Efectividad de la inmunonutrición en el manejo nutricional perioperatorio del cáncer gástrico / Effectiveness of immunonutrition in the perioperative nutritional management of gastric cancer

Objetivo: valorar la efectividad de la inmunonutrición (IN) frente a las fórmulas nutricionales estándar en pacientes operados de cáncer gástrico. Material y métodos: se trata de un estudio de vida real, de tipo observacional, retrospectivo y de cohortes. Para este estudio se incluyeron 134 pacientes, todos ellos sometidos a gastrectomía en en el Hospital Montecelo, entre diciembre de 2019 y diciembre de 2022. El grupo A (N = 79 pacientes) recibió nutrición estándar y el grupo B (N = 55 pacientes) recibió fórmulas con arginina, nucleótidos, ácidos grasos omega-3 y aceite de oliva virgen extra. Este protocolo se ha realizado de forma pre y postoperatoria por un periodo medio de 10 días. Se evaluaron el tiempo de estancia hospitalaria, la necesidad de nutrición parenteral (NPT), las complicaciones postoperatorias y las variables antropométricas y analíticas. Los análisis estadísticos se realizaron con el programa Stata 16.1.® Resultados: en el grupo de IN respecto al grupo de nutrición estándar: la estancia hospitalaria se reduce un 34 % (p < 0,001). La cantidad de pacientes que precisan NPT se reduce un 21,1 % (p = 0,022) y su duración también se reduce un 33,2 % (p < 0,001). El riesgo de complicaciones infecciosas es menor con la IN, concretamente un 70,1 % menos (p < 0,001). En cuanto a las otras complicaciones postoperatorias, la IN disminuye el riesgo de oclusión intestinal en un 84 % (p < 0,002), la dehiscencia de suturas en un 90,9 % (p < 0,001), la transfusión sanguínea en un 99,8 % (p < 0,001), el derrame pleural en un 90,9 % (p = 0,021), la insuficiencia renal aguda en un 84,02 % (p = 0,047) y la reintervención quirúrgica en un 69,93 % (p < 0,011). En el grupo de IN se observa una menor pérdida ponderal (p = 0,048) y una menor disminución de la albúmina (p = 0,005) y el colesterol postoperatorios (p < 0,001). Conclusión: la inmunonutrición reduce las complicaciones postoperatorias, disminuye la estancia hospitalaria..(AU)

Objective: to assess the effectiveness of immunonutrition (IN) compared to standard nutritional formulas in patients undergoing gastric cancersurgery. Material and methods: this is a real-life, observational retrospective cohort study. It included 134 patients, all of whom underwent gastrectomy at Montecelo Hospital between December 2019 and December 2022. Group A (n = 79 patients) received standard nutrition, and Group B (n = 55 patients) received formulas containing arginine, nucleotides, omega-3 fatty acids, and extra virgin olive oil. This protocol was carried out both pre and postoperatively for an average period of 10 days. The study evaluated hospital stay, the need for parenteral nutrition (PN), postoperativecomplications, as well as anthropometric and laboratory variables. Statistical analyses were performed using Stata 16.1.® Results: in the IN group compared to the standard nutrition group, the hospital stay was reduced by 34 % (p < 0.001). The number of patients requiring PN decreased by 21.1 % (p = 0.022), and its duration also decreased by 33.2 % (p < 0.001). The risk of infectious complications was lower with IN, specifically 70.1 % less (p < 0.001). As for other postoperative complications, IN reduced the risk of intestinal obstruction by 84 % (p < 0.002), suture dehiscence by 90.9 % (p < 0.001), blood transfusion by 99.8 % (p < 0.001), pleural effusion by 90.9 % (p = 0.021), acute renal failure by 84.02 % (p = 0.047), and surgical re-intervention by 69.93 % (p < 0.011). In the IN group, there was less weight loss (p = 0.048) and a smaller decrease in postoperative albumin (p = 0.005) and cholesterol (p < 0.001). Conclusion: immunonutrition reduces postoperative complications, decreases hospital stay, and optimizes nutritional outcomes.(AU)

[Effectiveness of immunonutrition in the perioperative nutritional management of gastric cancer]. / Efectividad de la inmunonutrición en el manejo nutricional perioperatorio del cáncer gástrico.

