[Structured Implementation and Modular In-house Training as Key Success Factors in Robotically Assisted Surgery - Evaluation Using the Example of Colorectal Surgery]. / Strukturierte Implementierung und modulares inhouse Training als zentrale Erfolgsfaktoren in der robotisch assistierten Chirurgie ­ Evaluation am Beispiel der kolorektalen Chirurgie.

OBJECTIVES: To demonstrate the applicability of structured implementation of robotic assisted surgery (RAS) and to evaluate a modular training procedure during the implementation phase in in-house mentoring. METHOD: Execution of a self-defined PDCA (PDCA: Plan-Do-Check-Act) implementation cycle accompanied by prospective data collection of patient characteristics, operation times, complications, conversion rates and postoperative length of stay of a modularly defined training operation (robotic assisted rectosigmoid resection - RARSR). RESULTS: Evaluation of 100 consecutive cases distributed among 3 trainees and an in-house mentor as internal control group. Presentation of qualitatively safe and successful implementation with a short learning curve of the training operation with balanced patient characteristics. CONCLUSIONS: Structured implementation enables the safe introduction of RAS in visceral surgery. In this context, modular training operations can facilitate the adoption of RAS by users under everyday conditions. For the first time, we demonstrate this within an in-house mentoring approach.

A phase II study of catumaxomab administered intra- and postoperatively as part of a multimodal approach in primarily resectable gastric cancer.

BACKGROUND: Postoperative relapse rate after gastrectomy and perioperative chemotherapy remain high in patients with advanced gastric cancer due to the spread of disseminated tumour cells in the peritoneal cavity. Perioperative administration of catumaxomab could potentially eliminate residual tumour cells after intended curative resection of the primary tumour. METHODS: This open-label, phase II study investigated the safety and efficacy of catumaxomab following neoadjuvant chemotherapy and subsequent surgery in patients with resectable (T2-4, N+, M0) gastric adenocarcinoma. Patients received catumaxomab intra- (single 10 µg dose) and postoperatively (10, 20, 50 and 150 µg on days 7, 10, 13 and 16, respectively). The primary endpoint was the postoperative complication rate (maximum rate defined as <62 %) within 30 days after surgery in patients who received at least the first catumaxomab dose. RESULTS: Of 64 patients treated with neoadjuvant chemotherapy, 58 underwent surgery and 54 received at least the first catumaxomab dose. Postoperative complications were reported in 18 of 54 evaluable patients (complication rate 33 %; 95 % confidence interval: 21-48 %); thus, the primary endpoint was met. The most frequent complications were pulmonary infection (17 %) and anastomosis insufficiency requiring surgery (11 %). The most common catumaxomab-related adverse events were pyrexia (67 %), leucocytosis (19 %), abdominal pain (17 %) and chills (17 %). The 4-year disease-free and overall survival rates were 38 and 50 %. CONCLUSION: Intra- and postoperative administration of catumaxomab as part of a multimodal treatment approach was feasible and tolerable in patients with advanced gastric cancer and should be further investigated in a randomised trial.

The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip.

BACKGROUND: To evaluate the effectiveness and safety of the DS Titanium Ligation Clip for appendicular stump closure in laparoscopic appendectomy. METHODS: Overall, 502 patients undergoing laparoscopic appendectomy were recruited for this observational multicentre study in nine study centres between October 2011 and July 2013. The clip was finally applied in 390 patients. Primary outcome variables were feasibility of the clip, intra-abdominal surgical site (abscesses, stump leakages) and superficial wound infections. Patients were followed 30 days after surgery. RESULTS: The clip was applicable in nearly 80 % of patients. Reasons for not applying the clip were mainly an inflamed caecum or a too large diameter of the appendix base. Superficial wound infections were found in nine (2.31 %), intra-abdominal abscesses in five (1.28 %), appendicular stump leak in one (0.26 %), and other adverse events in 22 (5.64 %) patients. In total, 12 (3.08 %) patients were re-admitted to hospital for treatment. Seven re-admissions were surgery-related; ten (2.56 %) patients had to be re-operated. One patient died during the course of the study due to persisting peritonitis (mortality 0.26 %). CONCLUSIONS: The results suggest that the DS Titanium Ligation Clip is a safe and effective option in securing the appendicular stump in laparoscopic appendectomy. The complication rates found with the use of the DS-Clip are comparable to the rates in the literature when other methods are used. TRIAL REGISTRATION: NCT01734837 .

