A database for oncological research and quality assurance: implementation and first experiences with the University Clinical Cancer Registry Regensburg.

Legal requirements, certification specifications, as well as the demand for real world data on cancer research and treatment led to the decision to establish the University Clinical Cancer Registry Regensburg. The first organizational step in the implementation process of this oncological data registry was the evaluation and acquisition of suitable tumor documentation and database software. For this purpose, an evaluation matrix comprising required database software criteria was designed and consented by a multidisciplinary group of experts. Next, a yearly report of the Institute for Cancer Center Certification (OnkoZert 2019) was considered to identify database software already in use. The identified systems were rated according to the established criteria matrix and other relevant aspects. Onkostar was the system considered most suited for building up an oncological data repository. In the second step, the central IT department implemented Onkostar on-premise and migrated digitally available data after an adaptation and verification process. In parallel, a uniformed process for handling emerging oncological research questions was established. For research requirements, a data analysis concept was established comprising a proposal for data extraction, procedural instructions, and statistical training materials. In the final step, the implemented software and the process for handling research requirements in practice were evaluated by using two exemplary use cases with the focus on clinic-wide analyses and currently relevant scientific topics. A 2-month test phase conducted by various user groups showed a preference for Onkostar tumor documentation software from IT-Choice, mainly because of its adjustability to support research and treatment. Newly added and migrated data can be used for certification and research purposes. This software also provides support in current tumor documentation by displaying the course of cancer disease for individual patients over time. Such oncological data registries can be a powerful tool for legally required cancer registration, the certification of medical centers, as well as for additional oncological research. Tumor databases can be helpful in projects on cancer treatment and scientific aims. The experiences made at the University Hospital Regensburg may be used as a guidance for implementing clinical databases in similar settings with interdisciplinary responsibilities.

"Topographic Shift": a new digital approach to evaluating topographic changes of the female breast.

PURPOSE: To assess precise topographic changes of the breast, objective documentation and evaluation of pre- and postoperative results are crucial. New technologies for mapping the body using digital, three-dimensional surface measurements have offered novel ways to numerically assess the female breast. Due to the lack of clear demarcation points of the breast contour, the selection of landmarks on the breast is highly dependent on the examiner, and, therefore, is prone to error when conducting before-after comparisons of the same breast. This study describes an alternative to volumetric measurements, focusing on topographic changes of the female breast, based on three-dimensional scans. METHOD: The study was designed as an interventional prospective study of 10 female volunteers who had planned on having aesthetic breast augmentation with anatomical, textured implants. Three dimensional scans of the breasts were performed intraoperatively, first without and then with breast implants. The topographic change was determined as the mean distance between two three-dimensional layers before and after augmentation. This mean distance is defined as the Topographic Shift. RESULTS: The mean implant volume was 283 cc (SD = 68.6 cc, range = 210-395 cc). The mean Topographic Shift was 7.4 mm (SD = 1.9 mm, range = 4.8-10.7 mm). The mean Topographic Shifts per quadrant were: I: 8.0 mm (SD = 3.3 mm); II: 9.2 mm (SD = 3.1 mm); III: 6.9 mm (SD = 3.5 mm); IV: 1.9 mm (SD = 4.3 mm). CONCLUSION: The Topographic Shift, describing the mean distance between two three-dimensional layers (for example before and after a volume changing therapy), is a new approach that can be used for assessing topographic changes of a body area. It was found that anatomical, textured breast implants cause a topographic change, particularly on the upper breast, in quadrant II, the décolleté.

Postural stability after patient-specific interpositional knee spacer or total knee arthroplasty: a comparative study.

PURPOSE: Total knee arthroplasty provides excellent results concerning functional demands, patient satisfaction and range of motion. Short-term results after implantation of patient-specific knee spacers also show encouraging results. We hypothesised that patient-specific interpositional devices provide better proprioception and postural stability by preserving the whole bone stock and both cruciate ligaments. METHODS: In this study we compared functional results, proprioception and postural stability 16 months after 20 consecutive patient-specific interpositional device implantations of the knee (group A) and 20 consecutive total knee arthroplasties (group B). Patients were evaluated using the Knee Society Score (KSS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Postural stability was analysed during single leg stance on a force platform (Biodex). RESULTS: There were no significant differences between both groups concerning functional results 16 months after the procedure. Concerning postural stability, significant differences were found between both groups. Comparing the operated-on and non-operated-on sides in single leg stance, the operated-on leg gained the same stability as the non-operated-on side in both groups. CONCLUSIONS: The successful treatment of knee osteoarthritis can restore postural stability to the level of the unaffected side-independent from the implanted devices and with preservation of soft tissue and bone stock. Superior postural stability in joint-preserving patient-specific interpositional knee devices compared with total knee arthroplasty had to be attributed to the different age of both groups.

