[The new patient rights act : the significance for surgeons]. / Zum neuen Patientenrechtegesetz : Bedeutung für den Chirurgen.

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.

[Valid liability law in surgery. Principles of legal requirements and clinical benchmarks exemplified by visceral surgery]. / Über das geltende Haftungsrecht in der Chirurgie. Grundsätzliche juristische Vorgaben und klinische Bezugspunkte am Beispiel der Viszeralchirurgie.

The spectacular increase in liability processes in the field of surgery and in particular in visceral surgery, necessitates an objectification of the conflict between surgical medical professionals and medico-legal institutions, firms of solicitors and courts. Out of court settlements assisted by expert opinion commissions of the Medical Council can avoid many legal conflicts. For improvement of the legal standpoint of a defendant medical professional an unambiguous, extensive and detailed documentation of medical examination findings, the indications for the planned operative intervention, extensive and detailed documentation on disclosure and informed consent of the patient for the planned operative intervention, an extensive, detailed careful and responsibly guided report of the operation as well as a systematic, orderly well-planned postoperative complication management are necessary to counter the accusation of an organizational failure of medical professionals and the accused hospital. The mutual building of confidence between surgical medical professionals and legal institutions is safeguarded by a comprehensive documentation and an unambiguous description and formulation of the medical discharge report on termination of inpatient treatment.

[Patient compliance and efficacy of diagnostic procedures in the surveillance of colorectal cancer: experience from a cancer center]. / Patientencompliance und Stellenwert diagnostischer Verfahren in der Tumornachsorge beim kolorektalen Karzinom: Erfahrungen aus einem Tumorzentrum.

Postoperative surveillance is an important part of the curative therapy of colorectal cancer patients. The effort and effectiveness of these surveillance programs are controversially discussed. We analyzed the practiced follow-up of patients who had undergone a curative resection of colorectal cancer to demonstrate the difficulty to validate the performed surveillance program and to point out possible improvements. For a follow-up period of 37 months (median) we included 530 patients with at least one postoperative examination. 70 patients ended the follow-up prematurely - out of these 56 % quit the surveillance during the first 18 months. Another 68 patients died during the follow-up period. Cancer recurred in 28 % of the patients (n = 109 metastasis, n = 26 local recurrences, 18 patients developed a secondary cancer). 90 % of these recurrences occurred within the first three years. 3525 follow-up examinations took place within 79 months. Patient histories and physical examinations were not helpful for the diagnosis of local recurrences; neither were laboratory routine screenings meaningful. Carcinoembryonic antigen (CEA) and CA 19 - 9 tests, ultrasonographic studies, chest XD-rays and colonoscopic procedures had a higher diagnostic value on the other hand. We demonstrated the problematic nature of the evaluation of different follow-up tests concerning their validity as they were part of a complex postoperative surveillance program. It is also important to point out that the success of the postoperative surveillance depends strongly on the compliance of the patients. To increase this compliance we suggest that the follow-up of patients should be more strongly oriented towards the incidence of recurrences.

Interferon beta-1a in ulcerative colitis: a placebo controlled, randomised, dose escalating study.

BACKGROUND: and aims: Administration of interferon (IFN)-beta may represent a rational approach to the treatment of ulcerative colitis through its immunomodulatory and anti-inflammatory effects. The present study was performed to evaluate the efficacy and tolerability of IFN-beta-1a. METHODS: Patients (n=18) with moderately active ulcerative colitis were randomised to receive IFN-beta-1a or placebo. IFN-beta-1a was started at a dose of 22 micro g three times a week subcutaneously, and the dose was increased at two week intervals to 44 micro g and then to 88 micro g if no response was observed. The maximum duration of treatment was eight weeks. End points were clinical treatment response, defined as a decrease of at least 3 points from baseline in the ulcerative colitis scoring system (UCSS) symptoms score and induction of endoscopically confirmed remission. RESULTS: Baseline characteristics and disease severity were similar in both groups. Data from 17 patients are included in this report (10 patients in the IFN-beta-1a group and seven patients in the placebo group). Clinical response was achieved in five patients (50%) in the IFN-beta-1a group and in one (14%) in the placebo group (P=0.14). Remission was achieved in three patients in the IFN-beta-1a group and in none in the placebo group (p=0.02). Most adverse reactions associated with IFN-beta-1a were influenza-like symptoms or injection site reactions, and were mild or moderate in severity. CONCLUSIONS: IFN-beta-1a may represent a promising novel treatment approach in ulcerative colitis.

