Requirements for the Acceptance of an App for Voice Therapy-A Usability Report Based on the "Oldenburger Logopädie App" (OLA).

OBJECTIVE: The prototype "Oldenburger Logopädie App" (OLA) was designed to support voice therapy for patients with recurrent paresis, such as to accompany homework or as a short-term substitute for regular therapy due to dropouts, such as during the COVID-19 pandemic. The treating speech and language pathologists (SLPs) unlocks videos individually applicable to the respective patients, in which the SLPs instruct the individual exercises. The app can be used without information technology knowledge or detailed instructions. MATERIALS AND METHODS: The prototype's usability was evaluated through a usability test battery (AttrakDiff questionnaire, System Usability Scale, Visual Aesthetics of Websites Inventory questionnaire) and informal interviews from the perspective of patients and SLPs. RESULTS: The acceptance, usability, user experience, self-descriptiveness, and user behavior of OLA were consistently given and mostly rated as positive. Both user groups rated OLA as practical and easy to use (eg, System Usability Scale: "practical" (agree: ∅ 49.5%), "cumbersome to use" (total: strongly disagree: ∅ 60.0%). However, the monotonous layout of the app and the instructional and exercise videos should be modified in the next editing step. An overview of relevant criteria for a voice therapy app, regarding design and functions, was derived from the results. CONCLUSION: This user-oriented feedback on the usability of the voice app provides the proof of concept and the basis for the further development of the Artificial intelligence-based innovative follow-up app LAOLA. In the future, it should be possible to support the treatment of all voice disorders with such an app. For the further development of the voice app, the therapeutic content and the effectiveness of the training should also be investigated.

Prophylactic slowly resorbable mesh in midline laparotomy to limit incisional hernia incidence: the prospective 'Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS)' cohort study protocol.

Background: Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh ("investigational device"). However, the effectiveness of this mesh in IH prevention has not been proved. Methods: The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Discussion: Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.

Personalized medicine for locally advanced rectal cancer: five years of complete clinical response after neoadjuvant radiochemotherapy-a case report with a literature review.

We present a case report of a 73-year-old male patient with a complete clinical response following neoadjuvant radiochemotherapy of mid-rectal adenocarcinoma. The patient was initially diagnosed with stage IIIB microsatellite stable mid-rectal adenocarcinoma in February 2017. During restaging in June 2017, which included rectoscopy, endosonography, computed tomography and magnetic resonance imaging, a complete clinical response was observed. After appropriate consultation, a watch-and-wait strategy was chosen. During stringent follow-up every 3 months for the first 3 years and thereafter every 6 months, no recurrence or regrowth was observed. After the fifth year of complete clinical response, we recommended an annual follow-up. As of November 2023, the patient has no signs of recurrence or late toxicity after radiochemotherapy. The omission of resection in patients with locally advanced rectal cancer and the establishment of a watch-and-wait strategy are currently under discussion as possible treatment courses in patients with complete clinical response. Long-term data on watch-and-wait strategies for patients with a complete clinical response in locally advanced rectal cancer are rare. A clear national and international accepted standardization of follow-up programs for patients managed by a watch-and-wait strategy in the long-term is missing. Here, we report the case of a patient who had undergone a follow-up program for more than five years and discuss the current literature. Our case report and literature review highlights that a watch-and-wait strategy does not seem to increase the risk of systemic disease or compromise survival outcomes in selected locally advanced rectal cancer patients. Thus, our case contributes to the growing body of knowledge on personalized and precision medicine for rectal cancer.

SonicGuard Sensor-A Multichannel Acoustic Sensor for Long-Term Monitoring of Abdominal Sounds Examined through a Qualification Study.

Auscultation is a fundamental diagnostic technique that provides valuable diagnostic information about different parts of the body. With the increasing prevalence of digital stethoscopes and telehealth applications, there is a growing trend towards digitizing the capture of bodily sounds, thereby enabling subsequent analysis using machine learning algorithms. This study introduces the SonicGuard sensor, which is a multichannel acoustic sensor designed for long-term recordings of bodily sounds. We conducted a series of qualification tests, with a specific focus on bowel sounds ranging from controlled experimental environments to phantom measurements and real patient recordings. These tests demonstrate the effectiveness of the proposed sensor setup. The results show that the SonicGuard sensor is comparable to commercially available digital stethoscopes, which are considered the gold standard in the field. This development opens up possibilities for collecting and analyzing bodily sound datasets using machine learning techniques in the future.

