The first robotic-assisted hysterectomy below the bikini line with the Dexter robotic system™.

Background: Robotic-assisted hysterectomy (RAH) is a widely accepted minimally invasive approach for uterus removal. However, as RAH is typically performed in the umbilical region, it usually results in scars in cosmetically suboptimal locations. This is the first case of RAH with cervicosacropexy performed below the bikini line, using the new Dexter robotic system™. Objectives: The aim of this article is to show the surgical steps of the first RAH with cervicosacropexy performed below the bikini line with the new Dexter robotic system™ (Distalmotion), and furthermore assess the feasibility of this approach using this robotic platform. Materials and Methods: A 43-year-old woman with uterine adenomyosis and recurrent uterine prolapse underwent a robotic-assisted subtotal hysterectomy with cervicosacropexy, performed below the bikini line, using the Dexter robotic system™, at the Clinic of Gynecology and Obstetrics at Universitätsklinikum Schleswig-Holstein (UKHS) in Kiel, Germany. Main outcome measures: Perioperative data, surgical approach specifics, objective, and subjective outcomes of this new approach. Results: The procedure was performed without intra-operative complications; estimated blood loss was 10 ml. Operative time was 150 minutes, console time 120 minutes, total docking time 6 minutes. Dexter performed as expected; no device-related issues or robotic arm collisions occurred. The patient did not require pain medication and was released on the second postoperative day. Conclusion: RAH performed below the bikini line using the Dexter robotic system™ is a feasible, safe, and adequate procedure. These initial results should be confirmed and further extensively refurbished with larger patient cohorts, and functional and psychological outcomes need further investigation.

Bariatric surgery in liver cirrhosis.

Introduction: Obesity is frequently associated with its hepatic manifestation, the nonalcoholic fatty liver disease (NAFLD). The most effective treatment for morbid obesity is bariatric surgery (BS) also improving NAFLD and liver function. In patients where NAFLD has already progressed to liver cirrhosis, BS can be considered a high-risk procedure. Hence, consideration of the procedure and the most appropriate timing is crucial. Material and Methods: Obese patients suffering from NAFLD who underwent BS from two German University Medical Centers were retrospectively analyzed. Results: Twenty-seven patients underwent BS. Most common procedures were laparoscopic Roux-en-Y-gastric (RYGB) and laparoscopic sleeve gastrectomy (SG). All patients suffered from liver cirrhosis Child A. A preoperative transjugular portosystemic shunt (TIPS) was established in three patients and failed in another patient. Postoperative complications consisted of wound healing disorders (n = 2), anastomotic bleeding (n = 1), and leak from the staple line (n = 1). This patient suffered from intraoperatively detected macroscopic liver cirrhosis. Excess weight loss was 73% and 85% after 1 and 2 years, respectively. Two patients suffered from postoperative aggravation of their liver function, resulting in a higher Child-Pugh score, while three could be removed from the waiting list for a liver transplantation. Conclusion: BS leads to weight loss, both after SG and RYGB, and potential improvement of liver function in liver cirrhosis. These patients need to be considered with care when evaluated for BS. Preoperative TIPS implantation may reduce the perioperative risk in selected patients.

An enhanced prognostic score for overall survival of patients with cancer derived from a large real-world cohort.

BACKGROUND: By understanding prognostic biomarkers, we gain insights into disease biology and may improve design, conduct, and data analysis of clinical trials and real-world data. In this context, we used the Flatiron Health Electronic Health Record-derived deidentified database that provides treatment outcome and biomarker data from >280 oncology centers in the USA, organized into 17 cohorts defined by cancer type. PATIENTS AND METHODS: In 122 694 patients, we analyzed demographic, clinical, routine hematology, and blood chemistry parameters within a Cox proportional hazard framework to derive a multivariable prognostic risk model for overall survival (OS), the 'Real wOrld PROgnostic score (ROPRO)'. We validated ROPRO in two independent phase I and III clinical studies. RESULTS: A total of 27 variables contributed independently and homogeneously across cancer indications to OS. In the largest cohort (advanced non-small-cell lung cancer), for example, patients with elevated ROPRO scores (upper 10%) had a 7.91-fold (95% confidence interval 7.45-8.39) increased death hazard compared with patients with low scores (lower 10%). Median survival was 23.9 months (23.3-24.5) in the lowest ROPRO quartile Q1, 14.8 months (14.4-15.2) in Q2, 9.4 months (9.1-9.7) in Q3, and 4.7 months (4.6-4.8) in Q4. The ROPRO model performance indicators [C-index = 0.747 (standard error 0.001), 3-month area under the curve (AUC) = 0.822 (0.819-0.825)] strongly outperformed those of the Royal Marsden Hospital Score [C-index = 0.54 (standard error 0.0005), 3-month AUC = 0.579 (0.577-0.581)]. We confirmed the high prognostic relevance of ROPRO in clinical Phase 1 and III trials. CONCLUSIONS: The ROPRO provides improved prognostic power for OS. In oncology clinical development, it has great potential for applications in patient stratification, patient enrichment strategies, data interpretation, and early decision-making in clinical studies.

