Depression, anxiety, fatigue, and quality of life in a large sample of patients suffering from head and neck cancer in comparison with the general population.

BACKGROUND: Treatment of head and neck cancer (HNC) often leads to visible and severe functional impairments. In addition, patients often suffer from a variety of psychosocial problems, significantly associated with a decreased quality of life. We aimed to compare depression, anxiety, fatigue and quality of life (QoL) between HNC patients and a large sample of the general population in Germany and to examine the impact of sociodemographic, behavioral and clinical factors on these symptoms. METHODS: We assessed data of HNC patients during the aftercare consultation at the Leipzig University Medical Center with a patient reported outcome (PRO) tool named "OncoFunction". Depression, anxiety, fatigue and QoL were assessed using validated outcome measures including the PHQ-9, the GAD-2, and the EORTC QLQ-C30 questionnaire. RESULTS: A total of 817 HNC patients were included in our study and compared to a sample of 5018 individuals of the general German population. HNC patients showed significantly higher levels of impairment in all dimensions assessed. Examination of association between depression, anxiety, fatigue and QoL and clinical as well as sociodemographic variables showed significant relationships between occupational status, ECOG-state, body mass index and time since diagnosis. CONCLUSIONS: HNC patients suffer significantly from psychological distress. The used questionnaires are suitable for the use in daily routine practice and can be helpful to increase the detection of depression, anxiety and fatigue and therefore can improve HNC aftercare.

Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI).

PURPOSE: This study evaluated the use of hyperspectral imaging for the determination of the resection margin during colorectal resections instead of clinical macroscopic assessment. METHODS: The used hyperspectral camera is able to record light spectra from 500 to 1000 nm and provides information about physiologic parameters of the recorded tissue area intraoperatively (e.g., tissue oxygenation and perfusion). We performed an open-label, single-arm, and non-randomized intervention clinical trial to compare clinical assessment and hyperspectral measurement to define the resection margin in 24 patients before and after separation of the marginal artery over 15 min; HSI was performed each minute to assess the parameters mentioned above. RESULTS: The false color images calculated from the hyperspectral data visualized the margin of perfusion in 20 out of 24 patients precisely. In the other four patients, the perfusion difference could be displayed with additional evaluation software. In all cases, there was a deviation between the transection line planed by the surgeon and the border line visualized by HSI (median 1 mm; range - 13 to 13 mm). Tissue perfusion dropped up to 12% within the first 10 mm distal to the border line. Therefore, the resection area was corrected proximally in five cases due to HSI record. The biggest drop in perfusion took place in less than 2 min after devascularization. CONCLUSION: Determination of the resection margin by HSI provides the surgeon with an objective decision aid for assessment of the best possible perfusion and ideal anastomotic area in colorectal surgery.

[Introduction of the Screening Tool OncoFunction for Functional Follow-up of Head and Neck Patients]. / Vorstellung des Screeningsystems (OncoFunction) für Funktionsstörungen im Kopf-Hals-Tumor-Follow-up.

INTRODUCTION: The follow-up for head and neck cancer (HNC) focussed on therapy control. Accessory long term functionality is important. Impairment of function is observed, but a comparable documentation is not established. Additional we frequently see psychooncological comorbidities, what complicates the assessment. This was the reason why Tschiesner et al. developed on the base of the "ICF Core set for head and neck cancer" a guideline for the Assessment of Function in HNC. In consequence of good results in other tumour entities we developed an electronic version (OncoFunction). METHODS: In a proof of concept study all patients of our follow up consultation from 07/13 to 03/14 were included. OncoFunction was given to patients in a digital form using tablet computers. The results were visible to the physician in a concentrated form before consultation and were supplemented by a physician questionnaire. Furthermore we evaluated the usability in 202 patients. RESULTS: We had 682 patient contacts. 530 patient contacts (77, 7%) used the questionnaire. The physician questionnaire was answered in 470 times. Finally there are from 69.8% of the patient contacts full datasets available. Between users and non-users of the questionnaire we see no difference. CONCLUSION: The use of a computer-based screening and feedback system (OncoFunction) in clinical use is feasible and excellent assessed by patients. The patient data are visible in a compact form for the physician and problems can clear addressed to the patient. One more benefit is the standardized follow up documentation and the use of comparable data in research.

