Free-Flap Reconstruction in Early-Stage Squamous Cell Carcinoma of the Oral Cavity : A Prospective Monocentric Trial to Evaluate Oncological Outcome and Quality of Life

Surgery is generally accepted as standard treatment in oral cancer, but the reconstructive procedures remain a matter of debate. The aim of this study was to evaluate oncological outcome and quality of life following surgical resection and free-flap reconstruction in patients with early oral squamous cell carcinoma. The presented trial was performed as a prospective, single-center observation study. Inclusion criteria were primary surgery in early-stage oral squamous cell carcinoma with free-flap reconstruction. Endpoints were overall and progression-free survival and quality of life up to 24 months after surgery. Twenty-six patients were included. Overall survival was 100% and progression-free survival was 92.3% in a maximum follow-up time of 21 months. Global quality of life showed no significant alteration after surgery. Patients reported a significant reduction in pain (p = 0.048) and a decreasing impairment of speech one year after surgery (p = 0.021). Free-flap reconstruction is a safe procedure that results in excellent oncological outcome and quality of life. Functional outcome is of high relevance in early-stage tumors of the head and neck and may mostly be affected by reconstructive procedures. Therefore, a prospective evaluation to explore success and the effects of surgical therapy is highly warranted

CDH12 as a Candidate Gene for Kidney Injury in Posterior Urethral Valve Cases:A Genome-wide Association Study Among Patients with Obstructive Uropathies

Background: Posterior urethral valves (PUVs) and ureteropelvic junction obstruction (UPJO) are congenital obstructive uropathies that may impair kidney development. Objective: To identify genetic variants associated with kidney injury in patients with obstructive uropathy. Design, setting, and participants: We included 487 patients born in 1981 or later who underwent pyeloplasty or valve resection before 18 yr of age in the discovery phase, 102 PUV patients in a first replication phase, and 102 in a second replication phase

Regional variation in hemoglobin distribution among individuals with chronic kidney disease: the ISN International Network of Chronic Kidney Disease (iNET-CKD) Cohorts

Introduction: Despite recognized geographic and sex-based differences in hemoglobin in the general population, these factors are typically ignored in patients with chronic kidney disease (CKD) in whom a single therapeutic range for hemoglobin is recommended. We sought to compare the distribution of hemoglobin across international nondialysis CKD populations and evaluate predictors of hemoglobin.Methods: In this cross-sectional study, hemoglobin distribution was evaluated in each cohort overall and stratified by sex and estimated glomerular filtration rate (eGFR). Relationships between candidate predictors and hemoglobin were assessed from linear regression models in each cohort. Estimates were subsequently pooled in a random effects model.Results: A total of 58,613 participants from 21 adult cohorts (median eGFR range of 17–49 ml/min) and 3 pediatric cohorts (median eGFR range of 26–45 ml/min) were included with broad geographic representation. Hemoglobin values varied substantially among the cohorts, overall and within eGFR categories, with particularly low mean hemoglobin observed in women from Asian and African cohorts. Across the eGFR range, women had a lower hemoglobin compared to men, even at an eGFR of 15 ml/min (mean difference 5.3 g/l, 95% confidence interval [CI] 3.7–6.9). Lower eGFR, female sex, older age, lower body mass index, and diabetic kidney disease were all independent predictors of a lower hemoglobin value; however, this only explained a minority of variance (R2 7%–44% across cohorts).Conclusion: There are substantial regional differences in hemoglobin distribution among individuals with CKD, and the majority of variance is unexplained by demographics, eGFR, or comorbidities. These findings call for a renewed interest in improving our understanding of hemoglobin determinants in specific CKD populations.</p