The predictive and prognostic significance of liquid biopsy in advanced epidermal growth factor receptor-mutated non-small cell lung cancer: A prospective study.

OBJECTIVE: To determine the predictive and prognostic roles of three blood-based biomarkers: circulating tumour DNA (ctDNA), circulating tumour cells (CTC) and carcinoembryonic antigen (CEA), in patients with advanced epidermal growth factor receptor-mutated (EGFR+) lung cancer. MATERIALS AND METHODS: We recruited 28 patients with 103 serial blood samples. We performed mutational analyses for EGFR mutations using droplet digital PCR (ddPCR) on ctDNA. We evaluated the accuracy of EGFR mutation detection in ctDNA compared with tissue biopsy. We also quantified CTCs, ctDNA and CEA in serially collected blood samples, and evaluated the baseline and changes in these blood-based biomarkers with clinical outcomes. RESULTS: EGFR mutation detection in plasma was highly concordant as compared with tissue biopsy. Detectable baseline ctDNA was associated with higher disease burden (p < 0.01). Early disappearance of ctDNA at 4 weeks was associated with radiological response at 12 weeks of treatment (p = 0.01) and improved progression free survival (PFS) (HR 5.47, 95%CI 1.32-22.72, p = 0.02) and overall survival (OS) (HR 5.46, 95%CI 1.28-23.22, p = 0.02). A decrease in CTC count at 4 weeks was associated with improved PFS (HR 3.81, 95%CI 1.13-12.79, p = 0.03) but not OS. 85% of patients with radiological progression had a ctDNA rise compared with 22% of patients with stable disease (p=0.01). ctDNA rise was seen on average 170 days prior to radiological progression. There is a significant association between the rise of CEA level with radiological progression (p=0.001). CONCLUSION: Early change in ctDNA, CTC and CEA levels may be long-term predictors of treatment benefit and failure prior to availability of radiological response data.

Expert consensus on a train-the-trainer curriculum for robotic colorectal surgery.

AIM: Robotic techniques are being increasingly used in colorectal surgery. There is, however, a lack of training opportunities and structured training programmes. Robotic surgery has specific problems and challenges for trainers and trainees. Ergonomics, specific skills and user-machine interfaces are different from those in traditional laparoscopic surgery. The aim of this study was to establish expert consensus on the requirements for a robotic train-the-trainer curriculum amongst robotic surgeons and trainers. METHOD: This is a modified Delphi-type study involving 14 experts in robotic surgery teaching. A reiterating 19-item questionnaire was sent out to the same group and agreement levels analysed. A consensus of 0.8 or higher was considered to be high-level agreement. RESULTS: Response rates were 93-100% and most items reached high levels of agreement within three rounds. Specific requirements for a robotic faculty development curriculum included maximizing dual-console teaching, theatre team training, nontechnical skills training, patient safety, user-machine interface training and telementoring. CONCLUSION: A clear need for the development of a train-the-trainer curriculum has been identified. Further research is needed to assess feasibility, effectiveness and clinical impact of a robotic train-the-trainer curriculum.

Robot-Assisted Oesophagectomy: Recommendations Towards a Standardised Ivor Lewis Procedure.