Therapist versus Machine-Immediate Effects of Manual versus Mechanical Lymphatic Drainage in Patients with Secondary Lymphedema.

Background: Complex decongestive therapy (CDT) is the standard and basic therapy for lymphedema. The central component of CDT is manual lymphatic drainage (MLD). In addition to CDT, other measures such as intermittent pneumatic compression therapy (IPCT) (active compression machine therapy) are available. In this prospective research study, the objective and subjective effects of MLD and IPCT on lymphedema of the lower extremity were investigated and both therapies were directly compared. Furthermore, the patients' body mass index (BMI) and stage of lymphedema were tested for their effect on the respective therapy. Methods: Patients participating in the study received both therapies (MLD and IPCT) on the same lymphedema-affected limb at an interval of two days. The objective volumetric therapy effect was measured by the digital volume measurement of the affected limb. The subjective effects of the therapies were measured using two specially designed questionnaires. Results: A total of 40 patients were included in the study. There was no significant difference in the volume differences between the interventions, BMI categories, lymphedema, or treatment order regarding the immediate and two-day effect. Conclusions: No significant difference was found in the subjective or objective therapy efficacy of the two methods. Intermittent pneumatic compression therapy is considered a comparable therapeutic procedure when properly indicated.

Laryngectomy plus postoperative radio(system)therapy versus primary radio(system) therapy for the treatment of locally advanced laryngeal and hypopharyngeal cancer - results from the University Clinical Cancer Registry Regensburg.

BACKGROUND: There are few adequate randomized clinical trials directly comparing the therapeutic options of primary laryngectomy (pLE) vs. primary radio(system)therapy (pR(S)T) in patients with locally advanced laryngeal and hypopharyngeal carcinoma and thus little clear scientific evidence to decide which patients will benefit most from which procedure. AIMS/OBJECTIVES: Aim was to compare survival between the therapeutic options and to learn from the limitations of this study, especially in the context of improved clinical assessment. MATERIAL AND METHODS: The clinical data of patients treated between January 2010 and February 2022 were obtained from the electronic database of the University Hospital Regensburg. Overall survival (OS) and progression-free survival (PFS) were compared between the treatment groups. RESULTS: The study included 193 patients (pLE n = 68, pR(S)T, n = 125). Median OS was 31.2 months and median PFS was 24.7 months with no significant difference between the treatment groups (p > .050). Patients who did not receive complete treatment as recommended by the tumor conference (n = 47, 24.4%) had a higher risk of death (p = .024). CONCLUSIONS AND SIGNIFICANCE: The results of our study are consistent with the survival data reported in the literature. More detailed systematic data in clinical routine (e.g. relevant comorbidities) are required to ensure guideline-based recommended therapy.

Head and neck oncology management in the time of COVID-19: results of a head and neck cancer center.

PURPOSE: Given the concerns about the effects of the COVID-19 pandemic on cancer care, we analyzed the treatment quality of the head and neck cancer center Regensburg before and throughout 2 years of the pandemic. We included data of 3 years to reflect the extended pandemic period as new developments continued to influence its course. METHODS: This retrospective review included all patients diagnosed with head and neck cancer in 2019, 2020, and 2021 who had not started treatment elsewhere prior to being referred to the head and neck cancer center. We compared tumor characteristics and times to therapy of patients diagnosed before COVID-19 in 2019 (n = 253), during COVID-19 in 2020 (n = 206), and in a phase of partial normalization in a persistent pandemic situation in 2021 (n = 247). RESULTS: Our data revealed no decrease in diagnoses or drift in stages toward more advanced stages. There was an increased percentage of diagnoses confirmed at the head and neck cancer center from 2019 (57.3%) to 2020 (68.0%) and to 2021 (65.6%) compared to confirmation at other institutions (2019, 42.7%; 2020, 32.0%; 2021, 34.4%; P = 0.041). Surgery and radiotherapy were performed with the same frequency. The median days between diagnosis and surgery were decreased in 2020 (19.5 days; P = 0.049) and 2021 (20.0 days; P = 0.026) in comparison to 2019 (23 days). The days to radiotherapy were not affected. CONCLUSION: The data indicate a consistent oncological performance for head and neck cancer patients in all waves of the pandemic and thereafter without a decrease in diagnoses or shift in stages.

Stereotactic Microwave Ablation of Hepatocellular Carcinoma: The Impact of Tumor Size and Minimal Ablative Margin on Therapeutic Success.

