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Background and Aims: This study aims to evaluate the analgesic effect of ultrasound-guided erector spinae plane block (ESPB) in paediatric lower abdominal surgeries. Methods: Randomised, prospective trial. Forty patients, aged 2–10 years with the American Society of Anesthesiologists Score of I and II scheduled for elective lower abdominal surgery were included in the study. Interventions: Patients were randomised into two groups as control group and ESPB group. Ultrasound-guided erector spinae plane block at L1 vertebral level was performed preoperatively using 0.5 ml/kg 0.25% bupivacaine (max 20 ml) for the patients in ESPB group. Analgesic requirements and time to first analgesic requirement were recorded and Face, Legs, Activity, Cry and Consolability (FLACC) scores for pain were recorded at 0, 1, 2, 3, 6, 12 and 24 h postoperatively. Results: Forty patients were included in the final analyses. Significant difference was determined between the groups on post-operative morphine requirement and FLACC scores at 3 h and 6 h postoperatively (P < 0.05). Significant difference was also determined in time to first dose of rescue analgesia between the groups (P < 0.05). Conclusions: This study shows that the ESPB provides adequate post-operative analgesia in paediatric patients undergoing lower abdominal surgery.

Background The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. We wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation. Methods This was a randomized, controlled, prospective study. We randomly allocated 90 adult patients with predicted normal airways into three groups. All patients underwent routine anesthesia using different laryngoscopes according to group allocation. We compared DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications. All outcomes were analyzed using SPSS13.0. Results Compared with the GlideScope, the Macintosh gave shorter times for DLT insertion (median: 96 (IQR: 51 [min–max: 62–376] s vs 73 (26 [48–419] s, p = 0.003); however, there was no difference between the Macintosh and C-MAC(D) (p = 0.610). The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D) (p = 0.001, p = 0.028, respectively). NRS of DLT delivery and insertion were significantly lower in the Macintosh than in the others (p p > 0.05). There were no significant differences in DLT misplacement, fiberoptic time or hemodynamic changes among the groups. Conclusions Compared with the Macintosh laryngoscope, the GlideScope® and C-MAC®(D) videolaryngoscopes may not be recommended as the first choice for routine DLT intubation in patients with predicted normal airways. Trial registration The study was prospectively registered at the Chinese Clinical Trial Registry (no. ChiCTR1900025718); principal investigator: Z.L.H.; date of registration: September 6, 2019.

Contaminated surfaces in a hospital serve as reservoirs for pathogen spread. The aim of this study was to evaluate UV lights in preventing the spread of a DNA tracer in an intensive care unit (ICU) through sterilization of highly touched surfaces. In a prospective trial, a non-pathogenic DNA virus was inoculated onto surfaces in an ICU patient room. Investigators swabbed frequently touched surfaces in non-inoculated ICU rooms at 24, 48, and 96 h post inoculation. Culture specimens were analyzed for the presence of viral DNA via PCR. After baseline data were obtained, UV lights were deployed in a standardized fashion onto vitals monitors, ventilators, keyboards, and intravenous (IV) pumps. Inoculation and culturing were then repeated. Prior to UV implementation, the DNA tracer disseminated to 10.10% of tested surfaces in non-inoculated rooms at 48 h. Post UV light deployment, only 1.20% of surfaces tested positive for the DNA tracer after 48 h. UV decontamination significantly retarded the spread of the virus DNA, with a relative reduction of 90% at 48 h from 10.10% of surfaces pre UV to 1.20% of surfaces post UV (p &lt, 0.0001). UV decontamination holds the potential to confer protection to patients by reducing the number of surfaces that can serve as a nidus for transfer.

Objective We aimed to evaluate the clinical utility and predictive value of stimulatory (TSAb) and blocking (TBAb) TSH receptor antibodies in the management of Graves’ disease (GD). Methods Hundred well-defined, consecutive, unselected, untreated hyperthyroid patients with GD were enrolled in a prospective two-year trial. Methimazole (MMI) was administered for 24 weeks according to baseline serum concentrations of free T3/free T4. Starting dose was 5–30 mg/day. Through a titration regimen, this dose was respectively tapered or increased at each subsequent study visit as the patient became euthyroid or remained hyperthyroid. Goals of therapy were to maintain normal fT4 and TSH levels. MMI therapy was stopped at week 24. The main outcome measure was clinical response versus non-response to a 24-week MMI treatment defined as biochemical euthyroidism versus persistent hyperthyroidism at week 24 and/or relapse at weeks 36, 48, and 96. TSAb was reported as percentage of specimen-to-reference ratio (cut-off SRR% 40% inhibition). Results Forty-four patients responded to MMI of whom 43% had Graves’ orbitopathy (GO) while 56 were non-responders (66% with GO, p Conclusions Serum TSAb levels are a biomarker for and mirror severity of GD. Their increase during MMI treatment is a marker for on-going disease activity. TSAb dilution analysis had additional predictive value.

Hypoxia—a common feature of the majority of solid tumors—is a negative prognostic factor, as it is associated with invasion, metastasis and therapy resistance. To date, a variety of methods are available for the assessment of tumor hypoxia, including the use of positron emission tomography (PET). A plethora of hypoxia PET tracers, each with its own strengths and limitations, has been developed and successfully validated, thereby providing useful prognostic or predictive information. The current review focusses on [18F]-HX4, a promising next-generation hypoxia PET tracer. After a brief history of its development, we discuss and compare its characteristics with other hypoxia PET tracers and provide an update on its progression into the clinic. Lastly, we address the potential applications of assessing tumor hypoxia using [18F]-HX4, with a focus on improving patient-tailored therapies.

