Two-stage hybrid Ivor-Lewis esophagectomy as surgical strategy to reduce postoperative morbidity for high-risk patients.

BACKGROUND: Ivor-Lewis esophagectomy (ILE) is the standard surgical care for esophageal cancer patients but postoperative morbidity impairs quality of life and reduces long-term oncological outcome. Two-stage ILE separating the abdominal and thoracic phase into two distinct surgical procedures has proven to enhance microcirculation of the gastric conduit and therefore most likely reduces complications. However, two-stage ILE has not been evaluated systematically in selected groups of patients scheduled for this procedure. This investigation aims to demonstrate the feasibility of two-stage ILE in high-risk patients. PATIENTS AND METHODS: In this retrospective analysis of data obtained from a prospective database, a consecutive series of 275 hybrid ILE (hILE) were included. Patients were divided into two groups based on one- or two-stage hILE. Postoperative complications were assessed according to ECCG (Esophageal Complication Consensus Group) criteria and compared using the Clavien-Dindo score. Indication for two-stage esophagectomy was classified as pre- or intraoperative decision. RESULTS: 34 out of 275 patients (12.7%) underwent two-stage hILE. Patients of the two-stage group were significantly older. In 21 of 34 patients (61.8%) the decision for a two-stage procedure was made prior to esophagectomy, in 13 (38.2%) patients intraoperatively after completion of the laparoscopic gastric mobilization. The most frequent preoperative reason to select the two-stage procedure was a stenosis of the coeliac trunc and superior mesenteric artery (n = 10). The predominant cause for an intraoperative change of strategy was a laparoscopically diagnosed hepatic fibrosis/cirrhosis (n = 5).Overall morbidity and major' complications (CD > IIIa) were comparable for both groups (11.7% in both groups). The overall anastomotic leak rate was 12.4% and was non-significant lower for the two-stage procedure. CONCLUSION: Two-stage hILE is a feasible concept to individualize the surgical treatment of patients with well-defined clinical risk factors for postoperative morbidity. It can also be applied after completion of the abdominal phase of IL esophagectomy without compromising the patient safety.

Outcomes and measurement instruments used in congenital melanocytic naevi research: A systematic review.

BACKGROUND: Congenital melanocytic naevi (CMN) can have a great impact on patients' lives due to the remarkable appearance and the risk of developing melanoma and neurocutaneous melanosis. Comparison of treatment efficacy is currently hindered by the lack of standard and uniform outcome reporting; this impedes guidance on optimal management policy. To address this, we aim to perform the first step in developing a core outcome set. With this systematic review, we identified a list of domains, outcomes (including patient reported outcomes) and outcome measurement instruments used in CMN research. METHODS: The review was registered in PROSPERO, registration number CRD42018095235. A search was conducted in EMBASE (Ovid), PubMed and the Cochrane Library from 2006 to January 2019. Studies with 10 or more patients, with all sizes of CMN and reporting outcomes on interventional and conservative management were included. RESULTS: A total of 1,285 individual studies was found; 63 studies were included. We extracted 57 different outcomes and 34 outcome measurement instruments showing large heterogeneity. Patient-reported outcomes were included in 38% of studies. Few outcome measurement instruments were described. Moreover, none of the studies reported that the used instruments were ever validated in a CMN population. CONCLUSION: Heterogeneity exists in outcomes and instruments used in CMN research. The development of a core outcome set may reduce this heterogeneity in future research, thereby enabling treatment comparison and eventually facilitating guidance on management. Furthermore, this overview demonstrates a need for the use and validation of (patient reported) outcome measurement instruments for CMN.

Protocol for the development of core set of domains of the core outcome set for patients with congenital melanocytic naevi (OCOMEN project).

BACKGROUND: Having large congenital melanocytic naevi (CMN) is associated with a psychosocial burden on patients and their parents because of its remarkable appearance and the extra care it may require. Large CMN also pose an increased risk of malignant melanoma or neurocutaneous melanosis. There is a lack of international consensus on what important outcome domains to measure in relation to treatment. This makes it difficult to compare options, to properly inform patients and their parents, and to set up treatment policy for CMN. Therefore, we aim to develop a core outcome set (COS), i.e. the minimum set of outcomes that are recommended to be measured and reported in all clinical trials of a specific health condition. This COS can be used in the follow-up of CMN patients with or without treatment, in clinical research and practice. METHODS: In the Outcomes for Congenital Melanocytic Nevi (OCOMEN) projects, we follow the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Core Outcomes Set Initiative (CS-COUSIN). This project entails the following: (i) a systematic review to identify the previous reported outcomes in literature; (ii) focus groups with national and international patients and parents to identify patient-important outcomes; (iii) classification of outcomes into outcome domains; (iv) e-Delphi surveys in which stakeholders (patients/parents and professionals) can rate the importance of domains and outcomes; and (v) an online consensus meeting to finalize the core outcome domains of the COS. RESULTS: The results will be disseminated by means of publication in a leading journal and presentations in international meetings or conferences. We engage international experts in CMN, both patients and professionals, to ensure the international utility and applicability of the COS.

