[The validity of routine data on quality assurance: A qualitative systematic review]. / Die Validität von Routinedaten zur Qualitätssicherung : Eine qualitative systematische Übersichtsarbeit.

BACKGROUND: The assessment of the quality of medical practice is a legitimate requirement by society. Reliable methods for measurement of the quality of performance are sought worldwide. Quality is often quantified by using administrative data and in Germany this method has been implemented by the health insurance company AOK. OBJECTIVES: (1) How is the AOK quality system rated by senior consultant surgeons? (2) How valid are quality statements derived from administrative data? METHODS: This article was compiled following the PRISMA (i.e. preferred reporting items for systematic reviews and meta-analyses) statement for qualitative systematic reviews. In order to answer the first question the Professional Association of German Surgeons (Berufsverband der Deutschen Chirurgen) initiated two surveys and to answer the second question a structured literature search following the PICO (i.e. patient problem or population, intervention, comparison control or comparator and outcomes) format was initiated. In addition numerous websites were contacted. RESULTS: Of the responding senior consultant surgeons 95% considered that the AOK method of quality measurement by administrative data is not objective. One third was definitely wrongly classified. The literature search revealed that no validation data exist for the AOK indicators, including the Elixhauser comorbidity risk score. Altogether, the sensitivity of indicators is poor when good sensitivity is defined by the Institute for Applied Quality Improvement and Research in Health Care (AQUA Institute) as ≥ 80 < 90%. CONCLUSIONS: Quality statements resulting from administrative data alone are unreliable.

[Clinical trials with medical devices: lack of quality illustrated for faecal incontinence]. / Therapiestudien mit Medizinprodukten: Mangelnde Qualität illustriert anhand analer Inkontinenz.

BACKGROUND: Medical devices must be safe and functioning states the law. Treatments with medical devices need not be efficacious to be allowed. We investigated special requirements and problems arising from the law. METHODS: The market for medical devices is contrasted with that for drugs. The requirements of relevant laws are discussed. Finally, published clinical studies on anal incontinence are analysed with respect to their methodological quality. RESULTS: Clinical trials of medical devices for treat-ing anal incontinence are of poor methodological quality thus preventing evaluation of the devices' utility. CONCLUSION: Large, high quality clinical studies of the efficacy of medical devices for treating anal incontinence are urgently needed. Only such studies enable health technology assessment and comprehensible decisions on reimbursement by health insurance.

[Obstructed defecation]. / Defäkationsobstruktion.

Adequate therapy of obstructed defecation (pelvic outlet obstruction) is often challenging, as the etiology and clinical symptoms include a wide range of disorders. Standardized diagnostic assessment has to differentiate between obstructed defecation caused by either pelvic outlet obstruction or slow transit constipation. Additionally, morphologic changes of colon, rectum, or the pelvic floor have to be separated from functional disorders. Providing defecography or dynamic MR of the pelvic floor, common causes of outlet obstruction such as sigmoidoceles, in which surgery is indicated, and rectal prolapse can be diagnosed with high accuracy. However, the diagnosis and therapeutic options in symptomatic rectocele and intussusception are controversial. Patients with functional disorders such as rectoanal dyssynergia are candidates for conservative treatment (biofeedback). To identify patients who will benefit from surgery for obstructed defecation, careful patient selection remains the crucial issue in diagnostic assessment.

[Present state of radio frequency ablation of liver tumors in Germany]. / Aktueller Stand der Radiofrequenzablation von Lebertumoren. Eine deutschlandweite Umfrage.

INTRODUCTION: Radio frequency ablation (RFA) represents a new technique for local destruction of liver tumors. Indication and procedure are poorly validated at present. METHOD: To record the actual nationwide RFA application in Germany, a survey of 2026 hospitals with standardized questionnaires was conducted. RESULTS: With a respond rate of 17.5%, results from 58 hospitals covering 1700 ablated patients were analyzed. In 25.9% of them, RFA is already used in potentially curative resectable tumors, in 22.4% even when incomplete ablation for tumor mass reduction is expected. Of the 58 hospitals, 75% combine resection and RFA to reach a so-called R-0 situation. The maximal tumor sizes they quoted for achieving complete ablation ranged from <3 cm to 11 cm. In contraindications for RFA, the tumor size, number of tumors, critical localization of the tumor, and disorders of liver function were mentioned the most. CONCLUSION: This survey documents significant discrepancies in indication, application, procedure, and results in RFA for liver tumors. The lack of general standards and an overestimation of the method may lead to uncritical application, neglect of standard therapy, or unsatisfying results.

Anastomotic leakage following low anterior resection: results of a standardized diagnostic and therapeutic approach.

BACKGROUND AND AIMS: This study analyzed the results of a standardized approach in anastomotic leakage following low anterior resection for rectal cancer without performance of a protective ileostomy during the primary operation. PATIENTS AND METHODS: The study included all 306 patients with rectal cancer electively undergoing low anterior resection with retroperitonealization of the anastomosis over 9 years. The diagnostic procedure for anastomotic leakage included serum laboratory investigations and abdominal CT together with contrast enema. Minor leakages, i.e., small leakages and pelvic abscess, were treated with rectoscopic lavage and/or CT-guided drainage of the abscess, respectively. Major leakage was defined as broad insufficiency with or without septicemia. Nonseptic patients were treated by ileostomy and rectoscopic treatment. In septic patients a revision of the anastomosis with loop ileostomy was performed. RESULTS: Anastomotic leakage was diagnosed in 30 patients (overall 9.8%; 12 major, 18 minor leakages). Common clinical signs were pelvic pain and fever. No patient developed a peritonitis. The most accurate diagnostic instrument was CT (96.7%). CONCLUSION: Retroperitonealization appears to prevent peritonitis in patients with anastomotic leakage following low anterior resection. A differential treatment leads to good results in terms of mortality and anorectal function.

