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Background: Cardiac graft denervation causes inadequate sinus tachycardia in patients after heart transplantation (HTX) which is associated with reduced survival. This study investigated the 5-year results of heart rate control with ivabradine or metoprolol succinate in patients after HTX., Methods: This registry study analyzed 104 patients receiving either ivabradine (n = 50) or metoprolol succinate (n = 54) within 5 years after HTX. Analysis included patient characteristics, medication, echocardiographic features, cardiac catheterization data, cardiac biomarkers, heart rates, and post-transplant survival including causes of death., Results: Demographics and post-transplant medication revealed no significant differences except for ivabradine and metoprolol succinate use. At 5-year follow-up, patients with ivabradine had a significantly lower heart rate (73.3 bpm) compared to baseline (88.6 bpm; P < 0.01) and to metoprolol succinate (80.4 bpm; P < 0.01), a reduced left ventricular mass (154.8 g) compared to baseline (179.5 g; P < 0.01) and to metoprolol succinate (177.3 g; P < 0.01), a lower left ventricular end-diastolic pressure (LVEDP; 12.0 mmHg) compared to baseline (15.5 mmHg; P < 0.01) and to metoprolol succinate (17.1 mmHg; P < 0.01), and a reduced NT-proBNP level (525.4 pg/ml) compared to baseline (3826.3 pg/ml; P < 0.01) and to metoprolol succinate (1038.9 pg/ml; P < 0.01). Five-year post-transplant survival was significantly better in patients with ivabradine (90.0%) versus metoprolol succinate (68.5%; P < 0.01)., Conclusion: Patients receiving ivabradine showed a superior heart rate reduction and a better left ventricular diastolic function along with an improved 5-year survival after HTX., (© 2020. The Author(s).)

Objectives: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation., Background Data: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear., Methods: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint., Results: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups., Conclusion: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts., Trial Registration: German Clinical Trials Register DRKS 00004900.

Postoperative pancreatic fistula is a major surgical complication that can follow pancreatic resection. Postoperative pancreatic fistula can develop as a consequence of leaking pancreatic fluid, which calls for an intraoperative indicator of leakage. But suitable indicators of pancreatic leakage have yet to be found. This study details the evidence-based development and early efficacy assessments of a novel pancreatic leakage indicator (SmartPAN), following the IDEAL framework of product development. We developed 41 SmartPAN prototypes by combining indicators of pancreatic fluid with a polysaccharide-microsphere matrix. The prototypes were assessed in vitro using porcine ( Sus scrofa domesticus ) pancreatic tissue and ex vivo with human pancreatic fluid. From these initial tests, we chose a hydrogel-based compound that uses the pH indicator bromothymol blue to detect alkali pancreatic fluid. This prototype was then assessed in vivo for usability, effectiveness and reliability using a porcine model. Treatment groups were defined by SmartPAN-reaction at initial pancreatic resection: indicator-positive or negative. Indicator-positive individuals randomly received either targeted closure of leakage sites or no further closure. We assessed SmartPAN's reliability and effectiveness by monitoring abdominal drainage for amylase and with relaparotomy after 48 h. SmartPAN responses were consistent between both surgical procedures and conformed to amylase measurements. In conclusion, we have developed the first surgery-ready indicator for predicting the occurrence of pancreatic leakage during pancreatic resection. SmartPAN can enable targeted prophylactic closure in a simple and reliable way, and thus may reduce the impact of postoperative pancreatic fistula by guiding peri- and post-operative management.

Importance: Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications., Objective: To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA., Design, Setting, and Participants: In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol., Interventions: Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA., Main Outcomes and Measures: The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution., Results: Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%)., Conclusions and Relevance: This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings., Trial Registration: German Clinical Trials Register: DRKS00007784.

