Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial.

Importance: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation. Objective: To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation. Design, Setting, and Participants: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020. Interventions: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194). Main Outcomes and Measures: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death). Results: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy. Conclusions and Relevance: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded. Trial Registration: ClinicalTrials.gov Identifier: NCT02377167.

Influence of Body Mass Index and Gender on Stigmatization of Obesity.

BACKGROUND: Stigmatization and discrimination of people with obesity due to their weight are a common problem that may lead to additional weight gain. This study evaluated the influence of different parameters on the stigmatization of obesity. MATERIAL AND METHODS: Participants of six groups (general population, patients with obesity, medical students, physicians, nurses in training and nurses; n = 490) answered the short-form fat phobia scale (FPS) between August 2016 and July 2017. The influence of body mass index (BMI), gender and other factors on total scores and single adjective pairs was analyzed. RESULTS: A total of 490 participants were evaluated. The total mean FPS rating was 3.5 ± 0.6. FPS was significantly lower (more positive) in participants with obesity (3.2 ± 0.7) compared with participants without obesity (3.5 ± 0.5, p < 0.001). Individuals with obesity and diabetes rated the FPS significantly lower (more positive), whereas age and gender did not have a significant influence. Participants with obesity linked obesity more often with good self-control (p < 0.001), being shapely (p = 0.002), industrious (p < 0.001), attractive (p < 0.001), active (p < 0.001), self-sacrificing (p < 0.001) and having more willpower (p < 0.001) than the participants without obesity. Females rated more positive in shapely versus shapeless (p = 0.038) and attractive versus non-attractive (p < 0.001) than males. CONCLUSIONS: The present study shows that stigmatization of obesity is present in medical professionals as well as the general population. People affected by obesity characterized other people with obesity more positively (e.g. attractive or active), whereas people without obesity linked negative characteristics with obesity. Gender had an influence only on single items of FPS but did not affect overall stigmatization of obesity.

Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial.

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.

Depth of anesthesia by Narcotrend® and postoperative characteristics in children undergoing cardiac surgery under extracorporeal circulation: a retrospective comparison of two anesthetic regimens.

BACKGROUND: Depth of anesthesia may be insufficient in pediatric cardiac anesthesia if a total intravenous anesthetic regimen with opioids and midazolam is used during cardiopulmonary bypass. The advantages of sevoflurane-based balanced anesthesia may be (1) a more graduated regulation of the depth of anesthesia during cardiopulmonary bypass and (2) a reduction in postoperative ventilation time for children in comparison with total intravenous anesthesia. AIM: To evaluate a possibly positive effect of sevoflurane-based balanced anesthesia in children undergoing cardiac surgery we analyzed whether this anesthetic regimen had a significant effect related to (1) depth of anesthesia, (2) the need for opioids during cardiopulmonary bypass as well as on postoperative characteristics such as (3) time of postoperative ventilation, and (4) duration of stay in the intensive care unit in comparison with total intravenous anesthesia. METHODS: In a retrospective analysis, data from heart-lung machine protocols from 2013 to 2016 were compared according to anesthetic regimen (sevoflurane-balanced anesthesia, n = 70 vs. total intravenous anesthesia, n = 65). Children (age: 8 weeks to 14 years) undergoing cardiac surgery with cardiopulmonary bypass were included. As a primary outcome measure, we compared Narcotrend® system-extracted data to detect insufficient phases of anesthetic depth during extracorporeal circulation under moderate hypothermia. Postoperatively, we measured the postoperative ventilation time and the number of days in the intensive care unit. Furthermore, we analyzed patients' specific characteristics such as opioid consumption during cardiopulmonary bypass. Regression analysis relating primary objectives was done using the following variables: anesthetic regimen, age, severity of illness/surgery, and cumulative dosage of opiates during cardiopulmonary bypass. RESULTS: No significant differences were observed in descriptive patient characteristics (age, body weight, height, and body temperature) between the two groups. Further, no significant differences were found in depth of anesthesia by analyzing phases of superficial B1-C2-electroencephalography Narcotrend® data. No marked difference between the groups was observed for the duration of postoperative intensive care unit stay. However, the postoperative ventilation time (median (95% CI, hours)) was significantly lower in the sevoflurane-based balanced anesthesia group (6.0 (2.0-15.0)) than in the total intravenous anesthesia group (13.5 (7.0-25)). A higher dosage of opioids and midazolam was required in the total intravenous anesthesia group to maintain adequate anesthesia during cardiopulmonary bypass. Regression analysis showed an additional, significant impact of the following factors: severity of illness and severity grade of cardiac surgery (according to Aristotle) on the primary endpoint. CONCLUSION: In children undergoing cardiac surgery in our department, the use of sevoflurane-balanced anesthesia during cardiopulmonary bypass showed no superiority of inhalational agents over total intravenous anesthesia with opioids and benzodiazepines preventing phases of superficial anesthesia, but a marked advantage for the postoperative ventilation time compared with total intravenous anesthesia.