A Clinical User Study Investigating the Benefits of Adaptive Volumetric Illumination Sampling.

Accurate and fast understanding of the patient's anatomy is crucial in surgical decision making and particularly important in visceral surgery. Sophisticated visualization techniques such as 3D Volume Rendering can aid the surgeon and potentially lead to a benefit for the patient. Recently, we proposed a novel volume rendering technique called Adaptive Volumetric Illumination Sampling (AVIS) that can generate realistic lighting in real-time, even for high resolution images and volumes but without introducing additional image noise. In order to evaluate this new technique, we conducted a randomized, three-period crossover study comparing AVIS to conventional Direct Volume Rendering (DVR) and Path Tracing (PT). CT datasets from 12 patients were evaluated by 10 visceral surgeons who were either senior physicians or experienced specialists. The time needed for answering clinically relevant questions as well as the correctness of the answers were analyzed for each visualization technique. In addition to that, the perceived workload during these tasks was assessed for each technique, respectively. The results of the study indicate that AVIS has an advantage in terms of both time efficiency and most aspects of the perceived workload, while the average correctness of the given answers was very similar for all three methods. In contrast to that, Path Tracing seems to show particularly high values for mental demand and frustration. We plan to repeat a similar study with a larger participant group to consolidate the results.

Qualitative and Economic Impact of Standardized and Digitalized Operation Room Processes in Obesity Surgery.

PURPOSE: The introduction of innovative digital solutions in healthcare lags compared to other industries but promises high potential to create value in efficiency and quality. Increasing economic pressure forces hospitals to optimize operating room (OR) processes, in which such solutions might provide additional support. MATERIALS AND METHODS: This retrospective case-control and monocentric study investigated if digitalized and standardized intraoperative surgical workflows of laparoscopic Roux-en-Y gastric bypass (LRYGB) have a significant impact on efficiency, quality, and economics. Logistic and linear regression models were used to apply propensity score matching (PSM) for efficiency and odds ratio for the quality analysis. RESULTS: The study included 49 patients per group. The results demonstrate a significant increase in efficiency and cost-effectiveness in the treatment group. Length of stay (LoS) was 1.2 days less than in the control group (5.6 vs. 4.4). The mean of total OR and skin-to-skin time increased by 3.7% (142.00 vs. 136.80) and 8.5%, respectively (93.88 vs. 85.94). The standard deviation (SD) of total OR and skin-to-skin time decreased by 7.36 min (26.86 vs. 34.22) and 8.98 min (23.20 vs. 32.18) in the treatment group. The results of the odds ratio did not provide any conclusions on quality. Overall, costs were reduced by 318 € per patient and total revenue improved by 10,073 €. CONCLUSION: The implementation of digital workflow management systems in obesity surgery improves economic efficiency. Hospital management and payors should evaluate further support in research of the digitization of the OR, followed by reimbursement to increase and facilitate the accessibility to digital support systems.

A virtual reality simulation of a novel way to illuminate the surgical field - A feasibility study on the use of automated lighting systems in the operating theatre.

Introduction: Surgical lighting systems have to be re-adjusted manually during surgery by the medical personnel. While some authors suggest that interaction with a surgical lighting system in the operating room might be a distractor, others support the idea that manual interaction with the surgical lighting system is a hygiene problem as pathogens might be present on the handle. In any case, it seems desirable to develop a novel approach to surgical lighting that minimizes the need for manual interaction during a surgical procedure. Methodes: We investigated the effect of manual interaction with a classical surgical lighting system and simulated a proposed novel design of a surgical lighting system in a virtual reality environment with respect to performance accuracy as well as cognitive load (measured by electroencephalographical recordings). Results: We found that manual interaction with the surgical lights has no effect on the quality of performance, yet for the price of a higher mental effort, possibly leading to faster fatigue of the medical personnel in the long run. Discussion: Our proposed novel surgical lighting system negates the need for manual interaction and leads to a performance quality comparable to the classical lighting system, yet with less mental load for the surgical personnel.