[The 'Surgical Deck': a new generation of integrated operational rooms for ENT]. / Das "Surgical Deck": Eine neue OP-Generation für die HNO-Chirurgie.

BACKGROUND: Existing operating room concepts do not meet modern technological opportunities anymore. The "Surgical Deck" is supposed to represent a prototype for a new operating room generation. The objective of the project is to achieve a better integration of functions and to develop an innovative concept for a highly developed surgical workstation. MATERIAL AND METHODS: 3 working areas are defined: Surgical, Airway and Technical Cockpit. The evaluation was conducted on 284 surgeries carried out from 01.08. 2011 to 31.01. 2012. The evaluation team consisted of 6 surgeons, 3 surgery nurses, 3 anesthesiologists and 4 anesthesia nurses. Within a detailed analysis, the data of 50 FESS surgeries were compared to those of a control group. RESULTS: Within the FESS group, the average slot time was reduced by 13%. 88.2% of those questioned assessed ergonomics as being better than in the conventional OR. 71.5% stated that the Surgical Deck provided an added value with regard to the surgical procedure. 91.3% confirmed that the system control required additional training. 79.3% described the cost-benefit-ratio as appropriate. For 96% of the surgeries, respondents said that they were feeling adequately supported by the technology. CONCLUSION: The results show a clear advantage of the system architecture. The Surgical Deck may present a solid foundation with regard to the transfer of the system into the clinical practice. This is relevant for new assistance functions such as process control software or navigation-based collision warning systems. It is to be expected that the project will significantly contribute to further develop the future surgical workstation and its standardization.

Keyword-augmented and semi-automatic generation of FESS reports: a proof-of-concept study.

INTRODUCTION: Surgical reports are usually written after a procedure and must often be reproduced from memory. Thus, this is an error-prone, and time-consuming task which increases the workload of physicians. In this proof-of-concept study, we developed and evaluated a software tool using Artificial Intelligence (AI) for semi-automatic intraoperative generation of surgical reports for functional endoscopic sinus surgery (FESS). MATERIALS AND METHODS: A vocabulary of keywords for developing a neural language model was created. With an encoder-decoder-architecture, artificially coherent sentence structures, as they would be expected in general operation reports, were generated. A first set of 48 conventional operation reports were used for model training. After training, the reports were generated again and compared to those before training. Established metrics were used to measure optimization of the model objectively. A cohort of 16 physicians corrected and evaluated three randomly selected, generated reports in four categories: "quality of the generated operation reports," "time-saving," "clinical benefits" and "comparison with the conventional reports." The corrections of the generated reports were counted and categorized. RESULTS: Objective parameters showed improvement in performance after training the language model (p < 0.001). 27.78% estimated a timesaving of 1-15 and 61.11% of 16-30 min per day. 66.66% claimed to see a clinical benefit and 61.11% a relevant workload reduction. Similarity in content between generated and conventional reports was seen by 33.33%, similarity in form by 27.78%. 66.67% would use this tool in the future. An average of 23.25 ± 12.5 corrections was needed for a subjectively appropriate surgery report. CONCLUSION: The results indicate existing limitations of applying deep learning to text generation of operation reports and show a high acceptance by the physicians. By taking over this time-consuming task, the tool could reduce workload, optimize clinical workflows and improve the quality of patient care. Further training of the language model is needed.

[A surgical micromanipulator in ear surgery: potential and comparison to freehand preparation]. / Ein chirurgischer Mikromanipulator in der Ohrchirurgie: Potenzial und Vergleich mit der freien Präparation.

