Frequency and associated symptoms of isthmoceles in women 6 months after caesarean section: a prospective cohort study.

PURPOSE: The purpose of this study was to determine the frequency of detection of isthmoceles by ultrasound 6 months after caesarean section (CS) and which symptoms associated with isthmocele formation occur after CS. Subsequently, it was determined how often the ultrasound finding "isthmocele" coincided with the presence of complaints. METHODS: A prospective multicentre cohort study was conducted with 546 patients from four obstetric centres in Berlin, who gave birth by primary or secondary CS from October 2019 to June 2020. 461 participants were questioned on symptoms 3 months after CS; 329 participants were included in the final follow-up 6 months after CS. The presence of isthmoceles was determined by transvaginal sonography (TVS) 6 months after CS, while symptoms were identified by questionnaire. RESULTS: Of the 329 women, 146 (44.4%) displayed an isthmocele in the TVS. There was no statistically significant difference in the manifestation of symptoms between the two groups of women with and without isthmocele; however, when expressed on a scale from 1 to 10 the intensity of both scar pain and lower abdominal pain was significantly higher in the set of women that had shown to have developed an isthmocele (p = 0.014 and p = 0.031, respectively). CONCLUSION: The prevalence of isthmoceles 6 months after CS was 44.4%. Additionally, scar pain and lower abdominal pain were more pronounced when an isthmocele was also observed in the TVS. TRIAL REGISTRATION: Trial registration number DRKS00024977. Date of registration 17.06.2021, retrospectively registered.

Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study.

BACKGROUND: Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Timely diagnostic and goal-directed therapies aim at the reduction of bleeding and need for allogeneic transfusions. METHODS: Single-centre, prospective, randomized trial assessing blood loss and transfusion requirements of 26 adult patients undergoing elective cardiac surgery at high risk for perioperative bleeding. Primary endpoint was blood loss at 24 h postoperatively. Random assignment to intra- and postoperative haemostatic management following either an algorithm based on conventional coagulation assays (conventional group: platelet count, aPTT, PT, fibrinogen) or based on point-of-care (PoC-group) monitoring, i.e. activated rotational thromboelastometry (ROTEM®) combined with multiple aggregometry (Multiplate®). Differences between groups were analysed using nonparametric tests for independent samples. RESULTS: The study was terminated after interim analysis (n = 26). Chest tube drainage volume was 360 ml (IQR 229-599 ml) in the conventional group, and 380 ml (IQR 310-590 ml) in the PoC-group (p = 0.767) after 24 h. Basic patient characteristics, results of PoC coagulation assays, and transfusion requirements of red blood cells and fresh frozen plasma did not differ between groups. Coagulation results were comparable. Platelets were transfused in the PoC group only. CONCLUSION: Blood loss via chest tube drainage and transfusion amounts were not different comparing PoC- and central lab-driven transfusion algorithms in subjects that underwent high-risk cardiac surgery. Routine PoC coagulation diagnostics do not seem to be beneficial when actual blood loss is low. High risk procedures might not suffice as a sole risk factor for increased blood loss. TRIAL REGISTRATION: NCT01402739 , Date of registration July 26, 2011.

Risk factors for 30-day complications after cancer surgery in geriatric patients: a secondary analysis.

BACKGROUND: The aim was to analyse the association between severity of complications up to 30 days after surgery and pre-operative nutritional and physical performance parameters. METHODS: The participants were a subsample of the previously published PERATECS study (ClinicalTrials.gov: NCT01278537) and included 517 onco-geriatric patients aged ≥ 65 years, undergoing thoracoabdominal, gynaecological, or urological surgery. Post-operative complications were classified according to the Clavien Classification System (CCS). Independent risk factors related to the severity of complications, defined as major complications (CCS IIIa-V) and graded complications (CCS grade 0-V), were analysed using logistic and ordinal regression, respectively. RESULTS: In total, 132 patients suffered major post-operative complications. The development of major post-operative complications was independently associated with body mass index (BMI) < 20 kg/m2 , hypoalbuminaemia (< 30 g/l), longer duration of surgery, and specific tumour sites (upper gastrointestinal, gynaecological, colorectal) (all P < 0.05). Higher-grade complications were predicted by Timed Up and Go (TUG) > 20 s, hypoalbuminaemia (< 30 g/l), higher American Society of Anesthesiologists (ASA) status III-IV, longer duration of surgery (> 165 min), and specific tumour sites (upper gastrointestinal, gynaecological) (all P < 0.05). Mini Nutritional Assessment (MNA) scores and weight loss were not independent risk factors for the severity of complications. CONCLUSIONS: Nutritional and physical performance risk factors that predicted the severity of complications differed between major and higher-grade post-operative complications, but hypoalbuminaemia independently predicted both. The results support the need for pre-operative risk screening. Due to the explorative nature of the study, further research is required in larger cohorts to corroborate these findings.