Background: Atrial fibrillation (AF) represents the most frequent arrhythmic disorder after thoracoabdominal esophageal resection and is associated with a significant increase in perioperative morbidity and mortality., Methods: In this retrospective cohort study, 167 patients who underwent thoracoabdominal esophagectomy at a large university hospital were assessed. We compared patients who received a 14-day postoperative course of diltiazem with a control group of patients who did not undergo diltiazem prophylaxis. Diltiazem therapy started immediately upon admission to the intensive care unit (ICU) with a loading dose of 0.25 mg/kg bodyweight (i.v.) followed by continuous infusion (0.1 mg/kg bodyweight/h) for 40-48 h. Oral administration (Dilzem ® 180 mg uno retard, once a day) was started on postoperative day 3., Results: A total of 117 patients were assessed. Twelve (10.3%) of all patients developed postoperative new-onset atrial fibrillation in the first 30 days after surgical intervention. Prevalence of new-onset AF showed no significant differences between the diltiazem group and control group (p = 0.74). The prevalence of bradycardia (14.7% vs. 3.6%; p = 0.03) and dose of norepinephrine required (0.09 vs. 0.04 µg/kg bodyweight/min; p = 0.04) were higher in the diltiazem group. There were no significant differences between the groups for the median postoperative duration of hospital/ICU stay or mortality., Conclusions: A prophylactic 14-day postoperative course of diltiazem was not associated with a reduction in new-onset AF or 30-day mortality following thoracoabdominal esophagectomy. Prophylactic diltiazem therapy was associated with drug-related adverse effects such as bradycardia and increased requirement of norepinephrine. German Clinical Trial Registration Number: DKRS00016631.

Background: Spine surgeries can pose many complications; however, peak timing of post-operative complications in the field of spine surgery is still not sufficiently delineated in the literature as yet. Nevertheless the determination of peak timing of post-operative complications has a significant influence on patient education and post-operative follow-up., Materials and Methods: This single-center study analyzed the medical records of 1179 patients that underwent spinal instrumentation between 2010 and 2015 at 3, 6, 12, 24 and 36 months postoperatively. Complications were analyzed according to their time of onset., Results: Of the 1179 patients included, 199 (16.9%) underwent revision surgery due to a complication. Peak timing for complications (72.9%) occurred within the first 3 months after surgery. Infection was the most common reason for revision surgery (42.7%) and most infections occurred within the first 3 months after surgery (early infections) (91.8% of infections). Peak timing for material failure occurred in the second post-operative year (46% of all detected prosthesis failures) (2.5% of all complications)., Discussion: Peak timing of post-operative complications post spinal instrumentation occurs as early on as within the first 3 months after surgery and post-operative infections remain the most common post-operative complication overall. Nonetheless, regular and long-term postoperative clinical and radiological follow-up is crucial, since in particular prosthesis failure has its peak timing in the second post-operative year.

Background: The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy., Methods: The PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%., Discussion: The results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy., Trial Registration: German Clinical Trials Register (DRKS), DRKS00013763 . Registered on 6 March 2018.

Background: One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning., Methods: PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative., Discussion: PATRONUS will provide essential insights into the patients' assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research., Trial Registration: German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111-1202-8863.

Purpose: Thoracoabdominal esophageal resection for malignant disease is frequently associated with pulmonary infection. Whether prolonged antibiotic prophylaxis beyond a single perioperative dose is advantageous in preventing pulmonary infection after thoracoabdominal esophagectomy remains unclear., Methods: In this retrospective before-and-after analysis, 173 patients between January 2009 and December 2014 from a prospectively maintained database were included. We evaluated the effect of a 5-day postoperative course of moxifloxacin, which is a frequently used antimicrobial agent for pneumonia, on the incidence of pulmonary infection and mortality after thoracoabdominal esophagectomy., Results: 104 patients received only perioperative antimicrobial prophylaxis (control group) and 69 additionally received a 5-day postoperative antibiotic therapy with moxifloxacin (prolonged-course). 22 (12.7%) of all patients developed pneumonia within the first 30 days after surgery. No statistically significant differences were seen between the prolonged group and control group in terms of pneumonia after 7 (p = 0.169) or 30 days (p = 0.133), detected bacterial species (all p > 0.291) and 30-day mortality (5.8 vs 10.6%, p = 0.274)., Conclusion: A preemptive 5-day postoperative course of moxifloxacin does not reduce the incidence of pulmonary infection and does not improve mortality after thoracoabdominal esophagectomy.