Self-directed training with e-learning using the first-person perspective for laparoscopic suturing and knot tying: a randomised controlled trial : Learning from the surgeon's real perspective.

BACKGROUND: Laparoscopic suturing and knot tying is essential for advanced laparoscopic procedures and requires training outside of the operating room. However, personal instruction by experienced surgeons is limitedly available. To address this, the concept of combining e-learning with practical training has become of interest. This study aims to investigate the influence of the first-person perspective in instructional videos, as well as the feasibility of a completely self-directed training curriculum for laparoscopic suturing and knot tying. MATERIALS AND METHODS: Ninety-one laparoscopically naïve medical students were randomised into two groups training with e-learning videos in either the first-person perspective (combining endoscopic view and view of hands/instruments/forearm motion) or the endoscopic view only. Both groups trained laparoscopic suturing and knot tying in teams of two until reaching predefined proficiency levels. Blinded, trained raters regularly assessed the participants' performance by using validated checklists. After training, participants filled out questionnaires regarding training experience and personal characteristics. RESULTS: Average training time to reach proficiency did not differ between groups [first-person perspective (min): 112 ± 44; endoscopic view only (min): 109 ± 47; p = 0.746]. However, participants from both groups perceived the first-person perspective as useful for learning new laparoscopic skills. Both groups showed similar baseline performances and improved significantly after training [Objective Structured Assessment of Technical Skills (OSATS) (max. 37 points): first-person perspective: 30.3 ± 2.3; endoscopic view only: 30.8 ± 2.3]. All participants managed to reach proficiency, needing 8-43 attempts without differences between groups. Visuospatial abilities (mental rotation) seemed to enhance the learning curve. CONCLUSION: Modifying instructional videos to the first-person perspective did not translate into a better performance in this setting but was welcomed by participants. Completely self-directed training with the use of e-learning can be a feasible training approach to achieve technical proficiency in laparoscopic suturing and knot tying in a training setting.

Heller myotomy versus endoscopic balloon dilatation for achalasia: A single center experience.

This study aimed to compare clinical results, symptom relief, quality of life and patient satisfaction after the 2 most common procedures for achalasia treatment: laparoscopic Heller myotomy (LHM) and endoscopic balloon dilatation (EBD).Patients treated at University Hospital of Heidelberg with LHM or EBD were included. A retrospective chart review of perioperative data and a prospective follow-up of therapeutic efficiency, Gastrointestinal Quality of Life Index (GIQLI) and patient satisfaction was conducted.Follow-up data (mean follow-up: 75.1 ±â€Š53.9 months for LHM group and 78.9 ±â€Š45.6 months for EBD) were obtained from 36 patients (19 LHM; 17 EBD). Eckardt score (median (q1,q3): 2 (1,4) in both groups, P = .91, GIQLI (LHM: 117 (91.5, 126) vs EBD: 120 (116, 128), P = .495) and patient satisfaction (3 (2,3) vs 3 (2,4), P = .883) did not differ between groups. Fifteen patients (78.9%) in LHM group and 11 (64.7%) in EBD group (P = .562) stated they would undergo the intervention again. All patients with EBD had at least 2 dilatations (100%), whilst only 2 patients (10.5%) had dilatation after LHM (P < .001). There were no complications after EBD, but 2 after LHM (10.5%, P = .517).Both LHM and EBD are able to control symptoms and provide similar quality of life and patient satisfaction. However, reintervention rate was higher following EBD, hence LHM provided a more sustained treatment than EBD.

Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study.

BACKGROUND: To assess late toxicity, quality of life and oncological outcome after consolidative whole abdominal radiotherapy (WART) following cytoreductive surgery and carboplatin/paclitaxel chemotherapy in high risk patients with advanced ovarian cancer FIGO stage III using IMRT (Intensity modulated radiation therapy). METHODS: The OVAR-IMRT-02 study is a multi-center single-arm phase-II-trial. Twenty patients with optimally debulked ovarian cancer stage FIGO III with complete remission after chemotherapy were treated with intensity modulated WART. A total dose of 30 Gy in 20 fractions was applied to the entire peritoneal cavity. Primary endpoint was treatment tolerability; secondary objectives were acute and chronic toxicities, quality of life, rates of therapy disruption/abortion, progression-free survival (PFS) and overall survival (OS). RESULTS: All patients completed treatment and 10/20 patients (50%) reached the final study follow-up of 36 months. Late side effects consisted of °1-°2 lower limb edema (44.5%), with one patient (5.6%) showing °3 edema. Three patients (16.7%) showed elevated gamma-Glutamyltransferase. There were no severe late side effects regarding renal or hepatic function or any gastrointestinal toxicity greater than °2. During WART, mean global health status decreased by 18.1 points (95%-CI: 7.1-29.0), but completely normalized after 6 months. The same trend was observed for the function scale scores. Kaplan-Meier-estimated 1-, 2- and 3-year PFS was 74, 51 and 40%, respectively. 1-, 2- and 3-year OS was 89, 83 and 83%, respectively. CONCLUSIONS: Intensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute and late toxicity and minor impact on long-term quality of life. Together with the promising results for PFS and OS, intensity modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov ( NCT01180504 ). Registered 12 August 2010 - retrospectively registered.

Distal radioulnar joint instability with three different injury patterns assessed by three-dimensional C-arm scans: a cadaveric study.

The aim of this study was to establish a radiographic method for detecting distal radioulnar joint instability intraoperatively. We created three successive instabilities in 12 intact Thiel-fixed upper limb specimens: lesion of the triangular fibrocartilage complex, Galeazzi injury and Essex-Lopresti injury. We made three-dimensional scans of the wrists in pronation and supination with a mobile C-arm. We used four validated measurement methods to quantify ulnar migration in the standard axial planes: the radioulnar line method, the subluxation ratio method, the epicentre method and the radioulnar ratio method. All types of instability showed significantly increased migration of the ulna compared with the control group. The subluxation ratio and the radioulnar ratio methods showed the highest sensitivity and specificity in detecting the instabilities. We conclude that these two methods are feasible for radiographically assessing distal radioulnar joint instability. Instability may be assumed if the migration of the ulna in the sigmoid notch is at least 45% of the length of the sigmoid notch, in which case wire transfixation of the distal radioulnar joint is advised.

Predictors of Risk and Success of Obesity Surgery.