Associations of postoperative mortality with the time of day, week and year.

Studies that have investigated circadian, weekday and seasonal variation in postoperative mortality have been relatively small or have been for scheduled surgery. We retrospectively tested a large mixed surgical cohort from a German tertiary care university hospital for the presence of cyclical variation in all-cause in-hospital mortality after operations performed between 2006 and 2013. We analysed mortality rates after 247,475 operations, adjusted for age, sex, comorbidities, location, urgency and duration of the surgery, and intra-operative blood transfusions. The mortality odds ratio (95%CI) after operations started in the morning (08:00-11:00) were lowest, 0.73 (0.66-0.80), p < 0.001 and highest for operations started in the afternoon (13:00-17:00), 1.29 (1.18-1.40), p < 0.001. Mortality at the weekend was the same as during the week. There was no seasonal variation in mortality, p = 0.12. However, the interference of four-yearly and ten-monthly cycle amplitudes resulted in higher mortality odds ratio (95%CI) in winter 2008-2009, 1.41 (1.18-1.69), p < 0.001, and lower mortality in spring 2011 and 2012, 0.70 (0.56-0.85) and 0.67 (0.53-0.85), p < 0.001 and p = 0.001, respectively. The ability to predict cyclical phenomena would facilitate the design of interventional studies, aimed at reducing mortality following surgery in the afternoon and when cycles interfere constructively.

The new agreement of the international RIGA consensus conference on nasal airway function tests.

The report reflects an agreement based on the consensus conference of the International Standardization Committee on the Objective Assessment of the Nasal Airway in Riga, 2nd Nov. 2016. The aim of the conference was to address the existing nasal airway function tests and to take into account physical, mathematical and technical correctness as a base of international standardization as well as the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Rhinomanometry, acoustic rhinometry, peak nasal inspiratory flow, Odiosoft-Rhino, optical rhinometry, 24-h measurements, computational fluid dynamics, nasometry and the mirrow test were evaluated for important diagnostic criteria, which are the precision of the equipment including calibration and the software applied; validity with sensitivity, specificity, positive and negative predictive values, reliability with intra-individual and inter-individual reproducibility and responsiveness in clinical studies. For rhinomanometry, the logarithmic effective resistance was set as the parameter of high diagnostic relevance. In acoustic rhinometry, the area of interest for the minimal cross-sectional area will need further standardization. Peak nasal inspiratory flow is a reproducible and fast test, which showed a high range of mean values in different studies. The state of the art with computational fluid dynamics for the simulation of the airway still depends on high performance computing hardware and will, after standardization of the software and both the software and hardware for imaging protocols, certainly deliver a better understanding of the nasal airway flux.

[Ocular blood flow regulation in glaucoma - examination with the ocular pressure flow analyzer (OPFA)]. / Okuläre Durchblutungsregulation beim Glaukom. Untersuchungen mit dem Ocular Pressure Flow Analyzer (OPFA).