Hypoxia-a common feature of the majority of solid tumors-is a negative prognostic factor, as it is associated with invasion, metastasis and therapy resistance. To date, a variety of methods are available for the assessment of tumor hypoxia, including the use of positron emission tomography (PET). A plethora of hypoxia PET tracers, each with its own strengths and limitations, has been developed and successfully validated, thereby providing useful prognostic or predictive information. The current review focusses on [18F]-HX4, a promising next-generation hypoxia PET tracer. After a brief history of its development, we discuss and compare its characteristics with other hypoxia PET tracers and provide an update on its progression into the clinic. Lastly, we address the potential applications of assessing tumor hypoxia using [18F]-HX4, with a focus on improving patient-tailored therapies.

The influence of the degree of a neuromuscular block (NMB) on surgical operating conditions during laparoscopic surgery is debated controversially. The extent of abdominal distension during the time course of the NMB was assessed as a new measurement tool. In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB&mdash, post-tetanic count (PTC) = 0, deep NMB&mdash, train-of-four count (TOF) = 0 and PTC = 1&ndash, 5, medium NMB&mdash, PTC &gt, 5 and TOF = 0&ndash, 1, shallow NMB&mdash, TOF &gt, full recovery&mdash, train-of-four ratio TOFR &gt, 90%. Simultaneously, the quality of operating conditions was assessed with a standardized rating scale (SRS) reaching from 1 (extremely poor conditions) to 5 (excellent conditions). Fifty patients could be included in the analysis. The abdominal wall length increased by 10&ndash, 13 mm induced by the capnoperitoneum. SRS was higher during intense NMB (4.7 &plusmn, 0.5) vs. full recovery (4.5 &plusmn, 0.5) (mean &plusmn, SD, p = 0.025). Generally, an intense NMB did not increase abdominal wall length induced by capnoperitoneum. Additionally, its influence on the quality of surgical operating conditions seems to be of minor clinical relevance.

INTRODUCTION AND OBJECTIVE:Organ preserving therapies are of particular interest in the treatment of localized prostate cancer (PC) with a goal of decreasing morbidity associated with radical treat...

Objective We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. Methods The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. Conclusions This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Patient-specific instrumentation (PSI) was usually applied in total knee arthroplasty (TKA) to acquire a favourable alignment. We hypothesized that using PSI had a potential risk of notching in the anterior femoral cortex, because the femoral component may be placed in an overextension position due to the distal femoral sagittal anteversion. The aim of this study was to figure out the relationship between the notch and the distal femoral sagittal anteversion in PSI-assisted TKA.One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA) were randomly divided into conventional instrumentation (CI) group and PSI group. The computed tomography (CT) data of lower extremities was collected and imported to the Mimics software to reconstruct the three-dimensional (3D) bone image of the femur. The angle between distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA) on sagittal plane was defined as distal femoral sagittal anteverted angle (DFSAA) and measured. The number of notch intra-operative and post-operative was recorded. Then, we calculated the incidence of the notch and analyzed its relationship with DFSAA.The average DFSAA of 262 femurs is 2.5° ± 1.5° (range, 0.0°-5.7°). When DFSAA ≥ 3°, the incidence of notch was 7.10% in CI group and 33.30% in PSI group, respectively, which shows significant statistical difference in the two groups (P = 0.016 0.05). When DFSAA 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 0.05).DFSAA could be taken as an indicator to predict the notch when performing TKA assisted with PSI. Especially when the DFSAA ≥ 3°, the risk of notch could be markedly increased.

PURPOSE The previously published single institution randomized prospective trial failed to show superiority in the 5-year biochemical and/or clinical disease failure (BCDF) rate with moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT). We now present 10-year disease outcomes using updated risk groups and definitions of biochemical failure. METHODS Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma were randomly assigned to receive C-IMRT (76 Gy in 38 fractions) or H-IMRT (70.2 Gy in 26 fractions). Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation. Men with intermediate risk were prescribed 4 months of ADT at the discretion of the treating physician. The primary endpoint was cumulative incidence of BCDF. We compared disease outcomes and overall mortality by treatment arm, with sensitivity analyses for National Comprehensive Cancer Network (NCCN) risk group adjustment. RESULTS Overall, 303 assessable men were randomly assigned to C-IMRT or H-IMRT. The median follow-up was 122.9 months. Per updated NCCN risk classification, there were 28 patients (9.2%) with low-risk, 189 (62.4%) with intermediate-risk, and 86 (28.4%) with high-risk prostate cancer. The arms were equally balanced for clinicopathologic factors, except that there were more black patients in the C-IMRT arm (17.8% v 7.3%; P = .02). There was no difference in ADT use ( P = .56). The 10-year cumulative incidence of BCDF was 25.9% in the C-IMRT arm and was 30.6% in the H-IMRT arm (hazard ratio, 1.31; 95% CI, 0.82 to 2.11). The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer–specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%). CONCLUSION H-IMRT failed to demonstrate superiority compared with C-IMRT in long-term disease outcomes.

SCOPUS: le.j, info:eu-repo/semantics/published

Background Inflammation and swelling of the sinus and nasal mucosa are commonly caused by viral infection, bacterial infection, or exposure to allergens and irritants. Sinonasal inflammation can cause symptoms of nasal congestion, facial pressure, and rhinogenic facial pain or “sinus pain”. A previous randomized controlled study demonstrated that acute treatment with non-invasive periorbital microcurrent stimulation resulted in a rapid and clinically meaningful reduction in self-report of sinus pain that significantly outperformed sham control treatment. Here, we assessed the acute durability of microcurrent pain relief and longitudinal effects of 4 weeks of daily microcurrent treatment in patients presenting with sinus pain. Methods Thirty subjects with moderate facial pain (numeric rating scale ≥5) attributed to self-reported sinonasal disease were enrolled in a single-arm, prospective interventional study. At enrollment, subjects were given a microcurrent treatment device and written instructions and self-administered the device to the bilateral periorbital regions for 5 mins. Subjects were instructed to treat themselves at home once daily and up to four times daily as needed for 4 weeks. Pain was measured both acutely and weekly during the 4 weeks of treatment using the numeric rating scale. Congestion and medication use data were collected weekly using the Congestion Quantifier 7 (CQ7) and medication diary, respectively. Results Thirty patients were enrolled and completed the study. Microcurrent therapy rapidly reduced post-treatment numeric rating scale for pain by − 1.2 at 10 mins (p = 0.0076), − 1.6 at 1 hr (p = 0.0007), − 1.9 at 2 hrs (p