BACKGROUND: Obesity surgery has proven successful for weight loss and the resolution of comorbidities. There is, however, little evidence on its success and the risk of complications when considering age of onset of obesity (AOO), years of obesity (YOO), preoperative body mass index (BMI), Edmonton obesity staging system (EOSS) score, and age as possible predictors of weight loss, the resolution of comorbidities, and the risk of complications. METHODS: Patients who underwent Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) from a prospective database were analyzed. Multiple regression analyses were used to predict comorbidities and their resolution, percentage excess weight loss (%EWL) and total weight loss (%TWL) 12 months after surgery, and the risk of complications using the predictors AOO, YOO, age, EOSS, and BMI. RESULTS: 180 patients aged 46.8 ± 11.1 years with a preoperative BMI 49.5 ± 7.5 were included. The number of preoperative comorbidities was higher with older age (ß = 0.054; p = 0.023) and a greater BMI (ß = 0.040; p = 0.036) but was not related to AOO and YOO. Patients with AOO as a child or adolescent were more likely to have an EOSS score of ≥2. Greater preoperative BMI was negatively associated with %EWL (ß = -1.236; p < 0.001) and older age was negatively associated with %TWL (ß = -0.344; p = 0.020). Postoperative complications were positively associated with EOSS score (odds ratio [OR] 1.147; p = 0.042) and BMI (OR 1.010; p = 0.020), but not with age. AOO and YOO were not related to postoperative outcome. CONCLUSION: Greater BMI was associated with a lower %EWL and age was associated with a low %TWL. YOO and AOO did not influence outcome. Age, BMI, and EOSS score were the most important predictors for risk and success after obesity surgery. Surgery should be performed early enough for optimal outcomes.

Video Teaching Leads to Improved Attitudes Towards Obesity-a Randomized Study with 949 Participants.

BACKGROUND: Obesity is a rising social and economic burden. Patients with obesity often suffer from stigmatization and discrimination. Underrecognition of obesity as a disease could be a contributing factor. The present study aimed to compare attitudes towards obesity with other chronic diseases and to evaluate the recognition of need of professional treatment. METHODS: Nine hundred and forty-nine participants (subgroups: general population, patients with obesity, nurses in training, nurses, medical students, physicians) were randomized to video teaching on obesity and control. Questionnaires on the burden and influence of obesity on daily life compared to other chronic diseases and the fat phobia scale (FPS) were answered. RESULTS: Burden of obesity was rated low (4.2 ± 1.3; rank 9 of 11) compared to other diseases. Bowel cancer (5.5 ± 0.9) had the highest and caries the lowest (2.7 ± 1.4) estimated impact. Females (p = 0.011) and older people (p < 0.001) rated burden of obesity high whereas general population (p < 0.001) and control (p < 0.001) rated it low. Females (p = 0.001) and people with higher BMI (p = 0.004) rated the influence of obesity on daily life high; the general population (p < 0.001; reference physicians) and the control group (p < 0.001) rated it low. FPS was lowest in patients with obesity (3.2 ± 0.7) and highest in the general population (3.6 ± 0.4) and medical students (3.6 ± 0.5; p < 0.001; compared to physicians). CONCLUSIONS: Obesity is underestimated as a disease compared to other chronic diseases and attitudes towards obesity are rather negative in comparison. Video teaching showed positive effects so a focus in medical education and public campaigns should aim to improve prevention and treatment of obesity.

Global Variation of Nutritional Status in Children Undergoing Chronic Peritoneal Dialysis: A Longitudinal Study of the International Pediatric Peritoneal Dialysis Network.

While children approaching end-stage kidney disease (ESKD) are considered at risk of uremic anorexia and underweight they are also exposed to the global obesity epidemic. We sought to investigate the variation of nutritional status in children undergoing chronic peritoneal dialysis (CPD) around the globe. The distribution and course of body mass index (BMI) standard deviation score over time was examined prospectively in 1001 children and adolescents from 35 countries starting CPD who were followed in the International Pediatric PD Network (IPPN) Registry. The overall prevalence of underweight, and overweight/obesity at start of CPD was 8.9% and 19.7%, respectively. Underweight was most prevalent in South and Southeast Asia (20%), Central Europe (16.7%) and Turkey (15.2%), whereas overweight and obesity were most common in the Middle East (40%) and the US (33%). BMI SDS at PD initiation was associated positively with current eGFR and gastrostomy feeding prior to PD start. Over the course of PD BMI SDS tended to increase on CPD in underweight and normal weight children, whereas it decreased in initially overweight patients. In infancy, mortality risk was amplified by obesity, whereas in older children mortality was markedly increased in association with underweight. Both underweight and overweight are prevalent in pediatric ESKD, with the prevalence varying across the globe. Late dialysis start is associated with underweight, while enteral feeding can lead to obesity. Nutritional abnormalities tend to attenuate with time on dialysis. Mortality risk appears increased with obesity in infants and with underweight in older children.