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses.

BACKGROUND: Balsalazide is a new 5-aminosalicylic acid (5-ASA) containing prodrug. Its efficacy in comparison with standard mesalazine therapy and the optimum dose for maintaining remission of ulcerative colitis are still unclear. AIMS: To compare the relapse preventing effect and safety profile of two doses of balsalazide and a standard dose of Eudragit coated mesalazine. METHODS: A total of 133 patients with ulcerative colitis in remission were recruited to participate in a double blind, multicentre, randomised trial: 49 patients received balsalazide 1.5 g twice daily, 40 received balsalazide 3.0 g twice daily, and 44 received mesalazine 0.5 g three times daily. Efficacy assessments were clinical activity index (CAI) and endoscopic score according to Rachmilewitz, and a histological score. In addition, laboratory tests were performed and urinary excretion of 5-ASA and its metabolite N-Ac-5-ASA was analysed. The study lasted for 26 weeks. RESULTS: Balsalazide 3.0 g twice daily resulted in a significantly higher clinical remission rate (77.5%) than balsalazide 1.5 g twice daily (43.8%) and mesalazine 0.5 g three times daily (56.8%) (p=0.006). The respective times to relapse were 161 days, 131 days (p=0.003), and 144 days (NS). Accordingly, pairwise contrasts of the final endoscopic score demonstrated a significant difference (p=0.005) between the two balsalazide treatment groups while differences between either of these two groups and mesalazine were not statistically significant. Patients treated with balsalazide excreted less 5-ASA and N-Ac-5-ASA than patients receiving mesalazine but these differences were not statistically significant. Discontinuation of the trial because of adverse effects occurred in nine patients: three in the balsalazide 1.5 g twice daily group, two in the balsalazide 3.0 g twice daily group, and four in the mesalazine 0.5 g three times daily group. No clinically important new drug safety related findings were identified in this study. CONCLUSIONS: High dose balsalazide (3.0 g twice daily) was superior in maintaining remission in patients with ulcerative colitis compared with a low dose (1.5 g twice daily) or a standard dose of mesalazine (0.5 g three times daily). All three treatments were safe and well tolerated.

[Pathology of liver cirrhosis and portal hypertension]. / Pathologie der Leberzirrhose und der portalen Hypertension.

Cirrhosis is a late stage finding in chronic liver diseases of different aetiology. It is defined morphologically as a diffuse process with the presence of fibrosis and structurally abnormal nodules. The consequences of cirrhosis are both, mechanical and functional. The mechanical complications result from intra- and extrahepatic shunting of blood and portal hypertension while the functional relevance bases upon a failure of liver cells to perform their physiological role in metabolism, synthesis and secretion. Beside these complications that are directly linked to liver function cirrhosis in itself is a risk factor for hepatocellular carcinoma.

[Pathohistological findings in liver metastases]. / Pathohistologische Befunde bei Lebermetastasen.

Metastatic tumors are the most common malignancies of the liver. The frequency distribution of the primary tumor location site closely resembles the frequency distribution of primary cancers in general. Yet, due to the liver's filter function of the portal blood-stream, metastatic tumors of the gastrointestinal tract are overrepresented. Most metastatic tumors show a nodular growth pattern with a demarcation of the tumor by inflammatory or fibrous reactive tissue; a diffuse metastatic tumor spread within the sinusoids is uncommon. Metastatic liver tumors may be the first clinically detectable manifestation of an unknown primary tumor. In these cases, the histological and immunohistochemical pattern of the metastatic tumor cells may give a clue of the location of the corresponding primary tumor.

Genetic analysis of inflammatory bowel disease in a large European cohort supports linkage to chromosomes 12 and 16.

