Measures of accommodative function in secondary school year 9 and year 13: a 4-year longitudinal study.

PURPOSE: To characterize accommodative function in secondary school children in year 9 and year 13 and assess the possible relationship between daily working conditions (number of near work hours and distances) and accommodation variables related to accommodative excess. METHODS: This was a prospective study. Participants were 43 subjects who were first examined in year 9 and then again when they were in year 13. The accommodation variables measured in each session were as follows: accommodation amplitude (AA), accommodative response (AR), monocular and binocular accommodation flexibility (MAF and BAF), negative relative accommodation (NRA), and positive relative accommodation (PRA). Other data recorded were the number of hours spent working at near vision tasks and the distances used for these tasks. Participants were classified as those with accommodation variables within the normal range (NA) and those with variables suggesting accommodative excess (AE). RESULTS: Several accommodative function variables were below normative values in both year 9 and year 13. The number of subjects classified as having AE went from 27.9% in year 9 to 58.1% in year 13 according to AR (p < 0.005) and from 23.3 to 46.5% according to MAF (p = 0.024). More near work was reported in year 13 (44.6 h/week) than year 9 (32.7 h/week) (p < 0.001). It emerged that subjects in year 13 spent more hours working at near if they had AE than if they were assigned to the NA group. No differences were detected in near work distances used by subjects in the NA and AE groups in both years. CONCLUSIONS: In both school years, values outside the norm were detected in several accommodative function measures. Also, devoting more hours to near work was linked to a greater extent of accommodative excess. We would therefore recommend regular accommodative function assessment in secondary school children.

A Predictive Score of Antitumour Activity of Novel Agents in Cancer Patients Treated in Early Phase Studies.

INTRODUCTION: Phase I trials aim to determine the maximum-tolerated dose of a particular drug while minimizing the number of patients exposed to either sub-therapeutic doses or severe toxicity. Thus, patient selection for phase I trials is a key component of any clinical trial design. Though several studies have been made to address this issue, patient selection still represents a major clinical challenge that needs further investigation. METHODS: Twenty-nine baseline clinical and analytical characteristics of 773 consecutive patients treated in phase I trials between 2008 and 2016 in START Madrid-CIOCC were analysed and correlated to objective response (OR), progression-free survival, median overall survival, toxicity, and treatment type. The ones associated to OR in the univariate analysis were included in the stepwise logistic regression multivariate and Cox analysis. The statistically significant ones were included in a predictive score (named here as the Madrid score) of antitumour activity. RESULTS: Body mass index (BMI) >25 (p = 0.027), two or less previous lines of treatment (p = 0.007), and normal levels of alkaline phosphatase (ALP) (p = 0.007) were found to positively correlate to radiological response. A Madrid score was generated using these three factors as predictive parameters: compared to a score of 2-3 (where 2 or 3 of these variables are altered), a score of 0-1 is associated with longer survival time (11.6 vs. 8.6 months; p = 0.005) and overall response (17 vs. 7.6%; p = 0.003). CONCLUSION: The predictive Madrid score, based on the BMI, number of prior lines of treatment, and ALP levels, might be helpful to accurately select patients who would benefit from oncology phase I clinical trials.

AT2R stimulation with C21 prevents arterial stiffening and endothelial dysfunction in the abdominal aorta from mice fed a high-fat diet.