Sensor-based machine learning for workflow detection and as key to detect expert level in laparoscopic suturing and knot-tying.

INTRODUCTION: The most common way of assessing surgical performance is by expert raters to view a surgical task and rate a trainee's performance. However, there is huge potential for automated skill assessment and workflow analysis using modern technology. The aim of the present study was to evaluate machine learning (ML) algorithms using the data of a Myo armband as a sensor device for skills level assessment and phase detection in laparoscopic training. MATERIALS AND METHODS: Participants of three experience levels in laparoscopy performed a suturing and knot tying task on silicon models. Experts rated performance using Objective Structured Assessment of Surgical Skills (OSATS). Participants wore Myo armbands (Thalmic Labs™, Ontario, Canada) to record acceleration, angular velocity, orientation, and Euler orientation. ML algorithms (decision forest, neural networks, boosted decision tree) were compared for skill level assessment and phase detection. RESULTS: 28 participants (8 beginner, 10 intermediate, 10 expert) were included, and 99 knots were available for analysis. A neural network regression model had the lowest mean absolute error in predicting OSATS score (3.7 ± 0.6 points, r2 = 0.03 ± 0.81; OSATS min.-max.: 4-37 points). An ensemble of binary-class neural networks yielded the highest accuracy in predicting skill level (beginners: 82.2% correctly identified, intermediate: 3.0%, experts: 79.5%) whereas standard statistical analysis failed to discriminate between skill levels. Phase detection on raw data showed the best results with a multi-class decision jungle (average 16% correctly identified), but improved to 43% average accuracy with two-class boosted decision trees after Dynamic time warping (DTW) application. CONCLUSION: Modern machine learning algorithms aid in interpreting complex surgical motion data, even when standard analysis fails. Dynamic time warping offers the potential to process and compare surgical motion data in order to allow automated surgical workflow detection. However, further research is needed to interpret and standardize available data and improve sensor accuracy.

Normal values of distal radioulnar translation assessed by three-dimensional C-arm scans: a cadaveric study.

We investigated whether mobile C-arm cone beam computer tomography (CBCT) could be used to measure radioulnar translation. The study was conducted on 31 Thiel-fixed intact cadaver arms. Three-dimensional scans of each wrist were carried out in pronation and supination. Four established measurement methods were used (radioulnar line, subluxation ratio, epicentre and radioulnar ratio methods) to measure radioulnar translation. The intraclass correlation coefficient for inter-observer and intra-observer reliability were excellent in three of four methods (>0.94). The reference ranges for physiological radioulnar translation were between -30% and 91% (radioulnar line method), -32% and 87% (subluxation ratio method), -40% and 23% (epicentre method), and 2% and 73% (radioulnar ratio method). Our results indicate that radioulnar translation in the distal radioulnar joint can be determined reliably using mobile C-arm CBCT. The normal values provide a basis for further experimental and clinical studies.

The Charlson Comorbidity and Barthel Index predict length of hospital stay, mortality, cardiovascular mortality and rehospitalization in unselected older patients admitted to the emergency department.