Background: Endobronchial ultrasound (EBUS) with transbronchial needle aspiration increases the diagnostic yield of lung cancer staging. The left adrenal gland (LAG) is a common site for lung cancer metastasis. The modality of transesophageal examination with an EBUS bronchoscope (EUS-B) routinely for LAG has not been assessed. Objective: The aim of this study was to prospectively assess if evaluation and tissue sampling of the LAG could routinely be implemented in an EBUS procedure. Methods: Patients referred for EBUS between March and August 2017 had assessment of the LAG via EUS-B. Fine-needle aspiration (FNA) was performed in cases with a suspicious LAG. The detection rate, procedure time, and learning curve of four experienced EBUS-bronchoscopists was assessed, plus the diagnostic accuracy and complication rate of FNA. Results: In total, 313 consecutive patients were included. The overall LAG detection rate was 87.5%. After the initial learning curve, the detection rate for all four bronchoscopists was >93%. The detection rate did not correlate with any patient characteristics. EUS-B-FNA revealed nine LAG metastases, with a sensitivity, specificity, and accuracy of 75%, 100%, and 99%, respectively. The mean EUS-B operation time was 194.4 s, with 594.8 s for FNA. There were no FNA-associated complications. Conclusions: Evaluation of the LAG with EUS-B could routinely be included in an EBUS procedure if necessary. A high detection rate can be achieved after an initial learning period. FNA of the LAG was feasible and safe. EUS-B of the LAG could be integrated into the usual EBUS/EUS-B procedure in lung cancer staging workup.

Introdução: Nutricosméticos têm sido utilizados como suplementos para crescimento capilar no tratamento de alopecias não cicatriciais, porém não existem estudos sobre o uso desses produtos em indivíduos abaixo de 18 anos de idade. Objetivo: Avaliar a eficácia e a tolerabilidade do uso de um produto nutricosmético à base de proteoglicanos em indivíduos menores de 18 anos, portadores de alopecias não cicatriciais. Métodos: Ensaio clínico, não controlado e prospectivo. Portadores de alopecias não cicatriciais, de ambos os sexos, com faixa etária entre seis e 18 anos, receberam nutricosmético contendo proteoglicano por seis meses. Fotos padronizadas pré e pós-tratamento foram avaliadas independentemente por três dermatologistas. Foi realizada contagem de fios em área de 1cm2 do couro cabeludo, e os pacientes responderam a questionário sobre melhora ou piora. Resultados: Foram incluídas 11 pacientes (100% do sexo feminino), nas quais 10 (91%) apresentaram melhora após seis meses, constatada por meio de avaliação fotográfica, contagem de fios e autoavaliação. Nenhuma paciente apresentou alergia. Duas pacientes apresentaram desconforto epigástrico transitório. Conclusões: O uso de nutricosmético à base de proteoglicanos foi eficaz e bem tolerado em crianças e adolescentes portadores de alopecias não cicatriciais.

To asses drains amylase (DA) cut-offs for the risk of clinically relevant postoperative pancreatic fistula (POPF) and define the optimal timing of drains removal based on daily DA assay and abdominal CT scan finding after pancreatoduodenectomy (PD). Different algorithms able to identify patients at higher risk of POPF and to assess the optimal time for drains removal after PD have been proposed. The most accurate DA cut-offs in the assessment of the risk of clinically relevant POPF were retrospectively identified. Data from a prospective trial for optimal timing of drains removal were analyzed. Then, to validate the cut-offs identified in the first phase, they were applied to the patients enrolled in the prospective trial. Patients with POD1 DA ≥ 666 U/L were at higher risk of clinically relevant POPF (p 0.0001). POD3 DA value ≥ 252 U/L predicted 88% of clinical relevant fistulas. POD3 DA level ≥ 207 U/L was able to predict 68% of biliary fistulas. Patients with abdominal collection ≥ 5 cm, showed a significantly higher rate (60% vs. 23%, p

Background While laparoscopic approach for right hemicolectomy (LRH) is considered appropriate for the surgical treatment of both malignant and benign diseases of right colon, there is still debate about how to perform the ileo-colic anastomosis. The ColonDxItalianGroup (CoDIG) was designed as a cohort, observational, prospective, multi-center national study with the aims of evaluating the surgeons’ attitude regarding the intracorporeal (ICA) or extra-corporeal (ECA) anastomotic technique and the related surgical outcomes. Methods One hundred and twenty-five Surgical Units experienced in colorectal and advanced laparoscopic surgery were invited and 85 of them joined the study. Each center was asked not to change its surgical habits. Data about demographic characteristics, surgical technique and postoperative outcomes were collected through the official SICE website database. One thousand two hundred and twenty-five patients were enrolled between March 2018 and September 2018. Results ICA was performed in 70.4% of cases, ECA in 29.6%. Isoperistaltic anastomosis was completed in 85.6%, stapled in 87.9%. Hand-sewn enterotomy closure was adopted in 86%. Postoperative complications were reported in 35.4% for ICA and 50.7% for ECA; no significant difference was found according to patients’ characteristics and technologies used. Median hospital stay was significantly shorter for ICA (7.3 vs. 9 POD). Postoperative pain in patients not prescribed opioids was significantly lower in ICA group. Conclusions In our survey, a side-to-side isoperistaltic stapled ICA with hand-sewn enterotomy closure is the most frequently adopted technique to perform ileo-colic anastomosis after any indications for elective LRH. According to literature, our study confirmed better short-term outcomes for ICA, with reduction of hospital stay and postoperative pain. Trial registration Clinical trial (Identifier: NCT03934151).

