No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair.

STUDY DESIGN: A randomized, controlled, prospective multicenter clinical trial with a parallel group design was initiated in eight surgical centers to compare a large-pore polypropylene mesh (Ultrapro®) to a small-pore polypropylene mesh (Premilene®) within a standardized retromuscular meshplasty for incisional hernia repair. METHODS: Between 2004 and 2006, patients with a fascial defect with a minimum diameter of 4 cm after vertical midline laparotomy were recruited for the trial. Patients underwent retromuscular meshplasty with either a large-pore or a small-pore mesh to identify the superiority of the large-pore mesh. Follow-up visits were scheduled at 5 and 21 days and 4, 12, and 24 months after surgery. A clinical examination, a modified short form 36 (SF-36®), a daily activity questionnaire, and an ultrasound investigation of the abdominal wall were completed at every follow-up visit. The primary outcome criterion was foreign body sensation at the 12-month visit, and the secondary endpoint criteria were the occurrence of hematoma, seroma, and chronic pain within 24 months postoperatively. RESULTS: In 8 centers, 181 patients were included in the study. Neither foreign body sensation within the first year after surgery (27.5% Ultrapro®, 32.2% Premilene®) nor the time until the first occurrence of foreign body sensation within the first year was significantly different between the groups. Regarding the secondary endpoints, no significant differences could be observed. At the 2-year follow-up, recurrences occurred in 5 Ultrapro® patients (5.5%) and 4 Premilene® patients (4.4%). CONCLUSION: Despite considerable differences in theoretical and experimental works, we have not been able to identify differences in surgical or patient-reported outcomes between the use of large- and small-pore meshes for retromuscular incisional hernia repair. TRIAL REGISTRATION: Clinical Trials NCT04961346 (16.06.2021) retrospectively registered.

Laterally closed tunnel technique with and without adjunctive photobiomodulation therapy for the management of isolated gingival recession-a randomized controlled assessor-blinded clinical trial.

The objective of this prospective randomized controlled single-center clinical trial was to prove the efficacy of adjunctive photobiomodulation in improving selected outcomes following the use of laterally closed tunnel technique for the management of isolated gingival recession. Nineteen participants (with isolated gingival recession) each treated by laterally closed tunnel technique were randomized to either add on treatment with control (sham laser application) or test group (photobiomodulation with 660 nm diode, 3.5 J/cm2 per point of application). The primary outcome variable was change in recession depth and secondary variables included recession width, width of keratinized gingiva, periodontal biotype, and VAS score for pain assessment and EHS index for early wound healing assessment. Analysis was performed using a linear mixed effects model. There were no significant differences in the gingival recession depth (p = 0.8324) and recession width (p-0.969) at 3-month follow-up. The VAS scores were significantly lower for the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) over time (p = < 0.0001) as well as per site (p = 0.0006) The Early Wound Healing Index scores were significantly higher in the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) group (p < 0.0001). The adjunctive use of photobiomodulation did not show a better outcome concerning recession depth but appears to provide faster healing of the surgical wounds and better patient comfort. The result needs further evaluation in particular with respect to long-term effect and due to limitation in sample size. Clinical Trial Registry of India: CTRI/2019/11/022012.

Single versus dual blockade of the renin-angiotensin system in patients with IgA nephropathy.

