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Introduction:. This study aimed to identify research areas that demand attention in multimodal data-driven surgery for improving data management in minimally invasive surgery. Background:. New surgical procedures, high-tech equipment, and digital tools are increasingly being introduced, potentially benefiting patients and surgical teams. These innovations have resulted in operating rooms evolving into data-rich environments, which, in turn, requires a thorough understanding of the data pipeline for improved and more intelligent real-time data usage. As this new domain is vast, it is necessary to identify where efforts should be focused on developing seamless and practical data usage. Methods:. A modified electronic Delphi approach was used; 53 investigators were divided into the following groups: a research group (n=9) for problem identification and a narrative literature review, a medical and technical expert group (n=14) for validation, and an invited panel (n=30) for two electronic survey rounds. Round 1 focused on a consensus regarding bottlenecks in surgical data science areas and research gaps, while round 2 prioritized the statements from round 1, and a roadmap was created based on the identified essential and very important research gaps. Results:. Consensus panelists have identified key research areas, including digitizing operating room (OR) activities, improving data streaming through advanced technologies, uniform protocols for handling multimodal data, and integrating AI for efficiency and safety. The roadmap prioritizes standardizing OR data formats, integrating OR data with patient information, ensuring regulatory compliance, standardizing surgical AI models, and securing data transfers in the next generation of wireless networks. Conclusions:. This work is an international expert consensus regarding the current issues and key research targets in the promising field of data-driven surgery, highlighting the research needs of many operating room stakeholders with the aim of facilitating the implementation of novel patient care strategies in minimally invasive surgery.

Abstract Exocrine and endocrine pancreas are interconnected anatomically and functionally, with vasculature facilitating bidirectional communication. Our understanding of this network remains limited, largely due to two-dimensional histology and missing combination with three-dimensional imaging. In this study, a multiscale 3D-imaging process was used to analyze a porcine pancreas. Clinical computed tomography, digital volume tomography, micro-computed tomography and Synchrotron-based propagation-based imaging were applied consecutively. Fields of view correlated inversely with attainable resolution from a whole organism level down to capillary structures with a voxel edge length of 2.0 µm. Segmented vascular networks from 3D-imaging data were correlated with tissue sections stained by immunohistochemistry and revealed highly vascularized regions to be intra-islet capillaries of islets of Langerhans. Generated 3D-datasets allowed for three-dimensional qualitative and quantitative organ and vessel structure analysis. Beyond this study, the method shows potential for application across a wide range of patho-morphology analyses and might possibly provide microstructural blueprints for biotissue engineering.

IntroductionViscoelastic hemostatic assays (VHA) are integral in contemporary hemostatic resuscitation, offering insights into clot formation, firmness, and lysis for rapid diagnosis and targeted therapy. Large animal models, particularly swine, provide anatomical and physiological analogies for coagulation research. Despite the growing use of VHAs, the ClotPro® device’s applicability in porcine models remains unexplored. This study investigates ClotPro® in a porcine model of abdominal surgery, severe hemorrhage, and resuscitation, comparing it with the established ROTEM® delta system.MethodsTwenty-seven healthy pigs underwent abdominal surgery, hemorrhage and resuscitation. ClotPro® and ROTEM® were used to assess viscoelastic hemostatic properties at baseline, after surgery, 60 min after shock induction, 60 and 120 min after resuscitation.ResultsClotting times in extrinsically and intrinsically stimulated assays exhibited fair to moderate correlation. Clot firmness in extrinsically stimulated tests could be used interchangeably while fibrin polymerization assays revealed significant differences between the devices. Fibrin polymerization assays in ClotPro® consistently yielded higher values than ROTEM®. Furthermore, the study evaluated the ClotPro® TPA-test’s applicability in porcine blood, revealing failure of lysis induction in porcine blood samples.ConclusionThis research contributes valuable insights into the use of ClotPro® in porcine models of hemorrhage and coagulopathy, highlighting both its applicability and limitations in comparison to ROTEM® delta. The observed differences, especially in fibrin polymerization assays, emphasize the importance of understanding device-specific characteristics when interpreting results. Due to its inapplicability, TPA-test should not be used in porcine blood to evaluate fibrinolytic potential. The study provides a foundation for future investigations into the use of different viscoelastic hemostatic assays in porcine animal models.