Stenosis of the celiac trunk is associated with anastomotic leak after Ivor-Lewis esophagectomy.

Transthoracic esophagectomy with gastric tube formation is the surgical treatment of choice for esophageal cancer. The surgical reconstruction induces changes of gastric microcirculation, which are recognized as potential risk factors of anastomotic leak. This prospective observational study investigates the association of celiac trunk (TC) stenosis with postoperative anastomotic leak. One hundred fifty-four consecutive patients with esophageal cancer scheduled for Ivor-Lewis esophagectomy were included. Preoperative staging computed tomography (CT) was used to identify TC stenosis. Any narrowing of the lumen due to atherosclerotic changes was classified as stenosis. Percentage of stenotic changes was calculated using the North American Symptomatic Carotid Endarterectomy Trial formula. Multivariable analysis was used to identify possible risk factors for leak. The overall incidence of TC stenosis was 40.9%. Anastomotic leak was identified in 15 patients (9.7%). Incidence of anastomotic leak in patients with stenosis was 19.4% compared to 2.3% in patients without stenosis. Incidence of stenosis in patients with leak was 86.7% (13 of 15 patients) and significantly higher than 38.8% (54 of 139 patients) in patients without leak (P < 0.001). There was a significant difference in median degree of TC stenosis (50.0% vs 39.4%; P = 0.032) in patients with and without leak. In the multivariable model, TC stenosis was an independent risk factor for anastomotic leak (odds ratio: 5.98, 95% CI: 1.58-22.61). TC stenosis is associated with postoperative anastomotic leak after Ivor-Lewis esophagectomy. Routine assessment of TC for possible stenosis is recommended to identify patients at risk.

Endoscopic and histopathologic reflux-associated mucosal damage in the remnant esophagus following transthoracic esophagectomy for cancer-5-year long-term follow-up.

Gastroesophageal reflux is a common problem following esophagectomy and reconstruction with gastric interposition. Despite a routine prescription of proton pump inhibitors, reflux-associated mucosal damage in the remnant esophagus is frequently observed. Purpose of this study is to evaluate mucosal damage in the esophageal remnant during long-term follow-up and to compare the prevalence of this damage between the subgroups of esophageal squamous cell and adenocarcinoma. All patients undergoing transthoracic Ivor-Lewis esophagectomy were prospectively entered in our IRB approved database. All patients underwent a routine check-up program with yearly surveillance endoscopies following esophagectomy. Only patients with a complete follow-up were included into this study. Endoscopic and histopathologic mucosal changes of the remnant esophagus were analyzed in close intervals. A total of 50 patients met the inclusion criteria, consisting of 31 adenocarcinomas (AC) and 19 squamous cell carcinomas (SCC). Mucosal damage was already seen 1 year after surgery in 20 patients macroscopically (43%) and in 21 patients microscopically (45%). At 5-year follow-up the prevalence for macroscopic and microscopic damage was 55% and 60%, respectively. The prevalence of mucosal damage was higher in AC patients than in SCC patients (1y-FU: 51% [AC] vs. 28% [SCC]; 5y-FU: 68% [AC] vs. 35% [SCC], P < 0.05). Newly acquired Barrett's esophagus was seen in 10 patients (20%) with two of those patients (20%) showing histopathologic proof of neoplasia. This study shows a high prevalence of reflux-associated mucosal damage in the remnant esophagus one year out of surgery and only a moderate increase in prevalence in the following years. Mucosal damage was more frequently seen in AC patients and the occurrence of de-novo Barrett's esophagus and de-novo neoplasia was high. Endoscopic surveillance with targeted biopsies seems to be an indispensable tool to follow patients after esophagectomy appropriately.

Preoperative airway colonization prior to transthoracic esophagectomy predicts postoperative pulmonary complications.