Introduction: Objective: to assess the effectiveness of immunonutrition (IN) compared to standard nutritional formulas in patients undergoing gastric cancer surgery. Material and methods: this is a real-life, observational retrospective cohort study. It included 134 patients, all of whom underwent gastrectomy at Montecelo Hospital between December 2019 and December 2022. Group A (N = 79 patients) received standard nutrition, and Group B (N = 55 patients) received formulas containing arginine, nucleotides, omega-3 fatty acids, and extra virgin olive oil. This protocol was carried out both pre and postoperatively for an average period of 10 days. The study evaluated hospital stay, the need for parenteral nutrition (PN), postoperative complications, as well as anthropometric and laboratory variables. Statistical analyses were performed using Stata 16.1.® Results: in the IN group compared to the standard nutrition group, the hospital stay was reduced by 34 % (p < 0.001). The number of patients requiring PN decreased by 21.1 % (p = 0.022), and its duration also decreased by 33.2 % (p < 0.001). The risk of infectious complications was lower with IN, specifically 70.1 % less (p < 0.001). As for other postoperative complications, IN reduced the risk of intestinal obstruction by 84 % (p < 0.002), suture dehiscence by 90.9 % (p < 0.001), blood transfusion by 99.8 % (p < 0.001), pleural effusion by 90.9 % (p = 0.021), acute renal failure by 84.02 % (p = 0.047), and surgical re-intervention by 69.93 % (p < 0.011). In the IN group, there was less weight loss (p = 0.048) and a smaller decrease in postoperative albumin (p = 0.005) and cholesterol (p < 0.001). Conclusion: immunonutrition reduces postoperative complications, decreases hospital stay, and optimizes nutritional outcomes.

Introducción: Objetivo: valorar la efectividad de la inmunonutrición (IN) frente a las fórmulas nutricionales estándar en pacientes operados de cáncer gástrico. Material y métodos: se trata de un estudio de vida real, de tipo observacional, retrospectivo y de cohortes. Para este estudio se incluyeron 134 pacientes, todos ellos sometidos a gastrectomía en en el Hospital Montecelo, entre diciembre de 2019 y diciembre de 2022. El grupo A (N = 79 pacientes) recibió nutrición estándar y el grupo B (N = 55 pacientes) recibió fórmulas con arginina, nucleótidos, ácidos grasos omega-3 y aceite de oliva virgen extra. Este protocolo se ha realizado de forma pre y postoperatoria por un periodo medio de 10 días. Se evaluaron el tiempo de estancia hospitalaria, la necesidad de nutrición parenteral (NPT), las complicaciones postoperatorias y las variables antropométricas y analíticas. Los análisis estadísticos se realizaron con el programa Stata 16.1.® Resultados: en el grupo de IN respecto al grupo de nutrición estándar: la estancia hospitalaria se reduce un 34 % (p < 0,001). La cantidad de pacientes que precisan NPT se reduce un 21,1 % (p = 0,022) y su duración también se reduce un 33,2 % (p < 0,001). El riesgo de complicaciones infecciosas es menor con la IN, concretamente un 70,1 % menos (p < 0,001). En cuanto a las otras complicaciones postoperatorias, la IN disminuye el riesgo de oclusión intestinal en un 84 % (p < 0,002), la dehiscencia de suturas en un 90,9 % (p < 0,001), la transfusión sanguínea en un 99,8 % (p < 0,001), el derrame pleural en un 90,9 % (p = 0,021), la insuficiencia renal aguda en un 84,02 % (p = 0,047) y la reintervención quirúrgica en un 69,93 % (p < 0,011). En el grupo de IN se observa una menor pérdida ponderal (p = 0,048) y una menor disminución de la albúmina (p = 0,005) y el colesterol postoperatorios (p < 0,001). Conclusión: la inmunonutrición reduce las complicaciones postoperatorias, disminuye la estancia hospitalaria y optimiza los resultados nutricionales.

Efectividad de la administración de urea para el tratamiento de la hiponatremia en la insuficiencia cardiaca / Effectiveness of urea administration for the treatment of hyponatremia in heart failure

Objetivos Valorar la eficacia y la seguridad de la urea en pacientes con hiponatremia e insuficiencia cardiaca (IC). Métodos y resultados Se trata de un estudio observacional retrospectivo analítico de pacientes con IC e hiponatremia (Na+ <135mmol/l). Se incluyeron 49 pacientes tratados con urea y 47 pacientes que no recibieron urea, todos ellos bajo tratamiento estándar (según práctica clínica habitual) de la IC, con seguimiento en el hospital Álvaro Cunqueiro de Vigo entre enero de 2013 y mayo de 2022. En el estudio se evaluó la normalización de los niveles de sodio (Na >135mmol/l). La natremia al inicio del tratamiento con urea oral era de 127±5,22mmol/l, a las 24horas el sodio era de 128±2,47 (p<0,009) y la media el día de la normalización fue de 135,19±4,23mmol/l (p<0,005). Los días de media para conseguir la normalización del sodio fueron 5,03±2,37. La uremia al inicio del tratamiento con urea era de 73±46,93mg/dl y la media el día de la normalización del Na+ fue de 116,05±63,64mg/dl (p<0,002). La dosis media de urea oral fue 22,5g/día. No se observaron efectos adversos relevantes, ni cambios en cuanto a las cifras de creatinina. Conclusiones El tratamiento con urea oral añadido al tratamiento estándar, durante cortos periodos de tiempo, es seguro y eficaz para corregir la natremia en pacientes con IC hipervolémica con hiponatremia.