The aim of the present study was to evaluate the effect of Compound 21 (C21), a selective AT2R agonist, on the prevention of endothelial dysfunction, extracellular matrix (ECM) remodeling and arterial stiffness associated with diet-induced obesity (DIO). Five-week-old male C57BL/6J mice were fed a standard (Chow) or high-fat diet (HF) for 6 weeks. Half of the animals of each group were simultaneously treated with C21 (1 mg/kg/day, in the drinking water), generating four groups: Chow C, Chow C21, HF C, and HF C21. Vascular function and mechanical properties were determined in the abdominal aorta. To evaluate ECM remodeling, collagen deposition and TGF-ß1 concentrations were determined in the abdominal aorta and the activity of metalloproteinases (MMP) 2 and 9 was analyzed in the plasma. Abdominal aortas from HF C mice showed endothelial dysfunction as well as enhanced contractile but reduced relaxant responses to Ang II. This effect was abrogated with C21 treatment by preserving NO availability. A left-shift in the tension-stretch relationship, paralleled by an augmented ß-index (marker of intrinsic arterial stiffness), and enhanced collagen deposition and MMP-2/-9 activities were also detected in HF mice. However, when treated with C21, HF mice exhibited lower TGF-ß1 levels in abdominal aortas together with reduced MMP activities and collagen deposition compared with HF C mice. In conclusion, these data demonstrate that AT2R stimulation by C21 in obesity preserves NO availability and prevents unhealthy vascular remodeling, thus protecting the abdominal aorta in HF mice against the development of endothelial dysfunction, ECM remodeling and arterial stiffness.

Tumor Grade Correlation Between Preoperative Biopsy and Final Surgical Specimen in Endometrial Cancer: The Use of Different Diagnostic Methods and Analysis of Associated Factors.

OBJECTIVE: This study aimed to identify the correlation between histology tumor grade of the preoperative biopsy using dilatation and curettage (D&C), Pipelle, or hysteroscopy and final surgical specimen in women with endometrioid endometrial cancer. MATERIALS AND METHODS: Patients on whom a preoperative biopsy was performed between 2009 and 2016 were reviewed and cases with apparent early-stage endometrioid endometrial cancer were included in the study. The accuracy of preoperative biopsy performed before hysterectomy using D&C, Pipelle, or hysteroscopy was compared. RESULTS: A total of 332 patients were included. The diagnostic method was D&C in 43 cases (13%), Pipelle in 102 (31%), and hysteroscopy in 187 (56%). The preoperative diagnosis included G1 tumors in 177 cases (53.3%), G2 in 103 (31%), and G3 in 52 (15.6%). The surgical specimen confirmed endometrioid endometrial tumor in 309 patients (93%).The accuracy rates of preoperative biopsy and surgical specimen were 74.69%, 73.19%, and 89.75% for G1, G2, and G3, respectively. Hysteroscopy showed better κ index (κ = 0.551) than did D&C (κ = 0.392) and Pipelle (κ = 0.430). Tumor diameter greater than 30 mm was the only factor independently associated with absence of correlation between preoperative and postoperative tumor grade (odds ratio [95% confidence interval], 1.959 [1.096-3.504], P = 0.023). CONCLUSIONS: Preoperative biopsy, regardless of the method, has its limitations in predicting the tumor grade compared with final surgical specimen in women with endometrioid endometrial cancer at an apparent early stage. Concordance between the biopsy and hysterectomy specimen is less likely to happen in the case of preoperative G1 or G2 tumors, as well as in big tumors. Although hysteroscopy was associated with the highest tumor grade agreement, no differences in correlation between the 3 methods (D&C, Pipelle, and hysteroscopy) were found.

Four Surgical Approaches to Cervical Excision During Laparoscopic Radical Trachelectomy for Early Cervical Cancer.

STUDY OBJECTIVE: To compare the clinical and oncological outcomes of four different approaches of cervical excision (CE) during radical trachelectomy (RT) for early cervical cancer. DESIGN: A retrospective comparative observational study was performed at Gynecology Department of the Hospital Italiano de Buenos Aires in Buenos Aires, Argentine. The study was composed of all consecutive women who had undergone laparoscopic RT for early cervical cancer between May 2011 and July 2016. They were divided in four groups according with different surgical approaches to perform the CE during RT; which are also detailed. (Canadian Task Force Classification III). SETTING: Tertiary care hospital. INTERVENTION: CE during radical trachelectomy for early cervical cancer. MEASUREMENT AND MAIN RESULTS: A total of 7, 6, 6 and 3 patients undergone Type A, B, C and D cervical excision during RT, respectively. No significant differences in terms of age, BMI, surgical time and length of hospital stay were found according with different types of CE. Patients in Type D had, however, a significantly higher EBL, p =.006. Similar histology characteristics in terms of histology type, tumor grade and size, as well as lymph node count were observed among groups. Only grade 1-2 postoperative complications were noted in 9 patients. One local recurrence after Type B CE was treated with radical surgery plus chemoradiaton; while other patient after Type A CE relapsed with peritoneal carcinomatosis managed with chemotherapy. CONCLUSION: Different types of cervical excision that are here described should be used according to each case based on specific clinical factors.