Background One in eight women is diagnosed with breast cancer in the course of their life. As systematic palliative treatment has only a limited effect on survival rates, the concept of health-related quality of life (HRQoL) was developed for measurement of patient-centered outcomes. Various studies have already demonstrated the reliability of paper-based patient-reported outcome (pPRO) and electronic patient-reported outcome (ePRO) surveys and that the 2 means of assessment are equally valid. Objective The aim of this study was to analyze the acceptance and evaluation of a tablet-based ePRO app for breast cancer patients and to examine its suitability, effort, and difficulty in the context of HRQoL and sociodemographic factors. Methods Overall, 106 women with adjuvant or advanced breast cancer were included in a 2-center study at 2 major university hospitals in Germany. Patients were asked to answer HRQoL and PRO questionnaires both on a tablet on-site using a specific eHealth assessment website and on paper. The suitability, effort, and difficulty of the app and self-reported technical skills were also assessed. Only the results of the electronically acquired data are presented here. The results of the reliability of the pPRO data have already been published elsewhere. Results Patients regarded the ePRO assessment as more suitable (80/106, 75.5%), less stressful (73/106, 68.9%), and less difficult (69/106, 65.1%) than pPRO. The majority of patients stated that ePRO assessment improves health care in hospitals (87/106, 82.1%). However, evaluation of ePROs depended on the level of education (P=.003) in the dimensions of effort and difficulty (regression analysis). The app was rated highly in all categories. HRQoL data and therapy setting did not show significant correlations with the app’s evaluation parameters. Conclusions The results indicate that ePRO surveys are feasible for measuring HRQoL in breast cancer patients and that those patients prefer ePRO assessment to pPRO assessment. It can also be seen that patients consider ePRO assessment to improve hospital health care. However, studies with larger numbers of patients are needed to develop apps that address the needs of patients with lower levels of education and technical skills.

Aim.To improve the outcomes in patients with pancreatic head cancer using intraoperative radiotherapy (IORT).Material and methods.Prospective trial included patients with ductal adenocarcinoma of the pancreatic head who underwent pancreatic surgery followed by IORT.Results.There were 63 patients with pancreatic ductal adenocarcinoma for the period from January 2013 till December 2016. IORT was applied in 31 cases. Annual, 3-year survival and disease-free survival were analyzed.Conclusion.Surgery followed by IORT is safe and current approach for pancreatic head cancer.

Objective To analyze the association between each element of a hands-on intervention in childbirth and the incidence of obstetric anal sphincter injuries (OASIS). Study Design We conducted a prospective, interventional quality improvement project and implemented a care bundle with five elements at an obstetric department in Denmark with 3,000 deliveries annually. We aimed at reducing the incidence of OASIS. In the preintervention period, 355 vaginally delivering nulliparous women were included. Similarly, 1,622 nulliparous women were included in the intervention period. The association of each element with the outcome was estimated using a regression analysis. Results The incidence of OASIS went down from 7.0 to 3.4% among nulliparous women delivering vaginally (p = 0.003; relative risk = 0.48; 95% confidence interval [CI]: 0.30–0.76). Number needed to treat was 28. Logistic regression analysis showed that using hand on the head of the child significantly reduced the risk of OASIS (odds ratio = 0.28; 95% CI: 0.14–0.58). Conclusion Using a quality improvement framework, we documented the individual elements of the intervention. Hand on the infant's head reduced the risk of OASIS.

Although azacitidine is the first-line drug for higher-risk myelodysplastic syndrome (MDS) patients, its efficacy for lower-risk MDS remains unestablished. Therefore, we conducted a prospective study to examine the efficacy and safety of a 5-day regimen of azacitidine (AZA-5) for lower-risk MDS. The primary endpoint was hematological improvement (HI) after 4 courses of therapy. A total of 51 patients with lower-risk MDS based on the French-American-British (FAB) classification (44 patients with refractory anemia [RA] and 7 patients with refractory anemia with ringed sideroblasts [RARS]) were enrolled from 6 centers in Japan. The median age was 75 years (range: 51-88). These patients received AZA-5 (75 mg/m2 ; once daily for 5 sequential days). The median number of AZA-5 courses was 8 (range: 1-57), and 45 patients (88.2%) received more than 4 courses. HI and transfusion independency were seen in 24 patients (47.1%) and 11 patients (39.2%), respectively. A total of 11 patients (21.6%) achieved complete remission or marrow remission. WT1 mRNA levels were not significantly correlated with therapy response. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 26 (51.0%) and 11 (21.5%) patients, respectively. Nonhematological grade 3 or 4 adverse events were observed in 9 patients (17.6%). Together, these results indicate that AZA-5 is feasible and effective for lower-risk MDS patients as well as for higher-risk MDS patients.

Introduction Temporary external fixation is a viable option for numerous conditions and fixations in orthopaedic and trauma surgery. If the external fixator is left in place it is necessary to disinfect it prior to surgery, yet the subsequent risk for bacterial contamination of the surgical site originating from the external fixator remains unknown. Material and methods In a prospective study, samples were taken at the time of definitive osteosynthesis to assess bacterial contamination of the surgical site and the external fixator in twenty consecutive patients treated with temporary external fixation for closed fractures from October 2016 until March 2017. Results Twenty external fixators of twenty patients with complete sampling and a mean follow-up of seven months (range: 3–14) were available for analysis. Ten out of 120 cultures of the surgical site (8.3%) were positive for bacterial growth in a total of seven patients (35%). Pathogen’s detected were Propionibacterium acnes (60%) and Staphylococcus epidermidis (30%). No contamination of the external fixator was detected. Conclusion We conclude that the presented perioperative management to decontaminate external fixators allows for a safe definitive osteosynthesis in a staged protocol without increasing bacterial contamination of the surgical site. It is safe to leave the external fixator in place for definitive osteosynthesis.