BACKGROUND: The results of studies of ocular blood flow (BF) regulation of patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG) and ocular hypertension (OH) are presented. METHODS AND PATIENTS: Examinations were carried out with the "OPFA", a newly developed ocular pressure flow analyzer (producer: tpm Lüneburg) on 92 patients with newly diagnosed glaucomas, among whom 48 patients had POAG, 22 NTG and 22 OH, and compared with age-matched groups of healthy subjects. The OPFA uses pneumatic coupling through special scleral suction cups to record ocular pulses with highly sensitive transducers and a suction pump for simultaneously increasing intraocular pressure (IOP). Following local drop anaesthesia on both eyes, IOP is artificially raised to suprasystolic values. While continuously lowering IOP, the ocular pulse is then recorded with increasing ocular perfusion pressure. We obtain the relative ocular pulse blood volume by correlating the ocular pulse amplitudes with a calibration volume of 1 µl. This enables us to collect reproducible data on intra- and inter-individual pulse blood volume (PVoc). The ocular perfusion pressure pulse blood volume curve characterizes the respective individual ocular circulation as well as systolic and diastolic ocular perfusion pressures. RESULTS: In healthy subjects, the ocular pulse blood volume remains stable over a certain range of ocular perfusion pressure (ppoc) changes. After exceeding a critical point (CP), the ocular pulse blood volume drops. We refer to the difference between the CP and IOP as the autoregulatory capacity (AC). In patients with POAG and in patients with NTG, the AC was reduced significantly compared with the groups of healthy subjects. The mean AC of patients with OH remained within the normal range. The ROC curves showed at an optimal cut-off value for POAG a sensitivity of 75.0 % and a specificity of 97.9 %, for NTG a sensitivity of 77.3 % and a specificity of 100 %. In patients with POAG and OH, the ocular arterial pressures were elevated. In patients with NTG they remained unchanged compared with the healthy subjects. The ocular perfusion pressures did not change in POAG as well as in NTG and OH. CONCLUSIONS: In patients with POAG and in patients with NTG the ocular BF regulation was impaired and detected by the OPFA device with a high level of reliability. Ocular arterial blood pressures were increased as a result of vascular regulation to keep up the ocular perfusion pressure and to maintain ocular perfusion.

Concurrent hyperfractionated accelerated radiotherapy with 5-FU and once weekly cisplatin in locally advanced head and neck cancer. The 10-year results of a prospective phase II trial.

PURPOSE: In this study, the acute toxicity and long-term outcome of a hyperfractionated accelerated chemoradiation regimen with cisplatin/5-fluorouracil (5-FU) in patients with locally advanced squamous cell carcinomas of head and neck were evaluated. PATIENTS AND METHODS: From 2000-2002, 38 patients with stage III (5.3 %) and stage IV (94.7 %) head and neck cancer were enrolled in a phase II study. Patients received hyperfractionated-accelerated radiotherapy with 72 Gy in 15 fractions of 2 Gy followed by 1.4 Gy twice daily with concurrent, continuous infusion 5-FU of 600 mg/m(2) on days 1-5 and 6 cycles of weekly cisplatin (30 mg/m(2)). Acute toxicities (CTCAEv2.0), locoregional control (LRC), metastases-free (MFS), and overall survival (OS) were analyzed and exploratively compared with the ARO 95-06 trial. RESULTS: Median follow-up was 11.4 years (95 % CI 8.6-14.2) and mean dose 71.6 Gy. Of the patients, 82 % had 6 (n = 15) or 5 (n = 16) cycles of cisplatin, 5 and 2 patients received 4 and 3 cycles, respectively. Grade 3 anemia, leukopenia, and thrombocytopenia were observed in 15.8, 15.8, and 2.6 %, respectively. Grade 3 mucositis in 50 %, grade 3 and 4 dysphagia in 55 and 13 %. The 2-, 5-, and 10-year LRC was 65, 53.6, and 48.2 %, the MFS was 77.5, 66.7, and 57.2 % and the OS 59.6, 29.2, and 15 %, respectively. CONCLUSION: Chemoradiation with 5-FU and cisplatin seems feasible and superior in terms of LRC and OS to the ARO 95-06C-HART arm at 2 years. However, this did not persist at the 5- and 10-year follow-ups.

Oesophageal Doppler and calibrated pulse contour analysis are not interchangeable within a goal-directed haemodynamic algorithm in major gynaecological surgery.