Purpose: Viral infections represent a serious threat for patients after liver transplantation (LT). The identification of risk factors during the early post-transplant period might help to improve prevention of viral infections after LT., Methods: Between 2004 and 2010, 530 adult patients underwent LT at a large university hospital serving a metropolitan region in Europe. This retrospective single-centre study analysed putative risk factors for early viral infections with herpes simplex virus-1 (HSV-1), varicella-zoster virus (VZV), Epstein-Barr virus (EBV), hepatitis A/B/C (HAV/HBV/HCV) and cytomegalovirus (CMV) in the first 3 months after LT., Results: The final analysis included 501 patients of whom 126 (25.1%) had documented viral infections after LT. No significant differences could be detected between patients with or without viral infections concerning 30- and 90-day mortality. Risk factors in the early post-transplant period identified by multivariate analysis included female gender (CMV, HSV-1), the post-operative need for continuous veno-venous hemofiltration (CMV), septic shock (CMV), detection of fungi (CMV) and the intraoperative amount of transfused blood (EBV)., Conclusions: Enhanced vigilance regarding opportunistic infections is crucial in the management of this high-risk population of immunocompromised patients. In particular, attention should be paid to avoidable conditions that increase the risk of renal replacement therapies in the post-LT setting, especially among women., Trial Registration: DRKS00010672 on German Clinical Trial Register.

Background: The prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients' wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting., Methods: Adult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department's standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat., Results: In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/- 12.0) days versus 16.1 (+/- 15.0) days, p = 0.285) were also similar in the intervention and control groups., Conclusions: Cluster randomization was feasible in the setting of preoperative patient education and reduced the risk of contamination effects. The results of this trial indicate good postoperative outcomes in patients undergoing major visceral surgery without superiority of preoperative patient education compared to standard patient care at a high-volume center. However, preoperative patient education is a helpful instrument not only for teaching patients but also for training the nursing staff., Trial Registration: German Clinical Trials Registry, DRKS00004226 . Registered on 23 October 2012. Registered 8 days after the first enrollment.

Background: Preoperative nutritional status has an impact on patients' clinical outcome. For pancreatic surgery, however, it is unclear which nutritional assessment scores adequately assess malnutrition associated with postoperative outcome., Methods: Patients scheduled for elective pancreatic surgery at the University of Heidelberg were screened for eligibility. Twelve nutritional assessment scores were calculated before operation, and patients were categorized as either at risk or not at risk for malnutrition by each score. The postoperative course was monitored prospectively by assessors blinded to the nutritional status. The primary endpoint was major complications evaluated for each score in a multivariable analysis corrected for known risk factors in pancreatic surgery., Results: Overall, 279 patients were analysed. A major complication occurred in 61 patients (21·9 per cent). The proportion of malnourished patients differed greatly among the scores, from 1·1 per cent (Nutritional Risk Index) to 79·6 per cent (Nutritional Risk Classification). In the multivariable analysis, only raised amylase level in drainage fluid on postoperative day 1 (odds ratio (OR) 4·91, 95 per cent c.i. 1·10 to 21·84; P = 0·037) and age (OR 1·05, 1·02 to 1·09; P = 0·005) were significantly associated with major complications; none of the scores was associated with, or predicted, postoperative complications., Conclusion: None of the nutritional assessment scores defined malnutrition relevant to complications after pancreatic surgery and these scores may thus be abandoned., (© 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Objectives: To assess pancreatic fistula rate and secondary endpoints after pancreatogastrostomy (PG) versus pancreatojejunostomy (PJ) for reconstruction in pancreatoduodenectomy in the setting of a multicenter randomized controlled trial., Background: PJ and PG are established methods for reconstruction in pancreatoduodenectomy. Recent prospective trials suggest superiority of the PG regarding perioperative complications., Methods: A multicenter prospective randomized controlled trial comparing PG with PJ was conducted involving 14 German high-volume academic centers for pancreatic surgery. The primary endpoint was clinically relevant postoperative pancreatic fistula. Secondary endpoints comprised perioperative outcome and pancreatic function and quality of life measured at 6 and 12 months of follow-up., Results: From May 2011 to December 2012, 440 patients were randomized, and 320 were included in the intention-to-treat analysis. There was no significant difference in the rate of grade B/C fistula after PG versus PJ (20% vs 22%, P = 0.617). The overall incidence of grade B/C fistula was 21%, and the in-hospital mortality was 6%. Multivariate analysis of the primary endpoint disclosed soft pancreatic texture (odds ratio: 2.1, P = 0.016) as the only independent risk factor. Compared with PJ, PG was associated with an increased rate of grade A/B bleeding events, perioperative stroke, less enzyme supplementation at 6 months, and improved results in some quality of life parameters., Conclusions: The rate of grade B/C fistula after PG versus PJ was not different. There were more postoperative bleeding events with PG. Perioperative morbidity and mortality of pancreatoduodenectomy seem to be underestimated, even in the high-volume center setting.