Objective: Intrauterine growth restriction (IUGR) is one of the most serious complications of pregnancy. Up to date, there is no evidence of achieving antenatal treatment of IUGR with abnormal placentation. Although, Sildenafil citrate has shown promising results, there are no firm conclusion till now. The aim of our study is to evaluate the use of Sildenafil citrate in the treatment of IUGR cases associated with impaired placental circulation. Materials and methods: This was a prospective non-randomized study conducted at Mansoura university hospitals starting from March 2016 till October 2017. The studied population included singleton pregnancy and suffering from IUGR associated with impaired placental circulation. Results: This study included 50 pregnant women. Cases were divided into two groups. The first group received sildenafil citrate and the second control group did not receive sildenafil citrate. After 4 weeks after the 1st dose of Sildenafil significant decrease in umbilical artery Doppler indices. There was a statistically significant difference in the mean birth weight at delivery and neonatal admission to the newborn nursery in sildenafil group. Conclusion: sildenafil citrate treatment may present a new hope towards better perinatal outcomes for pregnancies complicated by IUGR and impaired placental circulation that may help to decrease neonatal admission to the newborn nursery. Keywords: IUGR, Sildenafil citrate, Impaired placental circulation, Doppler ultrasonography

A prospective trial suggests target infliximab trough levels of 3-7 μg/mL, yet data on additional therapeutic benefits and safety of higher trough levels are scarce.To explore whether high infliximab trough levels (≥7 μg/mL) are more effective and still safe.In this cohort study of 183 patients (109 Crohn's disease and 74 ulcerative colitis) on infliximab maintenance treatment at a tertiary referral center we correlated fecal calprotectin and C-reactive protein to trough levels (426 samples) at different time points during treatment. Rates of infections were compared in quadrimesters (four-month periods) with high trough levels to quadrimesters with trough levels7 μg/mL during 420 patient-years.Fecal calprotectin and C-reactive protein (median [interquartile range]) were lower in patients with high trough levels (fecal calprotectin 66 mg/kg [30-257]; C-reactive protein 3 mg/L [3-3]) compared to trough levels below 7 μg/mL (fecal calprotectin 155 mg/kg [72-474]; C-reactive protein 3 mg/L [3-14.5]) (p .001). High trough levels were superior also after excluding samples with trough levels3 μg/mL from analysis. No differences in rates of infections were observed in quadrimesters with high trough levels (16/129 [12.4%]) compared to quadrimesters with trough levels7 μg/mL (32/344 [9.3%]) (p = .32). Maintaining high trough levels resulted in 32% (interquartile range: 2-54%) increase of infliximab consumption.High infliximab trough levels provide better control of inflammation in inflammatory bowel disease without increasing the risk of infection.

Aim The recurrence rates of pruritus after stopping nalfurafine hydrochloride are unknown in chronic liver disease. Methods A prospective confirmatory trial was carried out to determine the recurrence rates of pruritus after cessation of nalfurafine hydrochloride in chronic liver disease. After pretreatment with nalfurafine hydrochloride for 4 weeks or more, 15 consecutive Japanese patients, who confirmed the improvement of pruritus (decrease in the visual analogue scale (VAS) of ≥50 mm), were enrolled in the present study. Patients were classified to the continuous group (continuation of nalfurafine hydrochloride for 4 weeks) or the discontinuous group (cessation of nalfurafine hydrochloride) at the time of consent to study protocol, by self-determination. Results The recurrence rates (increase in VAS of ≥25 mm after stopping nalfurafine hydrochloride) were 100% (5 of 5 patients) and 0% (0 of 10) in the discontinuous and continuous groups, respectively. In the discontinuous group, 3 patients selected retreatment with nalfurafine hydrochloride as salvage therapy, and they generally recovered to the levels of VAS at the discontinuation of treatment. Conclusion The present prospective trial showed the high recurrence rates of pruritus after the stop of nalfurafine hydrochloride in chronic liver disease.

This study examines the association between household air pollution from use of polluting cooking fuels and perinatal mortality in Bangladesh. We analysed the data from the Bangladesh Demographic and Health Surveys (BDHS) 2004, 2007, 2011, and 2014. The two outcome variables were stillbirth and early neonatal mortality. The exposure variable was type of primary cooking fuel used in the household (clean vs. polluting). Bivariate and multivariable analyses were conducted to obtain the crude and adjusted odds ratio (aOR), respectively. In the adjusted model, the exposure to polluting fuels was associated with early neonatal mortality (aOR: 1.46, 95% confidence interval [CI]: 1.01–2.10), but not with stillbirth (aOR: 1.25, 95% CI: 0.85–1.84). The effect of cooking with agricultural crop waste was greater for stillbirth (aOR: 1.76, 95% CI: 1.10–2.80) and for early neonatal mortality (aOR: 1.78, 95% CI: 1.13–2.80) which was also associated with wood as the main fuel (aOR: 1.52, 95% CI: 1.04–2.21). Using polluting fuels in an indoor kitchen was associated with an increased odds of stillbirth (aOR: 4.12, 95% CI: 1.49–11.41). Cooking with polluting fuels is associated with perinatal mortality. The combined association of polluting cooking fuels and indoor kitchen location was greater for stillbirth. This effect and the effect of different fuel types need further investigation. Although this is a large sample, there are some limitations with the BDHS data in both recording the exposure and the outcomes. A large prospective trial is needed to determine the precise effect size.

