[Crataegus special extract WS 1442 in the treatment of early stages of CHD-associated heart failure].
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Cohort Studies↗
Biomedical subjects
W Lorenz
Publications and source records attributed to W Lorenz.
[The situation of patients with dementia may be rectified by Gingko Biloba].
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Aged↗
[The situation of patients with dementia may be rectified by Ginkgo biloba. Results of a health services research study concerning the ability of patients with dementia, quality of life of the nursing family members and total treatment costs].
UNLABELLED: BACKGROUND AND ISSSUES: Ginkgo biloba-extracts are often used in therapy of patients with dementia. In this study, benefit and structure of Ginkgo biloba-extract EGb 761 in treatment of patients with dementia was examined. PATIENTS AND METHODS: For the assessment of quality of life of care-taking relatives and patients as well as treatment costs were documented. The study was conducted as a non-randomised, two-armed cohort study with an open design for 683 slightly or moderately demented patients, aged between 65 and 80 years. Society's perspective was taken. Barthel-Index and MMST were also documented. Because of significant differences at inclusion of both cohorts, a matched-pairs-analysis and multiple regression analysis conducted. RESULTS: According to PLC a significant improvement in quality-of-life of care-taking relatives (p < 0.001) and patients (positive mood p = 0.018, negative mood p < 0.001) was only observed in the Ginkgo-cohort. Also Barthel-Index indicated an improvement in the Ginkgo-cohort (p < or = 0,001). MMST-scores increased significantly only in the Ginkgo-cohort (p < 0.001). Average total cost per patient amounted to 3.614,75 euro in the standard-cohort, whereas these costs per patient in the Ginkgo-cohort amounted to 3.031,78 euro (p = 0.067). Results were confirmed by matched-pairs-analysis. RESULTS: Ginkgo treatment has a valid place in caretaking structure of health services. Gingko attributes to a higher quality of life for both care-takers and patients, the progression of disease is slowed down and treatment costs are lower.
Activities of Daily Living↗
[Haemorrhoidectomy: conventional excision versus resection with the circular stapler. Prospective, randomized study].
BACKGROUND AND OBJECTIVE: The goal of this study was to compare two surgical methods of treating for haemorrhoids that aim at closure of the wound: resection with a circular stapler and a conventional, closed haemorrhoidectomy. PATIENTS AND METHODS: 80 patients (41 males, mean age 47,1 years) with haemorrhoids stage 3 were randomized and treated with stapler haemorrhoidectomy (test group; n = 40) or had an haemorrhoidectomy according to Fansler and Anderson (control group; n = 40). Following a standardized study protocol we compared postoperative results on the operating day and one week, six weeks, six months and one year afterwards uni- and multivariate analysis and we also calculated the costs. RESULTS: The stapler haemorrhoidectomy proved to be the method causing significantly reduced pain in the early postoperative period so that the patients needed less pain relief. They were able to return to work earlier. One year after stapler haemorrhoidectomy there were three episodes of postoperative bleedings that required intervention, one in the control group. Six patients still had haemorrhoids stage 3, six patients over the age of 65 had persistent anal incontinence (I degrees according to Parks) with proven sphincter dysfunction and disturbances in voiding their bowel with resulting deterioration of quality of life, significantly more frequent than in the control group. CONCLUSIONS: Stapler haemorrhoidectomy cures stage 3 haemorrhoids on a long term basis in 84.2 % of patients, costing less than all alternative treatments. In some cases, it can be associated with postoperative complications.
Adult↗
Histamine content of human osseous tissue: detection and possible source of plasma histamine increase during orthopaedic surgery.
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Adult↗
Sickness behavior of rats with abdominal sepsis can be improved by antibiotic and G-CSF prophylaxis in clinic modeling randomized trials.