BACKGROUND AND AIMS: The Charlson Comorbidity Index (CCI) is the most widely used assessment tool to report the presence of comorbid conditions. The Barthel index (BI) is used to measure performance in activities of daily living. We prospectively investigated the performance of CCI or BI to predict length of hospital stay (LOS), mortality, cardiovascular (CV) mortality and rehospitalization in unselected older patients on admission to the emergency department (ED). We also studied the association of CCI or BI with costs. METHODS: We consecutively enrolled 307 non-surgical patients ≥ 68 years presenting to the ED with a wide range of comorbid conditions. Baseline characteristic, clinical presentation, laboratory data, echocardiographic parameters and hospital costs were compared among patients. All patients were followed up for mortality, CV mortality and rehospitalization within the following 12 months. A multivariate analysis was performed. RESULTS: Mortality was increased for patients having a higher CCI or BI with a hazard ratio around 1.17-1.26 or 0.75-0.81 (obtained for different models) for one or ten point increase in CCI or BI, respectively. The prognostic impact of a high CCI or BI on CV mortality and rehospitalization was also significant. In a multiple linear regression using the same independent variables, CCI and BI were identified as a predictor of LOS in days. Multiple linear regression analysis did not confirm an association between CCI and costs, but for BI after adjusting for multiple factors. CONCLUSION: CCI and BI independently predict LOS, mortality, CV mortality, and rehospitalization in unselected older patients admitted to ED.

The Heidelberg VR Score: development and validation of a composite score for laparoscopic virtual reality training.

INTRODUCTION: Virtual reality (VR-)trainers are well integrated in laparoscopic surgical training. However, objective feedback is often provided in the form of single parameters, e.g., time or number of movements, making comparisons and evaluation of trainees' overall performance difficult. Therefore, a new standard for reporting outcome data is highly needed. The aim of this study was to create a weighted, expert-based composite score, to offer simple and direct evaluation of laparoscopic performance on common VR-trainers. MATERIALS AND METHODS: An integrated analytic hierarchy process-Delphi survey was conducted with 14 international experts to achieve a consensus on the importance of different skill categories and parameters in evaluation of laparoscopic performance. A scoring algorithm was established to allow comparability between tasks and VR-trainers. A weighted composite score was calculated for basic skills tasks and peg transfer on the LapMentor™ II and III and validated for both VR-trainers. RESULTS: Five major skill categories (time, efficiency, safety, dexterity, and outcome) were identified and weighted in two Delphi rounds. Safety, with a weight of 67%, was determined the most important category, followed by efficiency with 17%. The LapMentor™-specific score was validated using 15 (14) novices and 9 experts; the score was able to differentiate between both groups for basic skills tasks and peg transfer (LapMentor™ II: Exp: 86.5 ± 12.7, Nov. 52.8 ± 18.3; p < 0.001; LapMentor™ III: Exp: 80.8 ± 7.1, Nov: 50.6 ± 16.9; p < 0.001). CONCLUSION: An effective and simple performance measurement was established to propose a new standard in analyzing and reporting VR outcome data-the Heidelberg virtual reality (VR) score. The scoring algorithm and the consensus results on the importance of different skill aspects in laparoscopic surgery are universally applicable and can be transferred to any simulator or task. By incorporating specific expert baseline data for the respective task, comparability between tasks, studies, and simulators can be achieved.

Does rating with a checklist improve the effect of E-learning for cognitive and practical skills in bariatric surgery? A rater-blinded, randomized-controlled trial.

BACKGROUND: Mental training of laparoscopic procedures with E-learning has been shown to translate to the operating room. The present study aims to explore whether the use of checklists during E-learning improves transfer of skills to the simulated OR on a Virtual Reality (VR) trainer for Roux-en-Y gastric bypass (RYGB). METHODS: Laparoscopy naive medical students (n = 80) were randomized in two groups. After an E-learning introduction to RYGB, checklist group rated RYGB videos using the validated Bariatric Objective Structured Assessment of Technical Skills (BOSATS) checklist while group without checklist only observed the videos. Participants then performed RYGB on a VR-trainer twice and were evaluated by a blinded expert rater using BOSATS. A multiple choice (MC) knowledge test on RYGB was performed. Suturing on a cadaveric porcine small bowel was evaluated using objective structured assessment of technical skill (OSATS). RESULTS: Checklist group was better in the knowledge test (A 8.3 ± 1.1 vs. B 7.1 ± 1.3; p ≤ 0.001) and there was a trend towards better VR RYGB performance (BOSATS) on the first try (85.9 ± 10.2 vs. 81.1 ± 11.5; p = 0.058), but not on the second try (92.0 ± 9.7 vs. 89.3 ± 10.5; p = 0.251). Suturing as measured by OSATS was not different (29.5 ± 3.0 vs. 29.0 ± 3.5; p = 0.472). CONCLUSION: This study presents evidence that the use of a BOSATS checklist during E-learning helps trainees to improve their knowledge acquisition with E-learning. The transfer from mental training to the simulated OR environment seems to be partially enhanced by use of the BOSATS checklist. However, more research is required to investigate potential benefits.