BACKGROUND & AIMS: Inflammatory bowel disease (IBD) is a complex disorder of unknown etiology. Epidemiological investigations suggest a genetic basis for IBD. Recent genetic studies have identified several IBD linkages. The significance of these linkages will be determined by studies in large patient collections. The aim of this study was to replicate IBD linkages on chromosomes 12 and 16 in a large European cohort. METHODS: Three hundred fifty-nine affected sibling pairs from 274 kindreds were genotyped using microsatellite markers spanning chromosomes 12 and 16. Affection status of the sibling pairs was defined as Crohn's disease (CD) or ulcerative colitis (UC). RESULTS: Nonparametric statistical analyses showed linkage for both chromosomes. Two-point results for chromosome 12 peaked at D12S303 (logarithm of odds [LOD], 2.15; P = 0.003) for CD and at D12S75 (LOD, 0.92; P = 0.03) for UC. Multipoint analyses produced a peak LOD of 1.8 for CD. Chromosome 16 showed linkage for CD at marker D16S415 (LOD, 1.52; P = 0.007). Multipoint support peaked above markers D16S409 and D16S411 (LOD, 1.7). CONCLUSIONS: These data are consistent with linkage of IBD to chromosomes 12 and 16. The replication of genetic risk loci in a large independent family collection indicates important and common susceptibility genes in these regions and will facilitate identification of genes involved in IBD.

Olsalazine versus mesalazine in the treatment of mild to moderate ulcerative colitis.

AIM: To compare the efficacy and tolerability of olsalazine sodium with enteric-coated mesalazine in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis. PATIENTS AND METHODS: Patients with mild to moderate active ulcerative colitis were randomized to receive either olsalazine sodium, 3 g/day (n = 88), or mesalazine, 3 g/day (n = 80), for up to 12 weeks. RESULTS: Of the patients treated with olsalazine sodium, 52.2% achieved endoscopic remission, compared with 48.8% of patients treated with mesalazine. This difference was not significant (P = 0.67). There was a nonsignificant trend for patients with left-sided colitis or a more severe endoscopic grade to achieve remission if they were treated with olsalazine sodium than if they were treated with mesalazine. Both treatments were comparable with respect to clinical activity index and an investigator's global assessment. Seventy patients reported one or more adverse events; adverse events were seen in 45% of olsalazine sodium-treated patients and in 36% of mesalazine-treated patients. Eleven patients treated with olsalazine sodium and nine patients treated with mesalazine withdrew from the study because of adverse events. One patient treated with olsalazine sodium compared with two treated with mesalazine stopped treatment because of diarrhoea. Serious adverse events occurred in three patients treated with olsalazine sodium and in four treated with mesalazine. CONCLUSION: Therapeutic effectiveness and tolerance to the treatment did not differ between olsalazine sodium, 3 g/day, and mesalazine, 3 g/day, in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis within 12 weeks of treatment.

Solid phase competitive luminescence immunoassay for immunoglobulin A in faeces: development and clinical validation.

We describe a new simple solid-phase competitive luminescence immunoassay (LIA) for the determination of immunoglobulin A (IgA) in faeces. The assay utilizes an anti-alpha-chain IgA antibody which is coated to polystyrene beads and acridinium ester-labelled human IgA as tracer and, therefore, measures both monomeric and polymeric IgA. Dilution recovery of an internal standard was 96, 100 and 103%. Interassay and intra-assay coefficients of variation (C.V.) ranged from 4.5 to 12.9%. The upper limit of normal of faecal IgA in 122 healthy controls was found to be 300 mg/l IgA (mean 73 mg/l, specificity of 99.2%). Patients with inactive Crohn's disease (Crohn's disease activity index (CDAI < 150, n = 14) had faecal IgA values up to 3317 mg/l (mean 1073 mg/l; P < 0.0001). In the active group (CDAI > 150, n = 26) faecal IgA values ranged from 49 to 4094 mg/l (mean 1253 mg/l; P < 0.0001). Patients with ulcerative colitis were divided into a group with active disease (n = 18) and a remission group (n = 16) with values up to 1843 mg/l faecal IgA (man 486 mg/l; P < 0.0032) and up to 602 mg/l faecal IgA (mean 176 mg/l; P < 0.4833), respectively. We also studied patients with non-inflammatory diseases of the gut with this assay. This LIA has proved to be a reliable method for the determination of elevated faecal IgA concentrations and for the detection of pathological findings in the gastrointestinal tract, especially in Crohn's disease.

