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 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.

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.

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.

Investigating the attentional focus to workplace-related soundscapes in a complex audio-visual-motor task using EEG.

Introduction: In demanding work situations (e.g., during a surgery), the processing of complex soundscapes varies over time and can be a burden for medical personnel. Here we study, using mobile electroencephalography (EEG), how humans process workplace-related soundscapes while performing a complex audio-visual-motor task (3D Tetris). Specifically, we wanted to know how the attentional focus changes the processing of the soundscape as a whole. Method: Participants played a game of 3D Tetris in which they had to use both hands to control falling blocks. At the same time, participants listened to a complex soundscape, similar to what is found in an operating room (i.e., the sound of machinery, people talking in the background, alarm sounds, and instructions). In this within-subject design, participants had to react to instructions (e.g., "place the next block in the upper left corner") and to sounds depending on the experimental condition, either to a specific alarm sound originating from a fixed location or to a beep sound that originated from varying locations. Attention to the alarm reflected a narrow attentional focus, as it was easy to detect and most of the soundscape could be ignored. Attention to the beep reflected a wide attentional focus, as it required the participants to monitor multiple different sound streams. Results and discussion: Results show the robustness of the N1 and P3 event related potential response during this dynamic task with a complex auditory soundscape. Furthermore, we used temporal response functions to study auditory processing to the whole soundscape. This work is a step toward studying workplace-related sound processing in the operating room using mobile EEG.

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.

Weighted expectile regression for right-censored data.

Expectile regression can be used to analyze the entire conditional distribution of a response, omitting all distributional assumptions. Among its benefits are computational simplicity, efficiency, and the possibility to incorporate a semiparametric predictor. Due to its advantages in full data settings, we propose an extension to right-censored data situations, where conventional methods typically focus only on mean effects. We propose to extend expectile regression with inverse probability weights. Estimates are easy to implement and computationally simple. Expectiles can be converted to more easily interpreted tail expectations, that is, the expected residual life. It provides a meaningful effect measure, similar to the hazard rate. The results from an extensive simulation study are presented, evaluating consistency and sensitivity to violations of assumptions. We use the proposed method to analyze survival times of colorectal cancer patients from a regional certified high volume cancer center.

Predictors of adenoma size and location in primary hyperparathyroidism.

PURPOSE: In primary hyperparathyroidism (PHPT), intraoperative localization of the parathyroid adenoma can be challenging, especially in cases of negative preoperative imaging. Since a focused unilateral parathyroidectomy has benefits compared to a conventional bilateral neck exploration, the question arises whether adenoma size prediction can facilitate a targeted approach. We investigated whether single parathyroid adenoma size can be estimated using preoperative parathyroid hormone (PTH), calcium, and phosphate in patients with PHPT. Preoperative imaging accuracy was evaluated. METHODS: The data of 156 patients who underwent curative parathyroidectomy for single adenoma PHPT were analyzed retrospectively. Information obtained included laboratory data, imaging results, intraoperative data, and final pathology. Imaging accuracy was analyzed descriptively. The association between preoperative biochemical markers and adenoma dimensions was investigated using Spearman's correlation coefficient and multivariable regression modeling. RESULTS: Cervical ultrasound correctly predicted adenoma laterality in 95.5%, sestamibi scintigraphy in 80.6%, both had lower true-positive rates for quadrant prediction. Patients with negative imaging results showed higher thyroid volumes than those with positive results. Adenoma volume was positively correlated with preoperative PTH (p < 0.001) and calcium (p < 0.001) and negatively correlated with preoperative phosphate (p = 0.001). Using these preoperative biochemical markers and patient age and BMI, adenoma volume can be significantly predicted using the multivariable regression algorithm. CONCLUSION: Cervical ultrasound is superior to scintigraphy for predicting adenoma location and should be the first-choice imaging method, but both methods may be limited by increased thyroid volume. Large adenomas are more likely with higher PTH, higher calcium, and lower phosphate levels. In cases of undetermined adenoma location, an estimation of adenoma volume via our algorithm could corroborate sonographic volume measurements of the suspected adenoma.

Predictive factors for long-term survival after surgery for pancreatic ductal adenocarcinoma: Making a case for standardized reporting of the resection margin using certified cancer center data.