INTRODUCTION: Surgical accuracy in microscopic ear surgery is reduced by limited access and tremor. At this point a micromanipulator could have a positive influence. The goal of the study was: 1. To develop a system that would enable measurements of accuracy, time and precision during a manual approach to the middle ear 2. To apply a manipulator that can easily be a compact part of the regular setup in ear surgery 3. To compare the manual results critically considering accuracy and tremor reduction and to compare these results with those of a manipulator A manipulator in ear surgery does not need to be a highly complex structure with force feedback and multiple degrees of freedom. The surgeon's preparation in middle ear surgery is most of the time straight without potentially applying the 15 degrees of freedom the human hand can offer. The micromanipulator in this study was developed in order to serve as a compact, teleoperated instrument without limiting the surgeon's dexterity. The use of standard instruments facilitates the integration of the system in existing surgical procedures and sterilisation concepts. MATERIAL AND METHODS: Ten head and neck surgeons simulated an approach to the stapedial footplate on a modified 3D cast of a realistic human skull in an experimental OR. A perforator was moved to a reference point on the stapedial footplate. The movements were detected by means of an image acquisition system. Each trial was repeated more than 200 times, aiming both manually and with the aid of a micromanipulator (> 4,000 measurements). RESULTS: Accuracy for the manual and micromanipulator approach revealed no considerable differences. In absolute terms, the manual approach was more accurate. However, the learning curves indicated a stronger decrease in deviation when the micromanipulator was used and also less deviation in scatter plots. At the beginning, the time required for pointing increased when using the micromanipulator, but decreased to a greater extent in the course of the trial when compared to the manual approach. The work strain was distinctively lower when the micromanipulator was applied. CONCLUSION: The micromanipulator gave evidence of a stronger effect as regards individual improvement in accuracy and time span. The micromanipulator shows potential for improvements in accuracy as well as compensation for poor ergonomics.

Combined indocyanine green and quantitative perfusion assessment with hyperspectral imaging during colorectal resections.

Anastomotic insufficiencies still represent one of the most severe complications in colorectal surgery. Since tissue perfusion highly affects anastomotic healing, its objective assessment is an unmet clinical need. Indocyanine green-based fluorescence angiography (ICG-FA) and hyperspectral imaging (HSI) have received great interest in recent years but surgeons have to decide between both techniques. For the first time, two data processing pipelines capable of reconstructing an ICG-FA correlating signal from hyperspectral data were developed. Results were technically evaluated and compared to ground truth data obtained during colorectal resections. In 87% of 46 data sets, the reconstructed images resembled the ground truth data. The combined applicability of ICG-FA and HSI within one imaging system might provide supportive and complementary information about tissue vascularization, shorten surgery time, and reduce perioperative mortality.

[Intraoperative use of electronic patient records by the surgeon. An evaluation of the "MI Report" in ENT surgery]. / Intraoperative Bedienung einer elektronischen Patientenakte durch den Operateur. Einsatzbeurteilung des MI-Reports in der HNO-Chirurgie.

MOTIVATION: Surgeons often wish to view patient data during surgical procedures. To achieve this, the surgeon normally has to get unsterile to view the record himself, or request a nurse to do so. This procedure results in a time delay, longer anesthesia and higher treatment costs. MATERIAL AND METHODS: The "MI Report" (Karl Storz, Tuttlingen, Germany) was evaluated for its impact in ENT surgery in daily routine. The system consists of a sensor for gesture recognition and a large 52-in. display positioned centrally in the operating room. Usage of the system by the surgeon was recorded in 51 surgical procedures. RESULTS: Information was retrieved from the display on average 1.2 times per procedure. The system was not used at all in 20% of operations. The operation with the highest usage rate was tympanoplasty (1.6 views per operation). In 86% of cases, the system was used to confirm the therapy underway or make a decision on how to proceed with therapy. When trying to activate the system by making a particular hand gesture, the surgeon cancelled activation in 31% of attempts. CONCLUSION: A relation between the type of operation and information viewed could be shown. A benefit for the patient may be assumed on the basis of the reduced effort required to retrieve patient data as well as increased intraoperative consultation of patient records. The system provides the surgeon with greater flexibility and may reduce operating time.