Clinical and Oncologic Outcomes of Robotic Versus Abdominal Radical Hysterectomy for Women With Cervical Cancer: Experience at a Referral Cancer Center.

OBJECTIVES: To compare the clinical and oncologic outcomes of robotic radical hysterectomy (RRH) vs abdominal radical hysterectomy (ARH) in patients with cervical carcinoma. METHODS: A retrospective analysis of women who underwent radical hysterectomy for cervical cancer from December 2006 to December 2014 at European Institute of Oncology was performed. Patients who underwent RRH were compared with women operated on by ARH. The groups were matched by age, body mass index, tumor size, International Federation of Gynecology and Obstetrics stage, comorbidity, previous neoadjuvant chemotherapy, histology type, and tumor grade. RESULTS: A total of 203 and 104 women who underwent RRH and ARH, respectively, were analyzed. Baseline characteristics, stage of disease, histology type, and grade of differentiation were similar between groups. Surgical time was significantly shorter in the ARH group (208 vs 282 minutes, P ≤ 0.001). Robotic radical hysterectomy was associated with significantly less estimated blood loss (219 vs 104 mL, P = 0.001) and with significantly shorter hospital stay (5.2 vs 3.9 days, P ≤ 0.001). Abdominal radical hysterectomy was correlated with a significantly higher number of lymph nodes removed (25.8 vs 22, P = 0.003). None of the robotic procedures required conversion to laparotomy. A significantly higher number of patients in ARH required postoperative transfusion (11 [10.5%] vs 6 [2.9%], P = 0.006). Lower extremity lymphedema was significantly higher in ARH (28 [27.5%] vs 17 [8.3%], P = 0.001). Recurrence rates as well as progression-free survival and overall survival were similar between groups at a median follow-up of 41.64 months. CONCLUSIONS: Robotic radical hysterectomy is safe and feasible and is associated with improved clinical outcomes. Although longer follow-up is needed, early data show equivalent oncologic outcomes compared with other surgical modalities.

Robotic Versus Open Radical Hysterectomy in Women With Locally Advanced Cervical Cancer After Neoadjuvant Chemotherapy: A Single-institution Experience of Surgical and Oncologic Outcomes.

STUDY OBJECTIVE: To compare the surgical and oncologic outcomes of robotic radical hysterectomy (RRH) versus laparotomy in women with locally advanced cervical cancer (LACC) after neoadjuvant chemotherapy (NACT). SETTING: Oncology referral center. DESIGN: A retrospective comparative observational study was performed in 30 patients with LACC Fédération Internationale de Gynécologie et d'Obstétrique stage IB2-IIB who underwent RRH after NACT between February 2008 and December 2014. This group was compared with a cohort of 44 patients with similar characteristics who underwent abdominal radical hysterectomy after NACT (Canadian Task Force classification II2). PATIENTS: Patients with LACC FIGO stage IB2-IIB. INTERVENTIONS: A retrospective comparative observational study. MEASUREMENTS AND MAIN RESULTS: The mean (standard deviation [SD]) operative time was significantly longer in the robotic group (307.8 minutes [40.2] vs 233.7 minutes [61.9], p ≤ .001). On the contrary, the mean (SD) estimated blood loss was significantly lower in the robotic group (111.0 mL [69.6] vs 286.9 mL [159.1], p ≤ .001), and length of stay was significantly shorter (4.1 [2.4] days vs 5.8 days [3.3], p = .015). The incidence of intraoperative and early and late complications was not statistically significantly different between the 2 groups. The mean (SD) follow-up of patients was 35.6 months (28.4) and 43.7 months (23.2) in the open and robotic groups, respectively (p = .137). The disease recurrence rate (27.2% vs 20%) was similar between the 2 groups; sites and types of recurrences were also similar. Kaplan-Meier survival analysis for median progression-free survival and median overall survival were not statistically different comparing cohorts by surgery type. CONCLUSIONS: RRH after NACT in women with LACC is associated with similar perioperative and oncologic outcomes to open procedure. These results require further investigation to establish a more robust conclusion.

