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Biomedical subjects

M Koller

Publications and source records attributed to M Koller.

At least 91 records · Page 5Linked to original sources
PubMed1998

Spontaneous leak and transection of permanent subclavian catheters.

BACKGROUND AND OBJECTIVES: Implanted central venous access ports are frequently used. Spontaneous break and catheter transection are serious but rare complications of permanent subclavian catheters. We report our experience with this serious complication and identify possible warning signs. MATERIALS AND METHODS: Between 1990 and 1996, 285 permanent subclavian catheters were placed at the Sheba Medical Center, Tel Hashomer, Israel. RESULTS: We evaluated the patient population for this complication and searched for possible warning signs. A total of 12 patients (4.2%) with this complication were identified, 8 with transection and distal embolization and 4 with a partial tear only. The pinch-off sign was noted as an early warning in only 5 patients. All other patients developed symptoms only immediately before the diagnosis of this complication. The mean duration from insertion to identification of tear or transection was 9.6 months (range 1-24 months). CONCLUSION: Awareness and clinical suspicion are most important in identification and prevention of this serious complication. Catheters should be taken out when treatment is completed or after 12 months in order to prevent catheter breaks.

Adult↗
PubMed1998

[Clinical studies on emergency medicine. An application oriented classification, its planning and realization].

Clinical studies are usually conceived of as controlled randomized trials, as retrospective patient statistics or as single case reports. However, such a classification is too narrow and overlooks many other forms of study designs. This review, therefore, offers a more encompassing and practical classification of clinical studies for the field of emergency medicine. Randomized controlled trials fulfill scientific criteria at the highest level (gold standard): comparison, repeatability, objective measurement. At the same time, randomized trials also have to comply with demanding ethical criteria and must be justifiable in the individual patient. Therefore, comparable uncertainty with regard to the superiority of the treatment options under investigation is a sine qua non. In addition to randomized trials, six other groups of clinical trials have the potential to solve scientific questions in emergency medicine: observational studies, decision analysis, meta analysis, public health care studies, case reports and descriptive summary statistics and studies on ethical problems. This variability in trial designs calls for a clinically oriented methodologist; the concept and institutionalization of theoretical surgery has been a response to this demand. All study types in this review are illustrated by examples in emergency medicine. Literature for advanced reading in particular trial methodologies can be found in the reference list. A checklist summarizes all elements for designing and conducting randomized trials in emergency medicine. All clinical trials striving for a high standard of quality--whether randomized or not--depend on the following prerequisites:professional organization, time effort, a supportive social environment and a scientific culture.

Clinical Trials as Topic↗
PubMed1998

[Radiotherapy in surgical and nonsurgical patients. Therapy expectations, quality of life and physician assessment].

The present study investigates patients' expectations toward radiotherapy and their associations to quality of life and physician judgements. Fifty-five patients with tumors of different sites (30 with previous tumor-related surgery, 25 without surgery) admitted to the department of radiotherapy filled out a standardized questionnaire (EORTC QLQ-C30, PLC by Siegrist et al., therapy-related expectations and success) before and after inpatient radiotherapy. The corresponding physician ratings were collected. Fifty-eight percent of the patients expected the therapeutic goal "healing", whereas from the physician's standpoint this was realistic in only 7% of cases. The specific radiotherapy-related expectations "tumor control" and "pain relief" reached almost the same levels in patients and physician (71% vs 71% and 40% vs 44%). Patients with healing expectancy reported higher quality of life at the beginning of the therapy (53.4% vs 39.9%); patients expecting pain relief reported lower quality of life (37.1% vs 54.5%). Surgical patients who had been operated on within the past year (n = 18) showed a particularly high healing expectancy (83%), whereas patients whose operation dated back more than 1 year focused on pain relief as therapeutic goal (83%). The surgeon, as the primary contact person for patients, can influence patients' therapy-related expectations. In explaining the overall therapeutic strategy, surgeons should also mention the scope and limits of adjuvant therapies.

Adult↗
PubMed1998

Quality of life research in patients with rectal cancer: traditional approaches versus a problem-solving oriented perspective.