Solid-phase competitive luminescence immunoassay for lysozyme in faeces.

We have developed a new simple solid-phase luminescence immunoassay (LIA) for the determination of faecal lysozyme. The assay utilises a polyclonal capture antibody coated to polystyrene beads and acridinium ester-labelled human lysozyme as tracer. Samples are incubated with polystyrene beads and tracer overnight at 4 degrees C. After a thorough washing step, emitted light is measured by an automated luminometer for 2 seconds. The standard curve uses five standards ranging from 0.025 to 6.4 mg/l. The method has a sensitivity of 0.02 mg/l. Dilution recoveries for three samples were 88, 104 and 108%. Intraassay coefficients of variation (CV, n = 24) were 10.1% and 11.7% for a healthy control and a patient sample; interassay CV (n = 16) were 6.7% and 13.1% for the same healthy control but another patient sample. The normal range of faecal lysozyme in 80 healthy controls was found to be 0.02-1 mg/l (97.5 percentile) with a median of 0.28 mg/l. Fifty-three patients with Crohn's disease had faecal lysozyme values ranging from 0.16 to 100.7 mg/l with a median of 1.75 mg/l, and 30 patients with ulcerative colitis showed levels between 0.09 and 118 mg/l with a median of 1.11 mg/l. The assay has proved useful for differentiating healthy individuals from those with inflammatory bowel disease and might be a valuable tool for diagnosing or evaluating inflammatory bowel disease.

Double-blind dose-finding study of olsalazine versus sulphasalazine as maintenance therapy for ulcerative colitis.

OBJECTIVE: To determine the therapeutic efficacy and safety of three doses of olsalazine compared with the standard dose of sulphasalazine. DESIGN: Randomized double-blind multicentre 6-month study comparing three doses of olsalazine (0.5, 1.25 and 2.0 g daily) and sulphasalazine 2.0 g daily for maintaining remission in patients with ulcerative colitis. SETTING: Public hospitals and private practices in Germany, Austria and Switzerland. PATIENTS: A total of 162 patients with ulcerative colitis in remission. RESULTS: According to intention-to-treat analysis, the failure rates of the different treatment groups were not significantly different (36, 49 and 24% for 0.5, 1.25 and 2.0 g olsalazine daily and 32% for 2.0 g sulphasalazine daily). Olsalazine and sulphasalazine showed a tendency towards lower failure rates in extended (28%) than in distal disease (44%). The withdrawal rate due to adverse effects was 4%, the most frequent single event being diarrhoea (2.5, 5.2 and 11.7% for 0.5, 1.25 and 2.0 g olsalazine daily and 0% for sulphasalazine daily). CONCLUSION: This study found no significant differences between the therapeutic efficacy or safety of 0.5-2.0 g olsalazine daily. Because of its sulpha-free formulation olsalazine may, however, be preferred to sulphasalazine.

Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial.

The effect of olsalazine, an analogue of sulphasalazine, consisting of two molecules 5-aminosalicylic acid linked by an azobond has been investigated for the treatment of ulcerative colitis. In a randomised double blind trial we compared 2 g olsalazine with placebo for four weeks. Of the 105 patients, with mild to moderate ulcerative colitis, entered in the trial 52 received olsalazine, and 53 placebo. Treatment had to be terminated prematurely because of untoward effects of olsalazine (mainly diarrhoea) in three patients and treatment failure--that is, increased rectal bleeding in four patients (olsalazine group: one placebo group: three). After four weeks' treatment, a statistically significant improvement in the endoscopic findings in rectum and a positive trend in the reduction of rectal mucus and blood discharge was observed in the patients treated with olsalazine. No statistically significant difference was found for other factors, including stool frequency, consistency, urge to defecate, abdominal pain, and biopsy findings. A comparison between these clinical and endoscopic parameters at study entry and those at study completion (within drug evaluation) showed significant improvement in six of 10 parameters during treatment with olsalazine and in two of 10 during placebo treatment. This difference suggests the significant effect of olsalazine. We conclude that 2 g olsalazine was tolerated as well as placebo, apart from causing diarrhoea in some patients and was slightly superior to placebo during four weeks' treatment of mild to moderate ulcerative colitis. A study with 3 or 4 g olsalazine per day may show a more definite effect.