BACKGROUND: Evidence for the benefit of an intraoperative use of a goal-directed haemodynamic management has grown. We compared the oesophageal Doppler monitor (ODM, CardioQ-ODM™) with a calibrated pulse contour analysis (PCA, PiCCO2™) with regard to assessment of stroke volume (SV) changes after volume administration within a goal-directed haemodynamic algorithm during non-cardiac surgery. METHODS: The data were obtained prospectively in patients with metastatic ovarian carcinoma undergoing cytoreductive surgery. During surgery, fluid challenges were performed as indicated by the goal-directed haemodynamic algorithm guided by the ODM. Monitors were compared regarding precision and trending. Clinical characteristics associated with trending were studied by extended regression analysis. RESULTS: A total of 762 fluid challenges were performed in 41 patients resulting in 1524 paired measurements. The precision of ODM and PCA was 5.7% and 6.0% (P=0.80), respectively. Polar plot analysis revealed a poor trending between ODM and PCA with an angular bias of -7.1°, radial limits of agreement of -58.1° to 43.8°, and an angular concordance rate of 67.8%. Dose of norepinephrine (NE) (scaled 0.1 µg kg(-1) min(-1)) [adjusted odds ratio (OR) 0.606 (95% confidence interval, CI: 0.404-0.910); P=0.016] and changes in mean arterial pressure (MAP) to a fluid challenge (scaled 10%) [adjusted OR 0.733 (95% CI: 0.635-0.845); P<0.001] were associated with trending between ODM and PCA, whereas there was no relation to type of i.v. solution. CONCLUSIONS: Despite a similar precision, ODM and PCA were not interchangeable with regard to measuring SV changes within a goal-directed haemodynamic algorithm. A decrease in interchangeability coincided with increasing NE levels and greater changes of MAP to a fluid challenge.

Levetiracetam in patients with central neuropathic post-stroke pain--a randomized, double-blind, placebo-controlled trial.

BACKGROUND AND PURPOSE: Central post-stroke pain (CPSP) is a severe chronic neuropathic pain condition defined as a spontaneous pain or allodynia corresponding to a vascular lesion. It usually evolves weeks after stroke, and can distinctively impair the quality of life. Treatment is complex and mostly unsatisfactory. We hypothesized that the anti-epileptic drug levetiracetam (LEV) improves CPSP compared with placebo. The purpose of this study was to examine the efficacy and tolerability of LEV in patients with CPSP. METHODS: In a double-blind, placebo-controlled, crossover study design patients with CPSP lasting at least 3 months and a pain score ≥ 4 on the 11-point Likert scale were treated over two 8-week periods with a maximum dose up to 3000 mg LEV or placebo. Primary endpoint was a median pain lowering ≥ 2 in the final treatment week compared with the last baseline week. Secondary outcome measures comprised additional pain ratings, depression, sleep quality, quality of life and patients' global impression of change. RESULTS: Of 42 patients, 33 [61.5 years (40-76); 38% women] completed the study. Side effects and withdrawals were more frequent in the LEV (n = 5) group than in the placebo group (n = 1). Patients treated with LEV did not show any improvement of pain or changes in secondary outcome parameters compared with placebo. CONCLUSIONS: LEV is not effective in treatment for CPSP. The mode of action of LEV does not exert an analgesic effect in chronic CPSP.

Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction.