Variability of sleep bruxism—findings from consecutive nights of monitoring

Objectives!#!To determine sleep bruxism (SB) behavior during five consecutive nights and to identify correlations between SB episodes per hour (SB index) and sleep-time masseter-muscle activity (sMMA).!##!Material and methods!#!Thirty-one participants were included in the study. Of these, 10 were classified as sleep bruxers (group SB-1) and nine as non-sleep bruxers (group non-SB). The bruxism status of these 19 patients was identified by means of questionnaires, an assessment of clinical symptoms, and electromyographic/electrocardiographic data (Bruxoff® device). The remaining 12 participants were also identified as bruxers, but based exclusively on data from the Bruxoff device (group SB-2). Data analysis included descriptive statistics and Spearman's correlation to assess the relationship between the SB index and sMMA.!##!Results!#!Participants in group SB-1 showed an overall mean SB index of 3.1 ± 1.6 and a mean total sMMA per night of 62.9 ± 38.3. Participants in group SB-2 had an overall mean SB index of 2.7 ± 1.5 and a mean total sMMA of 56.0 ± 29.3. In the non-SB group, participants showed an overall mean SB index of 0.8 ± 0.5 and a mean total sMMA of 56.8 ± 30.3. Spearman's correlation yielded values of - 0.27 to 0.71 for the correlation between sMMA and SB index.!##!Conclusions!#!The data revealed variable SB activity and the absence of a reliable correlation between sMMA and the SB index.!##!Clinical relevance!#!The high variation in SB activity and lack of correlation between sMMA and the SB index should be considered when diagnosing SB.!##!Trial registration!#!Clinical Trials [NIH], clinical trial no. NCT03039985

Correlations between sleep bruxism and temporomandibular disorders

The aim of this study was to identify correlations between sleep bruxism (SB) and temporomandibular disorders (TMD) as diagnosed by means of the research diagnostic criteria for temporomandibular disorders (RDC/TMD). Sleep bruxism was diagnosed on the basis of I) validated questionnaires, II) clinical symptoms, and III) electromyographic/electrocardiographic data. A total of 110 subjects were included in the study. Fifty-eight patients were identified as bruxers and 52 as nonbruxers. A psychosocial assessment was also performed. An RDC/TMD group-I diagnosis (myofascial pain) was made for 10 out of 58 bruxers, whereas none of the nonbruxers received a diagnosis of this type. No significant differences were found between bruxers and nonbruxers with regard to RDC/TMD group-II (disc displacement) and group-III (arthralgia, arthritis, arthrosis) diagnoses. Somatization was significantly more common among bruxers than nonbruxers. Multivariate logistic regression analysis revealed that somatization was the only factor significantly correlated with the diagnosis of myofascial pain. The results of this study indicate a correlation between myofascial pain, as diagnosed using the RDC/TMD, and somatization. It seems that somatization is a stronger predictor of an RDC/TMD diagnosis of myofascial pain than sleep bruxism is

Ceramic Crowns and Sleep Bruxism: First Results from a Randomized Trial

Background: This randomized clinical trial was conducted to assess whether sleep bruxism (SB) is associated with an increased rate of technical complications (ceramic defects) in lithium disilicate (LiDi) or zirconia (Z) molar single crowns (SCs). Methods: Adult patients were classified as affected or unaffected by SB based on structured questionnaires, clinical signs, and overnight portable electromyography (BruxOff) and block randomized into four groups according to SB status and crown material (LiDi or Z): LiDi-SB (n = 29), LiDi-no SB (n = 24), Z-SB (n = 23), and Z-no SB (n = 27). Differences in technical complications (main outcome) and survival and success rates (secondary outcomes) one year after crown cementation were assessed using Fisher’s exact test with significance level α = 0.05. Results: No technical complications occurred. Restoration survival rates were 100% in the LiDi-SB and LiDi-no SB groups, 95.7% in the Z-SB group, and 96.3% in the Z-no SB group (p > 0.999). Success rates were 96.6% in the LiDi-SB group, 95.8% in the LiDi-no SB group (p > 0.999), 91.3% in the Z-SB group, and 96.3% in the Z-no SB group (p ≥ 0.588). Conclusions: With a limited observation time and sample size, no effect of SB on technical complication, survival, and success rates of molar LiDi and Z SCs was detected