Summary: Background: Open partial pancreatoduodenectomy (OPD) represents the current gold standard of surgical treatment of a wide range of diseases of the pancreatic head but is associated with morbidity in around 40% of cases. Robotic partial pancreatoduodenectomy (RPD) is being used increasingly, yet, no randomised controlled trials (RCTs) of RPD versus OPD have been published, leaving a low level of evidence to support this practice. Methods: This investigator-initiated, exploratory RCT with two parallel study arms was conducted at a high-volume pancreatic centre in line with IDEAL recommendations (stage 2b). Patients scheduled for elective partial pancreatoduodenectomy (PD) for any indication were randomised (1:1) to RPD or OPD with a centralised web-based tool. The primary endpoint was postoperative cumulative morbidity within 90 days, assessed via the Comprehensive Complication Index (CCI). Biometricians were blinded to the intervention, but patients and surgeons were not. The trial was registered prospectively (DRKS00020407). Findings: Between June 3, 2020 and February 14, 2022, 81 patients were randomly assigned to RPD (n = 41) or OPD (n = 40), of whom 62 patients (RPD: n = 29, OPD: n = 33) were analysed in the modified intention to treat analysis. Four patients in the OPD group were randomised, but did not undergo surgery in our department and one patient was excluded in the RPD group due to other reason. Nine patients in the RPD group and 3 patients in the OPD were excluded from the primary analysis because they did not undergo PD, but rather underwent other types of surgery. The CCI after 90 days was comparable between groups (RPD: 34.02 ± 23.48 versus OPD: 36.45 ± 27.65, difference in means [95% CI]: −2.42 [−15.55; 10.71], p = 0.713). The RPD group had a higher incidence of grade B/C pancreas-specific complications compared to the OPD group (17 (58.6%) versus 11 (33.3%); difference in rates [95% CI]: 25.3% [1.2%; 49.4%], p = 0.046). The only complication that occurred significantly more often in the RPD than in the OPD group was clinically relevant delayed gastric emptying. Procedure-related and overall hospital costs were significantly higher and duration of surgery was longer in the RPD group. Blood loss did not differ significantly between groups. The intraoperative conversion rate of RPD was 23%. Overall 90-day mortality was 4.8% without significant differences between RPD and OPD. Interpretation: In the setting of a very high-volume centre, both RPD and OPD can be considered safe techniques. Further confirmatory multicentre RCTs are warranted to uncover potential advantages of RPD in terms of perioperative and long-term outcomes. Funding: Federal Ministry of Education and Research (BMBF: 01KG2010).

Abstract At the beginning of the COVID-19 pandemic, it was assumed that SARS-CoV-2 could be transmitted through surgical smoke generated by electrocauterization. Minimally invasive surgery (MIS) was targeted due to potentially higher concentrations of the SARS-CoV-2 particles in the pneumoperitoneum. Some surgical societies even recommended open surgery instead of MIS to prevent the potential spread of SARS-CoV-2 from the pneumoperitoneum. This study aimed to detect SARS-CoV-2 in surgical smoke during open and MIS. Patients with SARS-CoV-2 infection who underwent open surgery or MIS at Heidelberg University Hospital were included in the study. A control group of patients without SARS-CoV-2 infection undergoing MIS or open surgery was included for comparison. The trial was approved by the Ethics Committee of Heidelberg University Medical School (S-098/2021). The following samples were collected: nasopharyngeal and intraabdominal swabs, blood, urine, surgical smoke, and air samples from the operating room. An SKC BioSampler was used to sample the surgical smoke from the pneumoperitoneum during MIS and the approximate surgical field during open surgery in 15 ml of sterilized phosphate-buffered saline. An RT-PCR test was performed on all collected samples to detect SARS-CoV-2 viral particles. Twelve patients with proven SARS-CoV-2 infection underwent open abdominal surgery. Two SARS-CoV-2-positive patients underwent an MIS procedure. The control group included 24 patients: 12 underwent open surgery and 12 MIS. One intraabdominal swab in a patient with SARS-CoV-2 infection was positive for SARS-CoV-2. However, during both open surgery and MIS, none of the surgical smoke samples showed any detectable viral particles of SARS-CoV-2. The air samples collected at the end of the surgical procedure showed no viral particles of SARS-CoV-2. Major complications (CD ≥ IIIa) were more often observed in SARS-CoV-2 positive patients (10 vs. 4, p = 0.001). This study showed no detectable viral particles of SARS-CoV-2 in surgical smoke sampled during MIS and open surgery. Thus, the discussed risk of transmission of SARS-CoV-2 via surgical smoke could not be confirmed in the present study.

Abstract Hyperspectral Imaging (HSI) is a relatively new medical imaging modality that exploits an area of diagnostic potential formerly untouched. Although exploratory translational and clinical studies exist, no surgical HSI datasets are openly accessible to the general scientific community. To address this bottleneck, this publication releases HeiPorSPECTRAL ( https://www.heiporspectral.org ; https://doi.org/10.5281/zenodo.7737674 ), the first annotated high-quality standardized surgical HSI dataset. It comprises 5,758 spectral images acquired with the TIVITA® Tissue and annotated with 20 physiological porcine organs from 8 pigs per organ distributed over a total number of 11 pigs. Each HSI image features a resolution of 480 × 640 pixels acquired over the 500–1000 nm wavelength range. The acquisition protocol has been designed such that the variability of organ spectra as a function of several parameters including the camera angle and the individual can be assessed. A comprehensive technical validation confirmed both the quality of the raw data and the annotations. We envision potential reuse within this dataset, but also its reuse as baseline data for future research questions outside this dataset. Measurement(s) Spectral Reflectance Technology Type(s) Hyperspectral Imaging Sample Characteristic - Organism Sus scrofa