In order to investigate the hypothesis that the mammalian target of rapamycin inhibitor everolimus (EVR) shows anticytomegalovirus (CMV) activity in pediatric patients, we analyzed the impact of EVR-based immunosuppressive therapy on CMV replication and disease in a large cohort (n = 301) of pediatric kidney allograft recipients. The EVR cohort (n = 59), who also received low-dose cyclosporin, was compared with a control cohort (n = 242), who was administered standard-dose cyclosporin or tacrolimus and an antimetabolite, mostly mycophenolate mofetil (91.7%). Multivariate analysis revealed an 83% lower risk of CMV replication in the EVR cohort than in the control cohort (p = 0.005). In CMV high-risk (donor+/recipient-) patients (n = 88), the EVR-based regimen was associated with a significantly lower rate of CMV disease (0% vs. 14.3%, p = 0.046) than the standard regimen. In patients who had received chemoprophylaxis with (val-)ganciclovir (n = 63), the CMV-free survival rates at 1 year and 3 years posttransplant (100%) were significantly (p = 0.015) higher in the EVR cohort (n = 15) than in the control cohort (n = 48; 1 year, 75.0%; 3 years, 63.3%). Our data suggest that in pediatric patients at high risk of CMV, an EVR-based immunosuppressive regimen is associated with a lower risk of CMV disease than a standard-dose calcineurin inhibitor-based regimen., (© Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Amiodarone is a frequently used antiarrhythmic drug in patients with end-stage heart failure. Given its long half-life, pre-transplant use of amiodarone has been controversially discussed, with divergent results regarding morbidity and mortality after heart transplantation (HTX)., Aim: The aim of this study was to investigate the effects of long-term use of amiodarone before HTX on early post-transplant atrial fibrillation (AF) and mortality after HTX., Methods: Five hundred and thirty patients (age ≥18 years) receiving HTX between June 1989 and December 2012 were included in this retrospective single-center study. Patients with long-term use of amiodarone before HTX (≥1 year) were compared to those without long-term use (none or <1 year of amiodarone). Primary outcomes were early post-transplant AF and mortality after HTX. The Kaplan-Meier estimator using log-rank tests was applied for freedom from early post-transplant AF and survival., Results: Of the 530 patients, 74 (14.0%) received long-term amiodarone therapy, with a mean duration of 32.3±26.3 months. Mean daily dose was 223.0±75.0 mg. Indications included AF, Wolff-Parkinson-White syndrome, ventricular tachycardia, and ventricular fibrillation. Patients with long-term use of amiodarone before HTX had significantly lower rates of early post-transplant AF (P=0.0105). Further, Kaplan-Meier analysis of freedom from early post-transplant AF showed significantly lower rates of AF in this group (P=0.0123). There was no statistically significant difference between patients with and without long-term use of amiodarone prior to HTX in 1-year (P=0.8596), 2-year (P=0.8620), 5-year (P=0.2737), or overall follow-up mortality after HTX (P=0.1049). Moreover, Kaplan-Meier survival analysis showed no statistically significant difference in overall survival (P=0.1786)., Conclusion: Long-term use of amiodarone in patients before HTX significantly reduces early post-transplant AF and is not associated with increased mortality after HTX.

Background: Perioperative chemotherapy improves survival in patients with advanced esophagogastric cancer, but the optimal treatment regimen remains unclear. More intensive chemotherapy may improve outcome, but also increase toxicity and complications., Methods: A total of 843 patients were included in this retrospective study and stratified in 4 groups: doublet therapy with cisplatin or oxaliplatin and 5-fluorouracil (groups A/B) or triplet therapy with additional epirubicin or taxane (groups C/D). The influence of the different neoadjuvant chemotherapy regimens on response, prognosis, and complications was assessed., Results: Clinical and pathological response were associated with longer overall survival (OS; p < 0.001). No significant differences regarding response or OS were found, but there was a trend toward better outcome in group D (taxane-containing triplet). In the subgroup of 669 patients with adenocarcinomas of the esophagogastric junction (AEG), patients who had received taxane-containing regimens had a significantly longer OS (p = 0.037), but taxane use was not an independent factor in multivariate analysis. Triple therapy with taxanes did not result in a higher complication rate or postoperative mortality., Conclusions: Although no superior neoadjuvant chemotherapy regimen was identified for patients with esophagogastric adenocarcinoma, taxane-containing regimens should be further investigated in randomized trials, especially in patients with AEG tumors.