Evaluation of new motorized articulating laparoscopic instruments by laparoscopic novices using a standardized laparoscopic skills curriculum

Background!#!Motorized articulating laparoscopic instruments (ALI) offer more degrees of freedom than conventional laparoscopic instruments (CLI). However, a difficult learning curve and complex instrument handling are still a problem of ALI. We compared the performance of new prototypes of motorized ALI with CLI in a series of standardized laparoscopic tasks performed by laparoscopic novices. Further, usability of the new ALI was assessed.!##!Methods!#!A randomized cross-over study with 50 laparoscopic novices who either started with CLI and then changed to ALI (CA) or vice versa (AC) was conducted. All participants performed the European training in basic laparoscopic urological skills (E-BLUS) with each instrument in given order. Time and errors were measured for each exercise. Instrument usability was assessed.!##!Results!#!Overall, using CLI was significantly faster (CLI 4:27 min vs. ALI 4:50 min; p-value 0.005) and associated with fewer exercise failures in needle guidance (CLI 0 vs. ALI 12; p-value 0.0005) than ALI. Median amount of errors was similar for both instruments. Instrument sequence did not matter, as CA and AC showed comparable completion times. Regarding the learning effect, participants were significantly faster in the second attempt of exercises than in the first. In the needle guidance task, participants using CLI last demonstrated a significant speed improvement, whereas ALI were significantly slower in the second run. Regarding usability, CLI were preferred over ALI due to lighter weight and easier handling. Nevertheless, participants valued ALI's additional degrees of freedom.!##!Conclusion!#!Using new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI. An explanation could be that participants felt overwhelmed by ALI and that ALI have an own distinct learning curve. As participants valued ALI's additional degrees of freedom, however, a future application of ALI could be for training purposes, ideally in combination with CLI

Development and Validation of a Novel Scoring System for Noninvasive Nonalcoholic Steatohepatitis Detection in Bariatric Patients

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

Reliability and reproducibility of sciatic nerve magnetization transfer imaging and T2 relaxometry

Objectives!#!To assess the interreader and test-retest reliability of magnetization transfer imaging (MTI) and T2 relaxometry in sciatic nerve MR neurography (MRN).!##!Materials and methods!#!In this prospective study, 21 healthy volunteers were examined three times on separate days by a standardized MRN protocol at 3 Tesla, consisting of an MTI sequence, a multi-echo T2 relaxometry sequence, and a high-resolution T2-weighted sequence. Magnetization transfer ratio (MTR), T2 relaxation time, and proton spin density (PSD) of the sciatic nerve were assessed by two independent observers, and both interreader and test-retest reliability for all readout parameters were reported by intraclass correlation coefficients (ICCs) and standard error of measurement (SEM).!##!Results!#!For the sciatic nerve, overall mean ± standard deviation MTR was 26.75 ± 3.5%, T2 was 64.54 ± 8.2 ms, and PSD was 340.93 ± 78.8. ICCs ranged between 0.81 (MTR) and 0.94 (PSD) for interreader reliability and between 0.75 (MTR) and 0.94 (PSD) for test-retest reliability. SEM for interreader reliability was 1.7% for MTR, 2.67 ms for T2, and 21.3 for PSD. SEM for test-retest reliability was 1.7% for MTR, 2.66 ms for T2, and 20.1 for PSD.!##!Conclusions!#!MTI and T2 relaxometry of the sciatic nerve are reliable and reproducible. The values of measurement imprecision reported here may serve as a guide for correct interpretation of quantitative MRN biomarkers in future studies.!##!Key points!#!• Magnetization transfer imaging (MTI) and T2 relaxometry of the sciatic nerve are reliable and reproducible. • The imprecision that is unavoidably associated with different scans or different readers can be estimated by the here presented SEM values for the biomarkers T2, PSD, and MTR. • These values may serve as a guide for correct interpretation of quantitative MRN biomarkers in future studies and possible clinical applications

Robotic versus open partial pancreatoduodenectomy (EUROPA): a randomised controlled stage 2b trialResearch in context

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