BACKGROUND: Inhibitors of the renin-angiotensin system (RAS) are cornerstones of supportive therapy in patients with IgA nephropathy (IgAN). We analyzed the effects of single versus dual RAS blockaQueryde during our randomized STOP-IgAN trial. METHODS: STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under continuous single or dual RAS blocker therapy over the entire 3 years of the trial phase. Primary and secondary STOP-IgAN trial endpoints, i.e. frequencies of full clinical remission, eGFR-loss ≥ 15 and ≥ 30 ml/min/1.73 m2 and ESRD onset, were analyzed by logistic regression and linear mixed effects models. RESULTS: Among the 112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial. Neither RAS blocker strategy significantly affected full clinical remission, eGFR-loss rates, onset of ESRD. Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase. This was particularly evident in patients without additional immunosuppression during the randomized trial phase, where proteinuria increased by 0.2 g/g creatinine in the dual RAS blockade group. In contrast, proteinuria decreased in patients under single RAS blocker therapy by 0.3 g/g creatinine. The course of eGFR remained stable and did not differ between the RAS treatment strategies. CONCLUSION: In the STOP-IgAN cohort, neither RAS blocker regimen altered renal outcomes. Patients on dual RAS blockade even exhibited higher proteinuria over the 3-year trial phase.

Correction: SNiPER: a novel hypermethylation biomarker panel for liquid biopsy based early breast cancer detection.

[This corrects the article DOI: 10.18632/oncotarget.27303.].

Debris and Smear Layer Removal in Curved Root Canals Using the Dual Wavelength Er,Cr:YSGG/Diode 940 nm Laser and the XP-Endoshaper and Finisher Technique.

Objective: To validate the capability of the dual wavelength laser (Er,Cr:YSGG and diode 940 nm) and the XP-Endoshaper and finisher in removing the smear layer from curved canals. Methods: Forty curved root canals were prepared using the R25 file of the Reciproc® system. The teeth were randomly divided into five groups: G1: negative control irrigated with distilled water, G2: positive control irrigated with EDTA 17% and a final rinse of NaOCl 3%, G3: XP-Endoshaper and finisher with EDTA 17%, G4: dual wavelength Er,Cr:YSGG (1.25 W, 50 Hz, 50 µs) and diode 940 nm (2 W, 50% DC), and G5: dual wavelength Er,Cr:YSGG (2 W, 20 Hz, 50 µs) and diode 940 nm (2 W, 50% DC). Laser scanning microscope images (1000 × ) were scored with the Hülsmann scoring system. Results: Superior smear layer removal was observed in G5 in comparison with G4, especially in the apical third of the canal. Furthermore, the XP-Endoshaper and finisher exhibited positive results in all parts of the canal. Conclusions: The higher power output of the Er,Cr:YSGG in the dual wavelength laser may be a suitable approach to remove the smear layer from the apical third of curved canals. Moreover, the XP-Endoshaper and finisher with EDTA could expose the dentinal tubules, however, the negative side effects of applying EDTA 17% for longer periods must be taken into consideration. This work is clinically significant as it addresses the main aim of endodontic treatment and provides a suitable method to remove the debris, smear layer, and bacterial remnants from the clinically challenging curved root canals.

SNiPER: a novel hypermethylation biomarker panel for liquid biopsy based early breast cancer detection.

INTRODUCTION: Mammography is the gold standard for early breast cancer detection, but shows important limitations. Blood-based approaches on basis of cell-free DNA (cfDNA) provide minimally invasive screening tools to characterize epigenetic alterations of tumor suppressor genes and could serve as a liquid biopsy, complementing mammography. METHODS: Potential biomarkers were identified from The Cancer Genome Atlas (TCGA), using HumanMethylation450-BeadChip data. Promoter methylation status was evaluated quantitatively by pyrosequencing in a serum test cohort (n = 103), a serum validation cohort (n = 368) and a plasma cohort (n = 125). RESULTS: SPAG6, NKX2-6 and PER1 were identified as novel biomarker candidates. ITIH5 was included on basis of our previous work. In the serum test cohort, a panel of SPAG6 and ITIH5 showed 63% sensitivity for DCIS and 51% sensitivity for early invasive tumor (pT1, pN0) detection at 80% specificity. The serum validation cohort revealed 50% sensitivity for DCIS detection on basis of NKX2-6 and ITIH5. Furthermore, an inverse correlation between methylation frequency and cfDNA concentration was uncovered. Therefore, markers were tested in a plasma cohort, achieving a 64% sensitivity for breast cancer detection using SPAG6, PER1 and ITIH5. CONCLUSIONS: Although liquid biopsy remains challenging, a combination of SPAG6, NKX2-6, ITIH5 and PER1 (SNiPER) provides a promising tool for blood-based breast cancer detection.