The present paper critically appraises two recent overviews of the literature on rectal cancer and quality of life (QL). These reviews focus on the Anglo-American literature, largely neglect research from other countries, and provide little stimulus regarding future research directions. As an alternative perspective we propose the concept of problem-solving oriented QL research. The major theme is that the QL concept must be integrated into the clinical arena. To begin with, QL researchers must make themselves understandable. We outline several ways in which this can be achieved: (a) placing QL in a broader concept together with outcomes that are more familiar to clinicians; (b) depicting individual patients in the form of QL profiles; (c) clarifying the psychosocial/clinical correlates of particular QL scores of interest; and (d) conducting studies with a definitive practical goal in mind and integrating practitioners and patients into the study group. We illustrate the feasibility of such a research program by performance data from our Marburg-Biedenkopf field trial. Pursuing an ambitious research strategy that integrates experimental and applied research, the QL movement will have the chance to show that it is not merely l'art pour l'art, but indeed is beneficial to society.

Humans↗
PubMed1998

Sentinel lymph node involvement--a predictor for axillary node status with breast cancer--has the time come?

AIMS: Axillary node dissection for breast cancer is important for staging and its prognostic value. Sentinel nodes are defined as the first nodes into which the primary cancer drains. This study investigates whether identification, removal and pathological examination of these nodes indicates whether the completion of axillary lymphadenectomy is required. METHODS: Using a vital dye injected at the primary tumour site, we were able to identify sentinel nodes in 96 out of 98 women examined. RESULTS: An average number of 2.7 +/- 1.2 nodes per patient were identified as sentinel nodes. In 83% of cases there was a correlation between the involvement of the sentinel nodes and the rest of the axillary nodes. In 14% of patients the sentinel nodes were the only nodes involved with tumour. In three cases the sentinel nodes were negative, but other axillary nodes were tumour-positive. CONCLUSION: The major problem in routine application of this method to the decision to perform axillary lymph node dissection (ALND) is the time needed for pathological identification of lymph node involvement by tumor.

Adult↗
PubMed1997

BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).

Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.

Adult↗
PubMed1997

Recombinant and nonrecombinant factor XIII and its effect on bone ingrowth and strength of fixation.

Thirty cylindrical, commercially pure, titanium fiber, porous-coated Ti6Al4V implants were inserted press-fit into the proximal humeral portion of 30 sheep humeri to determine the systemic effect of recombinant factor XIII and placenta-derived factor XIII concentrate on bone ingrowth and strength of fixation. For both the recombinant factor XIII and the factor XIII concentrate group, the volume of bone ingrowth and the strength of fixation were higher than for the control specimens. However, the difference was only significant for the factor XIII concentrate group.

Animals↗
PubMed1997

Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia.

We enrolled and treated 122 patients with idiopathic cervical dystonia in a double-blind, placebo-controlled safety and efficacy study of botulinum toxin type B (BotB). Both A-responsive and A-resistant patients were enrolled. Patients received intramuscular injections of either BotB (2,500 U, 5,000 U, or 10,000 U) or placebo. The primary outcome measure of efficacy was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at 4 weeks following study drug administration. Secondary measures of efficacy were TWSTRS-Severity, -Disability, and -Pain subscale scores, and Analog Pain Assessment, Investigator Global Assessment, Patient Global Assessment, and Sickness Impact Profile scores. Duration of effect was estimated with an intent-to-treat analysis of responders. Safety measures included clinical parameters, laboratory tests, and adverse events. The primary and most of the secondary analyses indicated a statistically significant treatment effect and a dose response. BotB is safe, well tolerated, and efficacious in the treatment of cervical dystonia at the doses tested.

Adult↗
PubMed1997

Avoiding diarrhea after subtotal colectomy with primary anastomosis in the treatment of colon cancer.

BACKGROUND: Subtotal colectomy has been criticized as causing increased frequency of stool passage, thus adding to the patients' morbidity. We review our experience with subtotal colectomy and determine the factors affecting postoperative diarrhea. STUDY DESIGN: One hundred thirty-six patients with colon cancer were treated by primary subtotal colectomy. Of these, 30 percent underwent an emergency resection; 15 percent, semi-emergency resection; and 55 percent, elective subtotal colectomy. There were 29 complications and 3 deaths. RESULTS: The incidence of complications was higher when the operation was carried out on an emergency or semi-emergency basis. In assessing the patients' increased postoperative stool frequency, there was no difference between the groups; but, the length of the remaining colon and the resected terminal ileum had a significant effect on postoperative diarrhea. If less than 10 cm of terminal ileum is resected and more than 10 cm of colon is left above the peritoneal reflection, there is a marked decrease in the incidence of diarrhea after subtotal colectomy. CONCLUSIONS: Subtotal colectomy is an acceptable treatment for left colonic carcinoma, electively as well as in emergency situations. Postoperative diarrhea can be minimized by attention to the length of small bowel and sigmoid that are resected.