BACKGROUND AND AIM: In clinical sepsis research nearly all immune-modulators have demonstrated no benefit in regard to the 28-day mortality rate. Other endpoints such as quality of life have become more attractive, but clinically relevant animal models analyzing an equivalent to quality of life by measurement of sickness behavior are extremely rare. The concept of clinic modeling randomized trials was used in an animal trial to model clinical complexity and conditions of a randomized clinical trial. METHODS: 80 adult male Wistar rats were randomly assigned to (1) control: anesthesia and sham operation, (2) sepsis: laparotomy and peritoneal infection with human stool bacteria, (3) sepsis with antibiotic prophylaxis: cefuroxime/metronidazole and (4) sepsis with antibiotic plus a cytokine prophylaxis with granulocyte-colony stimulating factor (GCSF). Endpoints were physiological and behavioral parameters. RESULTS: The combination of antibiotics plus G-CSF was most effective in reducing mortality. All infected animals showed reduced open field activity acutely after infection, and recovery was improved during the 9 day follow-up in rats with prophylactic treatments. In the social interaction test, but not in the elevated plus-maze anxiety test, prophylaxis was also efficient, especially with antibiotics and G-CSF. CONCLUSIONS: The results show that improving sickness behavior in septic rats with G-CSF plus antibiotics may be a promising approach.
Animals↗
[Lateral, partial sphincter myotomy as therapy of chronic anal fissue. Long-term outcome of an epidemiological cohort study].
AIM: We observed a relatively high rate of severe forms of anal incontinence in patients who had undergone lateral, partial, internal, open sphincterotomy for chronic fissure in ano years ago in our clinic. An explicit investigation of pre- and postoperative data for a representative patient group was undertaken to find out whether this incidental finding proved to be meaningful. PATIENTS AND METHODS: The perioperative data from 523 patients who underwent sphincterotomy (Parks) between 1986 and 1997 were analyzed by uni- and multivariate analysis. RESULTS: Of 209 patients included in the study, 94.7% could be considered healed after operation. Up until the 12th postoperative week, 14.8% of patients were incontinent in stage I and II (Parks). This increased up to 21% at the time of follow-up, mainly in stage II and III, which significantly differed from a healthy control group. CONCLUSION: Lateral sphincterotomy leads in most cases to quick healing of the chronic fissure in ano with a low recurrence rate. The added effect of degenerative changes was observed to be linked, however, with a higher long-term rate of anal incontinence.
Adult↗
Systematic development of a guideline for early detection of prostate cancer: the German way in the evidence gap.
OBJECTIVE: To develop an evidence-based guideline, helping physcians make prudent decisions about diagnostic care for men wishing to undergo examination for early detection of prostate cancer. METHODS: A guideline development group, comprised of twenty healthcare professionals, including urologists, clinical chemists, pathologists, geriatricians, epidemiologists, technicians and a member of a patient self-help group, systematically gathered, evaluated, and discussed the most recent research available on early detection of prostate cancer. Nominal group technique (NGT) was employed to facilitate the decision-making process. RESULTS: The NGT was sufficient to find a consensus among different medical disciplines in a timely fashion. A standardized guideline, containing a short version for physicians and a standardized patient information booklet, for nation-wide use was developed. CONCLUSIONS: Population-based screening is not favoured, instead information should be given to men in their 50-70s, to enable shared decision-making between physician and patient for or against PSA-based early detection of prostate cancer.
Germany↗
Functional parameters before and after parathyroidectomy: a prospective, randomized long-term trial on different rat strains.
For clinical controls before and after parathyroidectomy and for evaluation of the function of transplants of parathyroid tissue, it is necessary to establish standard values of relevant laboratory parameters for donor and recipient animals as well as for different types of nutrition. Since no such data are yet available, it was the purpose to define such standards. In a prospective randomized trial on 400 rats of the Dark Agouti (DA) and Lewis strain, different functional laboratory parameters such as total calcium, intact parathyroid hormone, phosphate, 1.25-dihydroxyvitamin D, and alkaline phosphatase were measured under a standard and low calcium diet over a period of 40 weeks. Two hundred of these animals underwent a parathyroidectomy four weeks after the beginning of the study and specimens were evaluated histologically. For all eight different study groups normal values could be defined within tight limits for parameters which describe the function of the parathyroid gland or elements of calcium metabolism under different conditions. The optimal conditions for a transplantation model of parathyroid glands were established. Lewis-rats were identified as the ideal donor and DA rats as the better recipient animals. These data can serve as reference values for future studies on transplantation of the parathyroid without immunosuppression.