Aims/Introduction Hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus fluctuate throughout the year. However, there are few studies that have evaluated the therapeutic effect of hypoglycemic agents while considering such fluctuations. In a multicenter study (Januvia Multicenter Prospective Trial in Type 2 Diabetes Study), pretreatment patients with type 2 diabetes mellitus were divided into seven groups and given sitagliptin for 1 year. The aim of the present study was to evaluate the differences in the therapeutic effect, and the efficacy of sitagliptin in patients with type 2 diabetes mellitus based on the month the administration of the drug began as a subanalysis of the Januvia Multicenter Prospective Trial in Type 2 Diabetes Study. Materials and Methods Patients with type 2 diabetes mellitus were divided into four groups according to the month of initiation of sitagliptin. Changes in HbA1c in each group were compared at 3 and 12 months after administration of sitagliptin. As a negative correlation has been reported between baseline HbA1c and the degree of change after administration of sitagliptin, an analysis using the residual error from the approximate line was carried out. Results In the analysis of the degree of change in HbA1c, patients in the group in which administration of sitagliptin was started between August and October had the lowest degree of improvement at 3 months after starting sitagliptin. However, there was no significant intergroup difference in improvement at 12 months after the start of sitagliptin. The same result was also obtained in residual analysis. Conclusions The present study suggested that the season of administration of sitagliptin influenced the subsequent hypoglycemic effect even after analysis excluding the influence of HbA1c value at the start of treatment. This study provides possibility, showing that seasonal fluctuations have an effect on the efficacy of antidiabetic drugs.

BACKGROUND AND AIMS Various methods have been reported as aids to cecal intubation. This study aimed to prospectively investigate whether an abdominal obstetric binder (AOB) used during pregnancy and attached to the patients' abdomen during colonoscopy could facilitate effective colonoscopic insertion. METHODS This was a prospective study of 451 consecutive outpatient colonoscopies performed by a single experienced endoscopist. The recruited patients were randomly separated into two groups that received colonoscopy either with (Group A) or without an AOB attached (Group B). The cecal intubation time, cecal intubation length of the colonoscope, use of manual pressure, position change of each patient, and the number of patients with abdominal distension were collected for comparison. RESULTS A total of 451 patients (224 in Group A and 227 in Group B) were ultimately included in this study. In Group A, cecal intubation time and cecal intubation length of colonoscope (CIL) were significantly reduced (P

Aim: The Methylene Blue (MB) is commonly used dye for Sacrococcygeal Pilonidal Sinus Disease (SPSD). The aim of this randomized prospective trial was to determine the benefits and effectiveness of (MB) for (SPSD) by comparing the results of Karydakis flap procedure. Patients and Methods: Between January 2016 and April 2017, a total of 100 patients with sacrococcygeal pilonidal sinus disease were randomly assigned to two equal groups which underwent Karydakis flap procedure with or without MB usage. Patients age, gender, BMI, duration of the disease and number of the orifices, excised specimen height, width, area, circumference, depth, volume,postoperative complications and duration of hospital stay were recorded. Results: Characteristics of the patients were similar in both groups. In the MB used group all the parameters except the depth of the excised specimens found as statistically significant (p

Aims The aim of this study was to evaluate the long-term inducible displacement of cemented tibial components ten years after total knee arthroplasty (TKA). Patients and Methods A total of 15 patients from a previously reported prospective trial of fixation using radiostereometric analysis (RSA) were examined at a mean of 11 years (10 to 11) postoperatively. Longitudinal supine RSA examinations were acquired at one week, one year, and two years postoperatively and at final follow-up. Weight-bearing RSA examinations were also undertaken with the operated lower limb in neutral and in maximum internal rotation positions. Maximum total point motion (MTPM) was calculated for the longitudinal and inducible displacement examinations (supine versus standing, standing versus internal rotation, and supine versus standing with internal rotation). Results All patients showed some inducible displacement. Two patients with radiolucent lines had greater mean standing-supine MTPM displacement (1.35; sd 0.38) compared with the remaining patients (0.68; sd 0.36). These two patients also had a greater mean longitudinal MTPM at ten years (0.64; sd 0.50) compared with the remaining patients (0.39; sd 0.13 mm). Conclusion Small inducible displacements in well-fixed cemented tibial components were seen ten years postoperatively, of a similar magnitude to that which has been reported for well-fixed components one to two years postoperatively. Greater displacements were found in components with radiolucent lines. Cite this article: Bone Joint J 2018;100-B:170–5.

Background and study aims With magnifying narrow-band imaging (M-NBI) of the gastric mucosa, a characteristic demarcation line (DL) is occasionally found in non-cancerous depressed lesions. This DL forms multiple convex shapes along the edge of the epithelia of surrounding mucosa. We have termed this novel finding a multiple convex DL (MCDL). In this study, we clarified the prevalence of an MCDL in depressed gastric lesions detected in patients at high risk for gastric cancer and determined the diagnostic yield necessary to distinguish between cancer and non-cancer. Patients and methods This was a post hoc analysis of a multicenter prospective trial. In total, 362 small (≤ 10 mm) depressed lesions were detected in 1353 patients. Presence or absence of a DL in target lesions was evaluated on M-NBI images. The proportion of MCDLs among lesions with a DL was evaluated. Results Images of 347 lesions (39 cancerous and 308 non-cancerous) were evaluable. A DL was present in 252/347 lesions (73 %). When the cutoff value for the proportion of MCDLs needed to distinguish non-cancer from cancer was set at two-thirds, an MCDL was observed in 86/252 lesions (34 %). In 86 lesions with an MCDL, 83 (97 %) were non-cancerous. The sensitivity, specificity, positive predictive value, and negative predictive value of an MCDL for non-cancerous lesions were 38 %, 91 %, 97 %, and 19 %, respectively. Conclusions Presence of an MCDL had high specificity and positive predictive value for non-cancerous lesions. Evaluating the shape of the DL is useful for differentiation between cancer and non-cancerous lesions.