A considerable number of reports have been published on the feasibility, techniques, and early postoperative results of robotic-assisted oesophageal surgery. However, these are mostly smaller case series, suggesting that the robot-assisted Ivor Lewis procedure is still in the implementation phase and far from being standardised. Oesophageal surgeons from seven robotic university centres in Germany, experienced in both minimally invasive and robot-assisted minimally invasive surgery, took part in a workshop on robot-assisted surgery. An intensive exchange of opinions and experiences, followed by a step-by-step re-enactment of the operation in a cadaver lab, enabled us to develop a standardised robot-assisted Ivor Lewis surgical workflow, which is presented here. Systematic and objective comparison of experiences and results using a robot-assisted Ivor Lewis procedure has made it possible to develop a standardised surgical workflow that is now clinically applied in our centres. It is hoped that standardisation of this procedure will help to maintain patient safety, prevent medical errors, and facilitate the learning curve, while introducing robotic surgery into a centre.

[Preconditioning of the lungs and circulation before visceral and thoracic surgical interventions]. / Präkonditionierung von Lunge und Kreislauf vor viszeral- oder thoraxchirurgischen Eingriffen.

BACKGROUND: Estimation of the perioperative risk plays a decisive role in the surgical indications, particularly in view of the demographic change. For this reason, prehabilitation concepts for reducing perioperative risk nowadays play an increasingly important role. OBJECTIVE: Presentation of the current recommendations for preoperative diagnostics in thoracic surgical interventions as well as existing prehabilitation concepts and their practical applicability. MATERIAL AND METHODS: A selective review of the literature was carried out by searching the electronic databases PubMed, Cochrane Library and ISRCTN, including the guidelines of the American College of Chest Physicians (ACCP) and the European Society of Thoracic Surgery (ESTS). RESULTS: Preconditioning includes the conservative treatment of underlying diseases, smoking cessation and prehabilitation. Prehabilitation is an increasingly pressing concept in routine clinical practice, even though the evidence is limited due to the very heterogeneous study situation. Overall, however, there is a tendency for positive effects on the quality of life and postoperative complications as well as convalescence. CONCLUSION: In addition to preoperative diagnostics to assess the perioperative risk, effective preconditioning of patients is also necessary. For this an interdisciplinary approach including anesthesia, pneumology, psychotherapy and physiotherapy is necessary. In addition to the conservative medicinal optimization, prehabilitation concepts are gaining in importance and will certainly become established in routine clinical practice. From the surgical perspective, minimally invasive approaches and parenchyma-sparing resections also serve to reduce risks.

Development and multicentre validation of a prognostic model to predict resectability of pancreatic head malignancy.

BACKGROUND: At the time of planned pancreatoduodenectomy patients frequently undergo exploratory laparotomy without resection, leading to delayed systemic therapy. This study aimed to develop and validate a prognostic model for the preoperative prediction of resectability of pancreatic head tumours. METHODS: This was a retrospective study of patients undergoing attempted resection for confirmed malignant tumours of the pancreatic head in a university hospital in Hannover, Germany. The prognostic value of patient and tumour characteristics was investigated in a multivariable logistic regression model. External validation was performed using data from two other centres. RESULTS: Some 109 patients were included in the development cohort, with 51 and 175 patients in the two validation cohorts. Eighty patients (73·4 per cent) in the development cohort underwent resection, and 37 (73 per cent) and 141 (80·6 per cent) in the validation cohorts. The main reasons for performing no resection in the development cohort were: local invasion of vasculature or arterial abutment (15 patients, 52 per cent), and liver (12, 41 per cent), peritoneal (8, 28 per cent) and aortocaval lymph node (6, 21 per cent) metastases. The final model contained the following variables: time to surgery (odds ratio (OR) 0·99, 95 per cent c.i. 0·98 to 0·99), carbohydrate antigen 19-9 concentration (OR 0·99, 0·99 to 0·99), jaundice (OR 4·45, 1·21 to 16·36) and back pain (OR 0·02, 0·00 to 0·22), with an area under the receiver operating characteristic (ROC) curve (AUROC) of 0·918 in the development cohort. AUROC values were 0·813 and 0·761 in the validation cohorts. The positive predictive value of the final model for prediction of resectability was 98·0 per cent in the development cohort, and 91·7 and 94·7 per cent in the two external validation cohorts. [Corrections added on 18 July 2018, after first online publication: The figures for OR of the variables time to surgery and CA19-9 in the abstract and in Table 3 and Table 4 were amended from 1·00 to 0·99]. CONCLUSION: For preoperative prediction of the likelihood of resectability of pancreatic head tumours, this validated model is a valuable addition to CT findings.