Conception and prospective multicentric validation of a Robotic Surgery Training Curriculum (RoSTraC) for surgical residents: from simulation via laboratory training to integration into the operation room.

There is a lack of training curricula and educational concepts for robotic-assisted surgery (RAS). It remains unclear how surgical residents can be trained in this new technology and how robotics can be integrated into surgical residency training. The conception of a training curriculum for RAS addressing surgical residents resulted in a three-step training curriculum including multimodal learning contents: basics and simulation training of RAS (step 1), laboratory training on the institutional robotic system (step 2) and structured on-patient training in the operating room (step 3). For all three steps, learning content and video tutorials are provided via cloud-based access to allow self-contained training of the trainees. A prospective multicentric validation study was conducted including seven surgical residents. Transferability of acquired skills to a RAS procedure were analyzed using the GEARS score. All participants successfully completed RoSTraC within 1 year. Transferability of acquired RAS skills could be demonstrated using a RAS gastroenterostomy on a synthetic biological organ model. GEARS scores concerning this procedure improved significantly after completion of RoSTraC (17.1 (±5.8) vs. 23.1 (±4.9), p < 0.001). In step 3 of RoSTraC, all participants performed a median of 12 (range 5-21) RAS procedures on the console in the operation room. RoSTraC provides a highly standardized and comprehensive training curriculum for RAS for surgical residents. We could demonstrate that participating surgical residents acquired fundamental and advanced RAS skills. Finally, we could confirm that all surgical residents were successfully and safely embedded into the local RAS team.

Can surgery follow the dictates of the pandemic "keep your distance"? Requirements with COVID-19 for hygiene, resources and the team.

Since the beginning of the pandemic, there have been restrictions in the daily care of surgical patients - both elective and emergency. Readying supply capacities and establishing isolation areas and areas for suspected cases in the clinics have led to keeping beds free for treating (suspected) COVID-19 cases. It was therefore necessary to temporarily postpone elective surgery. Now, elective care can be gradually resumed with the second phase of the pandemic in Germany. However, it remains the order of the day to adapt pre-, intra- and post-operative procedures to the new COVID-19 conditions while maintaining specialized hygiene measures. This concerns the correct procedure for the use of personal protective materials as well as process adjustment for parallel treatment of positive and negative patients in the central OR, and handling of aerosols in the operating theater, operating room, and surgical site under consideration of staff and patient protection. Although dealing with surgical smoke in the operating theater has long been criticized, COVID-19 is forcing a renaissance in this area. Finally, the choice of surgical method, whether open surgery or minimally invasive procedures, is critical in determining how many colleagues are exposed to the risk of infection from COVID-19 patients, sometimes for hours. Here, robot-assisted surgery can comply with the pandemic's requirement to "keep your distance" in a unique way, since the surgeon can operate at virtually any distance from the surgical site, at least with regard to aerosol formation and exposure.

Bacterobilia in pancreatic surgery-conclusions for perioperative antibiotic prophylaxis.