Factors for overall survival after pancreatic ductal adenocarcinoma (PDAC) seem to be nodal status, chemotherapy administration, UICC staging, and resection margin. However, there is no consensus on the definition for tumor free resection margin. Therefore, univariate OS as well as multivariate long-term survival using cancer center data was analyzed with regards to two different resection margin definitions. Ninety-five patients met inclusion criteria (pancreatic head PDAC, R0/R1, no 30 days mortality). OS was analyzed in univariate analysis with respect to R-status, CRM (circumferential resection margin; positive: ≤1mm; negative: >1mm), nodal status, and chemotherapy administration. Long-term survival >36 months was modelled using multivariate logistic regression instead of Cox regression because the distribution function of the dependent data violated the requirements for the application of this test. Significant differences in OS were found regarding the R status (Median OS and 95%CI for R0: 29.8 months, 22.3-37.4; R1: 15.9 months, 9.2-22.7; p = 0.005), nodal status (pN0 = 34.7, 10.4-59.0; pN1 = 17.1, 11.5-22.8; p = 0.003), and chemotherapy (with CTx: 26.7, 20.4-33.0; without CTx: 9.7, 5.2-14.1; p < .001). OS according to CRM status differed on a clinically relevant level by about 12 months (CRM positive: 17.2 months, 11.5-23.0; CRM negative: 29.8 months, 18.6-41.1; p = 0.126). A multivariate model containing chemotherapy, nodal status, and CRM explained long-term survival (p = 0.008; correct prediction >70%). Chemotherapy, nodal status and resection margin according to UICC R status are univariate factors for OS after PDAC. In contrast, long-term survival seems to depend on wider resection margins than those used in UICC R classification. Therefore, standardized histopathological reporting (including resection margin size) should be agreed upon.

Risk factors for Graves' Orbitopathy in surgical patients-Results of a 10-year retrospective study with review of the literature.

Introduction: We investigated known (eg age, smoking, thyrotropin receptor autoantibody (TRAb)) and new risk factors (eg thyroid peroxidase autoantibodies (TPO-Ab), thyroid size, or BMI) for Graves' disease (GD) and Graves' orbitopathy (GO), especially in combination with each other, to determine which factors play the most important role in the development of GO. Methods: From 2008 to 2018, n = 500 patients with GD were included in this retrospective single-centre case-control study. N = 231 (46%) had a GO and n = 269 (54%) showed no GO. Differences in risk factors were determined by Mann-Whitney U and chi-square test. Combined influences of factors were examined by multivariable logistic regression. Results: Age at first diagnosis of GD (OR = 1.043, p < .006), smoking status (OR = 2.64, p < .026) and TRAb (OR = 1.046, p < .01) had a significant impact on GO. The factors gender, TPO-Ab titre, BMI, TSH titre, T3 and T4 were not significant. Conclusion: As it has been shown in univariate analyses, smoking, age and TRAb levels have a negative impact on the onset and course of GD and GO. Via multivariable regression, we could additionally show that smoking is the most important factor out of those analysed. TRAb might be a helpful surrogate parameter in the assessment of the progress of GO and therefore might be one factor in the decision-making process for potential early operative surgery. With regard to the hitherto unclear role of BMI, thyroid size and TPO-Ab in the course of GO, this study could not find any clinically relevant influence.

The Influence of Prophylactic Calcium and Magnesium Supplementation on Postoperative Quality of Life and Hypocalcemia After Total Thyroidectomy: Study Protocol for a Randomized Controlled Trial.

Background: We want to investigate if a routine preoperative dietary supplementation of calcium and magnesium prior to thyroidectomy for nodular goiter and graves' disease can influence patients' outcome with regards to hypocalcemia associated symptoms and quality of life in order to reduce the risk of post-thyroidectomy hypocalcemia and to improve patient's quality of life. Methods: The study will be conducted as a two-armed randomized controlled trial including patients scheduled for total thyroidectomy. Patients assigned to the intervention group will receive calcium carbonate and magnesium oxide starting 2 weeks preoperatively. Primary outcome is the postoperative quality of life measured by the ThyPRO-39 and EQ-5D questionnaires. Secondary outcome is the assessment of postoperative biochemical (calcium and PTH levels) and clinical hypocalcemia (symptoms as reported by the patient). Discussion: A prophylactic dietary supplementation with calcium and magnesium, which could easily be implemented in the preoperative setting, could potentially help to avoid or reduce hypocalcemia-associated symptoms and improve quality of life. In the event of a positive outcome, this preoperative procedure can be an inexpensive way to prepare patients scheduled for thyroidectomy and can possibly reduce disease-specific costs by reducing the postoperative complication rate. Clinical Trial Registration: DRKS00017195 in the German clinical trials register (Deutsches Register Klinischer Studien, DRKS) on the 22.05.2019.