Alkaline Phosphatase↗
Checking for interviewer bias in outcome assessment: a method for strengthening the design of prospective, randomised trials in surgery.
BACKGROUND: Blind, randomised trials are conceived as the gold standard in clinical research, but this ideal, in its strict sense, can rarely be achieved in surgical settings. One way to strengthen the study design is to check for observer bias in the assessment and evaluation of surgical outcome. METHOD: In a randomised, prospective trial comparing nasogastric versus gastrostomy tubes the primary endpoint was the subjective inconvenience induced by the tube system and was assessed in the context of a standardised face-to-face interview. These interviews were tape-recorded on a pocket memo. Two independent raters listened to these interviews and judged--on the basis of how the interviewer formulated the questions--which treatment arm they thought the patients were assigned to and how confident they were in their judgement. RESULTS: The overall proportion of correct judgements was 50.5% for rater 1 and 53.2% for rater 2. In other words, both judgement performances were not greater than chance. Nevertheless, the raters' confidence in their judgements increased significantly ( P<0.05) in the course of the rating procedure, whereas the actual proportion of correct judgements did not. There was no overlap between the two raters [kappa = 0.022, not significant (NS)] and between actual group assignment and both raters' judgements (kappa = 0.012, NS and kappa = 0.110, NS). CONCLUSION: The two independent raters were not able to detect systematic variations in the interviewing style that were contingent on treatment arm assignment. This gives further credence to the results of the randomised trial showing greater patient-reported discomfort and inconvenience with the nasogastric tube than with the gastrostomy tube. The present report describes a feasible method to monitor subtle biases that may occur in trial settings. This helps to strengthen the design of randomised clinical trials in surgery.
Feasibility Studies↗
Survival of the quality of life concept.
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Delivery of Health Care↗
Early and late histamine release induced by albumin, hetastarch and polygeline: some unexpected findings.
OBJECTIVE: The perioperative use of colloidal plasma substitutes is still under discussion. We therefore conducted a prospective randomised study with three commonly used plasma substitutes to examine their histamine releasing effects in 21 volunteers. MATERIAL OR SUBJETS: 21 male volunteers were enrolled in this prospective, randomised, controlled clinical study. Endpoints were the incidence of early and late histamine release and the time course of the release kinetics. Normovolemic hemodilution technique was used with hydroxyethyl starch (n = 6), human albumin (n = 6) and polygeline (n = 9). Measurement and observation period was 240 min after the start of the plasma substitute infusion. Heart rate, blood pressure, SaO(2), clinical symptoms/signs and plasma histamine were measured during the observation period. RESULTS: The incidence of histamine release over the whole observation period in all three groups was 100%. Histamine release occurred frequently in all three groups until 30 min (50%-78%) and up to 240 min (late release reaction: 67%-83%) after the start of infusion. Surprisingly even hydroxyethyl starch, which is regarded as a generally safe and effective plasma substitute, caused high incidences of late histamine release (67%). Histamine release is a well known side effect of polygeline and - to a lesser extent - also of albumin, but was a novel finding for hydroxyethyl starch. CONCLUSIONS: We demonstrated for the first time histamine releasing effects of hydroxyethyl starch over a long period of time after administration. This perioperatively and for intensive care possibly relevant finding should make clinicians aware of late side effects not yet connected with the clinical use of these colloidal plasma substitutes.
Adult↗
[Mesenteric traction syndrome during the operation of aneurysms of the abdominal aorta--histamine release and prophylaxis with antihistaminics].