BACKGROUND: Postoperative delirium in elderly patients is a frequent complication and associated with poor outcome. The aim of this parallel group study was to determine whether monitoring depth of anaesthesia influences the incidence of postoperative delirium. METHODS: Patients who were planned for surgery in general anaesthesia expected to last at least 60 min and who were older than 60 yr were included between March 2009 and May 2010. A total of 1277 patients of a consecutive sample were randomized (n=638 open, n=639 blinded) and the data of 1155 patients were analysed (n=575 open, n=580 blinded). In one group, the anaesthesiologists were allowed to use the bispectral index (BIS) data to guide anaesthesia, while in the other group, BIS monitoring was blinded. Cognitive function was evaluated at baseline, 1 week, and 3 months after operation. RESULTS: Delirium incidence was lower in patients guided with BIS. Postoperative delirium was detected in 95 patients (16.7%) in the intervention group compared with 124 patients (21.4%) in the control group (P=0.036). In a multivariate analysis, the percentage of episodes of deep anaesthesia (BIS values <20) were independently predictive for postoperative delirium (P=0.006; odds ratio 1.027). BIS monitoring did not alter the incidence of postoperative cognitive dysfunction (7th day P=0.062; 90th day P=0.372). CONCLUSIONS: Intraoperative neuromonitoring is associated with a lower incidence of delirium, possibly by reducing extreme low BIS values. Therefore, in high-risk surgical patients, this may give the anaesthesiologist a possibility to influence one precipitating factor in the complex genesis of delirium. Clinical trial registration ISRCTN Register: 36437985. http://www.controlled-trials.com/ISRCTN36437985/.

Balanced crystalloid compared with balanced colloid solution using a goal-directed haemodynamic algorithm.

BACKGROUND: Controversy exists regarding the optimal i.v. fluids for use with a goal-directed haemodynamic algorithm. METHODS: In a double-blind pilot study, we randomly assigned 50 patients with primary ovarian cancer undergoing cytoreductive surgery to receive either balanced crystalloid or balanced starch (HES, 130/0.4, 6%) solutions up to the dose limit (50 ml kg(-1)). Fluids were administered to optimize stroke volume measured by oesophageal Doppler within a goal-directed haemodynamic algorithm. RESULTS: Baseline subject characteristics were similar in both groups. The balanced HES solution maintained stroke volume (P=0.012) better with administration of less fluid. Subjects in the colloid group reached the dose limits of the study medication less frequently (92% vs 62%, P=0.036) and later (2:26 vs 3:33 h, P=0.006) and also required less transfusion of fresh-frozen plasma units (6.0 vs 3.5 units, P=0.035) compared with the crystalloid group. Intra- and postoperative urine output and perioperative plasma levels of creatinine and neutrophil gelatinase-associated lipocalin as renal injury marker were similar in both groups. No differences in the length of intensive care unit and hospital stay were found. CONCLUSIONS: Using a goal-directed haemodynamic algorithm to optimize stroke volume, a balanced HES solution is associated with better haemodynamic stability and reduced need for fresh-frozen plasma. There were no signs of renal impairment by colloid solutions when fluid administration is targeted to optimize cardiac preload.

Fatigue in multiple sclerosis is closely related to sleep disorders: a polysomnographic cross-sectional study.

BACKGROUND: Sleep disorders can cause tiredness. The relationship between sleep disorders and fatigue in patients with multiple sclerosis (MS) has not yet been investigated systematically. OBJECTIVE: To investigate the relationship between fatigue and sleep disorders in patients with MS. METHODS: Some 66 MS patients 20 to 66 years old were studied by overnight polysomnography. Using a cut-off point of 45 in the Modified Fatigue Impact Scale (MFIS), the entire cohort was stratified into a fatigued MS subgroup (n=26) and a non-fatigued MS subgroup (n=40). RESULTS: Of the fatigued MS patients, 96% (n=25) were suffering from a relevant sleep disorder, along with 60% of the non-fatigued MS patients (n=24) (p=0.001). Sleep-related breathing disorders were more frequent in the fatigued MS patients (27%) than in the non-fatigued MS patients (2.5%). Significantly higher MFIS values were detected in all (fatigued and non-fatigued) patients with relevant sleep disorders (mean MFIS 42.8; SD 18.3) than in patients without relevant sleep disorders (mean MFIS 20.5; SD 17.0) (p<0.001). Suffering from a sleep disorder was associated with an increased risk of fatigue in MS (odds ratio: 18.5; 95% CI 1.6-208; p=0.018). CONCLUSION: Our results demonstrate a clear and significant relationship between fatigue and sleep disorders.

Central area for induction of anesthesia and job satisfaction.