BACKGROUND: Jaundice or preoperative cholestasis (PC) are typical symptoms of pancreatic masses. Approximately 50% of patients undergo preoperative biliary drainage (PBD) placement. PBD is a common cause of bacterobilia (BB) and is a known surgical site infection risk factor. An adjustment of preoperative antibiotic prophylaxis (PAP) may be reasonable according to the profile of BB. For this, we examined the microbiological findings in routine series of patients. AIM: To investigate the incidence and profile of biliary bacterial colonization in patients undergoing pancreatic head resections. METHODS: In the period from January 2009 to December 2015, 285 consecutive pancreatic head resections were performed. Indications for surgery were malignancy (71%), chronic pancreatitis (18%), and others (11%). A PBD was in 51% and PC was in 42%. The standard PAP was ampicillin/sulbactam. Intraoperatively, a smear was taken from the hepatic duct. An analysis of the isolated species and resistograms was performed. Patients were categorized according to the presence or absence of PC (PC+/PC-) and PBD (PBD+/PBD-) into four groups. Antibiotic efficiency was analyzed for standard PAP and possible alternatives. RESULTS: BB was present in 150 patients (53%). BB was significantly more frequent in PBD+ (n =120) than in PBD- (n = 30), P < 0.01. BB was present both in patients with PC and without PC: (PBD-/PC-: 18%, PBD-/PC+: 30%, PBD+/PC-: 88%, PBD+/PC+: 80%). BB was more frequent in malignancy (56%) than in chronic pancreatitis (45%). PBD, however, was the only independent risk factor in multivariate analysis. In total, 357 pathogens (342 bacteria and 15 fungi) were detected. The five most common groups (n = 256, 74.8%) were Enterococcus spp. (28.4%), Streptococcus spp. (16.9%), Klebsiella spp. (12.6%), Escherichia coli (10.5%), and Enterobacter spp. (6.4%). A polymicrobial BB (PBD+: 77% vs PBD-: 40%, P < 0.01) and a more frequent detection of Enterococcus (P < 0.05) was significantly associated with PBD+. In PBD+, the efficiency of imipenem and piperacillin/tazobactam was significantly higher than that of the standard PAP (P < 0.01). CONCLUSION: PBD-/PC- and PBD-/PC+ were associated with a low rate of BB, while PBD+ was always associated with a high rate of BB. In PBD+ patients, BB was polymicrobial and more often associated with Enterococcus. In PBD+, the spectrum of potential bacteria may not be covered by standard PAP. A more potent alternative for prophylactic application, however, was not found.

CC-chemokine activation in acute pancreatitis: enhanced release of monocyte chemoattractant protein-1 in patients with local and systemic complications.

OBJECTIVE: Systemic leukocyte activation is claimed to trigger inflammatory response and remote organ dysfunction in acute pancreatitis. Chemokines are inflammatory mediators with potent leukocyte-activating properties and have been shown to be involved in the pathophysiological process of experimental acute pancreatitis. However, as little is known about their role in human disease we investigated local and systemic concentrations of different CC-chemokine members in patients with acute pancreatitis. PATIENTS AND METHODS: We included 68 patients with acute pancreatitis in the present study. Local complications in terms of necrosis were present in 37 (54%) patients of whom 21 (57%) developed pancreatic infections. Monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory protein-1alpha (MIP-1alpha) and macrophage inflammatory protein-1beta (MIP-1beta) concentrations were measured daily over 2 weeks after study inclusion by ELISA in sera and lesser sac aspirates. RESULTS: MCP-1 serum concentrations showed a dramatic increase in patients who developed local complications and/or remote organ failure. Herein, a close correlation was found between the severity of remote organ failure and the degree of MCP-1 elevation. Multiple regression analysis identified pancreatic infections as well as renal and cardiocirculatory failure as independent variables associated with enhanced systemic MCP-1 release. MIP-1alpha levels remained unaffected by local complications and showed a significant increase only; if multiple organ dysfunction syndrome (MODS) developed or patients subsequently died. In contrast, MIP-1beta concentrations correlated with neither the presence nor the severity of any complication. Compared with systemic concentrations, local lesser sac aspirates revealed significantly higher levels of MCP-1, whereas MIP-1alpha and MIP-1beta were not different. CONCLUSIONS: Complicated acute pancreatitis is associated with significantly elevated local and systemic concentrations of the CC-chemokine MCP-1. Our results suggest that, among the CC-chemokine members investigated, MCP-1 might play a pivotal role in the pathological mechanism of complicated acute pancreatitis.

Intraoperative Schnellschnittuntersuchungen parapylorischer Lymphknoten bei der pyloruserhaltenden Pankreaskopfresektion: Gibt es eine klinische Relevanz?