Adult↗
PubMed1997

[Value of preoperative blood coagulation analysis for assessment of hemorrhage risk in general surgery].

Coagulation studies, i.e. platelet count, prothrombin time (PT) and activated partial thrombin time (aPTT) are commonly employed preoperatively to identify patients at risk. In a retrospective study we evaluated the usefulness of these screening tests to predict postoperative bleeding in 1447 patients with abdominal and thoracic surgery. Forty-six patients (3.2%) experienced postsurgical bleeding. 12.2% of our patients had abnormal coagulation studies. The sensitivity of abnormal coagulation studies with respect to postoperative bleeding was 23.9%. The sensitivity of the parameter "patient at risk", i.e. patients with suspected coagulopathies due to drugs or disease of the liver or kidney, was 56.5%. Thirty-four out of 1008 patients without risk factors had abnormal coagulation tests but an uneventful postoperative course. Preoperative screening of PT and aPTT should be reserved for patients with known or suspected inherited or acquired coagulopathies.

Adult↗
PubMed1996

Symptom reporting in cancer patients: the role of negative affect and experienced social stigma.

BACKGROUND: Recent research suggests that patients' appraisal of somatic symptoms is more closely related to emotional variables (particularly negative affect) than to their actual health as determined by external criteria. METHODS: Sixty surgical cancer patients who at the time of a routine follow-up examination filled out the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire-C30, which included a positive/negative affect scale and a scale tapping into experienced social stigma. Patients' health status was determined in two ways: the examining physician gave a global judgement on a standardized scale at the end of the examination, and an additional two external physicians later rated the patients based on the findings listed in the medical record. RESULTS: Patients' reports of somatic symptoms were strongly correlated with two measures of negative affect (r = 0.75 and r = 0.65, respectively) and with experienced social stigma (r = 0.51). In contrast, the correlations between reported symptoms and the examining or external physicians' ratings were considerably weaker (r = 0.31 and r = 0.19). According to a multiple linear regression with 6 predictors, negative affect was the best single predictor of symptom reporting (beta = 0.68; P < 0.001) and global quality of life (beta = 0.48; P < 0.001). Factor analysis yielded a dimension of somatopsychosocial distress that accounted for 44.1% of the variance and is comprised of reported symptoms (factor loading = 0.86), negative affect (0.90 and 0.82), experienced social stigma (0.74), and global quality of life (0.70). Physicians' ratings and positive affect constituted two additional separate factors. CONCLUSIONS: Cancer patients' reporting of somatic symptoms by means of a standardized quality of life questionnaire is closely related to emotional and social distress and is not equivalent to health status as determined from a clinical perspective. Researchers and practitioners have to be aware of this fact when interpreting quality of life data. Furthermore, negative affect deserves attention as an important signal for intervention in tumor follow-up programs.

Abdominal Neoplasms↗
PubMed1996

Occupational health services for shift and night workers.

It is important for an occupational health service to plan health supervision and measures for shift and night workers considering the biorhythmic and psychosocial desynchronisation, as well as the frequent prevalence of combined effects of adverse environmental and working conditions. The measures taken should be preventive to reduce the expected health risks rather than being rehabilitative. Both a medical surveillance and a counselling service are recommended before and during engagement in shift and night work. Sleep, digestive, metabolic and cardiovascular troubles should be noted and followed up. Medical counselling is especially necessary in the first months of shift and night work exposure and then after long-term exposure. The postulate for timed surveillance and intervention is supported by data of our epidemiologic investigations. The importance of the single health measures is underlined by direct reference to the relevant literature. Recommendations that should be applied in all countries and enterprises are in accordance with the ILO Night Work Convention 1990a and include: (1) appropriate occupational health services provided for night and shift workers, including counselling; (2) first aid facilities during all shift hours; (3) the option of transfer to day work when certified unfit for night work for reasons of health; and (4) measures for women on night shifts, in particular special maternity protection (transfer to day work, social security benefits or an extension of maternity leave). Examples of occupational health services already installed in some states for shift and night workers, and information on future developments are given. Up to now the medical service has been implemented mostly on the basis of collective agreements rather than on the basis of legal provisions. The Austrian Night Shift/Heavy Work Law Regulations of 1981, revised 1993, are cited: workers exposed to night shifts under defined single or combined additional heavy workloads are entitled to a special health assessment, additional rest pauses, additional free time and early retirement depending on years of exposure.