Background: The currently used D-dimer (DD) cutoff point is associated with a large number of negative CT-pulmonary angiographies (CTPA). We hypothesized presence of deficiency in the current cutoff and a need to look for a better DD threshold. Materials and Methods: We conducted a retrospective medical records analysis of all patients who had a CTPA as part of pulmonary embolism (PE) workup over a 1-year period. All emergency room (ER) patients who had DD assay checked prior to CTPA were included in the analysis. We assessed our institutional cutoff point and tried to test other presumptive DD thresholds retrospectively. Results: At our institution 1591 CTPA were performed in 2014, with 1220 scans (77%) performed in the ER. DD test was ordered prior to CTPA imaging in 238 ER patients (19.5%) as part of the PE workup. PE was diagnosed in 14 cases (6%). The sensitivity and specificity of the currently used DD cutoff (0.5 mcg/mL) were found to be 100% and 13%, respectively. Shifting the cutoff value from 0.5 to 0.85 mcg/mL would result in a significant increase in the specificity from 13% to 51% while maintaining the same sensitivity of 100%. This would make theoretically 84 CTPA scans, corresponding to 35% of CTPA imaging, unnecessary because DD would be considered negative based on this presumptive threshold. Conclusions: Our results suggest a significant deficiency in the institutional DD cutoff point with the need to find a better threshold through a large multicenter prospective trial to minimize unnecessary CTPA scans and to improve patient safety.

Background: Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy...

Study objective In the initial description of the serratus anterior plane block (SAPB), both superficial and deep SAPB provided effective blockade. The purpose of this study was to investigate the difference in opioid consumption and postoperative analgesia between superficial and deep SAPB for patients undergoing mastectomy. Design Randomized prospective trial. Setting Academic hospital. Patients 64 women, >18 years of age, ASA I-III, undergoing single or bilateral mastectomy, with and without lymph node biopsy, with and without tissue expander reconstruction. Intervention Either superficial or deep SAPB by an ultrasound-guided technique in addition to multimodal analgesia. Measurements The primary outcome was opioid consumption in the first 24 h. Secondary outcomes were pain scores, satisfaction scores, incidence of PONV, length of stay and block performance time. Results Subjects who received a deep SAPB required 30% less oral morphine equivalents (OME) (113.5 mg vs. 147 mg, p = 0.009) and reported lower pain scores. There were no significant differences in satisfaction scores, incidence of PONV, LOS, or block performance time between the two groups. Conclusion There was a significant difference in opioid consumption between the deep and superficial SAPB groups. Subjects in the deep SAPB group had lower pain scores at 12 h; however, the difference was not statistically significant at other time points. While both the superficial and the deep SAPB can be used for post-operative analgesia in patients undergoing mastectomy, our study suggests that the deep SAPB may improve analgesia to a greater degree than the superficial SAPB as shown through decreased opioid consumption of 30% over a 24-h period post-block. Clinical trial number and registry URL clinicaltrials.gov : NCT03154658

Summary Total mesorectal excision (TME) is a standard surgical procedure for rectal cancer. Robotic surgery has the potential to minimize the disadvantages of laparoscopic rectal resection. Circumferential margin and macroscopic quality assessment of the resected specimen are the major prognostic factors for local recurrence of the disease. The aim of this study was to research the macroscopic assessment of the quality of TME after robotic-assisted rectal resections for rectal cancer performed in a single center. Data was prospectively collected about macroscopic assessment of the quality of TME in thirteen patients after robotic-assisted rectal resections for rectal cancer between 09.04.2014 and 31.12.2016. After all robotic TMEs, a pathologist made macroscopic assessment of the completeness of the mesorectal excision. The quality of TME was complete in 12 cases and nearly complete in one case. The circumferential and distal resection margins were negative in all cases. The mean number of harvested lymph nodes was nine. This study indicated that using robotic surgery for rectal cancer does not lead to worsening the quality of TME. Further studies in this field are necessary.

Context: The lack of efficacy of octreotide in the medical treatment of Cushing’s disease (CD) may result from suppressive effects of hypercortisolism on somatostatin receptor subtype 2 (SST2) expression by corticotroph adenomas. We previously demonstrated that SST2 mRNA expression levels in corticotroph tumor cells from patients preoperatively treated with cortisol-lowering therapy are significantly higher compared to those from patients with uncontrolled CD at time of surgery. It may be hypothesized that control of cortisol production induced by steroidogenesis inhibitors may reverse SST2 expression and increase efficacy of tumor-directed therapy with octreotide. Objective: To evaluate the efficacy of a sequential strategy of initiation treatment with ketoconazole (KTC) to reduce cortisol levels, followed by octreotide as maintenance therapy in patients with CD. Patients and Design: 14 adult patients with CD were prospectively enrolled. All patients started on KTC (600-800 mg/day), and once cortisol levels were normalized, octreotide 20 mg/4 weeks was initiated which could eventually be increased to 30 mg/4 weeks. After two months of combined therapy, patients were maintained on octreotide monotherapy until the end of the study period (9 months). Treatment success was assessed by the mean of 2 collections of urinary free cortisol (UFC) levels. Results: The mean age of our study population (14 patients) was 48.6 years, 64% (n=8) were female, 85% (n=12) were newly diagnosed and naïve in treatment. Ketoconazole was able to normalize UFC level in 11 (79%) patients. Subsequently, octreotide effectively sustained normal UFC levels in 3 patients (27%) (responders). Four (36%) other patients showed a partial response to octreotide. In 3 patients, normal UFC levels were sustained for one- or two-months following discontinuation of KTC and in the other partial responder, the UFC levels at follow-up decreased by at least 50% of the baseline levels. The remaining 4 (36%) patients developed hypercortisolism as soon as ketoconazole was stopped (non-responders). Responders to octreotide had lower UFC levels at baseline when compared to partial and non-responders (1.40 ± 0.06 vs. 2.05 ± 0.20 ULN, p=0.08). Two of three responders showed improvement in weight, waist circumference, and systolic and diastolic blood pressure during the treatment period. In terms of side effects, one patient discontinued KTC because of gastrointestinal intolerance and 5 patients had a transient increase in liver enzymes. Conclusions: This proof-of-concept study shows that the sequential treatment with ketoconazole to lower cortisol levels followed by octreotide to maintain normal cortisol production seems effective in a subset of patients with mild CD. Ongoing studies aim to evaluate whether this is the result from increased SST2 expression in corticotroph adenomas.