Introduction: In the past, elderly patients with upper GI cancers were excluded from surgery or multimodal treatment only due to their advanced age. In an aging society this way of patient selection seems to be questionable. The aim of this retrospective exploratory study was to investigate how patients with upper GI cancer over the age of 70 years differ from younger patients in the postoperative course and which parameters influence overall survival in older patient populations., Patients and Methods: From 2002 to 2012 1,005 patients underwent resection of esophageal or gastric cancer at the University of Heidelberg. 272 patients were older than 70 years and analyzed in subgroups (70-74 years: n = 146; 75-79 years: n = 82; 80 years or older: n = 44). Patients older than 70 years were compared to patients under 70 years (n = 733) with focus on differences in patients characteristics and outcome. Statistical analyses were made retrospectively on a prospective database., Results: Fewer older patients were treated neoadjuvantly (< 70 years: 41.5%; > 70 years: 24.7%, P < 0.001) and extended resection (abdominothoracic approach) was applied less frequently compared to patients under 70 years (< 70 years: 38.9%; > 70 years: 19.9%, P < 0.001). The pNM-category (HR 1.41/2.56) and R-status (HR 1.78) remain the most important predictive factor for survival (all < 0.001). Female patients had a longer survival than men over the age of 70 (84.9 vs. 23.5 months, P < 0.01). Patients over 80 years had a significant shortened overall survival (> 80 years: 16.7 vs. < 70 years: 37.4 months) compared to the other subgroups (P < 0.001) and a significant increased in-hospital mortality (> 80 years: 20.5% vs. < 70 years: 6.0%, P = 0.002)., Conclusions: An exclusion from surgical therapy due to advanced age in general seems not to be justified. However, the decision for a surgical resection in patients over 80 years should be made with caution. pNM-categories and R0-resection remain the most important predictive factors for overall survival in all subgroups. No survival benefit for neoadjuvant treatment in patients over 70 years was found, while women survived longer than men. However, the decision concerning a (radio) chemotherapy should be made individually in each patient., (© 2015 Wiley Periodicals, Inc.)