Use of TachoSil® to Prevent Symptomatic Lymphocele after an Aggressive Tumor Debulking with Lymphadenectomy for Advanced Stage Ovarian Cancer. A Pilot Study.

OBJECTIVE: To describe the incidence of symptomatic lymphocele (SLC) after an aggressive tumor debulking surgery and lymphadenectomy in patients with ovarian cancer and peritoneal carcinomatosis with or without TachoSil®. MATERIAL AND METHODS: A pilot retrospective comparative observational study was performed between patients with advanced ovarian cancer International Federation of Gynecology and Obstetrics stages III-IV who underwent complete debulking surgery and radical retroperitoneal lymphadenectomy. In 18 patients, 4 TachoSil® patches were placed in the retroperitoneal area, since January 2014-October 2014. This group was compared with other 18 consecutive patients matched by age, International Federation of Gynecology and Obstetrics stage, surgical complexity, American Society of Anesthesiologists score, comorbidity, and BMI without the use of TachoSil®. RESULTS: Baseline characteristics were similar between groups. There were no statistically significant differences in terms of surgical complexity, surgical time, estimated blood loss, node removed, length of hospital stay, and complications between groups. SLC was diagnosed in 7 patients (38.8%) without TachoSil®, and in 2 patients (11.1%) with TachoSil® (p = 0.121). The use of TachoSil® was associated with a statistically significant lower re-admission rate (p = 0.041) and with a significantly shorter time to adjuvant chemotherapy (p = 0.02). CONCLUSIONS: Using TachoSil® in women with advanced stage ovarian cancer who underwent radical debulking with retroperitoneal lymph node dissection is associated with a non-statistically significant reduction in the incidence of SLC. A larger-scale randomized controlled study should be conducted to confirm our preliminary results.

Surgical outcomes and complications of prophylactic salpingectomy at the time of benign hysterectomy in premenopausal women.

STUDY OBJECTIVE: To compare the surgical outcome and short-term postoperative complications in premenopausal women who had undergone hysterectomies for benign indication with or without prophylactic bilateral salpingectomy. DESIGN: A cohort of consecutive women who had undergone hysterectomy plus bilateral salpingectomy between May 2012 and July 2014 (group A) were compared with the same number of consecutive premenopausal patients who had undergone simple hysterectomy operated on before May 2012 (group B). Inclusion criteria included premenopausal women and benign indication for surgery (Canadian Task Force classification III). SETTING: tertiary care hospital. INTERVENTION: Salpingectomy versus no salpingectomy at the time of benign hysterectomy. MEASUREMENTS AND MAIN RESULTS: A total of 97 and 71 patients were included in groups A and B, respectively. No differences between the 2 groups were observed regarding patient characteristics. The average operative time, estimated blood loss, uterine size, and intraoperative complications were similar between groups. The mean (standard deviation) length of hospitalization time was 43.7 (22.4) hours in group A and 53.9 (83.5) hours in group B (p = .008). There were no significant differences in terms of the incidence of postoperative complications, emergency visits after readmission, and hospital readmission between both groups of patients. CONCLUSION: Prophylactic salpingectomy at the time of benign hysterectomy in premenopausal women is safe and feasible and does not worsen surgical outcomes or the incidence of intraoperative and postoperative complications.

Accuracy of ICG compared with technetium-99 m for sentinel lymph node biopsy in vulvar cancer.