HINTERGRUND: Die pyloruserhaltende Pankreaskopfresektion (PPPD) ist als onkologisches Standardverfahren etabliert. Lokal fortgeschrittene Tumoren können eine erweiterte Resektion erforderlich machen. Ebenso soll früheren Arbeiten zufolge bei Tumornachweis in den parapylorischen Lymphknoten (PLK) eine distale Magenresektion im Sinne einer klassischen Whipple-Operation indiziert sein. Entsprechend diesen Empfehlungen haben wir intraoperative Schnellschnittuntersuchungen der PLK in unseren Routineablauf integriert. Im Rahmen dieser Studie haben wir die klinische Relevanz dieses Vorgehens hinterfragt. METHODEN: Bei 105 onkologischen Patienten im Zeitraum von 2006-2012 bestand die Indikation zur PPPD. In allen Fällen erfolgte eine intraoperative Schnellschnittuntersuchung der PLK. Die Patienten wurden bezüglich Primärtumor, Anzahl der untersuchten Lymphknoten (LK) (gesamt und parapylorisch) sowie Auswirkungen auf das operative Konzept untersucht. Es handelt sich um eine retrospektive Studie, die auf prospektiv erhobenen Daten unserer Pankreasdatenbank basiert. ERGEBNISSE: Die Primärtumoren waren 72 Pankreaskopfkarzinome und 33 extrapankreatische Karzinome (Gallengangskarzinom, Ampullenkarzinom, Duodenalkarzinom). 73 Patienten waren nodalpositiv. Insgesamt wurden 2391 LK untersucht, von denen 325 parapylorisch lokalisiert waren. Die intraoperative Schnellschnittuntersuchung erbrachte lediglich bei 4 Patienten mit Pankreaskopfkarzinom jeweils einen positiven PLK; daraufhin erfolgte eine distale Magenresektion. In keinem der distalen Magenresektate waren Tumorresiduen nachweisbar. Lokale chirurgisch-technische Probleme im Sinne von Durchblutungsstörungen des Magens ergaben sich durch die regionale Lymphadenektomie nicht. PLK waren nur beim Pankreaskarzinom positiv. In der Subgruppe der nodalpositiven Patienten mit Pankreaskopfkarzinom hatten 8% der Patienten einen positiven PLK. SCHLUSSFOLGERUNG: Die regionale parapylorische Lymphadenektomie ist beim Pankreaskarzinom in einigen (5%) Fällen onkologisch sinnvoll. Der Nutzen einer intraoperativen Schnellschnittuntersuchung mit nachfolgender Konsequenz für eine etwaige distale Magenresektion ist anhand unserer Daten nicht belegbar.

One-day point prevalence of emerging bacterial pathogens in a nationwide sample of 62 German hospitals in 2012 and comparison with the results of the one-day point prevalence of 2010.