Mesenteric traction syndrome occurs during abdominal surgery and is described as sudden tachycardia, hypotension and flush. Among other etiological factors, eventeration or mesenteric traction of the small intestine may cause histamine release from mesenteric mast cells. Therefore, our hypothesis was that mesenteric traction syndrome could be positively influenced by prophylactic administration of H1- and and H2-antihistamines. Seventeen male patients (ASA groups III-V, 48-78 years old) were investigated in a randomised double blind study during elective abdominal aortic aneurysm (AAA) repair; which, in our opinion, is one of the most standardised surgical procedures. Eight patients had pre-anaesthetic prophylaxis with 0.1 mg/kg BW dimetindene (H1-receptor antagonist) plus 5 mg/kg BW cimetidine (H2-receptor antagonist) diluted with 100 ml 0.9% NaCl, while 9 patients received a placebo (100 ml 0.9% NaCl). Anaesthesia and invasive haemodynamic monitoring were standardised in all patients. Haemodynamic parameters, plasma histamine concentrations and clinical symptoms were determined one min after skin incision (HS), and 5 and 20 min after mesenteric traction (5' EV and 20' EV). Statistical analyses were performed using the Student's t-test, the Mann-Whitney-U-test for continuous data and Chi2-test for incidences. The incidence of histamine release was 55.5% (5/9) in the placebo group vs. 37.5% (3/8) in the antihistamine group (p > 0.05, Chi2-test). Plasma histamine levels (mean +/- SD) were higher in the placebo group than in the antihistamine group at 5 and 20 min after mesenteric traction, but there was no statistical significance. Arrhythmias were significantly more frequent in the placebo group (6 times) than in the antihistamine group (none) (p = 0.005 Chi2-test). Systolic blood pressure was not statistically different between the groups (e.g. 5 min after mesenteric traction, mean +/- SD; placebo 111 +/- 20 mm Hg vs. antihistamines 119 +/- 35 mm Hg). In the placebo group, however, the haemodynamics only stabilised 5 min after mesenteric traction when anaesthetic gas concentration was repeatedly reduced and vasopressor/volume administration was increased (placebo group = 20 times vs. antihistamine group = 8 times (p = 0.001, Chi2-test). From these results we conclude that prophylactic administration of antihistamines reduces in particular the incidence of arrhythmias and the number of stabilising measures during mesenteric traction. Prophylaxis with H1- and H2-antihistamines may therefore be of perioperative benefit and should be considered in AAA surgery.
Aged↗
Histamine release in mesenteric traction syndrome during abdominal aortic aneurysm surgery: prophylaxis with H1 and H2 antihistamines.
OBJECTIVE AND DESIGN: Mesenteric traction syndrome is described as sudden tachycardia, hypotension and flush. Among other etiological factors eventeration or mesenteric traction of the small intestine may cause histamine release from mesenteric mast cells. We hypothesized that mesenteric traction syndrome may be positively influenced by prophylactic antihistamine administration. METHODS: Male patients (n = 17, ASA groups III-IV, 48-78 years old) were investigated in a randomised double blind study during elective abdominal aortic aneurysm (AAA) repair. Eight patients had pre-anaesthetic prophylaxis with dimetindene (H1-receptor antagonist) plus cimetidine (H2-receptor antagonist), 9 patients received placebo. Anaesthesia and invasive haemodynamic monitoring were standardised in all patients. Haemodynamic parameters, plasma histamine concentrations and clinical symptoms were determined 1 min after skin incision, as well as 5 and 20 min after mesenteric traction. Statistical analyses were performed using the Student's t-test, Chi2-test for incidences and Mann-Whitney-U-test for continuous data. RESULTS: The incidence of histamine release was 55.5% (5/9) in the placebo group vs. 37.5% (3/8) in the antihistamine group (p > 0.05, Chi2-test). Plasma histamine levels (mean +/- SD) were higher in the placebo group than in the antihistamine group at 5 and 20 min after mesenteric traction but the difference did not reach statistical significance. Arrhythmias were significantly more frequent in the placebo group (6 times) than in the antihistamine group (none) (p = 0.005 Chi2-test). Systolic blood pressure was not statistically different between groups (e.g. 5 min after mesenteric traction, mean +/- SD; placebo 111 +/- 20 mm Hg vs. antihistamines 119 +/- 35 mm Hg). However, in the placebo group the haemodynamics only stabilised 5 min after mesenteric traction when anaesthetic gas concentration was repeatedly reduced and vasopressor/volume administration was increased (placebo-group = 20 times/antihistamine-group = 8 times, p = 0.001, t-test). CONCLUSION: Prophylactic administration of antihistamines reduced the incidence of histamine release as well as the incidence of arrhythmias and the amount of stabilising measures during mesenteric traction. Prophylaxis with H1 and H2 antihistamines may be of perioperative benefit and should therefore be considered in AAA-surgery.