PURPOSE: Sentinel lymph node biopsy with radioactive tracer is the standard-of-care in lymph node status assessment in vulvar cancer. Indocyanine green fluorescence-ICG is a promising detection method, due to its advantages over technetium-99 m. In vulvar cancer, the procedure is controversial due to study heterogeneity and the small sample size in previous studies. This study evaluates ICG sentinel lymph node detection compared with the criterion-standard with technetium (dual modality method). METHODS: Preoperative technetium and intraoperative ICG for sentinel lymph node have been prospectively evaluated in early-stage vulvar cancer. The primary endpoint was to determine accuracy in the detection rate for ICG compared with technetium. Secondary objectives included tracer modality relationship with obesity, tumor size and location. RESULTS: In total, 75 patients participated at 8 centers; 38 had lateral and 37 had midline vulvar tumors. The overall sentinel lymph node detection rate was 85.3 % for technetium and 82.7 % for ICG. For lateral tumors, the detection rate was 84.2 % vs. 89.5 %, while it was 86.5 % vs. 75.7 % for middle tumors, using technetium and ICG, respectively. The median sentinel node harvest was 1.7 (range 1-4), with 24 % metastatic involvement. The sensitivity and positive predictive value for ICG based on the standard technique with technetium was 91.08 % (95 % CI, 83.76-95.84) and 94.8 % (95 % CI, 84.84-96.48), respectively. No significant differences were found comparing the two tracers in patients with midline lesions, obesity (body mass index ≥ 30) and tumor size ≥ 2-4 cm. CONCLUSION(S): ICG shows comparable performance parameters to the gold-standard of radioisotope localization.

Oncological outcomes of intraperitoneal chemotherapy in advanced ovarian cancer: BRCA mutation role.

INTRODUCTION: The knowledge of BRCA status offers a chance to evaluate the role of the intraperitoneal route in patients selected by biomolecular profiles after primary cytoreduction surgery in advanced ovarian cancer. MATERIALS AND METHODS: We performed a retrospective, multicenter study to assess oncological outcomes depending on adjuvant treatment (intraperitoneal [IP] vs intravenous [IV]) and BRCA status (BRCA1/2 mutated vs. BRCA wild type [WT]). The primary endpoint was to determine progression-free survival. The secondary objectives were overall survival and toxicity. RESULTS: A total of 288 women from eight centers were included: 177 in the IP arm and 111 in the IV arm, grouped into four arms according to BRCA1/2 status. Significantly better PFS was observed in BRCA1/2-mutated patients with IP chemotherapy (HR: 0.35; 95% CI, 0.16-0.75, p = 0.007), which was not present in BRCA1/2-mutated patients with IV chemotherapy (HR: 0.65; 95% CI, 0.37-1.12, p = 0.14). Significantly better OS was also observed in IP chemotherapy (HR: 0.17; 95% CI, 0.06-043, p < 0.0001), but was not present in IV chemotherapy in relation with BRCA mutation (HR: 0.52; 95% CI, 0.22-1.27, p = 0.15). For BRCA WT patients, worse survival was observed regardless of the adjuvant route used. The IP route was more toxic compared to the IV route, but toxicity was equivalent at the long-term follow-up. CONCLUSION: This retrospective study suggests that BRCA status can help to offer an individualized, systematic treatment after optimal primary surgery for advanced ovarian cancer, but is limited by the small sample size. Prospective trials are essential to confirm these results.

Platinum-based neoadjuvant chemotherapy followed by radical surgery for cervical carcinoma international federation of gynecology and obstetrics stage IB2-IIB.