BACKGROUND: Microwave ablation (MWA) has gained relevance in the treatment of hepatic malignancies and especially in hepatocellular carcinoma (HCC), and it is an important alternative to surgery. The purpose of the study was to evaluate whether the minimal ablative margin (MAM) or the initial tumor size has a greater effect on the success of stereotactic MWA of HCC regarding the time to local tumor progression (LTP) and overall survival (OS). METHODS: 88 patients, who received stereotactic MWA of 127 tumor lesions with a curative intention were included in this single-center, retrospective study. The MAM was evaluated in a side-by-side comparison of pre- and post-ablative, contrast-enhanced slice imaging. A Cox proportional hazard model with a frailty term was computed to assess the influence of the MAM and the maximum tumor diameter on the time to LTP and the OS. RESULTS: The maximum tumor diameter was identified as a significant positive predictor for LTP (hazard ratio 1.04, 95% CI 1.00-1.08, p = 0.03), but it was not a significant positive predictor for the OS (p = 0.20). The MAM did not have a significant influence on LTP-free survival (p = 0.23) and OS (p = 0.67). CONCLUSION: For the successful stereotactic MWA of HCC, the MAM and maximum tumor diameter might not have an influence on the OS, but the maximum tumor diameter seems to be an independent predictor of the time to LTP.

Health Care Workers' Sick Leave due to COVID-19 Vaccination in Context With SARS-CoV-2 Infection and Quarantine-A Multicenter Cross-Sectional Survey.

Background: Reactogenicity of coronavirus disease 2019 (COVID-19) vaccines can result in inability to work. The object of this study was to evaluate health care workers' sick leave after COVID-19 vaccination and to compare it with sick leave due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and quarantine leave. Methods: A multicenter cross-sectional survey was conducted at Regensburg University Medical Center and 10 teaching hospitals in South-East Germany from July 28 to October 15, 2021. Results: Of 2662 participants, 2309 (91.8%) were fully vaccinated without a history of SARS-CoV-2 infection. Sick leave after first/second vaccination occurred in 239 (10.4%) and 539 (23.3%) participants. In multivariable logistic regression, the adjusted odds ratio for sick leave after first/second vaccination compared with BNT162b2 was 2.26/3.72 for mRNA-1237 (95% CI, 1.28-4.01/1.99-6.96) and 27.82/0.48 for ChAdOx1-S (95% CI, 19.12-40.48/0.24-0.96). The actual median sick leave (interquartile range [IQR]) was 1 (0-2) day after any vaccination. Two hundred fifty-one participants (9.4%) reported a history of SARS-CoV-2 infection (median sick leave [IQR] 14 [10-21] days), 353 (13.3%) were quarantined at least once (median quarantine leave [IQR], 14 [10-14] days). Sick leave due to SARS-CoV-2 infection (4642 days) and quarantine leave (4710 days) accounted for 7.7 times more loss of workforce than actual sick leave after first and second vaccination (1216 days) in all fully vaccinated participants. Conclusions: Sick leave after COVID-19 vaccination is frequent and is associated with the vaccine applied. COVID-19 vaccination should reduce the much higher proportion of loss of workforce due to SARS-CoV-2 infection and quarantine.

Evaluation of joint awareness after acetabular fracture: Validation of the Forgotten Joint Score according to the COSMIN checklist protocol.

BACKGROUND: A fracture of the acetabulum is an uncommon, but serious injury. Established outcome tools do not reflect the patient's perspective after fracture of the hip joint. Originally designed for post-arthroplasty patients, the Forgotten Joint Score (FJS) is a patient-reported outcome measurement (PROM) tool evaluating the disease-specific health-related quality of life (HR-QoL). AIM: To validate the FJS in patients after acetabular fracture. METHODS: In a prospective mono-centric cohort study, we evaluated 100 patients at mean 5.2 ± 3.6 years after a fracture of the acetabulum. The validation study followed the complete COSMIN checklist protocol. For calculation of convergent validity, we used the Tegner-Activity Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol-5D, and a subjective rating of change as an anchor variable. RESULTS: We confirmed good internal consistency with a Cronbach's alpha of 0.95. With an intraclass correlation coefficient of 0.99 (95%CI: 0.97, 0.99), test-retest reliability of the FJS was excellent. Correlation coefficients between the questionnaires were moderate to high ranging from |0.56| to |0.83| (absolute value). No relevant floor or ceiling effects occurred. Standard error of measurement was 3.2 and smallest detectable change (SDC) was 8.8. Thus, changes greater than 8.8 points between two assessments denote a real change in FJS. CONCLUSION: The FJS is a valid and reliable tool for evaluation of patient-reported outcome in posttraumatic condition after acetabular fracture. The SDC indicating a real clinical improvement was 8.8 points in the FJS. We could confirm responsiveness of the FJS and found no relevant floor- or ceiling effects.