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).

BACKGROUND: Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone. METHODS: P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 µm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification. DISCUSSION: Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. TRIAL REGISTRATION: DRKS00027921, U1111-1273-4657.

The impact of resection margin distance on survival and recurrence in pancreatic ductal adenocarcinoma in a retrospective cohort analysis.

BACKGROUND: The prognostic effect of resection margin status following pancreatoduodenectomy for pancreatic ductal adenocarcinoma (PDAC) remains controversial, even with the implementation of standardized pathological assessment. We therefore investigated the impact of resection margin (RM) status and RM distance in curative resected PDAC on overall survival (OS), disease-free survival (DFS) and recurrence. METHOD: 108 patients were retrieved from a prospectively maintained database of a certified pancreatic cancer center. Distribution and relationships between circumferential resection margin (CRM) involvement (CRM≤1mm; CRM>1mm; CRM≥2mm) and their prognostic impact on OS and DFS were assessed using Kaplan-Meier statistics and the Log-Rank test. Multivariate logistic regression was used explain the development of a recurrence 12 months after surgery. RESULTS: 63 out of 108 patients had medial RM and 32 posterior RM involvement. There was no significant difference in OS and DFS between CRM≤1mm and CRM>1mm resections. Clearance at the medial margin of ≥2mm had an impact on OS and DFS, (RM≥2mm vs. RM<2mm: median OS 29.8 vs 16.8 months, median DFS 19.6 vs. 10.3 months). Multivariate analysis demonstrated that age, medial RM ≥2mm, lymph node status and chemotherapy were prognostic factors for OS and DFS. Posterior RM had no influence on OS or DFS. CONCLUSION: Not all RM seem to have the same impact on OS and DFS, and a clearance of 1mm for definition of a negative RM (i.e. CRM>1mm) seems not sufficient. Future studies should include more patients to stratify for potential confounders we could not account for. TRIAL REGISTRATION: This study was registered with the German Clinical Trials Registry (reference number DRKS0017425).

Flexible semiparametric mode regression for time-to-event data.

The distribution of time-to-event outcomes is usually right-skewed. While for symmetric and moderately skewed data the mean and median are appropriate location measures, the mode is preferable for heavily skewed data as it better represents the center of the distribution. Mode regression has been introduced for uncensored data to model the relationship between covariates and the mode of the outcome. Starting from nonparametric kernel density based mode regression, we examine the use of inverse probability of censoring weights to extend mode regression to handle right-censored data. We add a semiparametric predictor to add further flexibility to the model and we construct a pseudo Akaike's information criterion to select the bandwidth and smoothing parameters. We use simulations to evaluate the performance of our proposed approach. We demonstrate the benefit of adding mode regression to one's toolbox for analyzing survival data on a pancreatic cancer data set from a prospectively maintained cancer registry.

Thyroid disease-specific quality of life questionnaires - A systematic review.

INTRODUCTION: Thyroid diseases are very common and rarely life-threatening. One of the main therapeutic goals is an improvement in quality of life, making it important to measure in clinical and research settings. The aim of this systematic review is to provide an overview of the currently available thyroid-specific quality of life questionnaires with regard to their validation quality in order to make recommendations for clinical use with a special focus on German questionnaires. METHODS: A systematic literature search was performed in Pubmed, Google Scholar and the Cochrane Library. A total of 904 studies were identified. After excluding duplicates, non-English- or German-language texts, full texts that were not freely available and studies with irrelevant content, 64 studies reporting on 16 different questionnaires were included in the analysis. RESULTS: Four questionnaires concerned benign thyroid diseases (ThyPRO, ThyPRO-39, Thy-R-HRQoL and Thy-D-QOL), six malignant thyroid diseases (THYCA-QoL, ThyCa-HRLQOL, EORTC-Thy34, MADSI-Thy, QOL-Thyroid and ThyCAT), and six endocrine orbitopathy (GO-QOL, GO-QLS, TED-QOL, STED-QOL, TAO-QoL and Ox-TED). Only five questionnaires were at least developed, if not validated, in German, and five were developed in more than two languages. CONCLUSIONS: ThyPRO and the ThyPRO-39 are the best-evaluated questionnaires for benign thyroid diseases. Alternatively, in hypothyroid patients, the adequately validated Thy-D-QoL can be used. For malignant thyroid diseases, the choice should be made individually, as all six questionnaires (THYCA-QoL, ThyCA-HRQOL, EORTC-Thy34, MDASI-Thy, QOL-Thyroid and ThyCAT) have different strengths and weaknesses. The GO-QOL is the best-validated questionnaire in endocrine orbitopathy. However, the TED-QOL is also suitable as a short-screening questionnaire for these patients.