A central area for induction of anesthesia (CAIA) is supposed to optimize processes of preoperative patient preparation for anesthesia. The purpose of this study was to assess whether the separation of the anesthesia process into anesthesia induction and anesthesia maintenance is associated with residents' job satisfaction. The central area for induction of anesthesia model (CAIA model) was prospectively compared to the conventional model of anesthesia being induced, maintained and ended by the same anesthetist. Quality of senior staff supervision for each day as well as workday satisfaction was additionally graded by a Likert-scale. More than 80% of residents considered their workday as satisfying or very satisfying, regardless of the model applied. Furthermore, work day satisfaction was significantly associated with the quality of supervision provided by the teaching staff. It was concluded that time and attention provided by the teaching staff rather than the anesthesia organisational model were the major determinants of workday satisfaction.

Delayed treatment of delirium increases mortality rate in intensive care unit patients.

Delirium in the intensive care unit (ICU) is a serious complication associated with a poor outcome in critically ill patients. In this prospective observational study of the effect of a delay in delirium therapy on mortality rate, 418 ICU patients were regularly assessed using the Delirium Detection Score (DDS). The departmental standard required that if delirium was diagnosed (DDS >7), therapy should be started within 24 h. In total, 204 patients (48.8%) were delirious during their ICU stay. In 184 of the delirious patients (90.2%), therapy was started within 24 h; in 20 patients (9.8%), therapy was delayed. During their ICU stay, patients whose delirium treatment was delayed were more frequently mechanically ventilated, had more nosocomial infections (including pneumonia) and had a higher mortality rate than patients whose treatment was not delayed. Thus, it would appear that a delay in initiating delirium therapy in ICU patients was associated with increased mortality.

Computer-assisted decision support for changing practice in severe sepsis and septic shock.

Computer-assisted decision support systems (CDSS) are designed to improve infection management. The aim of this prospective, clinical pre- and post-intervention study was to investigate the influence of CDSS on infection management of severe sepsis and septic shock in intensive care units (ICUs). Data were collected for a total of 180 days during two study periods in 2006 and 2007. Of the 186 patients with severe sepsis or septic shock, 62 were stratified into a low adherence to infection management standards group (LAG) and 124 were stratified into a high adherence group (HAG). ICU mortality was significantly increased in LAG versus HAG patients (Kaplan-Meier analysis). Following CDSS implementation, adherence to standards increased significantly by 35%, paralleled with improved diagnostics, more antibiotic-free days and a shortened time until antibiotics were administered. In conclusion, adherence to infection standards is beneficial for patients with severe sepsis or septic shock and CDSS is a useful tool to aid adherence.

Documentation of post-operative nausea and vomiting in routine clinical practice.

This study investigated the quality of documentation of post-operative nausea and vomiting (PONV) by comparing incidences collected by a research team with those reported routinely by nursing personnel. A total of 560 patients passing through an interdisciplinary recovery room were included in the study. The overall recorded incidence of PONV over 24 h was 30.7%, which was in agreement with the predicted value of 32% calculated using incidences from published randomized controlled trials. Out of the total number of 86 cases of PONV in the recovery room only 36 (42%) were detected by nursing staff. Similarly, out of the total number of 129 cases of PONV on the ward over 24 h, only 37 (29%) were recognized by nursing staff during routine care. In conclusion, PONV in routine clinical care is likely to be under-reported. To use PONV as a valid quality measure, patients need to be actively asked about nausea and vomiting at frequent intervals in a standardized fashion. A considerable proportion of patients experience PONV after discharge from the recovery room, so the assessment of PONV should cover at least 24 h post-operatively.

Remifentanil reduces the incidence of post-operative delirium.

A secondary exploratory analysis of data from an observational study was used to study the influence of the opioid used for intraoperative anaesthesia on the incidence of post-operative delirium. Patients who had been admitted to the recovery room following elective general anaesthesia were divided into those who had received fentanyl or remifentanil. For unbiased patient analysis, matched pairs were built with respect to gender, age, physical status, anaesthetic type and surgery duration. In 752 patients, the overall incidence of delirium was 9.9% in the recovery room and 3.8% on the first post-operative day. Compared with the remifentanil group, the fentanyl group had a significantly higher incidence of delirium in the recovery room (12.2% versus 7.7%) and on the first post-operative day (5.8% versus 1.9%). Delirium in the recovery room and on the first post-operative day were both associated with a significantly prolonged post-operative hospital stay. The choice of intraoperative opioid influences the incidence of post-operative delirium. Remifentanil was associated with a lower incidence of post-operative delirium in the early post-operative period.