First Investigation of Dual-Wavelength Lasers (2780 nm Er,Cr:YSGG and 940 nm Diode) on Implants in a Simulating Peri-Implantitis Situation Regarding Temperature Changes in an In Vitro Pocket Model.

Objective: This study aimed to investigate the temperature changes and question the safe laser settings and protocols for laser-assisted peri-implantitis treatment in an in vitro environment. Materials and methods: Three types of implants (Neoss, Dentegris, and Camlog) were implanted in an artificial bone model (n = 15). The model was placed into a 37°C water bath to simulate the in vivo oral condition. Throughout the laser irradiation, K-type thermocouples were used to record the real-time temperature measurements at different anatomically important locations in the artificial bone. Results: In all of the temperature measurements, no temperature rise above the critical safe limit, that is, >47°C, was observed. Conclusions: Within the limitations of this in vitro study, the use of the dual-wavelength protocol [Er,Cr:YSGG (1 and 1.5 W, 25, 50, 75 Hz)] and the 940 nm diode (peak power 2 W, duty cycle 50%) can be considered a safe method in the treatment of peri-implantitis, regarding its thermal safety.

Renal outcomes of STOP-IgAN trial patients in relation to baseline histology (MEST-C scores).

BACKGROUND: The Oxford classification of IgA nephropathy (IgAN) defines histologic criteria (MEST-C) that provide prognostic information based on the kidney biopsy. There are few data on the predictive impact of this classification in randomized clinical trial settings. METHODS: We performed an exploratory analysis of MEST-C scores in 70 available renal biopsies from 162 randomized STOP-IgAN trial participants and correlated the results with clinical outcomes. Analyses were performed by researchers blinded to the clinical outcome of the patients. Biopsies had been obtained 6.5 to 95 (median 9.4) months prior to randomization. RESULTS: Mesangial hypercellularity (M1) associated with higher annual eGFR-loss during the 3-year trial (M1: - 5.06 ± 5.17 ml/min/1.73 m2, M0: - 0.79 ± 4.50 ml/min/1.73 m2, p = 0.002). An M0-score additionally showed a weak association with full clinical remission, whereas the percentage of patients losing ≥15 ml/min/1.73 m2 over the 3-year trial phase was higher among those scored as M1. Among patients with additional immunosuppression, ESRD occurred more frequently in patients when tubulointerstitial fibrosis (T1/2) was present (T1/2 = 33%, T0 = 0%, p = 0.008). In patients receiving supportive care only, ESRD frequencies were similar (T1/2 = 18%, T0 = 7%, p = 0.603). At randomization, eGFR was significantly lower when tubulointerstitial fibrosis was present (T1/2: 45.2 ± 15.7 ml/min/1.73 m2, T0: 74.6 ± 28.2 ml/min/1.73 m2, p < 0.0001). Endocapillary hypercellularity (E), and glomerular segmental sclerosis (S) were not associated with any clinical outcome parameter. In the analyzed cohort, patients with glomerular crescents (C1/2 scores) in their biopsies were more likely to develop ESRD during the 3-year trial phase, but this trend was only significant in patients under supportive care. CONCLUSIONS: This secondary analysis of STOP-IgAN biopsies indicates that M1, T1/2 and C1/2 scores associate with worse renal outcomes.

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia.

INTRODUCTION: Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. METHODS AND ANALYSIS: The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60. ETHICS AND DISSEMINATION: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER: DRKS00013644; Pre-results.

Urinary Biomarkers in the Prediction of Prognosis and Treatment Response in IgA Nephropathy.