Manual accuracy in comparison with a miniature master slave device--preclinical evaluation for ear surgery.

Manual accuracy in microsurgery is reduced by tremor and limited access. A surgical approach through the middle ear also puts delicate structures at risk, while the surgeon is often working at an unergonomic position. At this point a micromanipulator could have a positive influence. A system was developed to measure "working accuracy", time and precision during manipulation in the middle ear. 10 ENT-surgeons simulated a perforation of the stapedial footplate on a modified 3D print of a human skull in a mock OR. Each trial was repeated more than 200 times aiming manually and using a micro-manipulator. Data of over 4000 measurements was tested and graphically processed. Work strain was evaluated with a questionnaire. Accuracy for manual and micromanipulator perforation revealed a small difference. Learning curves showed a stronger decrease both in deviation and time when the micromanipulator was used. Also a lower work strain was apparent. The micromanipulator has the potential as an aiding device in ear surgery.

Effects of Intra-Abdominal Pressure on Lung Mechanics during Laparoscopic Gynaecology.

Investigating the relations between surgical actions and physiological reactions of the patient is essential for developing pre-emptive model-based systems. In this study, the effects of insufflating abdominal cavity with CO2 in laparoscopic gynaecology on the respiration system were analysed. Real-time recordings of anaesthesiology and surgical data of five subjects were acquired and processed, and the correlation between lung mechanics and the intra-abdominal pressure was evaluated. Alterations of ventilation settings undertaken by the anaesthesiologist were also considered. Experimental results demonstrated the high correlation with a mean Pearson coefficient of 0.931.Clinical Relevance- This study demonstrates the effects of intra-abdominal pressure during laparoscopy on lung mechanics and enables developing predictive models to promote a greater awareness in operating rooms.

An observation support system with an adaptive ontology-driven user interface for the modeling of complex behaviors during surgical interventions.

The field of surgical interventions emphasizes knowledge and experience; explicit and detailed models of surgical processes are hard to obtain by observation or measurement. However, in medical engineering and related developments, such models are highly valuable. Surgical process modeling deals with the generation of complex process descriptions by observation. This places high demands on the observers, who have to use a sizable terminology to denominate surgical actions, instruments, and patient anatomies, and to describe processes unambiguously. Here, we present a novel method, employing an ontology-based user interface that adapts to the actual situation and describe the principles of the system. A validation study showed that this method enables observers with little recording experience to reach a recording accuracy of >90%. Furthermore, this method can be used for live and video observation. We conclude that the method of ontology-supported recording for complex behaviors can be advantageously employed when surgical processes are modeled.

[Possibilities and perspectives of hyperspectral imaging in visceral surgery]. / Möglichkeiten und Perspektiven der Hyperspektralbildgebung in der Viszeralchirurgie.

HyperSpectral Imaging (HSI) technology enables quantitative tissue analyses beyond the limitations of the human eye. Thus, it serves as a new diagnostic tool for optical properties of diverse tissues. In contrast to other intraoperative imaging methods, HSI is contactless, noninvasive, and the administration of a contrast medium is not necessary. The duration of measurements takes only a few seconds and the surgical procedure is only marginally disturbed. Preliminary HSI applications in visceral surgery are promising with the potential of optimized outcomes. Current concepts, possibilities and new perspectives regarding HSI technology together with its limitations are discussed in this article.

First clinical evaluation of the navigated controlled drill at the lateral skull base.

Surgery on the lateral skull base puts delicate structures at risk. To support the surgeon in identifying and protecting the risk structures the principle of Navigated Control (NC) can be used for preventing iatrogenic injuries. In this paper the application of Navigated Control for surgery on the lateral skull base was investigated for the first time in clinical use. There was no risk structure damage with NC. Navigated Control in lateral skull base surgery seems to have a great potential for safe risk structure protection, a morbidity reduction and in a relief of strain for the surgeon.