Surgery plays a central role in the treatment of benign and malignant pancreatic diseases. Artificial intelligence (AI) is an important upcoming technology to support surgeons in pre-, intra-, and postoperative diagnosis, decision-making and training toward an optimized patient care. Current AI applications show a promising role in the evaluation of preoperative images for prediction of malignancy and resectability, intraoperative decision support, surgical training as well as a postoperative risk stratification to personalize the management of complications. This scoping review summarizes the most up to date developments of AI in pancreatic surgery with the highest available level of evidence.

BackgroundThe rapid adoption of robotic surgical systems across Europe has led to a critical gap in training and credentialing for gastrointestinal (GI) surgeons. Currently, there is no existing standardised curriculum to guide robotic training, assessment and certification for GI trainees. This manuscript describes the protocol to achieve a pan-European consensus on the essential components of a comprehensive training programme for GI robotic surgery through a five-stage process.Methods and analysisIn Stage 1, a Steering Committee, consisting of international experts, trainees and educationalists, has been established to lead and coordinate the consensus development process. In Stage 2, a systematic review of existing multi-specialty robotic training curricula will be performed to inform the formulation of key position statements. In Stage 3, a comprehensive survey will be disseminated across Europe to capture the current state of robotic training and identify potential challenges and opportunities for improvement. In Stage 4, an international panel of GI surgeons, trainees, and robotic theatre staff will participate in a three-round Delphi process, seeking ≥ 70% agreement on crucial aspects of the training curriculum. Industry and patient representatives will be involved as external advisors throughout this process. In Stage 5, the robotic training curriculum for GI trainees will be finalised in a dedicated consensus meeting, culminating in the production of an Explanation and Elaboration (E&E) document.Registration detailsThe study protocol has been registered on the Open Science Framework (https://osf.io/br87d/).

ABSTRACTMetastasis is a cancer-related systemic disease and is responsible for the greatest mortality rate among cancer patients. Interestingly, the interaction between the immune system and cancer cells seems to play a key role in metastasis formation in the target organ. However, this complex network is only partially understood. We previously found that IL-22 produced by tissue resident iNKT17 cells promotes cancer cell extravasation, the early step of metastasis. Based on these data, we aimed here to decipher the role of IL-22 in the last step of metastasis formation. We found that IL-22 levels were increased in established metastatic sites in both human and mouse. We also found that Th22 cells were the key source of IL-22 in established metastasis sites, and that deletion of IL-22 in CD4+ T cells was protective in liver metastasis formation. Accordingly, the administration of a murine IL-22 neutralizing antibody in the establishment of metastasis formation significantly reduced the metastatic burden in a mouse model. Mechanistically, IL-22-producing Th22 cells promoted angiogenesis in established metastasis sites. In conclusion, our findings highlight that IL-22 is equally as important in contributing to metastasis formation at late metastatic stages, and thus, identify it as a novel therapeutic target in established metastasis.

Abstract Background Hyperspectral imaging (HSI) is a novel imaging technology with the ability to assess microcirculatory impairment. We aimed to assess feasibility of performing HSI, a noninvasive, contactless method to assess microcirculatory alterations, during trauma resuscitation care. Methods This randomized controlled clinical trial was conducted in a dedicated trauma resuscitation room of a level one trauma center. We included adult patients who were admitted to the trauma resuscitation room. Patients were allocated in a 1:1 ratio to the HSI group (intervention) or control group. In addition to the standard of care, patients in the intervention group had two hyperspectral recordings (HSR) of their hand palm taken. Primary outcomes were the treatment duration of the primary survey (until end of ABCDE-evaluation, ultrasound and evaluation by the trauma team) and the total resuscitation room care (until transport to definitive care) as well as the ability to perform measurements from all HSR. Secondary outcomes were analyses from the intervention group compared to HSI measurements of 26 healthy volunteers including an analysis based on the ISS (Injury severity score) (

Abstract The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term ‘digital surgery’. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice. 38 international experts, across the fields of surgery, AI, industry, law, ethics and policy, participated in a four-round Delphi exercise. Issues were generated by an expert panel and public panel through a scoping questionnaire around key themes identified from the literature and voted upon in two subsequent questionnaire rounds. Consensus was defined if >70% of the panel deemed the statement important and

Abstract Visual discrimination of tissue during surgery can be challenging since different tissues appear similar to the human eye. Hyperspectral imaging (HSI) removes this limitation by associating each pixel with high-dimensional spectral information. While previous work has shown its general potential to discriminate tissue, clinical translation has been limited due to the method’s current lack of robustness and generalizability. Specifically, the scientific community is lacking a comprehensive spectral tissue atlas, and it is unknown whether variability in spectral reflectance is primarily explained by tissue type rather than the recorded individual or specific acquisition conditions. The contribution of this work is threefold: (1) Based on an annotated medical HSI data set (9059 images from 46 pigs), we present a tissue atlas featuring spectral fingerprints of 20 different porcine organs and tissue types. (2) Using the principle of mixed model analysis, we show that the greatest source of variability related to HSI images is the organ under observation. (3) We show that HSI-based fully-automatic tissue differentiation of 20 organ classes with deep neural networks is possible with high accuracy (> 95%). We conclude from our study that automatic tissue discrimination based on HSI data is feasible and could thus aid in intraoperative decisionmaking and pave the way for context-aware computer-assisted surgery systems and autonomous robotics.