Eight-plate epiphysiodesis: are we creating an intra-articular deformity?

Aims: Guided growth using eight-plates is commonly used for correction of angular limb deformities in growing children. The principle is of tethering at the physeal periphery while enabling growth in the rest of the physis. The method is also applied for epiphysiodesis to correct limb-length discrepancy (LLD). Concerns have been raised regarding the potential of this method to create an epiphyseal deformity. However, this has not been investigated. The purpose of this study was to detect and quantify the occurrence of deformities in the proximal tibial epiphysis following treatment with eight-plates. Patients and Methods: A retrospective study was performed including 42 children at a mean age of 10.8 years (3.7 to 15.7) undergoing eight-plate insertion in the proximal tibia for correction of coronal plane deformities or LLD between 2007 and 2015. A total of 64 plates were inserted; 48 plates (34 patients) were inserted to correct angular deformities and 16 plates (8 patients) for LLD. Medical records, Picture Archive and Communication System images, and conventional radiographs were reviewed. Measurements included interscrew angle, lateral and medial plateau slope angles measured between the plateau surface and the line between the ends of the physis, and tibial plateau roof angle defined as 180° minus the sum of both plateau angles. Measurements were compared between radiographs performed adjacent to surgery and those at latest follow-up, and between operated and non-operated plateaus. Statistical analysis was performed using BMDP Statistical Software. Results: Slope angle increased in 31 (49.2%) of operated epiphyses by a mean of 5° (1° to 23°) compared with 29 (31.9%) in non-operated epiphyses (p = 0.043). Roof angle decreased in 29 (46.0%) of operated tibias and in 25 (27.5%) of non-operated ones by a mean of 5° (1° to 18°) (p = 0.028). Slope angle change frequency was similar in patients with LLD, varus and valgus correction (p = 0.37) but roof angle changes were slightly more frequent in LLD (p = 0.059) and correlated with the change in inter screw angles (r = 0.74, p = 0.001). Conclusion: The use of eight-plates in the proximal tibia for deformity correction and limb-length equalization causes a change in the bony morphology of the tibial plateau in a significant number of patients and the effect is more pronounced in the correction of LLD. Cite this article: Bone Joint J 2018;100-B:1112-16.

Duodenal intussusception of the remnant stomach after biliopancreatic diversion: a case report.

BACKGROUND: We present a rare case of an antegrade intussusception of the remnant stomach four years after a biliopancreatic diversion. CASE PRESENTATION: A 55-year-old female patient presented with epigastric pain in our emergency room. Laboratory parameters showed an anemia as well as elevated transaminases and hyperbilirubinemia. The CT scan showed an intussusception of the remnant stomach into the duodenum followed by cholestasis. At laparotomy the remnant stomach was resected. CONCLUSION: Bowel obstruction and intussusception after bariatric surgery are a rare but often unrecognized complication. Sonography as well as a CT scan should be performed. The exploratory laparoscopy however is the most valuable diagnostic tool in patients with suspected intussusception, due to the high rate of non-specific symptoms and misinterpreted radiographic investigations.

[Robot-assisted vs laparoscopic gastric bypass : First experiences with the DaVinci system in bariatric surgery]. / Roboterassistierter vs. laparoskopischer Magenbypass : Erste Erfahrungen mit dem DaVinci-System in der bariatrischen Chirurgie.

Conventional laparoscopy is the gold standard in bariatric surgery. Internationally, robot-assisted surgery is gaining in importance. Up to now there are only few reports from Germany on the use of the system in bariatric surgery. Since January 2017 we have been performing robot-assisted gastric bypass surgery. It remains unclear whether the use of the robotic system has advantages over the well-established laparoscopic technique. Within a period from January to early August 2017 a total of 53 gastric bypass operations were performed. Of these 16 proximal redo Roux-en-Y gastric bypass operations were performed with the DaVinci Si system versus 29 laparoscopic procedures. A retrospective analysis of the perioperative course was carried out. Body weight, body mass index (BMI), Edmonton obesity staging system (EOSS) and American Society of Anesthesiologists (ASA) classification did not show significant differences. There were also no significant differences in terms of estimated blood loss, intraoperative complications, duration of surgery, postoperative inflammatory parameters and weight loss. There was no mortality and no need for revisional surgery in either group. After laparoscopic surgery there was a delayed occurrence of a leak of the gastrojejunostomy followed by readmission and endoscopic negative pressure wound therapy. The results show that the proximal Roux-en-Y gastric bypass can be performed safely and efficiently using the DaVinci surgical system. Significant differences to the conventional laparoscopic procedure were not found. Larger randomized controlled trials are needed to define the role of the DaVinci system in bariatric surgery.