BACKGROUND/AIMS: The addition of immunosuppression to supportive care reduces proteinuria in a subset of patients with IgA nephropathy (IgAN) but is associated with an increased rate of adverse events. The present work investigates whether urinary biomarkers are able to identify subjects who benefit from immunosuppression and to predict the progression of disease in a sub-cohort of the STOP-IgAN trial. METHODS: Urinary neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), calprotectin, and the product of tissue inhibitor of metalloproteinase-2 and insulin-like growth factor-binding protein 7 (TIMP2•IGFBP7) were measured in all available urine samples obtained at the time point of enrollment in the STOP-IgAN trial (n=113). RESULTS: Biomarker concentrations in both the overall study population and the subgroup with additional immunosuppression did not differ in subjects reaching vs. not reaching full clinical remission, eGFR loss ≥ 15, or 30 ml/min/1.73 m2 over the 3-year trial phase (p> 0.05 each). Receiver-operating characteristic curves showed a poor predictive accuracy of each biomarker for the above-mentioned parameters in the overall study population (areas under the curve ≤0.611). Accordingly, there was neither a significant correlation of any biomarker and adverse outcome in linear regression analysis, nor between biomarker concentrations at enrollment and change in the eGFR over the 3-year observation period. CONCLUSION: NGAL, KIM-1, calprotectin, and [TIMP-2]•[IGFBP7] had neither a prognostic value for the progression of IgAN, nor for the response to immunosuppression in the present sub-cohort of the STOP-IgAN trial. The search for appropriate biomarkers for an individualized treatment strategy in IgAN continues.

Incidence of adult respiratory distress syndrome in trauma patients: A systematic review and meta-analysis over a period of three decades.

BACKGROUND: In trauma patients, acute respiratory distress syndrome (ARDS) is associated with high morbidity and mortality. Changes in diagnostics, management, and treatment may have influenced the incidence of ARDS. Therefore, the purpose of this article is to evaluate whether there is a difference in the incidence of posttraumatic ARDS (1) over time, (2) attributable to geographic distribution, and 3) related to admitting surgical subspecialities. METHODS: A comprehensive search of articles published in English and German language was conducted using PubMed, MEDLINE, and the ISI Web of Science. Search terms included ARDS, acute respiratory distress syndrome, multiple trauma, polytrauma, and surgery. A meta-regression was performed to analyze differences between several decades of patient recruitment (decade 1, 1981-1990; decade 2, 1991-2000; decade 3, 2001-2010), geographic location (North America and Europe), and the type of admitting surgical service (general vs. orthopedic trauma), respectively. Statistical analyses were performed with R (version 3.1.2, metafor package). RESULTS: The search included studies between January 1, 1980, and December 31, 2015 and revealed 43 trials from 40 publications (117,951 patients, 7,816 with posttraumatic ARDS). The median incidences over the last three decades were similar between decade 1 (10.4%), decade 2 (7.7%), and decade 3 (8.0%) (p = 0.8322). Geographical observations comparing central Europe and North America revealed no statistically significant difference (Europe 13.0%) and North America (6.9%), (p = 0.0696). The ARDS incidence in patients published based on a general surgery service (9.8%) was comparable to those published by orthopedic trauma surgeons (7.0%) (p = 0.3436). CONCLUSION: The results of this meta-analysis discard the assumption that the following factors have influenced the incidence of posttraumatic ARDS: There was neither a change in the incidence over the last decades, nor a geographical difference within western societies, nor associated with the admitting surgical subspeciality. LEVEL OF EVIDENCE: Systematic review, level III.

Zinc enhances the number of regulatory T cells in allergen-stimulated cells from atopic subjects.