Abstract The precise location of gastric and colorectal tumors is of paramount importance for the oncological surgeon as it dictates the limits of resection and the extent of lymphadenectomy. However, this task proves sometimes to be very challenging, especially in the laparoscopic setting when the tumors are small, have a soft texture, and do not invade the serosa. In this view, our research team has developed a new instrument adapted to minimally-invasive surgery, and manipulated solely by the operating surgeon which has the potential to locate precisely tumors of the digestive tract. It consists of an inductive proximity sensor and an electronic block encapsulated into an autoclavable stainless-steel cage that works in tandem with an endoscopic hemostatic clip whose structure was modified to increase detectability. By scanning the serosal side of the colon or stomach, the instrument is capable to accurately pinpoint the location of the clip placed previously during diagnostic endoscopy on the normal bowel mucosa, adjacent to the tumor. In the current in-vivo experiments performed on large animals, the modified clips were transported without difficulties to the point of interest and attached to the mucosa of the bowel. Using a laparoscopic approach, the detection rate of this system reached 65% when the sensor scanned the bowel at a speed of 0.3 cm/s, and applying slight pressure on the serosa. This value increased to 95% when the sensor was guided directly on the point of clip attachment. The detection rate dropped sharply when the scanning speed exceeded 1 cm/s and when the sensor-clip distance exceeded the cut-off value of 3 mm. In conclusion, the proposed detection system demonstrated its potential to offer a swift and convenient solution for the digestive laparoscopic surgeons, however its detection range still needs to be improved to render it useful for the clinical setting.

IntroductionKidney dysfunction is common in patients with aortic stenosis (AS) and correction of the aortic valve by transcatheter aortic valve implantation (TAVI) often affects kidney function. This may be due to microcirculatory changes.MethodsWe evaluated skin microcirculation with a hyperspectral imaging (HSI) system, and compared tissue oxygenation (StO2), near-infrared perfusion index (NIR), tissue hemoglobin index (THI) and tissue water index (TWI) in 40 patients undergoing TAVI versus 20 control patients. HSI parameters were measured before TAVI (t1), directly after TAVI (t2), and on postinterventional day 3 (t3). The primary outcome was the correlation of tissue oxygenation (StO2) to the creatinine level after TAVI.ResultsWe performed 116 HSI image recordings in patients undergoing TAVI for the treatment of severe aortic stenosis and 20 HSI image recordings in control patients. Patients with AS had a lower THI at the palm (p = 0.034) and a higher TWI at the fingertips (p = 0.003) in comparison to control patients. TAVI led to an increase of TWI, but had no uniform enduring effect on StO2 and THI. Tissue oxygenation StO2 at both measurement sites correlated negatively with creatinine levels after TAVI at t2 (palm: ρ = −0.415; p = 0.009; fingertip: ρ = −0.519; p < 0.001) and t3 (palm: ρ = −0.427; p = 0.008; fingertip: ρ = −0.398; p = 0.013). Patients with higher THI at t3 reported higher physical capacity and general health scores 120 days after TAVI.ConclusionHSI is a promising technique for periinterventional monitoring of tissue oxygenation and microcirculatory perfusion quality, which are related to kidney function, physical capacity, and clinical outcomes after TAVI.Clinical trial registrationhttps://drks.de/search/de/trial, identifier DRKS00024765.