Surgical treatment options following chemotherapy plus cetuximab or bevacizumab in metastatic colorectal cancer-central evaluation of FIRE-3.

BACKGROUND: The FIRE-3 trial investigated combination chemotherapy plus either cetuximab or bevacizumab in patients with untreated metastatic colorectal cancer (mCRC) not scheduled for upfront surgery. We aimed to determine the number of patients who present with potentially resectable disease during systemic first-line therapy and to compare the findings with study reports concerning resections and outcome. PATIENTS AND METHODS: This evaluation of 448 patients was performed as central review blinded for treatment, other reviewers' evaluations and conducted interventions. Resectability was defined if at least 50% of the reviewers recommended surgical-based intervention. Overall survival was assessed by Kaplan-Meier method. RESULTS: Resectability increased from 22% (97/448) at baseline before treatment to 53% (238/448) at best response (P < 0.001), compared with an actual secondary resection rate for metastases of 16% (72/448). At baseline (23% versus 20%) and best response (53% versus 53%), potential resectability of metastases in this molecular unselected population was similar in cetuximab-treated patients versus bevacizumab-treated patients and not limited to patients with one-organ disease. The actual resection rate of metastases was significantly associated with treatment setting (P = 0.02; university hospital versus hospital/practice). Overall survival was 51.3 months (95% confidence interval [CI] 35.9-66.7) in patients with resectable disease who received surgery, 30.8 months (95% CI 26.6-34.9) in patients with resectable disease without surgery and 18.6 months (95% CI 15.8-21.3) in patients with unresectable disease (P < 0.001). CONCLUSIONS: Our findings illustrate the potential for conversion to resectability in mCRC, certain reluctance towards metastatic resections in clinical practice and the need for pre-planned and continuous evaluation for metastatic resection in high-volume centres. CLINICALTRIALS. GOV-IDENTIFIER: NCT00433927.

Fully robotic da Vinci Ivor-Lewis esophagectomy in four-arm technique-problems and solutions.

The aim of this technical note is a step-by-step description of a fully robotic abdominothoracic esophagectomy with an intrathoracic esophagogastrostomy. We report on our technique and short-term results of 75 patients undergoing an Ivor-Lewis esophagectomy using a fully robotic 4-arm approach in the abdominal and thoracic phase with a hand-sewn intrathoracic anastomosis. There are several important steps and differences to consider compared to the conventional minimal invasive approach (patient's positioning, anaesthesiological set up, port placement, gastric conduit pull up, technique of esophagostrostomy). Mean operative time was 392 minutes (240-610) with a 94% R0 resection status. Conversion to open procedure occurred in 2 (2.6%) in the abdominal, and 14 (18.2%) in the thoracic phase. Main reasons for conversion were problems during the lifting of the gastric conduit and difficulties in the construction of the esophagogastrostomy. The rate dropped during the last 20 patients (1/20 (10%). Our results suggest that the reported technique is safe and feasible. It satisfies the oncological principles and provides the advantages of robotic assisted minimal invasive surgery.

Emerging surface characterization techniques for carbon steel corrosion: a critical brief review.

Carbon steel is a preferred construction material in many industrial and domestic applications, including oil and gas pipelines, where corrosion mitigation using film-forming corrosion inhibitor formulations is a widely accepted method. This review identifies surface analytical techniques that are considered suitable for analysis of thin films at metallic substrates, but are yet to be applied to analysis of carbon steel surfaces in corrosive media or treated with corrosion inhibitors. The reviewed methods include time of flight-secondary ion mass spectrometry, X-ray absorption spectroscopy methods, particle-induced X-ray emission, Rutherford backscatter spectroscopy, Auger electron spectroscopy, electron probe microanalysis, near-edge X-ray absorption fine structure spectroscopy, X-ray photoemission electron microscopy, low-energy electron diffraction, small-angle neutron scattering and neutron reflectometry, and conversion electron Moessbauer spectrometry. Advantages and limitations of the analytical methods in thin-film surface investigations are discussed. Technical parameters of nominated analytical methods are provided to assist in the selection of suitable methods for analysis of metallic substrates deposited with surface films. The challenges associated with the applications of the emerging analytical methods in corrosion science are also addressed.