Blood selenium and glutathione peroxidase status in patients with colorectal cancer.

PURPOSE: It is still controversial whether a low selenium level and a reduced activity of the selenium-dependent enzyme, glutathione peroxidase, in blood are associated with an increased risk and poor prognosis of cancer in humans. This study evaluates whether colorectal cancer patients have lower serum selenium and glutathione peroxidase levels than a gender-matched and age-matched control group and whether there is a correlation to clinical data and prognosis. METHODS: In a retrospective study, serum selenium and glutathione peroxidase activity of 106 patients with colorectal cancer were determined. Clinical data were provided by our long-term follow-up program for colorectal cancer patients. RESULTS: Patients with a selenium level <70 microg/l had a significantly lower mean survival time and a lower cumulative cancer-related survival rate than patients with a selenium level >70 microg/l (P = 0.0009). When considering the different tumor stages, a decline of the mean selenium level in the T4 carcinoma group was found in the analysis of variance (P < 0.05). The lowest selenium level was found for patients with advanced tumor disease and in a preoperative situation, ie., high tumor burden. In comparison with the control group, the cancer group showed a significant reduction of serum glutathione peroxidase activity (P < 0.01) but no significant difference in selenium level. CONCLUSIONS: These results support the hypothesis of an association between low selenium level and advanced tumor disease. From our data, it cannot be decided whether this phenomenon is more likely to be a consequence or a causative factor for development and course of the disease.

[Non-occlusive ischemic enteropathy--diagnosis, differential diagnosis and therapy]. / Nichtokklusive ischämische Enteropathie--Diagnose, Differentialdiagnose und Therapie.

Reduced cardiac output is the pathogenetic principle of non-occlusive disease. Prerequisites for early diagnosis include anamnesis, clinical and laboratory findings, sonography, mesentericography, contrast enema, and coloscopy. Conservative treatment with vasoactive drugs is promising in early stages. As the abdominal symptoms develop latently, laparotomy is indicated in most cases in order to identify necrosis or perforation and to allow surgery according to the intraoperative findings. Despite indisputable progress made during the past years, the death rate in our patients (n = 42) is still 43%. Only early diagnosis and consequential therapy can achieve better results.

[Improving anal continence performance by intensive continence training]. / Verbesserung der analen Kontinenzleistung durch Kontinenz-Intensiv-Training.

Ten children of six to sixteen years with anal incontinence following anal atresia were treated with a conservative intensive continence training programme for a period of 6 to 18 months. The continence efficiency distinctly improved by an optic and acoustic biofeedback conditioning, transcutaneous electrostimulation of the pelvic muscles, by physical examinations and a sensibility training, as well as by contraction exercises. Not only the partial continence ability with low atresia but also the incontinence with high anal atresia could be improved to a level of continence, especially short-time continence. The essential success is based on an improvement of the strength and duration of the muscle contraction, of the sensible perception and of the nerval coordination of the pelvic muscles. After two weeks of therapy, 90% of the possible maximum increase had already been achieved. Thus, an evaluation of the training success was possible. This continence training programme proved an ideal supplement to surgical therapy. Even if other methods of therapy are exhausted, continence training is indicated for the improvement of anal sphincter function.

[Biofeedback training and functional electrostimulation for improving incontinence in children with anal atresia]. / Biofeedback-Training und funktionelle Elektrostimulation zur Verbesserung der Inkontinenz bei Kindern mit Analatresie.

Eleven children with anal incontinence following a pull-through operation for anorectal agenesis (4 low, 7 high anomalies) were treated with a conservative continence training program (optic/acoustic biofeedback, transcutaneous electrical stimulation, physical therapy, contraction exercises and sensibility training). All patients with one exception showed subjective and objective improvement of continence. Sphincter contraction increased by 80% in high and by 40% in low anomalies. For a short time electrostimulation provided an improvement of up to 20% in sphincter pressure. One additional success was improved coordination. Beside surgical therapy and other methods continence training is always indicated.

[Perioperative prophylaxis in elective colorectal surgery]. / Untersuchungen zur perioperativen Prophylaxe in der elektiven colorectalen Chirurgie.

The effects of perioperative antibiotic prophylaxis in elective colon surgery was evaluated in a prospective study on 100 patients. Bowel cleansing was done by orthograde lavage. The patients were divided into 5 groups receiving equally cefotaxime 3 x 2 g, lamoxactam 3 x 2 g, cefmenoxime 3 x 1 g, mezlocillin 3 x 5 g an piperacillin 3 x 4 g. Mucosa biopsies of the resected colon were taken for aerobic and anaerobic cultures. Further mucosal serum probes were frozen immediately for determination of tissue and serum levels of the antibiotics. Our results show that bacterial growth of the colon mucosa was significantly reduced. Anaerobes were identified in only 8%. The tissue concentrations exceeded the MIC-levels of the identified bowel organisms many times over. The clinical infection rate was 4%. All administered antibiotics can be recommended without reservation.