OBJECTIVE: The objective of this study was to determine the response rate to chemotherapy, as well as the progression-free survival (PFS), the overall survival (OS), and the main prognostic factors in patients treated at the European Institute of Oncology in Milan, Italy. METHODS: Retrospective data were collected on patients with uterine cervical carcinoma, International Federation of Gynecology and Obstetrics (FIGO) stage IB2 to IIB, who underwent platinum-based neoadjuvant chemotherapy (NACT) followed by radical hysterectomy. RESULTS: A total of 121 patients were studied. The median (range) age was 45 years old (23-69 years). The distribution of patients by International Federation of Gynecology and Obstetrics stage was as follows: n = 88 (73%) with stage IB2, n = 7 (6%) with stage IIA, and n = 26 (21%) with stage IIB. The median (range) tumor size was 50 mm (20-90 mm). Neoadjuvant chemotherapy involved a combination of cisplatin, paclitaxel, and ifosfamide in 80 patients (65%). Using this treatment, 112 patients (93%) received 3 cycles of NACT, whereas 6 (5%) received 4 cycles. Complete and partial pathology response was observed in 9 patients (7%) and 79 patients (66%), respectively. Adjuvant radiotherapy was not necessary in 65% of patients. A 5-year PFS and OS of 58% and 71%, respectively, were observed. Independent prognostic factors for PFS and OS were identified, including response to NACT, persistent lymph node metastases, and parametrial involvement. CONCLUSIONS: Neoadjuvant chemotherapy in this group of tumors is a promising treatment strategy and should be discussed with patients. Although these results are comparable to those obtained by standard chemoradiation treatment, one strategy should not be recommended over the other until the results of the ongoing phase 3 trial for NACT are released.

Optimal cytoreduction: is a CT's picture worth a surgeon's word?

INTRODUCTION: The presence of residual disease after cytoreductive surgery is subjectively determined by the surgeon at the end of the operation. Nevertheless, in up to 21-49% of CT scans, residual disease can be found. The aim of this study was to establish the relationship between post-surgical CT findings after optimal cytoreduction in patients with advanced ovarian cancer and oncological outcome. MATERIAL AND METHODS: Patients with advanced ovarian cancer (FIGO II and IV), diagnosed between 2007 and 2019 in Hospital La Fe Valencia, in whom cytoreductive surgery was performed, achieving R0 or R1, were assessed for eligibility (n = 440). A total of 323 patients were excluded because a post-operative CT scan was not performed between the third and eighth post-surgery week and prior to the start of chemotherapy. RESULTS: 117 patients were finally included. The CT findings were classified into three categories: no evidence, suspicious or conclusive of residual tumour/progressive disease. 29.9% of CT scans were "conclusive of residual tumour/progressive disease". No differences were found when the DFS (p = 0.158) and OS (p = 0.215) of the three groups were compared (p = 0.158). CONCLUSION: After cytoreduction in ovarian cancer with no macroscopic disease or residual tumour < 1 cm result, up to 29.9% of post-operative CT scans before chemotherapy found measurable residual or progressive disease. Notwithstanding, a worse DFS or OS was not associated with this group of patients.

Knee Isokinetic Profiles and Reference Values of Professional Female Soccer Players.

Few studies have previously evaluated isokinetic parameters in female soccer players in comparison to those in males. The aim of this study was to describe normative quadriceps (Q) and hamstring (H) muscle strength values in professional female soccer players and to examine differences between dominant leg (DL) and nondominant leg (NDL). A standardized test protocol of concentric knee extension and flexion test protocol was conducted using the dynamometer isokinetic system (IsoMEd 2000). All the participants were healthy female professional soccer players from Spanish first and second division teams. Players were assessed for peak torque (PT) and maximum work (MW) values at 60°/s, 180°/s, and 240°/s. The mean difference was 7.17 (p-value = 0.0036), 4.4 (p-value = 0.0386), and 4.25 Nm (p-value = 0.0241) at speed 60°, 180°, and 240°/s, respectively. No statistically significant differences were detected for H-Q values between DL and NDL. This difference was 6.44 (p-value = 0.0449), and 5.87 J (p-value = 0.0266) at speed 60°, and 180°/s. The present study can be a tool that health professionals working with female professional soccer players in their care can use to assess and monitor a particular player.

Material and sedation-analgesia in the neonatal lumbar puncture procedure.