PURPOSE: The trace element zinc is essential for immune function and its regulation. Since zinc deficiency and allergic hyperresponsive reactions are often accompanied, the influence of zinc on allergen-induced cell growth, CD4+ regulatory T (Treg) cell numbers and cytokine expression during allergic immune reactions was investigated. METHODS: Peripheral blood mononuclear cells (PBMCs) from non-atopic and atopic subjects were treated with timothy grass allergen pre-incubated with or without zinc. Proliferation was determined by analyzing the incorporation of 3H-thymidine. Intracellular zinc and Foxp3 levels and cell surface antigens were measured by FACS, cytokine expression by ELISA and real-time PCR. RESULTS: Incubation with 50 µM zinc sulfate (Zn50) enhances cytosolic zinc concentrations in CD3+ T cells. The data also reveal that the combination of Zn50 plus allergen significantly reduces PBMC proliferation of atopic subjects. Additionally, Zn50 plus allergen enhances Th1 cytokine responses shown by increased interferon (IFN)-γ/interleukin (IL)-10 ratios as well as enhanced tumor necrosis factor-α release. In response to allergen, zinc increases Treg cells and upregulates the mRNA expression of cytotoxic T-lymphocyte antigen-4 in atopic subjects. Interestingly, Zn50 alone leads to an increase of CD4+CD25high(hi)+ cells in atopic and non-atopic subjects. CONCLUSIONS: Zinc may regulate unwanted hyperresponsive immune reactions by suppressing proliferation through a significant shift from IL-10 to the Th1 cytokine IFN-γ, and enhanced regulatory T cell numbers. Therefore, zinc supplementation may be a promising tool for the therapy of allergies, without negatively affecting the immune system.

Subtarsal Versus Transconjunctival Approach-Esthetic and Functional Long-Term Experience.

PURPOSE: In addition to the transconjunctival approach, the subtarsal incision is one of the most commonly used procedures for surgical exploration of the orbital floor and infraorbital rim. However, available data are limited regarding validity and long-term esthetic and functional outcomes. The aim of this study was to verify the favorable clinical results of the subtarsal approach and compare these results with the transconjunctival procedure. MATERIALS AND METHODS: Forty-five patients (subtarsal group, n = 30; transconjunctival group, n = 15) were examined 6 to 30 months after surgical intervention using a standardized follow-up. Clinically noted complications, such as paresthesia, epiphora, or ocular foreign body sensation, were scored. Postoperative scar formation was investigated using the modified Vancouver Scar Scale (mVSS) and recorded according to standardized photographic documentation procedures. Photographic images were evaluated in a blinded manner by experts and nonexperts according to fixed criteria. Concomitant photographic evaluation was performed by age- and gender-matched healthy controls. Recorded data analyzed by χ2 test and unrelated samples analyzed by the Wilcoxon-Mann-Whitney test were statistically significant (P = .05). RESULTS: Comparable complication rates were found for the 2 approaches without any significant differences (P = .29). Using the subtarsal approach, discrete scar formation was discerned in 7 of 30 cases. Moreover, categorization by the mVSS showed that, in 93.3% of cases, the scar was measured as unremarkable hyper- or hypotrophy (mean, 1.7 of 10 possible points). No statistically significant differences in conspicuous scars and asymmetries were observed between the 2 approaches in the nonexpert and expert groups (P > .05). CONCLUSION: The results of the present study confirm that the subtarsal approach is a safe and esthetically favorable method.

Primary vitrectomy for rhegmatogenous retinal detachment in pseudophakic eyes: 20-gauge versus 25-gauge vitrectomy.