Objectives To assess the efficacy and safety of urea in patients with hyponatremia and heart failure (HF). Methods and results This is a retrospective observational analytical study of patients with HF and hyponatremia (Na+ <135mmol/L). Forty-nine patients treated with urea and 47 patients who did not receive urea, all under standard treatment (according to usual clinical practice) for HF, were included and followed up at Álvaro Cunqueiro Hospital in Vigo (Spain) between January 2013 and May 2022. The study evaluated the normalization of sodium levels (Na >135mmol/L). The initial natremia at the start of oral urea treatment was 127±5.22 mmol/L, at 24h the sodium level was 128±2.47 (P<.009), and the mean on the day of normalization was 135.19±4.23mmol/L (P<.005). The average number of days to achieve sodium normalization was 5.03±2.37 days. The initial uremia at the start of urea treatment was 73±46.93mg/dL, and the mean on the day of Na+ normalization was 116.05±63.64mg/dL (P<.002). The average oral urea dose was 22.5g/day. No relevant adverse effects were observed, nor were there significant changes in creatinine levels. Conclusions Oral urea treatment, when added to standard treatment for short periods of time, is safe and effective in correcting natremia in patients with hypervolemic HF with hyponatremia. (AU)

Efectividad de la administración de urea para el tratamiento de la hiponatremia en la insuficiencia cardiaca / Effectiveness of urea administration for the treatment of hyponatremia in heart failure

Objetivos Valorar la eficacia y la seguridad de la urea en pacientes con hiponatremia e insuficiencia cardiaca (IC). Métodos y resultados Se trata de un estudio observacional retrospectivo analítico de pacientes con IC e hiponatremia (Na+ <135mmol/l). Se incluyeron 49 pacientes tratados con urea y 47 pacientes que no recibieron urea, todos ellos bajo tratamiento estándar (según práctica clínica habitual) de la IC, con seguimiento en el hospital Álvaro Cunqueiro de Vigo entre enero de 2013 y mayo de 2022. En el estudio se evaluó la normalización de los niveles de sodio (Na >135mmol/l). La natremia al inicio del tratamiento con urea oral era de 127±5,22mmol/l, a las 24horas el sodio era de 128±2,47 (p<0,009) y la media el día de la normalización fue de 135,19±4,23mmol/l (p<0,005). Los días de media para conseguir la normalización del sodio fueron 5,03±2,37. La uremia al inicio del tratamiento con urea era de 73±46,93mg/dl y la media el día de la normalización del Na+ fue de 116,05±63,64mg/dl (p<0,002). La dosis media de urea oral fue 22,5g/día. No se observaron efectos adversos relevantes, ni cambios en cuanto a las cifras de creatinina. Conclusiones El tratamiento con urea oral añadido al tratamiento estándar, durante cortos periodos de tiempo, es seguro y eficaz para corregir la natremia en pacientes con IC hipervolémica con hiponatremia.

Objectives To assess the efficacy and safety of urea in patients with hyponatremia and heart failure (HF). Methods and results This is a retrospective observational analytical study of patients with HF and hyponatremia (Na+ <135mmol/L). Forty-nine patients treated with urea and 47 patients who did not receive urea, all under standard treatment (according to usual clinical practice) for HF, were included and followed up at Álvaro Cunqueiro Hospital in Vigo (Spain) between January 2013 and May 2022. The study evaluated the normalization of sodium levels (Na >135mmol/L). The initial natremia at the start of oral urea treatment was 127±5.22 mmol/L, at 24h the sodium level was 128±2.47 (P<.009), and the mean on the day of normalization was 135.19±4.23mmol/L (P<.005). The average number of days to achieve sodium normalization was 5.03±2.37 days. The initial uremia at the start of urea treatment was 73±46.93mg/dL, and the mean on the day of Na+ normalization was 116.05±63.64mg/dL (P<.002). The average oral urea dose was 22.5g/day. No relevant adverse effects were observed, nor were there significant changes in creatinine levels. Conclusions Oral urea treatment, when added to standard treatment for short periods of time, is safe and effective in correcting natremia in patients with hypervolemic HF with hyponatremia. (AU)

[Effectiveness of urea administration for the treatment of hyponatremia in heart failure]. / Efectividad de la administración de urea para el tratamiento de la hiponatremia en la insuficiencia cardiaca.