Abstract Background Hyperspectral imaging (HSI) could provide extended haemodynamic monitoring of perioperative tissue oxygenation and tissue water content to visualize effects of haemodynamic therapy and surgical trauma. The objective of this study was to assess the capacity of HSI to monitor skin microcirculation and possible relations to perioperative organ dysfunction in patients undergoing pancreatic surgery. Methods The hyperspectral imaging TIVITA® Tissue System was used to evaluate superficial tissue oxygenation (StO2), deeper layer tissue oxygenation (near-infrared perfusion index (NPI)), haemoglobin distribution (tissue haemoglobin index (THI)) and tissue water content (tissue water index (TWI)) in 25 patients undergoing pancreatic surgery. HSI parameters were measured before induction of anaesthesia (t1), after induction of anaesthesia (t2), postoperatively before anaesthesia emergence (t3), 6 h after emergence of anaesthesia (t4) and three times daily (08:00, 14:00, 20:00 ± 1 h) at the palm and the fingertips until the second postoperative day (t5–t10). Primary outcome was the correlation of HSI with perioperative organ dysfunction assessed with the perioperative change of SOFA score. Results Two hundred and fifty HSI measurements were performed in 25 patients. Anaesthetic induction led to a significant increase of tissue oxygenation parameters StO2 and NPI (t1–t2). StO2 and NPI decreased significantly from t2 until the end of surgery (t3). THI of the palm showed a strong correlation with haemoglobin levels preoperatively (t2: r = 0.83, p < 0.001) and 6 h postoperatively (t4: r = 0.71, p = 0.001) but not before anaesthesia emergence (t3: r = 0.35, p = 0.10). TWI of the palm and the fingertip rose significantly between pre- and postoperative measurements (t2–t3). Higher blood loss, syndecan level and duration of surgery were associated with a higher increase of TWI. The perioperative change of HSI parameters (∆t1–t3) did not correlate with the perioperative change of the SOFA score. Conclusion This is the first study using HSI skin measurements to visualize tissue oxygenation and tissue water content in patients undergoing pancreatic surgery. HSI was able to measure short-term changes of tissue oxygenation during anaesthetic induction and pre- to postoperatively. TWI indicated a perioperative increase of tissue water content. Perioperative use of HSI could be a useful extension of haemodynamic monitoring to assess the microcirculatory response during haemodynamic therapy and major surgery. Trial registration German Clinical Trial Register, DRKS00017313 on 5 June 2019

Introduction The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG).Methods and analysis This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up.Ethics and dissemination Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access.Trial registration number DRKS00025765.

Introduction: Nonalcoholic fatty liver disease covers a broad spectrum. Simple steatosis has usually a benign course while nonalcoholic steatohepatitis (NASH) can progress into hepatocellular carcinoma, and cirrhosis. Therefore, differentiating patients with benign steatosis and NASH is crucial. Liver biopsy, the usual gold standard for NASH diagnosis, cannot be used as a screening method due to its associated risks. This is especially problematic for obese patients with a prevalence of nonalcoholic fatty liver disease (NAFLD) in >80% of patients. The aim of this study was therefore to develop and validate a noninvasive NASH screening test in a cohort of high-risk, morbidly obese patients. Methods: This prospective study examined diagnostic accuracy in accordance with STARD guidelines. 112 liver biopsies were consecutively assigned to either a training or validation cohort. Using the Bedossa histological scoring system, the cohorts were subdivided into NASH versus NAFLD/No NAFLD. Predictors of NASH were evaluated with receiver operating characteristic (ROC) curves. A model was then constructed using a backward stepwise logistic regression and evaluated in an independent validation cohort. Results: 53.5% of the patients had NASH and 4 patients had cirrhosis. Mean body mass index (BMI) was 49.8 ± 7.5 kg/m2. Backward stepwise logistic regression identified 4 parameters associated with the presence of NASH: alanin-aminotransferase, albumin, BMI, and triglycerides. The noninvasive NASH detection score (NI-NASH-DS) had an ROC of 0.851 and 0.727 in the training and validation cohorts, respectively. Sensitivity and specificity were 77.1% and 88% in the training cohort and 88% and 48% in the validation cohort which was much better than the established noninvasive scores. Discussion/Conclusion: The NI-NASH-DS is easy-to-use, inexpensive, and noninvasive and can reliably detect NASH in patients with morbid obesity. Due to its simplicity, it can be used frequently and repeatedly.

Abstract. The natural connection between the duodenum and the pancreatic duct enables a minimally invasive access to the pancreas. Endoscopically this access is already regularly used, mainly for diagnostic and even for certain therapeutic purposes. With per-oral pancreatoscopy the endopancreatic approach allows the direct visualization of the pancreatic duct system potentially improving the diagnostic work-up of pancreatic cystic neoplasms, intrapancreatic strictures and removal of pancreatic duct stones. However, the endopancreatic access can equally be applied for surgical interventions. The objective of this review is to summarize endoscopic and surgical interventions using the endopancreatic access. Endopancreatic surgery stands for a further development of the endoscopic technique: a rigid endoscope is transabdominally introduced over the duodenum and the papilla to enable resections of strictures and inflamed tissue from inside the pancreas under visual control. While the orientation and localization of target structures using this minimally invasive approach is difficult, the development of an accurate image guidance system will play a key role for the clinical implementation and widespread use of endoscopic and surgical endopancreatic interventions.