Aortic Aneurysm, Abdominal↗
Influence of antibiotic prophylaxis on mortality and perioperative histamine release in trauma: experiments with clinic modelling randomized trials in animals.
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Anesthesia↗
[How do general surgery patients experience the intensive care unit? Results of a prospective observational study].
INTRODUCTION: Subjective experiences of patients during their stay in the intensive care unit (ICU) have so far rarely been described. The aim of this study was to analyze the experiences of patients during their stay in the ICU. METHODS: In a prospective study, 100 general surgical ICU patients were recorded consecutively. A questionnaire that covered a broad range of possible ICU experiences was handed out to patients shortly following their stay in ICU. At the same time, a questionnaire was given to the personnel of the ICU to investigate how well nurses and doctors were able to adopt the patients' perspectives of the ICU experience. RESULTS: Concerning the physical symptoms, insomnia was to the fore (67% of patients). Despite pain medication, 25% of patients reported severe pain. The main psychological symptom was a feeling of helplessness (29% of patients). As a general cause for concern, 48% of patients complained about limited mobility. The patients were critical of the presence of severely ill patients. The standards of nursing and medical attention, however, were judged very positively. The evaluation of the staff differed from the patients' experiences in many respects; the clearest differences concerned the items of pain, sleeping disorders and the observance of privacy. CONCLUSIONS: The study results led to several practical consequences in the quality of management procedure (e.g., the introduction of a thorough night's rest at the ICU, optimized information for patients). Additionally, we initiated further studies concerning the quality of life of ICU patients.
Adult↗
[Surgical decision making and behavior. Social psychology explanations and research perspectives].
Social psychology is the discipline that investigates thought processes, emotions, and behaviors in the interpersonal context. There are three broad topic domains: understanding oneself and other persons, interpersonal relations, and group influence. The most important method is the experiment. The value of the social psychological perspective is illustrated with regard to the following surgical research questions: How do surgeons arrive at their decisions? How do surgeons confirm their decisions? Why do decision aids (computer support, guidelines) receive so little acceptance? How should patients be informed? Which group processes play a role in the operating theatre? What are the determinants of patient outcomes? Social psychology can extend surgical research in three respects: better understanding of everyday phenomena in the clinical and surgical arena, methodologically refined and stronger patient-oriented study designs, and new perspectives for improved patient outcomes.
Adult↗
Primary breast cancer therapy in six regions of Germany.
Studies from six regions of Germany (Aachen (W1), Dresden (E1), Jena (E2), Marburg (W2), Munich (W3), and Stuttgart (C1)) have been compared to verify and assess the quality of healthcare using breast cancer as an example. All of the data collection was carried out in comprehensive cancer centres and is population-based, with the exception of C1. Classic prognostic factors and the initial treatment of 8661 women with breast cancer, diagnosed between 1996 and 1998, were examined. Primary therapy, breast conserving therapy (BCT), and the use of subsequent local radiation and/or systemic therapy (chemotherapy or hormonal therapy) were analysed. BCT was performed on 39.3-57.7% of patients. By pT-category, the proportion of BCT in the six regions were as follows: for pTis between 37.8 and 64.3%, for pT1 between 51.7 and 71.5%, for pT2 between 25.9 and 51.1%, for pT3 between 0 and 13.1% and for pT4 between 0 and 15.2%. Multivariate analyses, adjusted for age and biological factors, showed a significant influence of the treating hospital on the mastectomy rate. The use of radiotherapy after BCT (80%) was quite homogeneous in the six regions. The application of radiotherapy after mastectomy, however, varied between 10.4 and 32.2%. In all regions, for premenopausal patients, the use of adjuvant systemic therapy almost reflected the St. Gallen-Consensus recommendations. In contrast, post-menopausal women with positive lymph nodes were not always treated according to these standards. In all regions, age had an influence on the administration of treatment: elderly breast cancer patients received less BCT, less radiotherapy and less adjuvant therapy than recommended in the St. Gallen-Consensus. Feedback of the results was made available to each hospital, providing a comparative summary of patient care that could be used by the participating hospitals for self-assessment and quality-control.
Age Distribution↗