignant pleural mesothelioma. METHODS: Tumor tissue of a malignant pleural mesothelioma cohort (n = 107) treated with platinum/gemcitabine (n = 46) or platinum/pemetrexed (n = 61) induction chemotherapy followed by extrapleural pneumonectomy was assembled on a tissue microarray. Immunohistochemical expression of excision repair cross-complementation group 1 (nuclear) and ribonucleotide reductase M1 (nuclear and cytoplasmic) was assessed for its prognostic impact (association with overall survival or freedom from recurrence). RESULTS: Patients with high nuclear ribonucleotide reductase M1 expression before chemotherapy showed significantly longer freedom from recurrence (P = .03). When specifically analyzed in the subgroup of patients receiving platinum/gemcitabine followed by extrapleural pneumonectomy, high nuclear ribonucleotide reductase M1 was associated with prolonged freedom from recurrence (P = .03) and overall survival (P = .02). Low excision repair cross-complementation group 1 expression in prechemotherapy tumor tissues was associated with significantly longer freedom from recurrence (P = .04). Nuclear ribonucleotide reductase M1 and excision repair cross-complementation group 1 were independent prognosticators of freedom from recurrence in addition to pT stage in multivariate analysis. CONCLUSIONS: In the present study, nuclear ribonucleotide reductase M1 and excision repair cross-complementation group 1 expression were identified as independent prognosticators for freedom from recurrence of malignant pleural mesothelioma in patients undergoing induction chemotherapy followed by extrapleural pneumonectomy.

Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women.

INTRODUCTION: Overactive bladder syndrome (OAB) is a chronic disorder that often requires long-term treatment. There is a growing interest in new substances. In vitro experiments of Bryophyllum pinnatum (BP) on porcine bladder muscle have shown a muscle-relaxing effect. In this clinical trial we evaluated BP versus placebo regarding efficacy and safety. MATERIALS AND METHODS: Prospective, double-blind randomized, placebo-controlled study with 20 patients (10 BP, 10 placebo); medication over 8 weeks; dosage 3×2 capsules BP 50% (350 mg)/day or placebo (lactose). Primary aim: reduction of the micturition frequency/24h. Secondary aim: change in quality of life, alterations of parameters in the bladder diary and adverse events (AE). Statistical analysis was performed with IBM SPSS Statistics 20. The groups were compared using Fisher's exact test and the Mann-Whitney test; the visits using the Wilcoxon signed ranks test. RESULTS: Both groups did not differ significantly in demographical data. For the primary endpoint, a trend in the reduction of the micturition frequency/24h in the BP group was found: 9.5±2.2 before and 7.8±1.2 after BP versus 9.3±1.8 before and 9.1±1.6 after placebo, p=0.064. From visit 2 to visit 4, micturition frequency/24h improved in 8/10 patients in the BP group (p=0.037). In the placebo group, micturition frequency/24h improved in 5/9 patients (p=0.89). Improvement of the QoL did not differ between the two groups. The incidence of AE was similar in both groups, no SAE occurred. CONCLUSION: The successful safety outcome and positive trend for efficacy permits BP to be further evaluated as a favorable treatment option for OAB.

Evaluation of brain toxicity following near infrared light exposure after indocyanine green dye injection.

Indocyanine green (ICG) has excellent safety records and is widely used in medical diagnosis. Recently, a new method has been developed to estimate cerebral blood flow (CBF) using ICG in combination with near-infrared spectroscopy (NIRS). The new technique may be of wide clinical interest, as it is noninvasive and easy to perform at the bedside in stroke patients. Additionally, ICG with the use of specific wavelength lasers is documented to be effective in photodynamic therapy (PDT). Under normal conditions ICG does not cross the intact blood brain barrier (BBB). However, in patients with brain injuries where the BBB may be disturbed, ICG could accumulate in brain parenchyma and in combination with NIR-light exposure, phototoxicity could occur. The aim of the present study was to examine the possible toxicity of ICG in combination with NIRS in a specific setting for CBF measurements. In five rats with mannitol induced BBB breakdown no traces of ICG were found during spectrophotometric analysis of the brain cell suspensions. In ten rats with disrupted BBB there were no significant increases of brain temperature or histological signs of brain damage following 1 h NIR-light exposure after ICG injection. The existing literature concerning the application of ICG in combination with NIR light is reviewed.