Purpose: To investigate functional and subjective outcome parameters after arthroscopic debridement of central articular disc lesions (Palmer type 2C) and to correlate these findings with ulna length., Methods: Fifty patients (15 men; 35 women; mean age, 47 y) with Palmer type 2C lesions underwent arthroscopic debridement. Nine of these patients (3 men; 6 women; mean static ulnar variance, 2.4 mm; SD, 0.5 mm) later underwent ulnar shortening osteotomy because of persistent pain and had a mean follow-up of 36 months. Mean follow-up was 38 months for patients with debridement only (mean static ulnar variance, 0.5 mm; SD, 1.2 mm). Examination parameters included range of motion, grip and pinch strengths, pain (visual analog scale), and functional outcome scores (Modified Mayo Wrist score [MMWS] and Disabilities of the Arm, Shoulder, and Hand [DASH] questionnaire)., Results: Patients who had debridement only reached a DASH questionnaire score of 18 and an MMWS of 89 with significant pain reduction from 7.6 to 2.0 on the visual analog scale. Patients with additional ulnar shortening reached a DASH questionnaire score of 18 and an MMWS of 88, with significant pain reduction from 7.4 to 2.5. Neither surgical treatment compromised grip and pinch strength in comparison with the contralateral side. We identified 1.8 mm or more of positive ulnar variance as an indication for early ulnar shortening in the case of persistent ulnar-sided wrist pain after arthroscopic debridement., Conclusions: Arthroscopic debridement was a sufficient and reliable treatment option for the majority of patients with Palmer type 2C lesions. Because reliable predictors of the necessity for ulnar shortening are lacking, we recommend arthroscopic debridement as a first-line treatment for all triangular fibrocartilage 2C lesions, and, in the presence of persistent ulnar-sided wrist pain, ulnar shortening osteotomy after an interval of 6 months. Ulnar shortening proved to be sufficient and safe for these patients. Patients with persistent ulnar-sided wrist pain after debridement who had preoperative static positive ulnar variance of 1.8 mm or more may be treated by ulnar shortening earlier in order to spare them prolonged symptoms., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Introduction: Delirium is a frequent complication after cardiac surgery. Although various risk factors for postoperative delirium have been identified, the relationship between nocturnal breathing disorders and delirium has not yet been elucidated. This study evaluated the relationship between sleep-disordered breathing (SDB) and postoperative delirium in cardiac surgery patients without a previous diagnosis of obstructive sleep apnea., Methods: In this prospective cohort study, 92 patients undergoing elective cardiac surgery with extracorporeal circulation were evaluated for both SDB and postoperative delirium. Polygraphic recordings were used to calculate the apnea-hypopnea index (AHI; mean number of apneas and hypopneas per hour recorded) of all patients preoperatively. Delirium was assessed during the first four postoperative days using the Confusion Assessment Method. Clinical differences between individuals with and without postoperative delirium were determined with univariate analysis. The relationship between postoperative delirium and those covariates that were associated with delirium in univariate analysis was determined by a multivariate logistic regression model., Results: The median overall preoperative AHI was 18.3 (interquartile range, 8.7 to 32.8). Delirium was diagnosed in 44 patients. The median AHI differed significantly between patients with and without postoperative delirium (28 versus 13; P = 0.001). A preoperative AHI of 19 or higher was associated with an almost sixfold increased risk of postoperative delirium (odds ratio, 6.4; 95% confidence interval, 2.6 to 15.4; P <0.001). Multivariate logistic regression analysis showed that preoperative AHI, age, smoking, and blood transfusion were independently associated with postoperative delirium., Conclusions: Preoperative SDB (for example, undiagnosed obstructive sleep apnea) were strongly associated with postoperative delirium, and may be a risk factor for postoperative delirium.

Background: Our purposes were to analyze radiographic changes around humeral components and to determine the influence of these changes on the clinical outcome of shoulder arthroplasty., Methods: Three hundred and ninety-five shoulders with primary osteoarthritis were treated with a shoulder replacement and were analyzed clinically and radiographically with a standardized protocol. Radiographs were evaluated for osteolysis and stress-shielding of the proximal part of the humerus and loosening of the humeral and glenoid components. The arthroplasty configurations included (1) hemiarthroplasty with cement (thirty shoulders), (2) hemiarthroplasty without cement (thirty-six), (3) total shoulder replacement with a cemented stem and a cemented flat-backed glenoid component (eighty-nine), (4) total shoulder replacement with a cemented stem and a cemented convex-backed glenoid component (ninety-four), (5) total shoulder replacement with a cemented stem and an uncemented metal-backed glenoid component (seventy-nine), and (6) total shoulder replacement with an uncemented stem and a cemented convex-backed glenoid component (sixty-seven). The mean duration of follow-up was 8.2 years (range, four to eighteen years)., Results: The Constant score and shoulder motion were significantly greater at the latest follow-up examination than preoperatively (p < 0.001). One cemented stem loosened after a periprosthetic fracture, and another was judged to be at risk for loosening. Stress-shielding was noted only around uncemented stems in 63% of the shoulders with such stems. Osteolysis of the proximal part of the humerus occurred only with total shoulder arthroplasty in 43% of the shoulders. Patients with osteolysis had a poorer clinical outcome (p < 0.001). Shoulders with osteolysis around the proximal part of the humerus had more glenoid loosening and polyethylene wear (p < 0.001)., Conclusions: Glenoid issues have a substantial effect on humeral bone in shoulder arthroplasty. Polyethylene wear appears to be associated with the development of osteolysis of the proximal part of the humerus after total shoulder arthroplasty. With our implants, stress-shielding was only observed with uncemented humeral stems. The uncemented and cemented stem designs analyzed in this study appeared comparable and can be recommended for clinical use.