PURPOSE: Respiratory complications are responsible to a high degree for postoperative morbidity and mortality after Ivor-Lewis esophagectomy. The etiology of respiratory failure is known to be multifactorial with preoperative impaired lung function being the most important one. The aim of this study was to investigate the correlation between preoperative airway colonization (PAC) and postoperative respiratory complications. METHODS: In this observational study, 64 patients with esophageal cancer were included. All patients underwent Ivor-Lewis esophagectomy with laparoscopic or open gastric mobilization. After induction of anesthesia and intubation with a double-lumen tube, bronchial exudate was collected by random endoluminal suction for further microbiological work-up. Length of postoperative mechanical ventilation (<24 h, 24-72 h, >72 h), re-intubation, and tracheostomy were recorded as primary and secondary study endpoints. RESULTS: In 13 of 64 study patients (20.3 %), pathological colonization of the bronchial airways could be proved prior to esophagectomy. Haemophilus species was the most frequently identified pathogen. PAC was associated with a longer history of smoking (p = 0.025), a lower preoperative forced expiratory volume (FEV1, p = 0.009) or vital capacity (VC, p = 0.038), a prolonged postoperative mechanical ventilation (p < 0.001), and a higher frequency of re-intubation (p < 0.001) and tracheostomy (p = 0.017). In the multivariate analysis, PAC was identified as an independent predictor of respiratory failure (hazard ratio 11.4, 95 % confidence interval 2.6-54, p = 0.002). Mortality in the PAC group was 30.8 % compared to 0 % in patients without PAC (p < 0.0001). CONCLUSION: PAC is a significant risk factor for postoperative respiratory failure. A routine bronchoscopy and bronchoalveolar lavage as part of preoperative management prior to esophagectomy need to be discussed.

Efficacy and tolerability of a botulinum toxin type A free of complexing proteins (NT 201) compared with commercially available botulinum toxin type A (BOTOX) in healthy volunteers.

PURPOSE: This randomized controlled trial was performed to compare the novel botulinum toxin type A free of complexing proteins (NT 201) with the marketed preparation BOTOX degrees regarding efficacy and tolerability. METHODS: Fourteen healthy volunteers received a single intramuscular injection into the extensor digitorum brevis (EDB) muscle of either 4 units NT 201, or 4 units of BOTOX degrees randomised by foot. Compound muscle action potential (CMAP) measurements were recorded for up to 90 days after injection. RESULTS: Both drugs produced a maximum decline between Day 7 and Day 14. At Day 90, administration of both drugs resulted in approximately a 40% CMAP decline as compared to baseline. Duration of paralytic effect was comparable in both groups, at all response thresholds tested. Both drugs were well tolerated. CONCLUSION: The effects of small amounts of NT 201 and BOTOX degrees injected into the EDB muscle are comparable in terms of efficacy, time to onset of action, duration of action, and tolerability.

Management of tongue-tie in children: a survey of paediatric surgeons in Australia.

OBJECTIVES: To explore the beliefs and practices of Australian surgeons regarding surgical intervention to release tongue-tie and to determine the main referral sources. In addition, we aimed to ascertain if there were differences in beliefs and practices according to surgical specialty. METHODS: Four hundred surgeons in three different surgical specialties were surveyed via questionnaire. Multiple choice response questions and open ended questions were used to explore beliefs and practices surrounding tongue-tie assessment, management and follow up. The questionnaires were distributed by email (where available), followed by fax and mail. RESULTS: A response rate of 80.8% (n = 323) was obtained. Of these, 236 (73%) reported they practised surgery to release tongue-tie; 46% were oral and maxillofacial surgeons, 37% were plastic surgeons and 17% were paediatric general surgeons. Indications for surgical management and follow up varied according to surgical specialty. There was no clear consensus regarding clinical indicators for surgery or functional outcomes following surgery. CONCLUSIONS: It appears that until a prospective study designed to address some of the controversial issues outlined is undertaken, we will remain ignorant about the need for surgery to release tongue-tie in children.

Randomized, placebo-controlled, double-blind trial with interferon-alpha with and without amantadine sulphate in primary interferon-alpha nonresponders with chronic hepatitis C.

In primary interferon-alpha (IFN-alpha) nonresponders with chronic hepatitis C, retreatment with IFN-alpha has only limited efficacy with sustained response rates below 10%. Therefore, the aims of the present study were to compare the efficacy and safety of IFN-alpha alone or in combination with amantadine sulphate in nonresponders to previous IFN-alpha monotherapy. Fifty-five IFN-alpha nonresponders with chronic hepatitis C (mean age: 46.6 years) received IFN-alpha 6 MIU thrice weekly for 24 weeks followed by 3 MIU thrice weekly for additional 24 weeks. Amantadine sulphate (n=26) or a matched placebo (n=29) was given orally twice daily for 48 weeks. Because of a low initial response rate at week 12 (13/55 patients) and a high breakthrough rate (8/13 patients) after IFN-alpha dose reduction in week 24, a virological end-of-treatment response with undetectable serum HCV-RNA (< 1000 copies/mL) was achieved in only five patients (IFN-alpha/amantadine sulphate, one patient; IFN-alpha/placebo, four patients). After 24 weeks follow-up a sustained virological response was observed in only two patients receiving IFN-alpha and placebo. Health-related quality-of-life analysis showed a substantial improvement of the Profile of Mood States (POMS) scale concerning the subscales fatigue (P < 0.05) and vigor (P < 0.05) in patients receiving combined IFN-alpha/amantadine sulphate treatment compared with those treated with IFN-alpha alone. IFN-alpha/amantadine sulphate combination therapy was well tolerated without any serious adverse events. In conclusion, retreatment with IFN-alpha and amantadine sulphate does not increase the low sustained virological response rates of IFN-alpha therapy in primary IFN-alpha nonresponders with chronic hepatitis C, but may lead to a sustained improvement of health-related quality-of-life.