Intraoperative 3D Comparison of Round and Anatomical Breast Implants: Dispelling a Myth.

BACKGROUND: Thanks to 3D imaging, it is possible to measure the influence of different parameters on breast augmentation. In this study, we compare the effect of different shapes and sizes of breast implants on the topography of the resulting breast. Furthermore, the impact of different breast implants on inter-landmark distances and on changes of the nipple position was assessed. METHODS: This interventional prospective study was carried out on 10 female patients after collecting informed consent. 3D scans of the native and augmented breasts were performed intraoperatively with small, medium, and large sizes of both anatomical and round implants, resulting in a total of n = 130 single breast scans. These scans were analyzed for topographic shift quantification, nipple migration, and inter-landmark distances of the breast. RESULTS: Implant size, but not implant shape leads to significant topographic shifts of the breast (p < 0.001 and p = 0.900, respectively). Both round and anatomical implants lead to a significantly higher volumetric increase in the upper quadrants compared to the lower quadrants (p < 0.001). Nipple migration into the superomedial quadrant was seen in about 90% of augmentations. No evident differences in inter-landmark distances were observed when round and anatomical implants of different sizes were compared. CONCLUSIONS: Implant size rather than shape influences the postoperative aesthetic results. No significant difference in topographic shift was found comparing round and anatomical implants, suggesting that both implant shapes result in comparable aesthetic outcomes.

Assessment of concentration and penetration depth of cisplatin in human lung tissue after decortication and hyperthermic exposure.

BACKGROUND: Hyperthermic perfusion of the pleural cavity with cisplatin after pleurectomy/decortication is an additional therapeutic option to reduce local relapse of malignant pleural tumours. Although there are data on the clinical effect, only little is known about the local impact on human lung tissue by cisplatin. The objective of this experimental study is to evaluate both the concentration and the penetration depth of cisplatin in human lung tissue after normothermic and hyperthermic exposure under ex-vivo-in-vitro conditions. METHODS: This study was approved by the local ethics committee. In total, 46 patients underwent elective lobectomy and wedge resections were taken from the resected lobes. A decortication of the visceral pleura was performed under ex-vivo conditions, and the tissue samples were incubated with cisplatin (c =0.05 mg/mL) at 37, 42 or 45 °C for 60 minutes. Then the mass concentration of platinum was measured with flameless atomic absorption spectroscopy and then converted into cisplatin concentration. In addition, the current data were compared with previous data of our working group (42 °C, without decortication). RESULTS: The overall maximum penetration depth was 7.5 mm due to limitations of our methods. The functional maximum penetration depth did not vary with temperature (P=0.243) but by decortication (P<0.001). The cisplatin concentration decreased with increasing penetration depth (P<0.001). An increase of temperature showed no effect on the cisplatin concentration in decorticated tissue samples (P=0.985). However, decortication at 42 °C significantly increased the cisplatin concentration in comparison to not decorticated tissue samples (P=0.005). CONCLUSIONS: Decortication of the visceral pleura increases the cisplatin concentration in the lung tissue. Therefore, it possibly reduces the likelihood of a local relapse. An increase of temperature did not show any effect.

A decade of reconstructive surgery: outcome and perspectives of free tissue transfer in the head and neck. Experience of a single center institution.

PURPOSE: Free flaps have become the standard option in reconstructive surgery of the head and neck. Even though many authors have outlined the reliability of free transplants, there is an ongoing discussion about treatment options for patients bearing particular risks as previous irradiation treatment. In this analysis, we aim to address these patients with particular risk profiles by comparing different flap entity outcome parameters. METHODS: We retrospectively analyzed a cohort of 494 patients who underwent flap surgery between 2009 and 2018 in our department. Focusing on free microvascular transplants, we additionally analyzed the pectoralis major myocutaneous flap as the most frequently used vascular pedicled flap. Data analysis was performed by uni- and multivariate statistics. RESULTS: Overall flap success rate was 90%, with the radial forearm flap occurring to be most reliable (93%) in head and neck reconstruction. Previous radiation therapy (RT) and intraoperative revision of vascular anastomosis during primary surgery significantly resulted in impaired transplant outcome with a success rate of 91.8% (no RT) vs. 83.7% (RT), respectively. There was a negative linear correlation between incision to suture time and number of flaps per year (R2 = 0.67). CONCLUSIONS: Preoperative radiation therapy and intraoperative revision of anastomosis significantly impair outcome of microvascular flaps in the head and neck and oral cavity, whereas patient's age is not a predictor of flap failure. Increasing case number and experience reduces time of flap surgery as well as rate of complications and flap failure.