Journal Article↗
PubMed1996

The effect of anesthesia type on needle localization breast biopsy: another point of view.

BACKGROUND: Efforts directed at early detection of breast cancer have resulted in an increased incidence of nonpalpable mammographic lesions that warrant excisional biopsy. The most common localization method is by use of the hook wire technique, or needle localization biopsy. Although much has been written about the localization technique, the impact of the method of anesthesia on the accuracy of the biopsy and especially on the completeness of the excision has not been clarified. PATIENTS AND METHODS: We studied 450 needle localization breast biopsies to determine whether the type of anesthesia (local versus general) influenced the accuracy and completeness of the biopsy. We compared 153 biopsies performed under local anesthesia to 297 done under general anesthesia. RESULTS: The use of local versus general anesthesia did not affect accuracy; however, it did determine the inability to achieve clean margins (27.6% versus 7.3%, respectively, P <0.02). It was more difficult to excise completely specimens located deeper than 3 cm in the breast, when the localizing needle travelled more than 3 cm, and when the lesions were of the microcalcification mammographic pattern. CONCLUSIONS: For lesions mammographically suspicious for malignancy, mainly those located deeper than 3 cm, general anesthesia is preferred.

Anesthesia, General↗
PubMed1996

Regional hyperthermic perfusion with cisplatin following surgery for malignant melanoma of the extremities.

BACKGROUND: The study was undertaken to review our experience in the treatment of extremity melanoma with hyperthermic isolated limb perfusion (HILP), using cisplatin as the chemotherapeutic agent. We also evaluated the best timing for regional lymph node dissection in relation to the perfusion. PATIENTS AND METHODS: Sixty patients with advanced malignant melanoma of the limbs were treated with HILP used mainly as an adjuvant treatment. There were 56 lower- and 4 upper-limb HILPs. Cisplatin was used at a dose of 20 mg/L of limb volume. Temperature at the tumor site was 39 degrees C to 40 degrees C. Postoperative complications, disease-free period, and time to recurrence were recorded. RESULTS: There were no deaths related to the procedure. Forty-seven percent of the patients developed local complications; most complications were minor and resolved within 60 days. The local complication rate was higher when HILP was performed shortly after or simultaneously with regional lymph node dissection. None of the patients had systemic complications. Mean survival time from treatment was 87.2 months. Currently, 35 patients (58%) are alive and free of disease 52.7 +/- 22.5 months after HILP. Twelve patients (20%) are alive with recurrent disease, of which 5 recurred locally. The average time (+/- standard error of the mean) to recurrence was 24.5 +/- 13.8 months after perfusion. CONCLUSIONS: HILP with cisplatin is a relatively safe procedure, which seems to increase locoregional control of advanced malignant melanoma of the extremity. Separating the timing of lymph node dissection from HILP by 6 to 8 weeks reduces the complication rate.

Aged↗
PubMed1996

[Acute inpatient treatment of manias. Effects of independent variables on neuroleptic dosage and length of stay].

Investigations of drug therapy regimens in the treatment of acute mania are rare, selective, methodically problematic, and contradictory. The goal of the present study is to describe the practice of mania treatment in a large unselected collective of patients for the first time, and, following reduction of the data to global parameters such as length of stay, neuroleptic daily and total doses, to determine sources of variance and the strength of their effects by means of explorative data analysis. In contrast to widely held opinions, neuroleptics are used as primary medication in all grades of severity of manic illness. The daily dose comprises 496 +/- 379 mg of chlorpromazine (CPZ) equivalents; this result supports the first dose determination study and is at odds with other studies with much higher dosages. The amount of mean daily medication is only influenced by the severity of illness according to variance analysis, the effect is moderately strong. Neuroleptics appear to have causal effects, a property that has so far only been attributed to prophylactic medication, which is given in 80% of cases; the different application forms have no effect on the neuroleptic dosage, although they do affect the length of stay slightly. The mean length of stay is 46.6 +/- 35.7 days and is slightly affected by age, sex, severity of illness and compliance.

Acute Disease↗