INTRODUCTION: Lumbar puncture (LP) is a frequent procedure during the neonatal period. Correctly performing this technique can avoid many of its complications. OBJECTIVE: To evaluate the LP procedure in neonates in Spanish hospitals, studying the type of material and the sedation-analgesia used. MATERIAL AND METHODS: Cross-sectional study conducted in Spain gathering data through a survey research distributed by email through the Segurneo-SEN Hospital Network and the Spanish Neonatal Society. Data on the LP technique in neonates were collected. RESULTS: A total of 301 participants were analysed. Most professionals used a trocar needle with a stylet as the first option (89.7%); however, when the LP failed or was blood-stained, 32.2% changed the type of needle. A total of 143 doctors gave their subjective feeling about the type of needle: they only use trocar needles with stylet (41.3%), the technique is easier using scalp-vein needles (32.2%), there is less probability of a blood-stained LP, or failed using scalp-vein needles (7.7%), they choose the type of needle depending on the size of the newborn (10.5%), indifference when using one type or another needle (8.4%). Almost all (99%) of the surveyed doctors used some type of analgesia. The most widely used measures were topical anaesthetics (90.3%) and sucrose (82.2%). CONCLUSIONS: Currently, the LP procedure in the neonatal period is mainly performed with a trocar needle with a stylet and with the widespread use of different analgesic measures.

The impact of submucosal fatty tissue during colon endoscopic submucosal dissection in a western center.

OBJECTIVES: Obesity is associated with submucosal fatty tissue. The main aim of this study was to assess the impact of submucosal fatty tissue on the success of colonic endoscopic submucosal dissection (C-ESD) in a western population. METHODS: This was a retrospective analysis of 125 consecutive C-ESDs performed between October 2015 and July 2017. Fatty tissue sign was defined as positive when the submucosal layer was covered with fatty tissue. The complexity of performing an ESD was assessed by the performing endoscopist, defined by the occurrence of intraprocedural perforation, inability to complete an en-bloc resection or a procedure time exceeding 180 min. RESULTS: Fatty tissue sign positive was present in 44.8% of the procedures. There were 28 (22.4%) c-ESD defined as complex. Factors associated with complex ESD included; fatty tissue sign [odds ratio (OR) 12.5; 95% confidence interval (CI), 1.9-81.9; P = 0.008], severe fibrosis (OR 148.6; 95% CI, 6.6-3358.0; P = 0.002), poor maneuverability (OR 267.4; 95% CI, 11.5-6212.5; P < 0.001) and polyp size ≥35 mm (OR 17.2; 95% CI, 2.6-113.8; P = 0.003). In patients demonstrating the fatty tissue sign, BMI and waist-to-height ratio (WHtR) were higher (27.8 vs. 24.7; P < 0.001 and 0.56 vs. 0.49; P < 0.001, respectively) and en-bloc resection was achieved less frequently (76.8 vs. 97.1%, P = 0.001). Multivariate analysis revealed higher risk of fatty tissue sign positive associated with WHtR ≥0.52 (OR 26.10, 95% CI, 7.63-89.35, P < 0.001). CONCLUSION: This study demonstrates that the fatty tissue sign contributes to procedural complexity during C-ESD. Central obesity correlates with the likelihood of submucosal fatty tissue and as such should be taken into account when planning procedures.

[Material and sedation-analgesia in the neonatal lumbar puncture procedure]. / Material y sedoanalgesia en el procedimiento de punción lumbar neonatal.

INTRODUCTION: Lumbar puncture (LP) is a frequent procedure during the neonatal period. Correctly performing this technique can avoid many of its complications. OBJECTIVE: To evaluate the LP procedure in neonates in Spanish hospitals, studying the type of material and the sedation-analgesia used. MATERIAL AND METHODS: Cross-sectional study conducted in Spain gathering data through a survey research distributed by email through the Segurneo-SEN Hospital Network and the Spanish Neonatal Society. Data on the LP technique in neonates were collected. RESULTS: A total of 301 participants were analysed. Most professionals used a trocar needle with a stylet as the first option (89.7%); however, when the LP failed or was blood-stained, 32.2% changed the type of needle. A total of 143 doctors gave their subjective feeling about the type of needle: they only use trocar needles with stylet (41.3%), the technique is easier using scalp-vein needles (32.2%), there is less probability of a blood-stained LP, or failed using scalp-vein needles (7.7%), they choose the type of needle depending on the size of the new-born (10.5%), indifference when using one type or another needle (8.4%). Almost all (99%) of the surveyed doctors used some type of analgesia. The most widely used measures were topical anaesthetics (90.3%) and sucrose (82.2%). CONCLUSIONS: Currently, the LP procedure in the neonatal period is mainly performed with a trocar needle with a stylet and with the widespread use of different analgesic measures.