[Robot-assisted liver resection]. / Roboterassistierte Leberresektion.

Robotic liver resection can overcome some of the limitations of laparoscopic liver surgery; therefore, it is a promising tool to increase the proportion of minimally invasive liver resections. The present article gives an overview of the current literature. Furthermore, the results of a nationwide survey on robotic liver surgery among hospitals in Germany with a DaVinci system used in general visceral surgery and the perioperative results of two German robotic centers are presented.

[Robotic pylorus-preserving pancreaticoduodenectomy : Video article]. / Roboterassistierte pyloruserhaltende Pankreaskopfresektion : Videobeitrag.

Pylorus-preserving pancreaticoduodenectomy is one of the most complex procedures in general surgery. Laparoscopic pancreaticoduodenectomy was initially described in 1994; however, its worldwide distribution is so far limited to only a few specialist centers. Robotic surgery using the DaVinci® system can overcome many limitations of laparoscopic surgery. The system is a promising tool for a more widespread introduction of minimally invasive surgery for pancreatic diseases. Mortality rates of 0-5% and pancreatic fistula rates of 0-35% are described in the literature; therefore, thorough complication management is crucial in the postoperative course. The video presents a robotic pylorus-preserving pancreaticoduodenectomy for periampullary carcinoma in a female patient.

Immunization of rhesus macaques with Echinococcus multilocularis recombinant 14-3-3 antigen leads to specific antibody response.

E. multilocularis (Em) is the etiologic agent of alveolar echinococcosis (AE), a severe and potentially fatal disease, primarily affecting the liver of and occurring in aberrant intermediate hosts, e.g., humans and non-human primates. Due to increasing numbers of spontaneous cases of AE in the Old World monkey colonies of the German Primate Center, the question arose as to whether vaccination of non-human primates may represent a useful prophylactic approach. In this pilot study, the recombinant antigen Em14-3-3, which has provided a 97 % protection against E. multilocularis challenge infection in rodent models, was used for the first time to immunize rhesus macaques. In order to increase immunogenicity, the antigen was formulated with different adjuvants including Quil A®, aluminum hydroxide (alum), and muramyl dipeptide (MDP). Also, different vaccination regimens were tested. All vaccinated animals developed antigen-specific antibodies. While Quil A® induced a local adverse reaction, alum proved to be the most potent adjuvant in terms of induced antibody levels, longevity as well as tolerability. In conclusion, our pilot study demonstrated that recombinant Em14-3-3 is safe and immunogenic in rhesus monkeys. As a next step, efficacy of the vaccination remains to be explored.

[Immunological Markers in Organ Transplantation]. / Marker der Immunantwort bei Organtransplantation.

The immunological monitoring in organ transplantation is based mainly on the determination of laboratory parameters as surrogate markers of organ dysfunction. Structural damage, caused by alloreactivity, can only be detected by invasive biopsy of the graft, which is why inevitably rejection episodes are diagnosed at a rather progressive stage. New non-invasive specific markers that enable transplant clinicians to identify rejection episodes at an earlier stage, on the molecular level, are needed. The accurate identification of rejection episodes and the establishment of operational tolerance permit early treatment or, respectively, a controlled cessation of immunosuppression. In addition, new prognostic biological markers are expected to allow a pre-transplant risk stratification thus having an impact on organ allocation and immunosuppressive regimen. New high-throughput screening methods allow simultaneous examination of hundreds of characteristics and the generation of specific biological signatures, which might give concrete information about acute rejection, chronic dysfunction as well as operational tolerance. Even though multiple studies and a variety of publications report about important advances on this subject, almost no new biological marker has been implemented in clinical practice as yet. Nevertheless, new technologies, in particular analysis of the genome, transcriptome, proteome and metabolome will make personalised transplantation medicine possible and will further improve the long-term results and graft survival rates. This article gives a survey of the limitations and possibilities of new immunological markers in organ transplantation.