Effects of intensive physiotherapy on Quality of Life (QoL) after pancreatic cancer resection: a randomized controlled trial.

BACKGROUND: Patients have significantly lower QoL scores after pancreatic resection due to cancer in the physical and psychological domains compared to healthy controls or other cancer patients. Intensified physiotherapy or physical training can increase QoL by reducing fatigue levels and improving physical functioning. However, data on the long-term effects of intensive or supervised physiotherapy is lacking. The aim of this exploratory study is the assessment of QoL in the intervention group, using various QoL questionnaires in their validated German translations and gather data on its feasibility in the context of chemotherapy with a follow-up of 12 months (and develop concepts to improve QoL after pancreatic cancer resection). METHODS: Fifty-six patients (mean age: 66.4 ± 9.9 years) were randomized in this study to intervention (cohort A, n = 28) or control group (cohort B, n = 28). Intervention of intensified physiotherapy program consisted of endurance and muscle force exercises using cycle ergometer. In the control group physiotherapy was limited to the duration of the hospital stay and was scheduled for 20 min on 5 days per week. The clinical visits took place 2 days preoperatively, 1 week, 3 months, 6 months and 12 months postoperatively. Both groups attended the follow-up program. QoL was evaluated using the Short Physical Performance Battery (SPPB), Short Form-8 Health Survey (SF-8) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and pancreatic cancer-specific module QLQ-PAN26 questionnaires. The course of QoL was evaluated using a repeated measures ANOVA and a per protocol design. RESULTS: Of the initial 56 randomized patients, 34 finished the 12 months follow-up period. There were no adverse events due to the intervention and 80% of patients in the intervention group where adherent. There was no significant influence on physical performance as measured by SPPB and SF-8 questionnaire. However, after 6 months patients in the intervention group regained their prior physical condition, whereas the control group did not. Intensive physiotherapy significantly influenced various factors of QoL measured with the C30 questionnaire positively, such as physical functioning (p = 0.018), role functioning (p = 0.036), and appetite loss (p = 0.037), even after 6 months. No negative effects in patients undergoing chemotherapy compared to those without chemotherapy was observed. CONCLUSION: This first randomized controlled study with a 12-month follow-up shows that supervised physiotherapy or prescribed home-based exercise after pancreatic cancer resection is safe and feasible and should be proposed and started as soon as possible to improve certain aspects of QoL. TRIAL REGISTRATION: German Clinical Trials Register (No: DRKS00006786 ); Date of registration: 01/10/2014.

The development of visuospatial abilities and their impact on laparoscopic skill acquisition: a clinical longitudinal study.

OBJECTIVES: To investigate how visuospatial abilities develop and influence intraoperative laparoscopic performance during surgical residency training programmes. BACKGROUND: Laparoscopic surgery is a challenging technique to acquire and master. Visuospatial ability is an important attribute but most prior research have predominantly explored the influence of visuospatial abilities in lab-based settings and/or among inexperienced surgeons. Little is known about the impact of visuospatial profiles on actual laparoscopic performance and its role in shaping competency. METHOD: A longitudinal observational cohort study using a pair-matched design over 27 months. At baseline, visuospatial profiles of 43 laparoscopic surgeons of all expertise levels and 19 control subjects were compared. The development of visuospatial abilities and their association with intraoperative performance of 18 residency surgeons were monitored during the course of their laparoscopic training. RESULTS: Laparoscopic surgeons significantly outperformed the control group on the measure of spatial visualisation (U = 273.0, p = 0.03, η2 = 0.3). Spatial visualisation was found to be a significant predictor of laparoscopic expertise (R2 = 0.70, F (1.60) = 6.788, p = 0.01) and improved with laparoscopic training (B = 4.01, SE = 1.83, p = 0.02, 95% CI [0.40, 7.63]). From month 6 to 18, a strong positive correlation between spatial visualisation and intraoperative depth perception (r = 0.67, p < 0.01), bimanual dexterity (r = 0.60, p < 0.01), autonomy (r = 0.78, p < 0.01) and the total score (r = 0.70, p < 0.01) were observed but a strong relationship remained only with autonomy (r = 0.89, p < 0.01) and total score (r = 0.80, p < 0.01) at 18 months. CONCLUSION: In this longitudinal cohort study, visuospatial abilities associate with laparoscopic skills and improve with training. Spatial visualisation may be characteristic of laparoscopic expertise as it has clear association with competency development during laparoscopy residency training programme.