Background: We investigated whether Neuron-specific enolase (NSE) serum concentration predicts long-term mortality and poor neurological outcome in adult cardiac arrest patients. Methods: Within this prospective observational study, we included consecutive adult patients admitted to the intensive care unit (ICU) after cardiac arrest. NSE was measured upon ICU admission and on days 1, 2, 3, 5 and 7. Results: Of 403 patients, 176 (43.7%) survived. Median follow-up duration was 43.7 months (IQR 14.3 to 63.0 months). NSE levels on day 3 were increased more than threefold in non-survivors compared to survivors (median NSE (ng/mL) 19.8 (IQR 15.7 to 27.8) vs. 72.6 (IQR 26 to 194)) and showed the highest prognostic performance for mortality compared to other days of measurement, with an AUC of 0.81 and an adjusted hazard ratio of 1.55 (95% CI 1.41 to 1.71, p &lt, 0.001). Subgroup analysis showed an excellent sensitivity and negative predictive value of 100% of NSE in patients &lt, 54 years of age. Conclusion: NSE measured three days after cardiac arrest is associated with long-term mortality and neurological outcome and may provide prognostic information that improves clinical decision making. Particularly in the subgroup of younger patients (&lt, 54 years), NSE showed excellent negative predictive value.

Background: Chronic red blood cell (RBC) transfusion is an established therapy to prevent stroke in patients with sickle cell anemia (SCA). Chronic transfusion, however, requires considerable blood resources and has risks so a strategy to decrease transfusion requirements is highly desirable especially given blood shortages. Chronic transfusion also can fail to prevent progressive cerebrovascular disease so further optimization of this therapy is needed. Hydroxyurea has been studied as an alternative to chronic transfusion, but alone it provides inadequate cerebrovascular protection for patients at highest risk for stroke. Combination therapy hydroxyurea and transfusion (HAT) may provide benefits over either therapy alone because each ameliorates the pathology of SCA via different mechanisms. To evaluate the feasibility and impact of HAT on transfusion requirements, we conducted a single-arm clinical trial (NCT03644953). Methods: Pediatric patients with SCA already receiving simple chronic transfusion for stroke prevention for at least one year were approached. Patients with poor adherence to chronic transfusion defined by having a hemoglobin (Hb) S >45% and a transfusion interval >5 weeks in the last year were excluded. Enrolled patients were started on hydroxyurea 20 mg/kg/day and continued on simple chronic transfusions with the same transfusion protocol. Transfusion volumes were based on the pre-transfusion Hb to achieve a target post-transfusion Hb of 11.5-12.0 g/dL. Hydroxyurea was dose escalated to achieve a HAT target dose (HAT-TD) defined by either an absolute neutrophil count 10g/dL with HbS >30%. Transfusion volumes and pre-transfusion laboratory values were compared the year before HAT and the year after HAT-TD. Results: A total of 19 eligible patients were offered participation and 14 enrolled (74% recruitment ratio). The median age was 11.2 years (range 5.3-19.8). The primary indication for chronic transfusion was history of an abnormal transcranial Doppler ultrasound (n=7), overt stroke (n=6), and progression of cerebral vasculopathy (n=1). Five participants ended the study prematurely (care transferred to another hospital, nonadherence to transfusions, patient desire to not take medications, hair thinning, family concern after a hospitalization); none had a serious adverse event that was attributed to HAT. Among the 9 participants who completed the study, the median HAT-TD was 25 mg/kg/dose (range 20-30) and was achieved after a median of 18 weeks (range 0-26). The median hydroxyurea adherence ratio, measured by pill counts, was 91%. One patient with baseline splenomegaly developed splenic sequestration requiring hospitalization; there were no other serious adverse events attributed to HAT. One patient developed a pre-transfusion Hb >11 g/dL and HbS >45%. This patient had hydroxyurea held for 12 weeks and was changed to partial manual exchange transfusions. With HAT, patients had a significant increase in pre-transfusion total Hb, HbS, HbF, and MCV; and a significant decrease in ANC and LDH (Table). After HAT-TD, 8/9 participants received fewer RBCs with a significant median RBC volume reduction of 19.4 ml/kg/year (p=.02, Figure). The single patient who received more RBCs after HAT-TD had suspected nonadherence to hydroxyurea returning only 33% of dispensed hydroxyurea bottles. While receiving HAT 8/9 patients had brain magnetic resonance imaging for clinical monitoring after a median of 75 weeks (range 29-100), no patient had a new infarct or progressive vasculopathy. Conclusion: Hydroxyurea added to chronic transfusion therapy for patients with SCA is feasible. HAT effectively decreases transfusion volumes so can help conserve blood resources. While Hb S% increases with HAT, this increase is relatively small and markers of hemolysis improved. Most patients are able to safely continue simple transfusions when hydroxyurea is added, but a few may require exchange transfusions. The effect of HAT on cerebrovascular disease warrants further study. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.