Testing of rod objects by grazing-incidence interferometry: experiment.

A grazing-incidence interferometer for the testing of technical surfaces for macroscopic surface deviations is described. Computer-generated holograms serve as beam splitters and references for the workpieces tested. The sensitivity of the interferometer depends on the period of the computer-generated holograms. The method is demonstrated at a rod object of convex profile. Using phase-stepping techniques, the grazing-incidence interferometer provides fast measurements of the entire mantle surface of the test sample with submicrometer precision.

[Intimal hyperplasia after Fogarty maneuver in bilateral popliteal artery embolism and mitral valve stenosis]. / Intimahyperplasie nach Fogarty-Manöver bei beidseitiger Poplitealarterienembolie und Mitralklappenstenose.

Although embolectomy by Fogarty's manoeuvre is the therapy of choice for cardio-arterial and arterio-arterial embolism it might be followed by complications. Our patient showed progressive arterial occlusive disease caused by intimal proliferation. So the decision whether embolectomy or a different therapeutic procedure should be applied must always be done individually. Especially with young female patients the intervention is to be carried out carefully. Alternative methods like percutaneous aspiration embolectomy and fibrinolytic therapy should always be considered.

Axicon-type test interferometer for cylindrical surfaces: systematic error assessment.

The principle and the alignment aberration functions are described for an axicon-type test interferometer for measuring cylindrical mantle surfaces. Additionally, we show that the derived systematic alignment functions fulfill for reasonably small misalignments the requirements for measurements in the range of approximately 1/100 of a fringe. We verify this with optical path-length calculations, using ray tracing.

Endotoxin-induced changes of endothelial cell viability and permeability: protective effect of a 21-aminosteroid.

Endotoxic shock results in endothelial cell dysfunction and oedema formation. Endotoxin decreased in a concentration-dependent fashion endothelial cell viability with maximum effects by adding 10 micrograms/ml lipopolysaccharide for 48 h (47 +/- 15% and 22 +/- 2.6% of control cells in the presence or absence of foetal calf serum, respectively). Furthermore, incubation (10 h) with lower concentrations of lipopolysaccharide (1 microgram/ml) significantly increased endothelial cell permeability to 250% compared to control values. The 21-aminosteroid U-74389G (10 microM) prevented the cytotoxic effect of lipopolysaccharide as well as the lipopolysaccharide-induced increase in endothelial cell permeability. By contrast, the glucocorticoid methylprednisolone was less effective even at higher concentrations (100 microM). The effect of lipopolysaccharide is possibly due to oxidative stress and/or membrane destabilization rather than to the induction of inflammatory mediators, because of the reduced efficacy of the glucocorticoid.

Undifferentiated arthritis and spondylarthropathy as a challenge for prospective follow-up.

Diagnosis of arthritis with recent onset is still an unresolved problem. In 1984 we started an outpatient clinic for patients with early arthritis of less than one year duration. Of a total of 226 patients seen 149 (66%) had definite (n = 76; 34%) or probable (n = 73; 32%) inflammatory rheumatic disease, and 77 (34%) had degenerative or extraarticular rheumatic disease. Thirtynine patients were classified as undifferentiated arthritis. This undefined arthritis was often monoarticular (12%) and oligoarticuler (44%). One patient met 5 ARA-criteria for rheumatoid arthritis, 14 (36%) met 3-4 ARA-criteria and 25 (64%) only 1-2 ARA-criteria. ESR was elevated in only 23 (59%) patients, rheumatoid factor was positive in 7 (19%) patients and HLA-B27 was positive in 9 (23%) patients. Seventeen (44%) patients had a history of recent infections preceding the beginning of joint symptoms. Thus undifferentiated arthritis represents a heterogeneous group of diseases. Despite diagnostic progresses in recent years a high proportion of early arthritis cannot be diagnosed definitely.