Background: In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasibility and the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgery., Methods/design: PEDUCAT is designed as a cluster-randomized controlled pilot study. The experimental group will visit a standardized preoperative seminar to learn how best to behave after surgery in addition to being given a standard information brochure, whereas the control group will only receive the information brochure. Outcome measures such as postoperative morbidity, postoperative pain, postoperative anxiety and depression, patient satisfaction, quality of life, length of hospital stay and postoperative mortality will be evaluated. Statistical analysis will be based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison, adjusting for age, center and quality of life before surgery. This is a pilot study to show the feasibility of the concept. Nevertheless, the planned sample size of n = 204 is large enough to show an effect with power of 90% and a significance level of 5%., Trial Registration: German Clinical Trial Register number: DRKS00004226.

Background: The International Study Group of Rectal Cancer (ISREC) has proposed a generally applicable definition and severity grading of (AL) after sphincter-preserving resection of the rectum. This work has been carried out to test for validity., Methods: A total of 746 patients who were identified from a prospective rectal cancer database underwent sphincter-preserving anterior resection of the rectum between October 2001 and January 2011. The incidence and severity of AL was determined using the criteria established by the ISREC. Patients with AL were categorized according to the ISREC scheme. The clinical outcomes were analyzed and compared between the groups., Results: The overall AL rate was 7.5% (56/746). The 56 patients with AL were distributed among the different groups as follows: Grade A, 16%; grade B, 23%; and grade C, 61%. Compared with the grade A patients, grades B and C patients had significantly elevated serum C-reactive protein levels (P < .01). None of the grade A patients were transferred to the intensive care unit (ICU). Their further hospital stay was uneventful. The length of stay in the ICU was significantly longer for grade C patients compared with grade B patients (P < .001). The median hospital stay of grade C patients was significantly longer than that of grades A and B patients (P < .001)., Conclusion: The definition and severity grading of AL after anterior resection of the rectum proposed by the ISREC provides a simple, easily applicable, and valid classification. Using this classification system may facilitate comparison of results from different studies on AL after sphincter-preserving rectal surgery., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Introduction: The impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on obesity and obesity-related diseases is unquestionable. Up to now, the technical descriptions of these techniques in animals/rats have not been very comprehensive., Methods: For SG and RYGB, operating time, learning curve, and intraoperative mortality in relation to weight of the rat and type of anesthesia were recorded. Furthermore, a review of the literature on experimental approaches towards SG and RYGB in rats was carried out, merging in a detailed technical description for both procedures., Results: The data presented here revealed that the mean operating time for SG (69.4 ± 22.2 min (SD)) was shorter than for RYGB (123.0 ± 20.7 min). There is a learning curve for both procedures, resulting in a reduced operating time of up to 60% in SG and 35% in RYGB (p < 0.05; t-test). However, with increased weight, operating time increases to about 80 min for SG and about 120 min for RYGB. Obese rats have an increased intraoperative mortality rate of up to 50%. After gaseous anesthesia the mortality can be even higher. The literature search revealed 40 papers dealing with SG and RYGB in rats. 18 articles (45%) contained neither photographs nor illustrations; 14 articles (35%) did not mention the applied type of anesthesia. The mortality rate was described in 15 papers (37.5%)., Conclusion: Experimental obesity surgery in rats is challenging. Because of the high mortality in obese rats operated under gaseous anesthesia, exercises to establish the techniques should be performed in small rats using intraperitoneal anesthesia.

Background: This study was designed to apply modern statistical methods to evaluate risk factors for anastomotic leakage after rectal cancer resection in a retrospective cohort of patients who received a colorectostomy. Whereas a diverting stoma and tumor height are considered proven risk factors for anastomotic leakage, a lack of evidence about additional risk factors persists., Methods: In a single-center study, 527 consecutive patients who received a colorectostomy after rectal cancer resection between 1991 and 2008 were retrospectively assessed. In addition to traditional uni- and multivariate regression, locally weighted scatterplot smoothing (LOWESS) regression and bootstrap analysis were applied to increase internal validity., Results: Anastomotic leakage occurred in 70 patients (13.3%; 95% confidence interval (CI), 10.5-16.5%) and mortality was 2.5% (95% CI, 1.4-4.2%). Diverting stoma (odds ratio (OR), 0.4; 95% CI, 0.17-0.61) and tumor height (OR, 0.88; 95% CI, 0.8-0.94) were proven to be protective. Neoadjuvant radiotherapy (OR, 2.15; 95% CI, 1.58-4.24) and intraoperative blood loss (OR, 1.05; 95% CI, 1.02-1.09) had a derogatory effect. Bootstrap analysis identified pre-existing vascular disease (95.5%), more advanced UICC stage III or IV tumors (95.7% or 91.5%, respectively), and intraoperative (96.1%) and postoperative (99.4%) blood substitution as harmful. Both intraoperative and postoperative blood substitution caused a dose-dependent increase in risk., Conclusions: Applying statistical resampling methods identified intraoperative blood loss, blood substitution, vascular disease, and advanced UICC stage as risk factors for anastomotic leakage. Greater distances between the tumor and the anal verge and performance of a diverting stoma were associated with a decreased risk of anastomotic leakage.