Measurement(s) colorectum Technology Type(s) Laparoscopy Factor Type(s) surgery type Sample Characteristic - Organism Homo sapiens Machine-accessible metadata file describing the reported data: https://doi.org/10.6084/m9.figshare.14178773

Abstract Background The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear stapled anastomosis is a promising technique for MIE because it is quite feasible even without robotic assistance. The aim of the present study is to compare total MIE with linear stapled anastomosis to open esophagectomy (OE) with circular stapled anastomosis with special regard to postoperative morbidity in an expertise-based randomized controlled trial (RCT). Methods/design This superiority RCT compares MIE with linear stapled anastomosis (intervention) to OE with circular stapled anastomosis (control) for Ivor-Lewis esophagectomy. It was initiated in February 2019, and recruitment is expected to last for 3 years. For inclusion, patients must be 18 years of age or more with a resectable primary malignancy in the distal esophagus. Participants with tumor localizations above the azygos vein, metastasis, or infiltration into adjacent tissue will be excluded. In an expertise-based approach, the allocated treatment will only be carried out by the single most experienced surgeon of the surgical center for each respective technique. The sample size was calculated with 20 participants per group for the primary endpoint postoperative morbidity according to comprehensive complication index (CCI) within 30 postoperative days. Secondary endpoints include anastomotic insufficiency, pulmonary complications, other intra- and postoperative outcome parameters such as estimated blood loss, operative time, length of stay, short-term oncologic endpoints, adherence to a standardized fast-track protocol, postoperative pain, and postoperative recovery (QoR-15). Quality of life (SF-36, CAT EORTC QLQ-C30, CAT EORTC QLQ-OES18) and oncological outcomes are evaluated with 60 months follow-up. Discussion MIVATE is the first RCT to compare OE with circular stapled anastomosis to total MIE with linear stapled anastomosis exclusively for intrathoracic anastomosis. The expertise-based approach limits bias due to heterogeneity of surgical expertise. The use of a dedicated fast-track protocol in both OE and MIE will shed light on the role of the access strategy alone in this setting. The findings of this study will serve to define which approach has the best perioperative outcome for patients requiring esophagectomy. Trial registration German Clinical Trials Register DRKS00016773 . Registered on 18 February 2019.

Three-dimensional bioprinting of an endocrine pancreas is a promising future curative treatment for patients with insulin secretion deficiency. In this study, we present an end-to-end concept from the molecular to the macroscopic level. Building-blocks for a hybrid scaffold device of hydrogel and functionalized polycaprolactone were manufactured by 3D-(bio)printing. Pseudoislet formation from INS-1 cells after bioprinting resulted in a viable and proliferative experimental model. Transcriptomics showed an upregulation of proliferative and ß-cell-specific signaling cascades, downregulation of apoptotic pathways, overexpression of extracellular matrix proteins, and VEGF induced by pseudoislet formation and 3D-culture. Co-culture with endothelial cells created a natural cellular niche with enhanced insulin secretion after glucose stimulation. Survival and function of pseudoislets after explantation and extensive scaffold vascularization of both hydrogel and heparinized polycaprolactone were demonstrated in vivo . Computer simulations of oxygen, glucose and insulin flows were used to evaluate scaffold architectures and Langerhans islets at a future perivascular transplantation site.

Abstract. Background:. Minimally invasive pancreatic surgery (MIPS) has developed over the last 3 decades and is nowadays experiencing an increased interest from the surgical community. With increasing awareness of both the public and the surgical community on patient safety, optimization of training has gained importance. For implementation of MIPS we propose 3 training phases. The first phase focuses on developing basic skills and procedure specific skills with the help of simulation, biotissue drills, video libraries, live case observations, and training courses. The second phase consists of index procedures, fellowships, and proctoring programs to ensure patient safety during the first procedures. During the third phase the surgeons aim is to safely implement the procedure into standard practice while minimizing learning curve related excess morbidity and mortality. Case selection, skills assessment, feedback, and mentoring are important methods to optimize this phase. The residual learning curve can reach up to 100 cases depending on the surgeons’ previous experience, selection of cases, and definition of the parameters used to assess the learning curve. Adequate training and high procedural volume are key to implementing MIPS safely.

Introduction Total pancreatoduodenectomy (TP) is the standard surgical approach for treating extended pancreas tumours. If TP is performed with splenectomy, the left gastric vein (LGV) sometimes needs to be sacrificed for oncological or technical reasons, which can result in gastric venous congestion (GVC). GVC can lead to gastric venous infarction, which in turn causes gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or total gastrectomy is usually performed if GVC occurs after TP. However, gastrectomy can be avoided by reconstructing the gastric venous outflow to overcome GVC and avoid gastric venous infarction. The current study aims to assess the role of gastric venous outflow reconstruction to prevent GVC after TP and avoid gastrectomy.Methods and analysis In the current single-centre observational pilot study, 20 patients will be assigned to study after intraoperative evaluation of gastric venous drainage after LGV resection during TP. During surgery, on-site evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry and spectral analysis will be performed. Postoperatively, patients will receive standard post-TP care and treatment. During hospitalisation, endoscopic examination with indocyanine green will be performed on the 1st, 3rd and 7th postoperative day to evaluate gastric ischaemia. Ischaemia markers will be evaluated daily after surgery. After discharge, patients will be followed-up for 90 days, during which mortality and morbidities will be recorded. The main endpoints of the study will include, rate of GVC, rate of gastric ischaemia, rate of postpancreatectomy gastrectomy, rate of reoperation, morbidity and mortality.Ethics and dissemination The study protocol has been reviewed and approved by the Ethics Committee of the University of Heidelberg. The results will be actively disseminated through peer-reviewed journals and conference presentations, and are expected in 2022.Trial registration number NCT04850430.