[Hyperspectral imaging of gastrointestinal anastomoses]. / Hyperspektral-Imaging bei gastrointestinalen Anastomosen.

INTRODUCTION: Anastomotic insufficiency (AI) remains the most feared surgical complication in gastrointestinal surgery, which is closely associated with a prolonged inpatient hospital stay and significant postoperative mortality. Hyperspectral imaging (HSI) is a relatively new medical imaging procedure which has proven to be promising in tissue identification as well as in the analysis of tissue oxygenation and water content. Until now, no data exist on the in vivo HSI analysis of gastrointestinal anastomoses. METHODS: Intraoperative images were obtained using the TIVITA™ tissue system HSI camera from Diaspective Vision GmbH (Pepelow, Germany). In 47 patients who underwent gastrointestinal surgery with esophageal, gastric, pancreatic, small bowel or colorectal anastomoses, 97 assessable recordings were generated. Parameters obtained at the sites of the anastomoses included tissue oxygenation (StO2), the tissue hemoglobin index (THI), near-infrared (NIR) perfusion index, and tissue water index (TWI). RESULTS: Obtaining and analyzing the intraoperative images with this non-invasive imaging system proved practicable and delivered good results on a consistent basis. A NIR gradient along and across the anastomosis was observed and, furthermore, analysis of the tissue water and oxygenation content showed specific changes at the site of anastomosis. CONCLUSION: The HSI method provides a non-contact, non-invasive, intraoperative imaging procedure without the use of a contrast medium, which enables a real-time analysis of physiological anastomotic parameters, which may contribute to determine the "ideal" anastomotic region. In light of this, the establishment of this methodology in the field of visceral surgery, enabling the generation of normal or cut off values for different gastrointestinal anastomotic types, is an obvious necessity.

Online time and resource management based on surgical workflow time series analysis.

PURPOSE: Hospitals' effectiveness and efficiency can be enhanced by automating the resource and time management of the most cost-intensive unit in the hospital: the operating room (OR). The key elements required for the ideal organization of hospital staff and technical resources (such as instruments in the OR) are an exact online forecast of both the surgeon's resource usage and the remaining intervention time. METHODS: This paper presents a novel online approach relying on time series analysis and the application of a linear time-variant system. We calculated the power spectral density and the spectrogram of surgical perspectives (e.g., used instrument) of interest to compare several surgical workflows. RESULTS: Considering only the use of the surgeon's right hand during an intervention, we were able to predict the remaining intervention time online with an error of 21 min 45 s ±9 min 59 s for lumbar discectomy. Furthermore, the performance of forecasting of technical resource usage in the next 20 min was calculated for a combination of spectral analysis and the application of a linear time-variant system (sensitivity: 74 %; specificity: 75 %) focusing on just the use of surgeon's instrument in question. CONCLUSION: The outstanding benefit of these methods is that the automated recording of surgical workflows has minimal impact during interventions since the whole set of surgical perspectives need not be recorded. The resulting predictions can help various stakeholders such as OR staff and hospital technicians. Moreover, reducing resource conflicts could well improve patient care.

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC.

PURPOSE: Clinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders. METHOD: The demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff. RESULTS: In the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms. CONCLUSION: The implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.

Application fields for the new Object Management Group (OMG) Standards Case Management Model and Notation (CMMN) and Decision Management Notation (DMN) in the perioperative field.

PURPOSE: Medical processes can be modeled using different methods and notations. Currently used modeling systems like Business Process Model and Notation (BPMN) are not capable of describing the highly flexible and variable medical processes in sufficient detail. METHODS: We combined two modeling systems, Business Process Management (BPM) and Adaptive Case Management (ACM), to be able to model non-deterministic medical processes. We used the new Standards Case Management Model and Notation (CMMN) and Decision Management Notation (DMN). RESULTS: First, we explain how CMMN, DMN and BPMN could be used to model non-deterministic medical processes. We applied this methodology to model 79 cataract operations provided by University Hospital Leipzig, Germany, and four cataract operations provided by University Eye Hospital Tuebingen, Germany. Our model consists of 85 tasks and about 20 decisions in BPMN. We were able to expand the system with more complex situations that might appear during an intervention. CONCLUSION: An effective modeling of the cataract intervention is possible using the combination of BPM and ACM. The combination gives the possibility to depict complex processes with complex decisions. This combination allows a significant advantage for modeling perioperative processes.