Virtual Reality for Surgical Planning - Evaluation Based on Two Liver Tumor Resections.

Purpose: For complex cases, preoperative surgical planning is a standard procedure to ensure patient safety and keep the surgery time to a minimum. Based on the available information, such as MRI or CT images, and prior anatomical knowledge the surgeons create their own mental 3D model of the organ of interest. This is challenging, requires years of training and an inherent uncertainty remains even for experienced surgeons. Goal: Virtual reality (VR) is by nature excellent in showing spatial relationships through its stereoscopic displays. Therefore, it is well suited to be used to support the understanding of individual anatomy of patient-specific 3D organ models generated from MRI or CT data. Utilizing this potential, we developed a VR surgical planning tool that provides a 3D view of the medical data for better spatial understanding and natural interaction with the data in 3D space. Following a user-centered design process, in this first user study, we focus on usability, usefulness, and target audience feedback. Thereby, we also investigate the individual impact the tool and the 3D presentation of the organ have on the understanding of the 3D structures for the surgical team. Methods: We employed the VR prototype for surgical planning using a standard VR setup to two real cases of patients with liver tumors who were scheduled for surgery at a University Hospital for Visceral Surgery. Surgeons (N = 4) used the VR prototype before the surgery to plan the procedure in addition to their regular planning process. We used semi-structured interviews before and after the surgery to explore the benefits and pitfalls of VR surgical planning. Results: The participants used on average 14.3 min (SD = 3.59) to plan the cases in VR. The reported usability was good. Results from the interviews and observations suggest that planning in VR can be very beneficial for surgeons. They reported an improved spatial understanding of the individual anatomical structures and better identification of anatomical variants. Additionally, as the surgeons mentioned an improved recall of the information and better identification of surgical relevant structures, the VR tool has the potential to improve the surgery and patient safety.

Immersive Anatomy Atlas: Learning Factual Medical Knowledge in a Virtual Reality Environment.

In order to improve learning efficiency and memory retention in medical teaching, furthering active learning seems to be an effective alternative to classical teaching. One option to make active exploration of the subject matter possible is the use of virtual reality (VR) technology. The authors developed an immersive anatomy atlas which allows users to explore human anatomical structures interactively through virtual dissection. Thirty-two senior-class students from two German high schools with no prior formal medical training were separated into two groups and tasked with answering an anatomical questionnaire. One group used traditional anatomical textbooks and the other used the immersive virtual reality atlas. The time needed to answer the questions was measured. Several weeks later, the participants answered a similar questionnaire with different anatomical questions in order to test memory retention. The VR group took significantly less time to answer the questionnaire, and participants from the VR group had significantly better results over both tests. Based on the results of this study, VR learning seems to be more efficient and to have better long-term effects for the study of anatomy. The reason for that could lie in the VR environment's high immersion, and the possibility to freely and interactively explore a realistic representation of human anatomy. Immersive VR technology offers many possibilities for medical teaching and training, especially as a support for cadaver dissection courses.

Micronutritional status after pylorus preserving duodenopancreatectomy: analysis of data from a randomized controlled trial.