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 (β = 0.054; p = 0.023) and a greater BMI (β = 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 (β = –1.236; p < 0.001) and older age was negatively associated with %TWL (β = –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.

Abstract Background There is an increasing need for objective and validated educational concepts. This holds especially true for surgical procedures like chest tube insertion (CTI). Thus, we developed an instrument for objectification of learning successes: the assessment scale based on Objective Structured Assessment of Technical Skill (OSATS) for chest tube insertion, which is evaluated in this study. Primary endpoint was the evaluation of intermethod reliability (IM). Secondary endpoints are ‘indirect’ interrater reliability (IR) and construct validity of the scale (CV). Methods Every participant (N = 59) performed a CTI on a porcine thorax. Participants received three ratings (one ‘direct’ on site, two ‘indirect’ via video rating). IM compares ‘direct’ with ‘indirect’ ratings. IR was assessed between ‘indirect’ ratings. CV was investigated by subgroup analysis based on prior experience in CTI for ‘direct’ and ‘indirect’ rating. Results We included 59 medical students to our study. IM showed moderate conformity (‘direct’ vs. ‘indirect 1’ ICC = 0.735, 95% CI: 0.554–0.843; ‘direct’ vs. ‘indirect 2’ ICC = 0.722, 95% CI 0.533–0.835) and good conformity between ‘direct’ vs. ‘average indirect’ rating (ICC = 0.764, 95% CI: 0.6–0.86). IR showed good conformity (ICC = 0.84, 95% CI: 0.707–0.91). CV was proven between subgroups in ‘direct’ (p = 0.037) and ‘indirect’ rating (p = 0.013). Conclusion Results for IM suggest equivalence for ‘direct’ and ‘indirect’ ratings, while both IR and CV was demonstrated in both rating methods. Thus, the assessment scale seems a reliable method for rating trainees’ performances ‘directly’ as well as ‘indirectly’. It may help to objectify and facilitate the assessment of training of chest tube insertion.

Objective: Obesity surgery provides sustainable weight loss, improvement of comorbidities, and improved quality of life (QOL). There is few evidence on the patient perspective and goals. This study compared expected and achieved weight loss, body shape, and QOL. Methods: Patients completed the Moorehead-Ardelt QOL questionnaire (MAQOL) and questionnaires on actual and expected weight loss and body shape, comorbidities, and goals of obesity surgery preoperatively and within 24 months postoperatively. Results: 44 patients completed questionnaires pre- and postoperatively. BMI, MAQOL and comorbidities significantly improved postoperatively. Patients’ expected weight loss goal corresponded to a postoperative BMI of 32.6 ± 5.6 kg/m2 and was not different from their achieved BMI within 24 months after surgery (33.9 ± 6.3 kg/m2, p = 0.276). Self-reported body shape improved but did not reach preoperatively expected goals. During the weight loss period, patients adapted their weight loss and body shape goals to higher levels. Patients attributed a higher part of their success in weight loss to surgery postoperatively (79.5 ± 22.0 vs. 89.1 ± 18.4%, p = 0.028). Conclusion: Patients lost as much weight as they had expected and later modified the goals to even greater weight loss. Body shape improved but did not reach expected levels. QOL improved independently from weight loss and body shape. Patients attributed successful weight loss predominantly to surgery.

Introduction Normalisation of macrocirculatory parameters during resuscitation therapy does not guarantee the restoration of microcirculatory perfusion in critical illness due to haemodynamic incoherence. Persistent microcirculatory abnormalities are associated with severity of organ dysfunction and mandate the development of bedside microcirculatory monitoring. A novel hyperspectral imaging (HSI) system can visualise changes in skin perfusion, oxygenation and water content at the bedside. We aim to evaluate the effectiveness of HSI for bedside monitoring of skin microcirculation and the association of HSI parameters with organ dysfunction in patients with sepsis and major abdominal surgery.Methods and analysis Three independent groups will be assessed and separately analysed within a clinical prospective observational study: (1) 25 patients with sepsis or septic shock (according to sepsis-3 criteria), (2) 25 patients undergoing pancreatic surgery and (3) 25 healthy controls. Patients with sepsis and patients undergoing pancreatic surgery will receive standard therapy according to local protocols derived from international guidelines. In addition, cardiac output of perioperative patients and patients with sepsis will be measured. Healthy controls undergo one standardised evaluation. The TIVITA Tissue System is a novel HSI system that uses the visible and near-infrared spectral light region to determine tissue microcirculatory parameters. HSI analysis (hand/knee) will be done in parallel to haemodynamic monitoring within defined intervals during a 72-hour observation period. HSI data will be correlated with the Sequential Organ Failure Assessment score, global haemodynamics, inflammation and glycocalyx markers, surgical complications and 30-day outcome.Ethics and dissemination The protocol has been approved by the local ethics committee of the University of Heidelberg (S-148/2019). Study results will be submitted to peer-reviewed journals and medical conferences.Trial registration number DRKS00017313; Pre-results.