Distance measures for surgical process models.

BACKGROUND: The development of new resources, such as surgical techniques and approaches, results in continuous modification of surgery. To assess these modifications, it is necessary to use measures that quantify the impact of resources on surgical processes. OBJECTIVES: The objective of this work is to introduce and evaluate distance measurements that are able to represent differences in the courses of surgical interventions as processes. METHODS: Hence, we present four different distance measures for surgical processes: the Jaccard distance, Levenshtein distance, Adjacency distance, and Graph matching distance. These measures are formally introduced and evaluated by applying them to clinical data sets from laparoscopic training in pediatric surgery. RESULTS: We analyzed the distances of 450 surgical processes using these four measures with a focus on the difference in surgical processes performed by novices and by experienced surgeons. The Levenshtein and Adjacency distances were best suited to measure distances between surgical processes. CONCLUSION: The measurement of distances between surgical processes is necessary to estimate the benefit of new surgical techniques and strategies.

Surgical workflow management schemata for cataract procedures. process model-based design and validation of workflow schemata.

OBJECTIVE: Workflow guidance of surgical activities is a challenging task. Because of variations in patient properties and applied surgical techniques, surgical processes have a high variability. The objective of this study was the design and implementation of a surgical workflow management system (SWFMS) that can provide a robust guidance for surgical activities. We investigated how many surgical process models are needed to develop a SWFMS that can guide cataract surgeries robustly. METHODS: We used 100 cases of cataract surgeries and acquired patient-individual surgical process models (iSPMs) from them. Of these, randomized subsets iSPMs were selected as learning sets to create a generic surgical process model (gSPM). These gSPMs were mapped onto workflow nets as workflow schemata to define the behavior of the SWFMS. Finally, 10 iSPMs from the disjoint set were simulated to validate the workflow schema for the surgical processes. The measurement was the successful guidance of an iSPM. RESULTS: We demonstrated that a SWFMS with a workflow schema that was generated from a subset of 10 iSPMs is sufficient to guide approximately 65% of all surgical processes in the total set, and that a subset of 50 iSPMs is sufficient to guide approx. 80% of all processes. CONCLUSION: We designed a SWFMS that is able to guide surgical activities on a detailed level. The study demonstrated that the high inter-patient variability of surgical processes can be considered by our approach.

Impact quantification of the daVinci telemanipulator system on surgical workflow using resource impact profiles.

BACKGROUND: It has yet to be determined whether surgical assist systems benefit surgical workflow. This question should be answered qualitatively and quantitatively and must be supported by evidence gathered from structured and rigorous analyses. METHODS: A method is presented to quantify the benefits of the daVinci telemanipulator system to surgical workflow. Based on the modeling of surgical processes, resource impact profiles (RIPs) were generated. RIPs are statistical mean intervention courses for a sample of surgical process models that were performed using a specific surgical assist system as a resource. A total of 12 laparoscopic and 12 telemanipulator-supported Nissen fundoplications were modeled and analyzed to quantify the impact of the surgical assist system. RESULTS: Few statistically significant benefits of the system to surgical workflow were found. It was found that the daVinci system is not superior to the conventional laparoscopic strategy if the surgeon follows the same workflow. CONCLUSIONS: RIPs are a valuable method to estimate the impact of a surgical assist system on the surgical workflow. For the use case investigated, changes in workflow may be necessary to fully benefit from the advantages of using a telemanipulator in Nissen fundoplications. Conversely, the telemanipulator may only reach its full potential in more complex operations.