PURPOSE: To report anatomical and functional outcome of 20-gauge versus 25-gauge primary pars plana vitrectomy for management of complex rhegmatogenous retinal detachment in pseudophakic eyes. METHODS: Prospective single-centre randomized comparative pilot trial. Fifty patients with retinal detachment (RD) not complicated by proliferative vitreoretinopathy grade B or C, who cannot be treated with a single meridional sponge, were randomized (1:1) from November 2006 to January 2010 to either 20-gauge or 25-gauge vitrectomy as first surgical intervention and followed up over a 12-month period, evaluating change in best-corrected visual acuity, anatomical success and intraocular pressure dysregulation. RESULTS: Mean visual acuity improved by 0.88 (SD 0.67) from 1.22 logMAR (SD 0.63) to 0.34 logMAR (SD 0.31) in the 20-gauge group and by 0.53 (SD 0.91) from 0.86 logMAR (SD 0.73) to 0.34 logMAR (SD 0.46) in the 25-gauge group. Final anatomical success rate was 100% and primary success rate was 69% at 6 months of follow-up. In the 20-gauge group, the retina was attached after one single procedure in 18 eyes (72%) and in 21 eyes (84%) of the 25-gauge group. Two patients in the 25-gauge group had hypotony at the first postoperative day which normalized within 6 weeks. CONCLUSION: In our series, transconjunctival sutureless 25-gauge and 20-gauge vitrectomy showed comparable results in pseudophakic RD not suitable for single sponge surgery with respect to visual outcome and retinal reattachment. Postoperative hypotony does not seem to be a significant problem of transconjunctival sutureless vitrectomy.

Effects of Smoking Cessation on Presynaptic Dopamine Function of Addicted Male Smokers.

BACKGROUND: There is evidence of abnormal cerebral dopamine transmission in nicotine-dependent smokers, but it is unclear whether dopaminergic abnormalities are due to acute nicotine abuse or whether they persist with abstinence. We addressed this question by conducting longitudinal positron emission tomography (PET) examination of smokers before and after 3 months of abstinence. METHODS: We obtained baseline 6-[(18)F]fluoro-L-DOPA (FDOPA)-PET scans in 15 nonsmokers and 30 nicotine-dependent smokers, who either smoked as per their usual habit or were in acute withdrawal. All smokers then underwent cessation treatment, and successful abstainers were re-examined by FDOPA-PET after 3 months of abstinence (n = 15). Uptake of FDOPA was analyzed using a steady-state model yielding estimates of the dopamine synthesis capacity (K); the turnover of tracer dopamine formed in living brain (kloss); and the tracer distribution volume (Vd), which is an index of dopamine storage capacity. RESULTS: Compared with nonsmokers, K was 15% to 20% lower in the caudate nuclei of consuming smokers. Intraindividual comparisons of consumption and long-term abstinence revealed significant increases in K in the right dorsal and left ventral caudate nuclei. Relative to acute withdrawal, Vd significantly decreased in the right ventral and dorsal caudate after prolonged abstinence. Severity of nicotine dependence significantly correlated with dopamine synthesis capacity and dopamine turnover in the bilateral ventral putamen of consuming smokers. CONCLUSIONS: The results suggest a lower dopamine synthesis capacity in nicotine-dependent smokers that appears to normalize with abstinence. Further investigations are needed to clarify the role of dopamine in nicotine addiction to help develop smoking prevention and cessation treatments.

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial.

BACKGROUND: Patients' need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain. METHODS: A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications. RESULTS: During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (p < 0.0001) and no difference after 7 days (p = 0. 7019). The pain intensity decreased significantly over time (p < 0.0001) and was significantly higher in the PH group (p < 0.0001). CONCLUSIONS: Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.

Effect of maxillary advancement on the change in the soft tissues after treatment of patients with class III malocclusion.

The aesthetic outcome of treatment has become increasingly important to patients having orthognathic surgery. The aim of this observational cohort study based on clinical records was to evaluate the effect of maxillary advancement on changes to the soft tissues. We studied 53 patients with class III malocclusion (29 women and 24 men, mean (SD) age 28 (11) years). We identified all patients treated between 1 January 2002 and 30 December 2013 who could be monitored postoperatively for 6 months. To study the effect of maxillary advancement on changes to the soft tissue we distinguished between patients who had had less than 6mm, and those with 6mm advancement or more. In those who had had less than 6mm, we found no significant changes in the soft tissue in the region of the nasolabial angle. However, the lip-chin- throat angle (p=0.016), cervical length (p=0.002), lower lip (p=0.007) and upper lip distance (p=0.0001) from the aesthetic line changed significantly. On the other hand, the changes to the soft tissue in the submental and nasolabial regions were significant in patients with 6mm advancement or more, and indicated a clear improvement in the aesthetic outcome of this region. This aesthetic change for the good in the submental and nasolabial regions after maxillary advancement of 6mm or more should be considered when planning treatment, and reduction in the mandibular setback will reduce the risk of development of a double chin.