[Adherence to treatment guidelines for postoperative nausea and vomiting. How well does knowledge transfer result in improved clinical care?]. / Einhaltung der Behandlungsrichtlinien für postoperative Ubelkeit und Erbrechen. Wie gut gelingt der Wissenstransfer hin zu einer besseren klinischen Versorgung?

BACKGROUND: In order to reduce the incidence of postoperative nausea and vomiting (PONV) a standard operating procedure (SOP) was developed in our department. This consists basically in the administration of one antiemetic intervention for moderate risk (2 risk factors), two interventions for high risk (3-4 risk factors) and no prophylaxis in patients who have no or only one risk factor. The aim of this study was to find out whether PONV prophylaxis according to our SOP was followed and led to a lower incidence of PONV. METHOD AND PATIENTS: A total of 2,729 patients were examined in a prospective observational study with post-ad hoc analysis in our department. Inclusion criteria were age over 14 years after general anesthesia and postoperative care in the recovery room. This group was examined in relation to compliance with the SOP. RESULTS: A total of 725 (26.6%), 1050 (38.5%) and 954 (35.0%) patients were grouped according to risk classification into groups with low, medium and high risks, respectively. An SOP compliant regime occurred in 668 patients (92.1%) of the low risk groups, in 373 patients (35.6%) of the moderate risk group and 177 patients (18.6%) of patients at high risk for PONV. In the high risk group 565 patients (59.2%) received at least one antiemetic medication. Patients with PONV were on average cared for 12 min longer in the recovery room (p=0.048). CONCLUSION: Patients with medium and high risk have a lower incidence of PONV than expected per risk calculation by complying with the SOP. However, the recommended risk-adapted approach was inadequately implemented. Considering this there is room for improvement. Moreover taking into account these implementation issues a general PONV prophylaxis may be beneficial.

Efficiency of adjuvant active specific immunization with Newcastle disease virus modified tumor cells in colorectal cancer patients following resection of liver metastases: results of a prospective randomized trial.

PURPOSE: Metastatic disease is a major cause of mortality in colorectal cancer patients. Even after complete resection of isolated liver metastases, recurrence develops in the majority of patients. Therefore, development of strategies to prevent recurrent liver metastases is of major clinical importance. The present prospectively randomised phase III trial investigates the efficiency of active specific immunotherapy (ASI) after liver resection for hepatic metastases of colorectal cancer. METHODS: Patients with histologically confirmed liver metastases from colorectal cancer were randomised to the vaccination or control group. After complete resection of liver metastases, patients randomised to the vaccination group received six doses of Newcastle disease virus (NDV) infected autologous tumour cell vaccine (ATV-NDV). The primary end-point was overall survival, secondary end-points were disease-free survival and metastases-free survival. RESULTS: Fifty-one patients were enrolled in the study with 50 patients available for analysis. The follow-up period was 116.1 +/- 23.8 month in the vaccination arm and 112.4 +/- 18.5 month in the control group. In the total patient group, no differences in the primary and secondary end-points were detected. Most interestingly, subgroup analysis revealed a significant advantage for vaccinated colon cancer patients with respect to overall survival [hazard ratio: 3.3; 95%, confidence interval (CI): 1.0-10.4; P = 0.042] and metastases-free survival (hazard ratio: 2.7; 95%, CI: 1.0-7.4; P = 0.047) in the intention-to-treat analysis. CONCLUSION: Active specific immunotherapy in unselected colorectal cancer patients was not effective for prevention of recurrent metastatic disease. However, in colon cancer patients, ASI with ATV-NDV appears to be beneficial prolonging overall and metastases-free survival.