BACKGROUND: Antibiotic resistance of bacterial pathogens is an emerging problem worldwide. To combat multidrug resistant organisms (MRDOs) networks of care providers have been established in all states in Germany. The HICARE-network, a project to combat MRDOs, founded by the Federal Ministry of Education and Research, has published data from 2010 of a voluntary, German-wide, multicenter point-prevalence survey in 2011 conducted in collaboration with the German Society of Hospital Hygiene. The aim of the present survey was the re-evaluation of the situation in 2012. METHOD: The survey was conducted as a voluntary, anonymous, point-prevalence in May 2012 using routine data of microbiological diagnostics of the hospitals. As in the former survey of 2010 it was differentiated between primary, secondary and tertiary care hospitals and only data from intensive care units, surgical and medical wards were collected. Based on the survey form used in 2010, an updated version was used including more pathogens and corrected issues observed in the former survey. Methicillin-resistant Staphylococcus aureus (MRSA) (total as well as separated in hospital-acquired (HA), community-acquired (CA) and lifestock-associated (LA) MRSA), vancomycin resistant Staphylococcus aureus (VRSA/GRSA), vancomycin resistant Enterococcus faecalis resp. Enterococcus faecium (VR-E. faecalis resp. VR-E. faecium), extended-spectrum-beta-lactamase-building (ESBL) E. coli (ESBL-EC) and Klebsiella pneumoniae (ESBL-KP), multiresistant Acinetobacter spp. (MAB), multiresistant Pseudomonas spp. (MRP), carbapenemase-producing Enterobacteriaceae (CRE) as well as Clostridium difficile (CD) infections and severe infections requiring ICU-treatment were included in the survey along with additional data on screening strategy, the equipment with infection control staff and possible confounders. RESULTS: Out of 1,550 hospitals asked to participate, 62 returned data (4%). Data from 56 hospitals including primary (26), secondary (20) and tertiary (10) care hospitals were analyzable (3.6%). The most frequently reported organisms were MRSA 1.53% [CI95: 1.32-1.75], followed by CDAD 1.30% [CI95: 1.11-1.50], ESBL-EC 0.97% [CI95: 0.80-1.14], and ESBL-KP 0.27% [CI95: 0.18-0.36], regardless of the level of care. Prevalence of MRDOs depended on the level of care and on the type of ward, as expected. Overall prevalence was highest on intensive care wards, and prevalences were remarkably high on medical wards compared to surgical wards. All tertiary care providers employed their own infection control nurse, while only ~70% of the secondary and primary care hospitals did. Surprisingly, in two of the ten participating tertiary care providers neither an internal nor an external infection control doctor was available. DISCUSSION: With more than 13,000 patients in 56 hospitals distributed all over Germany, the survey included more than three times as many patients as the first survey and therefore not only adds valuable information about the epidemiology of emerging nosocomial pathogens, but also helps to raise awareness of the problem of antibacterial resistance in Germany. The prevalences reported seem to be comparable to the results of the former survey and of other surveys published. Some hospitals reported to have no infection control personnel available at all. This statement is in line with another survey published in this issue.

Processing single-use medical devices for use in surgery - importance, status quo and potential.

In summary, it is possible with the technology and scientific knowledge currently available to allow products intended for single use to be reprocessed using validated and certified processing procedures, while maintaining the full function and without any loss in quality. How many times a product can be re-processed must be determined separately for each individual medical technology device; it is not possible to make any kind of blanket statement as to the permissible number of cycles. This is due to the differing construction, the various combinations of materials and the diverse demands made of each device during clinical use. The exigency of the reprocessing issue is evident both to the user and the primary manufacturer. For the user, where there is a correspondingly high-quality primary product with suitably costed, technically-sound and certified reprocessing procedures, repeat usage can mean real savings while maintaining full functionality in each use. For the primary manufacturers of highly specialised instruments, only part of which can be represented by the medical facility in terms of a corresponding DRG (Diagnosis-Related Group), it is reprocessing that opens the door to widespread routine clinical use. The patient, in turn, benefits greatly from this, since his demand for medical treatment using the most up-to-date technology is taken into account. If processing complies in full with medical technology and hygiene directives, from the medical point of view (without being able to definitively evaluate each individual case using this criterion) the specific advantages of the reprocessing procedure are obvious. In order to establish broad acceptance for the purposes of good marketing, corresponding controlling and quality instruments have to be developed to allow the decision-making process regarding the permissibility of the reprocessing of a certain device and the number of times it can be reprocessed using this procedure to be made transparent.Taking this a step further, possibilities arise for the establishment of corresponding quality-assurance instruments on the part of the clinical establishments involved, within which reprocessed products, in the interest of quality assurance, can be referred back to the processor in the event of defective function and can also be removed from clinical use prior to completing the intended number of processing cycles. Furthermore, it can be assumed that the widespread use of reprocessing procedures in today's high-cost single-use medical device sector will have a long-term cost/price-regulating effect for the primary products, to the benefit of the users. Thus, the heated debate regarding the safety of processing procedures that have already been certified and validated in accordance with current industry standards should be evaluated in particular from the point of view of the justified fears of the leading manufacturers with regard to their currently established market share. From a purely surgical point of view, the reprocessing of disposable products should be welcomed as a revolution. The main criteria for surgeons and medics should always be the benefit for the patient. If the quality is ensured through corresponding processing and validation procedures based on recognised certificates, then economic arguments take precedence. Cases in which a DRG (and thus a payment calculation) does not fully cover the use of medical devices are conceivable. Withholding medically necessary services on grounds of the costs, or making these services available to a limited extent only, is not acceptable from the medical point of view and furthermore goes beyond what is ethically acceptable. Each procedure, even the systematic use of reprocessing of suitable medical technology disposable items, should, where the quality is guaranteed, be supported unequivocally. Taken a step further, this branch of the economy will have a long-lasting price-regulating effect on the primary producers market.