Olsalazine in the treatment of mild to moderate ulcerative colitis: a randomized, placebo-controlled, double-blind, clinical trial.

Olsalazine, 2 g/day, was compared with placebo in 126 patients with mild or moderate ulcerative colitis. Evaluation after 4 weeks revealed a significant improvement in endoscopic findings in the rectum and sigmoid colon and in the clinical parameters rectal mucus and blood discharge, whereas no significant difference was found between olsalazine and placebo groups in clinical parameters, such as stool frequency and consistency, urge to defecate, abdominal pain and biopsy findings. It is concluded that olsalazine, 2 g/day, is tolerated as well as placebo except that it caused diarrhoea in some patients.

[Hepatitis markers in gastroenterological diseases in southwest Germany]. / Hepatitis-Marker bei gastroenterologischen Erkrankungen in Südwestdeutschland.

In 360 unselected patients with different gastroenterological diseases we found higher rates of positive hepatitis markers in non-specific inflammation and ulcer of stomach or small bowel as well as in liver diseases (24.5 resp. 41.7%) in comparison to a healthy population. There were no pathogenetic connections to the gastroenterological disease, HBs-antigen-carriers were not increased.

[Ambulatory diagnosis and therapy of ulcerative colitis]. / Zur ambulanten Diagnostik und Therapie der Colitis ulcerosa.

During an examination period of one year in a well defined population of 50 000 inhabitants 44 patients with colitis ulcerosa were diagnostically clarified and secured histologically. 37 patients (84.1%) could be treated and brought into a phase of remission with salazosulfapyridin (Azulfidine), glucocorticoids as well as a liberal gastroenterologic basic diet with restriction on dairy products and occasionally a diet, developed for astronauts. Only 7 patients (15.9%) had to be hospitalized for therapy because of accompanying illnesses, regression in the course of colitis and complications such as anemia and electrolyte imbalances. With view to the degree of severity, the majority of the patients showed signs of erosive and ulcerative changes as well as expanded pseudopolypic formations in the mucous membrane indicating the chronically continuing and chronically relapsing course of the disease. 54.5% of the affected showed endoscopical and histological changes in the rectosigmoid; an additional 27.2? had inflammatory changes up to the left colon flexure (see figure 2). Only 18.3% of the patients showed inflammatory attack of the entire colon. From the degree of severity of the inflammatory changes, the anatomic distribution and expansion in the large bowel, no difference in outpatient therapy with regard to its effectiveness can be seen.

[Ambulant coloscopy in colitis ulcerosa and colorectal cancer]. / Ambulante Koloskopie bei Colitis ulcerosa und kolorektalem Karzinom.

In the first year after establishing a gastroenterological center in a vineyard and industrial district with 220.000 inhabitants we examined 1.171 patients. In 36.53% we had diseases in the lower gastrointestinal tract excluding proctological disturbances. We could find out 37 cases of colitis ulcerosa and 42 colorectal cancers. Excluding two cancers in colon transversum and ascendens all the tumors were found by coloscopy. Previously 4 cases of colitis ulcerosa were identified by other methods, clinically or by rectoscopy. In 48.6% of the colitis ulcerosa the transfer was done by reason of blood in the feces. The melaena lingers between 1 month and 10 years. Other presumed diagnoses for transfer to our Institute were gastroenteritis, proctitis, hemorrhoids, fissure or ileitis terminalis Crohn. In some rare cases the supposed diagnosis was salmonellosis or mycosis of the intestinum. In colorectal cancers the main reason for special gastroenterological investigation was the addition of blood to stool, whether microscopically or visible. Abdominal pain or ileus were following in frequency. Clinical symptoms were to be reconstructed in 30.9% for six weeks, in 59% for six months and in 9.5% up to one year. Most of the colorectal tumors (85.7%) were localized distal from splenic colonflexur, mostly in the rectosigmoid and colon descendens (see figure 1). Ambulant coloscopy is a method for quickly and definitive clarification, if the practitioner will refer swiftly.