[Risk factors for the development of early hyponatraemia in the premature infant. A review of the practice of giving sodium in the first days of life]. / Factores de riesgo para el desarrollo de hiponatremia precoz en el prematuro. Revisión de nuestra práctica en administración de sodio en los primeros días de vida.

INTRODUCTION: A retrospective study was conducted in the Neonatal Intensive Care Unit of a tertiary hospital to determine the incidence of early hyponatraemia (first 48hours of life) in preterm infants. Risk and protection factors in this condition were also examined as a starting point for a change in the medical action when prescribing intravenous fluids. MATERIAL AND METHODS: The study included a sample of 256 premature babies (gestational age: 235-366) admitted to the Neonatal Intensive Care Unit of a tertiary hospital between January 2016 and June 2018. The number of patients receiving intravenous sodium in different intervals during the first 48hours of life was determined, as well as the number of those with hyponatraemia of any type (<135mmol / l), and moderate-severe (<130mmol / l). An analysis was made of the relationship between early hyponatraemia and weight / gestational age, antenatal steroids exposure, respiratory pathology, early sepsis, and perinatal asphyxia. RESULTS: Hyponatraemia occurred in 81 patients, 31.64% of the total (up to 50% in<30 weeks of gestational age), and was moderate-severe (<130mmol / l) in 17.3% of the cases. The period of time with the most cases of hyponatraemia was in the first 12hours of life (22.64%). Weight (P=.034), gestational age (P<.001) and respiratory disease (P<.001) were found to be risk factors and, in a multivariate analysis, the latter was independently related to early hyponatremia (P<.01, OR=5.24, 95% CI: 2.79-9.84). Antenatal betamethasone exposure did not show to be a protection factor. CONCLUSION: According to the results of this study, it is considered an advantage to provide sodium in the intravenous fluids prescribed during the first days of life, particularly in preterm infants of lower gestational age and with respiratory disease involvement.

Feasibility and learning curve of unsupervised colorectal endoscopic submucosal hydrodissection at a Western Center.

OBJECTIVES: Colorectal endoscopic submucosal dissection (CR-ESD) is an evolving technique in Western countries. We aimed to determine the results of the untutored implementation of endoscopic submucosal hydrodissection for the treatment of complex colorectal polyps and establish the learning curve for this technique. METHODS: This study included data from 80 consecutive CR-ESDs performed by a single unsupervised western therapeutic endoscopist. To assess the learning curve, procedures were divided into four groups of 20 each. RESULTS: En bloc resection was achieved in 55, 75, 75 and 95% cases in the consecutive time periods (period 1 vs. 4, P = 0.003). Curative resection was achieved in 55, 75, 70 and 95%, respectively (P = 0.037). Overall, series results demonstrated R0 resection in 75% of cases, with 23.7% requiring conversion to endoscopic piecemeal mucosal resection, and 1.25% incomplete resections. Complications included perforations (7.5%) and bleeding (3.7%). Multivariate analysis revealed factors more likely to result in association with non en bloc vs. En bloc resection, where polyp size ≥35 mm [70 vs. 23.4%; odds ratio (OR) 13.2 (1.7-100.9); P = 0. 013], severe fibrosis [40 vs. 11.7%; OR 10.2 (1.2-86.3); P = 0.033] and where carbon dioxide for insufflation was not used [65 vs. 30%; OR 0.09 (0.01-0.53); P = 0.008]. CONCLUSION: CR-ESD by hydrodissection has good safety and efficacy profile and offers well tolerated and effective treatment for complex polyps. As such, this technique may be useful in the West, in centers, where previous gastric ESD is not frequent or Japanese mentoring is not possible.