Effects of immunosuppressive and immunostimulative treatment on pancreatic injury and mortality in severe acute experimental pancreatitis.

OBJECTIVES: Acute pancreatitis is associated with substantial alterations of the immunologic host response which has been claimed to promote remote organ dysfunction, septic complications, and mortality. Treatment with immunomodulating substances has been subject of few experimental studies with still conflicting results. METHODS: We used the taurocholate-induced model of severe acute pancreatitis (SAP) in rats which were assigned to different treatment regimen: isotonic saline (SAP-S) for nontreated controls, recombinant rat interferon-gamma for immunostimulation (SAP-IFN-gamma), and FK506 for immunosuppression (SAP-FK506). Animals were killed after 3, 6, and 24 hours as well as 3 and 7 days, and parameters of local and systemic severity were assessed. RESULTS: Treatment with IFN-gamma and FK506 attenuated the progression of intrapancreatic necrosis within the first 24 hours after pancreatitis induction along with a substantial reduction of subsequent neutrophil tissue infiltration as shown by decreased myeloperoxidase activity. Enhanced cell death by apoptosis during the postacute course was reduced in FK506-treated animals only. Pancreatic interleukin (IL) 1beta messenger RNA up-regulation occurred early and was slightly suppressed in both treatment groups; tumor necrosis factor alpha (TNF-alpha) and IL-2 messenger RNA expression paralleled the onset of apoptosis and was markedly decreased in IFN-gamma- and FK506-treated rats. The 2 therapeutic regimens had similar effects on intrapancreatic and systemic IL-1beta and TNF-alpha protein release; however, the profiles of both cytokines were differently influenced. Whereas IFN-gamma and FK506 treatment lead to an enhanced intrapancreatic and systemic TNF-alpha protein release during the early course, IL-1beta concentrations were significantly reduced within the late intervals. Seven-day mortality was 44% in saline-, 29% in IFN-gamma-, and 25% in FK506-treated rats (P = not significant). CONCLUSIONS: Severe acute pancreatitis is associated with early alterations of the immune response comprising overt T-cell activation and impaired monocyte/macrophage function alike. Targeting either immunologic derangement improves local pancreatic damage and systemic severity. However, because mortality was not improved, a therapeutic benefit of immunomodulating substances in clinical SAP remains to be defined.

Clinical value of lipopolysaccharide-binding protein (LBP) determinations in acute pancreatitis.

BACKGROUND: Lipopolysaccharide-binding protein (LBP) is a class 1 acute-phase protein that binds and transfers bacterial lipopolysaccharide (LPS). This study investigated the clinical value of measuring LBP for stratifying biochemical severity in acute pancreatitis by using a recently developed fully automated assay technique. PATIENTS AND METHODS: We studied 71 patients with acute pancreatitis of whom 41 presented with a necrotizing course. Necrotizing pancreatitis was associated with pancreatic infections in 21 patients and with multiorgan dysfunction syndrome (MODS) in 18 patients. Serum LBP was measured for 14 days by a fully automated immunoassay and CRP was assessed on a daily routine basis. RESULTS: The relative quantitative systemic release of LBP was lower than that observed for CRP; however, the two parameters revealed similar dynamics, with a maximum increase in acute pancreatitis around the fourth day after onset of symptoms. As observed for CRP, LBP was significantly higher in patients who developed complications such as necrosis, pancreatic infections, single or combined MODS than in those who did not. Multiple regression analysis revealed that pulmonary failure and MODS were independent variables associated with enhanced LBP release, while the development of necrosis, pancreatic infections and MODS were the corresponding variables for increased CRP levels. CONCLUSIONS: Systemic LBP concentrations are significantly elevated in acute pancreatitis and closely correlate with overall disease severity. However, compared with CRP, LBP does not contribute to an improved severity stratification in acute pancreatitis.