Physical frailty and nutritional malassimilation are often observed after pancreaticoduodenectomy for pancreatic cancer. But long-term data concerning the course of micronutrient status is still missing. Micronutrient status after pylorus preserving pancreaticoduodenectomy with a follow-up of 12 months was evaluated using data of a randomized controlled trial. 47 patients were randomized with respect to the physiotherapy regimen they received (intensified physiotherapy: n = 22; standard physiotherapy: n = 25). Nutritional status was recorded preoperatively and postoperatively after one week, 3, 6 and 12 months. BMI, body fat measurement and albumin, lipid, iron and bone metabolism parameters, vitamins A, B1 B6 and B12, homocysteine, folic acid, and trace elements were measured. Laboratory values were analyzed descriptively. Differences between the groups were analyzed using the t-test in SPSS. For vitamin D, B1, B6 and iron a deficiency over time could be demonstrated with 50% of all patients or more being below normal range. The other laboratory values were in low normal range after 3 months and later. Significant differences between groups were found in cholesterol, HDL and selenium levels (corrected p-values < 0.033 in all cases). Vitamin D and iron should be supplemented postoperatively in the long term, and vitamin B1 and B6 substitution should be considered in symptomatic patients. Levels of malnutrition induced fatigue should be comparable between both groups. However, the role of nutritional status on other health-related aspects such as quality of life should be the focus of further studies.Trial Registration Number in the German Registry for Clinical Studies: DRKS00006786; Date of Registration: 01.10.2014.

Validity and reliability of the German version of the shortened thyroid-specific quality of life questionnaire (ThyPRO-39de).

OBJECTIVES: Validation of a German version of the ThyPRO-39 questionnaire for quality of life (QoL) in patients with benign thyroid diseases. DESIGN: Internal consistency, retest reliability, and validity were to be assessed in a test-retest study. METHODS: The ThyPRO-39 was translated based on standard methodology. A sample of 98 patients with benign thyroid diseases was tested with the ThyPRO-39de and the generic EuroQol 5D-5L. Forty-four patients with stable symptoms after 2 weeks formed the repeated measures sample. Cronbach's alpha was calculated for the ThyPRO-39de composite score and for each disease-specific scale. Intraclass correlations between the original and the repeated measures sample were calculated for each scale as well as Pearson correlations between various ThyPRO scales and the EuroQol. T-tests were used to test for differences in the goiter and hyperthyroid symptom scales between relevant patient groups and other patients. RESULTS: Internal consistency was between satisfactory and good, except for two scales (tiredness and cosmetic complaints/appearance). The test-retest correlation was between 0.62 and 0.8 for most scales, but below 0.5 for two scales (tiredness and impaired social life). There were significant correlations between the EuroQol index score and most aspects of the ThyPRO-39de. Only the hyperthyroid symptoms scale was specific for the relevant patient group (Graves' disease). CONCLUSION: The ThyPRO-39de may be recommended for use in clinical and research settings, especially with regards to the composite score. However, the underlying thyroid disease should always be kept in mind when interpreting the test results. A larger sample would be needed to implement further improvements.

Case Report: How an Iliac Vein Lesion During Totally Endoscopic Preperitoneal Repair of an Inguinal Hernia Can Be Safely Managed.

Inguinal hernia repair is a common surgical procedure with an acceptably low complication rate. However, complications with potentially life-threating consequences may occur in rare cases. These complications might be very challenging to manage, even more in laparo-endoscopic interventions compared to open repair. One of these challenges can be the treatment of an intraoperative injury to the iliac vein. To the best of our knowledge, a lesion of the iliac vein during TEP (totally endoscopic preperitoneal) for inguinal hernia repair, and a safe technique for its management have not been reported yet. We report the case of a 75-year-old male patient with previous abdominal surgery scheduled for TEP repair of an inguinal hernia. During surgery, the iliac vein was damaged. If we had performed a laparotomy in this situation, the potentially life-threatening condition of the patient could have deteriorated further. Instead, to avoid a potential CO2 associated embolism, the preperitoneal pressure was gradually reduced, and the positive end expiratory pressure (PEEP) was increased in the manner that a balance between excessive bleeding and potential development of a CO2 embolism was achieved. The injured vein was sutured endoscopically, and in addition a hemostatic patch was applied. We then continued with the planned surgical procedure. Thrombosis of the sutured vein was prevented by prophylactic administration of low molecular weight heparin until the 14th postoperative day. We conclude that in case of major vein injury during TEP, which might happen irrespective of prior abdominal surgery, the preperitoneal pressure and PEEP adjustment can be used to handle the complication.