OBJECTIVES: To assess the efficacy and safety of urea in patients with hyponatremia and heart failure (HF). METHODS AND RESULTS: This is a retrospective observational analytical study of patients with HF and hyponatremia (Na+ <135mmol/L). Forty-nine patients treated with urea and 47 patients who did not receive urea, all under standard treatment (according to usual clinical practice) for HF, were included and followed up at Álvaro Cunqueiro Hospital in Vigo (Spain) between January 2013 and May 2022. The study evaluated the normalization of sodium levels (Na >135mmol/L). The initial natremia at the start of oral urea treatment was 127±5.22 mmol/L, at 24h the sodium level was 128±2.47 (P<.009), and the mean on the day of normalization was 135.19±4.23mmol/L (P<.005). The average number of days to achieve sodium normalization was 5.03±2.37 days. The initial uremia at the start of urea treatment was 73±46.93mg/dL, and the mean on the day of Na+ normalization was 116.05±63.64mg/dL (P<.002). The average oral urea dose was 22.5g/day. No relevant adverse effects were observed, nor were there significant changes in creatinine levels. CONCLUSIONS: Oral urea treatment, when added to standard treatment for short periods of time, is safe and effective in correcting natremia in patients with hypervolemic HF with hyponatremia.

Test Strip Platform Spin-Off for Telomerase Activity Detection: Development of an Electrochemical Biosensor.

Telomerase overexpression has been associated directly with cancer, and the enzyme itself is recognized within the scientific community as a cancer biomarker. BIDEA's biosensing strip (BBS) is an innovative technology capable of detecting the presence of telomerase activity (TA) using electrochemical impedance spectroscopy (EIS). This BBS is an interdigital gold (GID) electrode array similar in size and handling to a portable glucose sensor. For the detection of the biomarker, BBS was modified by the immobilization of a telomere-like single strand DNA (ssDNA) on its surface. The sensor was exposed to telomerase-positive extract from commercially available cancer cells, and the EIS spectra were measured. Telomerase recognizes the sequence of this immobilized ssDNA probe on the BBS, and the reverse transcription process that occurs in cancer cells is replicated, resulting in the ssDNA probe elongation. This surface process caused by the presence of TA generates changes in the capacitive process on the electrode array microchip surface, which is followed by EIS as the sensing tool and correlated with the presence of cancer cells. The telomerases' total cell extraction protocol results demonstrate significant changes in the charge-transfer resistance (R ct) change rate after exposure to telomerase-positive extract with a detection limit of 2.94 × 104 cells/mL. Finally, a preliminary study with a small set of "blind" uterine biopsy samples suggests the feasibility of using the changes in the R ct magnitude change rate (Δ(ΔR ct/R cti)/Δt) to distinguish positive from negative endometrial adenocarcinoma samples by the presence or absence of TA.

Short- and long-term outcomes for single-port risk-reducing salpingo-oophorectomy with and without hysterectomy for women at risk for gynecologic cancer.

INTRODUCTION: Risk-reducing salpingo-oophorectomy has been established as one of the most effective strategies in risk reduction for ovarian and breast cancers among women at increased genetic risk. However, there are limited data regarding the single-port laparoscopic platform in the field of risk-reducing surgery. Our objective was to describe outcomes after single-port risk-reducing salpingo-oophorectomy with or without hysterectomy for reduction of ovarian, breast, or endometrial cancer risk. METHODS: A retrospective, single institution (Canadian Task Force Classification II.2) analysis was performed in women at high genetic or familial risk for ovarian/tubal/primary peritoneal cancer or with personal history of breast cancer who underwent single-port laparoscopic risk-reducing salpingo-oophorectomy with or without hysterectomy between October 2009 and December 2015. Data were collected on patient demographics, surgical procedure and characteristics, intra-operative findings, and post-operative outcomes. RESULTS: In total, 187 single-port laparoscopic surgeries were performed with a median follow-up of 204 (IQR 25-749) days. BRCA1/2, Lynch syndrome, or Cowden syndrome was diagnosed in 64.0% of patients. Additionally, 32.1% had a personal history of breast cancer, and 3.2% reported strong family history of ovarian and/or breast cancer. Single-port risk-reducing salpingo-oophorectomy with hysterectomy was performed in 53.5% of patients. The rate of adverse outcomes, including conversion to multiport laparoscopy or laparotomy (1.6%), intra-operative injury (1.6%), deep vein thrombosis (0.5%), urinary tract infection (2.7%), and/or incisional cellulitis (4.3%) were low. Three patients (1.6%) were diagnosed with malignancy on final pathology. All three patients were BRCA1-positive and their CA125 values were significantly lower than those without malignancy (p=<0.0001). CONCLUSIONS: Single-port laparoscopy is a safe option for patients undergoing risk-reducing salpingo-oophorectomy with or without hysterectomy. Standardized pre-operative evaluation criteria are needed to determine absolute risk of incidental malignancy, and the risk of identifying a malignancy should be reiterated to patients during pre-operative counseling.