One or two trainees per workplace for laparoscopic surgery training courses: results from a randomized controlled trial.

BACKGROUND: There are no standards for optimal utilization of workplaces in laparoscopic training. This study aimed to define whether laparoscopy training should be done alone or in pairs (known as dyad training). METHODS: This was a three-arm randomized controlled trial with laparoscopically naïve medical students (n = 100). Intervention groups participated alone (n = 40) or as dyad (n = 40) in a multimodality training curriculum with e-learning, basic, and procedural skills training using box and VR trainers. The control group (n = 20) had no training. Post-performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was measured as the primary outcome by blinded raters using the objective structured assessment of technical skills (OSATS). Global operative assessment of laparoscopic skills (GOALS), time for LC, and VR performances were secondary outcomes. RESULTS: There were no differences between groups for performance scores [OSATS: alone (40.2 ± 9.8) vs. dyad (39.8 ± 8.6), p = 0.995; alone vs. control (37.1 ± 7.4), p = 0.548; or dyad vs. control, p = 0.590; and GOALS score: alone (10.6 ± 3.0) vs. dyad (10.0 ± 2.7), p = 0.599; alone vs. control (10.1 ± 3.0), p = 0.748; or dyad vs. control, p = 0.998]. Dyad finished LC faster than control [median = 62.5 min (CI 58.0-73.0) vs. 76.5 min (CI 72.0-80+); p = 0.042], while there were no inter-group differences between alone vs. control [median = 69.0 min (CI 62.0-76.0) vs. control; p = 0.099] or alone vs. dyad (p = 0.840). Dyad and alone showed superior performance on the VR trainer vs. control for time, number of movements, and path length, but not for complications and application of cautery. CONCLUSIONS: The curriculum provided trainees with the laparoscopic skills needed to perform LC safely, irrespective of the number of trainees per workplace. Dyad training reduced the operation time needed for LC. Therefore, dyad training seems to be a promising alternative, especially if training time is limited and resources must be used as efficiently as possible. Trial registration German Clinical Trials Register: DRKS00004675.

Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial.

BACKGROUND: In natural orifice transluminal endoscopic surgery (NOTES) with transrectal (TR) access the intraoperative opening of the rectal wall poses a risk of intraperitoneal contamination and subsequent infectious complications. A rectal washout with a disinfectant may reduce this risk. The aim of the study was to assess the intraoperative contamination on the circular stapler pin when a rectal washout with povidone-iodine (RW-PI) or Ringer solution was performed in patients undergoing left-sided colectomy. Furthermore, the additional effect of an irrigation instrument on the contamination was evaluated. METHODS: In a patient and assessor blinded randomized controlled trial, patients undergoing left-sided colectomy were assigned to rectal washout with PI with an irrigation instrument (RW-PI; n = 23), rectal washout with Ringer solution with an irrigation instrument (RW-R; n = 21) or rectal washout with Ringer solution without an irrigation instrument (RW; n = 25). An end-to-end anastomosis with a circular stapler was performed. The contamination on the pin of the circular stapler was chosen as primary endpoint in order to simulate the intraabdominal contamination risk during TR NOTES. Secondary endpoints were contamination of the rectal mucosa, peritoneal contamination and postoperative morbidity. RESULTS: The contamination rate of the pin of the circular stapler did not differ (RW-PI 39.1%, RW-R 33.3%, RW 52.0%; P = 0.421), but contamination of the rectal mucosa was reduced (47.8% versus 95.2% versus 100%; P < 0.001) and peritoneal contamination tended to be reduced (39.1% versus 71.4% versus 60.0%; P = 0.09) when a rectal washout with PI was performed. The rates of infectious complications (17.4% versus 9.5% versus 12.0%; P = 0.821) and of overall complications (30.4% versus 28.6% versus 44.0%; P = 0.476) did not differ. CONCLUSIONS: Despite an intense rectal washout with PI, contamination of the stapler pin did not differ. Intraabdominal bacterial translocation was frequently encountered even after disinfectant rectal washout with PI. Further studies might focus on the clinical impact of intraabdominal contamination in TR NOTES.

Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial.

BACKGROUND: Hand-assisted laparoscopic living donor nephrectomy (HALDN) using a periumbilical or Pfannenstiel incision was developed to improve donor outcome after a kidney transplant. The aim of this study was to investigate two methods of hand assistance and kidney removal during HALDN and their effect on the time it takes for the donor to return to normal physical activity. METHODS/DESIGN: This study was initiated in November 2017 and is expected to last for 2 years. To be eligible for the study, donors must be more than 20 years of age and must not be receiving permanent pain therapy. Only donors with a single artery and vein in the graft are being enrolled in this trial. Donors with infections or scars in the periumbilical or hypogastric area, bleeding disorders, chronic use of immunosuppressive agents, or active infection will be excluded. Donors will be randomly allocated to either a control arm (periumbilical incision) or an intervention arm (Pfannenstiel incision). The sample size was calculated as 26 organ donors in each group. The primary endpoint is the number of days it takes the donor to return to normal physical activity (up to 4 weeks after the operation). Secondary endpoints are intraoperative outcomes, including estimated blood loss, warm ischemia time, and duration of the operation. Postoperative pain will be assessed using the visual analog scale, rescue analgesic use, and peak expiratory flow rate. Length of hospital stay, physical activity score, time to return to work, donor satisfaction, cosmetic score, postoperative complications, and all-cause mortality in living donors will also be reported. Delayed graft function, primary non-function, serum creatinine levels, and glomerular filtration rate will also be assessed in the recipients after transplantation. DISCUSSION: This is the first randomized controlled trial to compare the time it takes the living donor to return to normal physical activity after HALDN using two different types of incision. The comprehensive findings of this study will help decide which nephrectomy procedure is best for living donors with regard to patient comfort and satisfaction as well as graft function in the recipient after transplantation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03317184 . Registered on 23 October 2017.

Five-year outcome after pelvic floor reconstructive surgery: evaluation using dynamic magnetic resonance imaging compared to clinical examination and quality-of-life questionnaire.

Background Dynamic magnetic resonance imaging (dMRI) captures the entire pelvis during Valsalva maneuver and helps diagnosing pelvic floor changes after reconstructive surgery. Purpose To evaluate therapeutic outcome five years after reconstructive surgery using clinical examination, dMRI, and quality-of-life (QOL) questionnaire. Material and Methods Clinical examination, dMRI, and QOL questionnaire were conducted before surgery and in the follow-ups at 12 weeks, one year, and five years in women with pelvic organ prolapse (POP) stage ≥2. dMRI was performed at 1.5-T using a predefined protocol including sagittal T2-weighted (T2W) sequence at rest and sagittal T2W true-FISP sequence at maximum strain for metric POP measurements (reference points = bladder, cervix, pouch, rectum). Pelvic organ mobility (POM) was defined as the difference of the metric measurement at maximum strain and at rest. Results Twenty-six women with 104 MRI examinations were available for analysis. dMRI results mostly differ to clinical examination regarding the overall five-year outcome and the posterior compartment in particular. dMRI diagnosed substantially more patients with recurrent or de novo POP in the posterior compartment (n = 17) compared to clinical examination (n = 4). POM after five years aligns to preoperative status except for the bladder. POM reflects best the QOL results regarding defecation disorders. Conclusion A tendency for recurrent and de novo POP was seen in all diagnostic modalities applied. dMRI objectively visualizes the interaction of the pelvic organs and the pelvic floor after reconstructive surgery and POM correlated best with the women's personal impression on pelvic floor complaints.