Abstract 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.

Background: The impact an article has on a specific field is manifested by its number of citations. The aim of this systematic review was to perform a citation analysis and identify the 100 most-cited articles in the field of minimally invasive (MI) gastrointestinal (GI) surgery. Methods: The Institute for Scientific Information Web of Knowledge (1945–2017) was utilised to identify the top 100 most-cited articles in the field of MI GI surgery, using 19 distinct keywords. The data extracted were number of citations, time of publication, research topic, level of evidence, authorship and country of origin. Results: Of the 100 most-cited articles, the number of citations ranged from 3331 to 317 citations. Most publications reported on bariatric surgery (n = 36), followed by oncology (n = 26) and hepatobiliary surgery (n = 15). The studies were published in 26 different journals with the top three journals being Annals of Surgery (n = 30), New England Journal of Medicine (n = 10) and Obesity Surgery (n = 9). The studies were conducted in 17 different countries led by the USA (n = 51), the UK (n = 9) and France (n = 6). Articles were published on all levels of evidence: level I (n = 20), Level II (n = 29), Level III (n = 8), Level IV (n = 29) and Level V (n = 14). Conclusion: The study revealed citation classics in the field of MI surgery. Interestingly, a high level of evidence was not significantly associated with an increased citation number.

Background: The ultimate goal of haemodynamic therapy is to improve microcirculatory tissue and organ perfusion. Hyperspectral imaging (HSI) has the potential to enable noninvasive microcirculatory monitoring at bedside. Methods: HSI (Tivita® Tissue System) measurements of tissue oxygenation, haemoglobin, and water content in the skin (ear) and kidney were evaluated in a double-hit porcine model of major abdominal surgery and haemorrhagic shock. Animals of the control group (n = 7) did not receive any resuscitation regime. The interventional groups were treated exclusively with either crystalloid (n = 8) or continuous norepinephrine infusion (n = 7). Results: Haemorrhagic shock led to a drop in tissue oxygenation parameters in all groups. These correlated with established indirect markers of tissue oxygenation. Fluid therapy restored tissue oxygenation parameters. Skin and kidney measurements correlated well. High dose norepinephrine therapy deteriorated tissue oxygenation. Tissue water content increased both in the skin and the kidney in response to fluid therapy. Conclusions: HSI detected dynamic changes in tissue oxygenation and perfusion quality during shock and was able to indicate resuscitation effectivity. The observed correlation between HSI skin and kidney measurements may offer an estimation of organ oxygenation impairment from skin monitoring. HSI microcirculatory monitoring could open up new opportunities for the guidance of haemodynamic management.

[This corrects the article DOI: 10.1371/journal.pone.0139547.].

Following publication of the original article [1], the author reported that the given name and family name of all authors were swapped.

Mesh augmentation seems to reduce recurrences following laparoscopic paraesophageal hernia repair (LPHR). However, there is an uncertain risk of mesh-associated complications. Risk-benefit analysis might solve the dilemma.A systematic literature search was performed to identify randomized controlled trials (RCTs) and observational clinical studies (OCSs) comparing laparoscopic mesh-augmented hiatoplasty (LMAH) with laparoscopic mesh-free hiatoplasty (LH) with regard to recurrences and complications. Random effects meta-analyses were performed to determine potential benefits of LMAH. All data regarding LMAH were used to estimate risk of mesh-associated complications. Risk-benefit analysis was performed using a Markov Monte Carlo decision-analytic model.Meta-analysis of 3 RCTs and 9 OCSs including 915 patients revealed a significantly lower recurrence rate for LMAH compared to LH (pooled proportions, 12.1% vs. 20.5%; odds ratio (OR), 0.55; 95% confidence interval (CI), 0.34 to 0.89; p = 0.04). Complication rates were comparable in both groups (pooled proportions, 15.3% vs. 14.2%; OR, 1.02; 95% CI, 0.63 to 1.65; p = 0.94). The systematic review of LMAH data yielded a mesh-associated complication rate of 1.9% (41/2121; 95% CI, 1.3% to 2.5%) for those series reporting at least one mesh-associated complication. The Markov Monte Carlo decision-analytic model revealed a procedure-related mortality rate of 1.6% for LMAH and 1.8% for LH.Mesh application should be considered for LPHR because it reduces recurrences at least in the mid-term. Overall procedure-related complications and mortality seem to not be increased despite of potential mesh-associated complications.