Background: The conservative and surgical management of lumbar kyphosis is difficult and is a challenge for the orthopaedic surgeon. A kyphotic deformity of the lumbar spine is present in 8% to 20% of these patients. Most curves have very rigid components, often exceed 80 degrees at birth. The options for conservative management are limited. Bracing is extremely difficult, rarely effective, and in advanced stages impossible. We have been using the Warner and Fackler kyphectomy technique at our institution since 1994 as a standard procedure for treating children with lumbar kyphosis due to myelomeningocele., Results: This study was performed for a better understanding of the cause of the complications and optimizing the surgical technique., Aim: The aim of this study was to evaluate the longterm results, technical problems, early and late complications and the complication associated risk factors.

Unicompartmental knee arthroplasty (UKA) has become a frequently used treatment option for anteromedial osteoarthritis (OA) of the knee due to good clinical and functional results. However, serious complications like tibial plateau fractures have been reported. These can be associated with saw cuts during surgery. The purpose of this study was to analyse saw cuts during Sawbone preparations at instructional unicompartmental knee courses and to identify potential sources of surgical error. One hundred Sawbone preparations were performed by knee surgeons inexperienced with UKA. Sawing errors during preparation were analysed and quantified. Tibial and femoral errors can occur during preparation. At the proximal tibia three errors can be found: extended vertical cuts (A), extended horizontal cuts (B) and perforation of the posterior cortex. An ascending cut at the posterior femoral condyle (C) is possible during femoral preparation. Errors type A were found at a mean length of 2.4 mm+/-2.3 mm with a maximum value of 10.1 mm. In 18% errors of more than 4.0 mm were found. Type B errors showed an average value of 2.0 mm+/-1.7 mm with maximum values of 7.4 mm. Type C errors were found at a mean of 1.3 mm+/-1.0 mm (maximum value 5.1 mm). Our data showed that in 18% of the cases, vertical cutting errors of more than 4.0 mm occurred in inexperienced surgeons.

Development of stenosis or occlusion of the transjugular intrahepatic portosystemic stent shunt (TIPSS) is one of the major limiting factors in the long-term viability of this procedure. The efficacy of anticoagulation with heparin which is used in different centers is still unclear. In the present study, we evaluated the effect of phenprocoumon on shunt patency after TIPSS placement using Palmaz stents; 49 patients with Child's A and B cirrhosis, who underwent successful TIPSS placement were randomized into the treatment group (n = 24) who received phenprocoumon and a control group (n = 25). After 11 to 13 weeks, all patients were admitted and had a reevaluation that included control angiography by transjugular approach. Phenprocoumon treatment was stopped after the first reevaluation and both groups were followed for 1 year after randomization. During the 3-month treatment period 11 of 22 patients of the treatment group and 12 of 23 patients of the control group required reintervention because of an increased portosystemic gradient. Five of the 12 patients in the control group showed complete occlusion of the shunt, whereas no occlusion in the treatment group was observed (P < .05). During the mean follow-up of 8 months after the treatment was stopped, in both groups stenosis occurred in 50% of patients, but no further occlusion of the stent was observed. These data indicate that occlusion of the stent is related to thrombosis, whereas stenosis does not appear to be dependent on blood coagulation. In patients with preserved liver function occlusion of the shunt may be prevented by phenprocoumon treatment in the first 3 months after TIPSS placement. Thereafter shunt occlusion was not observed and further phenprocoumon treatment seemed unnecessary.