The Volume Behavior of Autogenous Iliac Bone Grafts After Sinus Floor Elevation: A Clinical Pilot Study.

Iliac crest is still regarded as one of the most viable source of autogenous graft materials for extensive sinus floor elevation. Three-dimensional resorption behavior has to be taken into account in anticipation of the subsequent insertion of dental implants. We performed 3-dimensional volume measurements of the inserted bone transplants in 11 patients (6 women and 5 men; mean age = 2.3 years) who underwent bilateral sinus floor elevation with autogenous iliac crest grafts. In order to determine the respective bone graft volumes, cone-beam computerized tomography studies of the maxillary sinuses were carried out directly after the operation (T0), as well as 3 months (T1) and 6 months (T2) postoperatively. The acquired DICOM (Digital Imaging and Communications in Medicine) data sets were evaluated using suitable analysis software. We evaluated statistical significance of graft volumes changes using a linear mixed model with the grouping factors for time, age, side, and sex with a significance level of P = .05. 38.9% of the initial bone graft volume, which amounted to 4.2 cm(3), was resorbed until T1. At T2, the average volume again decreased significantly by 18.9 % to finally reach 1.8 cm(3). The results show neither age nor side dependency and apply equally to both sexes. Without functional load, iliac bone grafts feature low-volume stability in sinus-augmentation surgery. Further clinical and animal studies should be done to detect the optimal timing for implant placement.

Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI.

PURPOSE: We investigated whether an abbreviated protocol (AP), consisting of only one pre- and one postcontrast acquisition and their derived images (first postcontrast subtracted [FAST] and maximum-intensity projection [MIP] images), was suitable for breast magnetic resonance imaging (MRI) screening. METHODS: We conducted a prospective observational reader study in 443 women at mildly to moderately increased risk who underwent 606 screening MRIs. Eligible women had normal or benign digital mammograms and, for those with heterogeneously dense or extremely dense breasts (n = 427), normal or benign ultrasounds. Expert radiologists reviewed the MIP image first to search for significant enhancement and then reviewed the complete AP (consisting of MIP and FAST images and optionally their nonsubtracted source images) to characterize enhancement and establish a diagnosis. Only thereafter was the regular full diagnostic protocol (FDP) analyzed. RESULTS: MRI acquisition time for FDP was 17 minutes, versus 3 minutes for the AP. Average time to read the single MIP and complete AP was 2.8 and 28 seconds, respectively. Eleven breast cancers (four ductal carcinomas in situ and seven invasive cancers; all T1N0 intermediate or high grade) were diagnosed, for an additional cancer yield of 18.2 per 1,000. MIP readings were positive in 10 (90.9%) of 11 cancers and allowed establishment of the absence of breast cancer, with a negative predictive value (NPV) of 99.8% (418 of 419). Interpretation of the complete AP, as with the FDP, allowed diagnosis of all cancers (11 [100%] of 11). Specificity and positive predictive value (PPV) of AP versus FDP were equivalent (94.3% v 93.9% and 24.4% v 23.4%, respectively). CONCLUSION: An MRI acquisition time of 3 minutes and an expert radiologist MIP image reading time of 3 seconds are sufficient to establish the absence of breast cancer, with an NPV of 99.8%. With a reading time < 30 seconds for the complete AP, diagnostic accuracy was equivalent to that of the FDP and resulted in an additional cancer yield of 18.2 per 1,000.