Glycaemic patterns in healthy elderly individuals and in those with impaired glucose metabolism - exploring the relationship with nonglycaemic variables.

OBJECTIVE: The SENIORLABOR study data were explored (i) to examine the evolution during senescence of the differences between measured glycated haemoglobin (HbA1c) values and the values predicted by using regression to extrapolate from measured fructosamine levels; (ii) to scrutinise the relationship between the glycation gap and insulin resistance using a homeostasis model assessment, and between the glycation gap and a low-grade inflammation marker (C-reactive protein serum concentration); and (iii) to investigate the glycation gap ranges in relation to triglyceride levels and kidney function. SUBJECTS AND METHODS: A total of 1432 Swiss individuals aged >60 years and classified as healthy (547), prediabetic (701) or diabetic (184) based on their fasting plasma glucose and HbA1c values were included in the study. The glycation gap was evaluated and assigned to one of four categories: <−0.5; −0.5 to <0.0; 0.0 to ≤0.5; >0.5. RESULTS: In healthy and prediabetic participants, the homeostasis model assessment for estimation of insulin resistance (p <0.01), high-sensitivity C-reactive protein (p <0.001) and triglyceride (p = 0.02) values tended to increase with increasing glycation gap category and were highest in the glycation gap category >0.5. Homeostasis model assessment for estimation of insulin resistance, high-sensitivity C-reactive protein and triglyceride levels tended to increase with increasing glycation gap category and were highest in the glycation gap category >0.5. Significant differences (p <0.01) between glycation gap categories were seen among different high-sensitivity C-reactive protein concentration groups. Interestingly, in diabetic participants, homeostasis model assessment for estimation of insulin resistance values, triglyceride concentrations and estimation of glomerular filtration values all decreased with decreasing glycation gap category. In the group of participants with a glycation gap >0.5, high-sensitivity C-reactive protein values tended to increase with increasing glycation gap, whereas for participants with type 2 diabetes and in the glycation gap group >0.5, high-sensitivity C-reactive protein levels tended to decrease as the glycation gap increased. The percentage of participants with type 2 diabetes mellitus increased from 2% in the glycation gap category <−0.5 to 76% in the glycation gap category >0.5. In contrast, the percentage of healthy participants fell from 85% to 7%. CONCLUSION: This is the first time that a direct comparison of healthy, prediabetic and diabetic participants, all assessed under identical conditions and using identical methodology, has clearly demonstrated a different glycation gap pattern. Thus, we contribute evidence that the glycation gap might be of interest in the care of diabetic patients and their prophylaxis, while acknowledging that more studies are needed to confirm our findings. (Trial registration number ISRCTN53778569).

Relación entre satisfacción laboral, estrés laboral y sus resultados en trabajadores de una institución de beneficencia de la Provincia de Concepción / Relationship between job satisfaction, work stress and its results in workers of a charity institution of the Province of Concepcion

Resumen: El objetivo de esta investigación es analizar la relación entre el estrés laboral y la satisfacción laboral en una Institución de Beneficencia en la Provincia de Concepción. Se desarrolla un estudio empírico trans versal, descriptivo correlacional, con un universo del estudio conformado por 184 trabajadores, segmentado en cinco grupos. El cuestionario autoadministrado y anónimo con 71 ítems divididos en 3 secciones: información general, estrés laboral y satisfacción laboral. El análisis de fiabilidad del cuestionario presento valores de alfa de Cronbach, para Satisfacción Laboral entre 0,656 y 0,923, para Estrés Laboral entre 0,635 y 0,927 siendo aceptable la fiabilidad en ambos. En general, respecto al estrés todos los grupos de trabajo se ubican en el cuadrante baja tensión, baja demanda psicológica, alto control laboral y alto apoyo global. Respecto a Satisfacción laboral el promedio general en las líneas de trabajo evaluadas es de 3,8 puntos, lo que denota un nivel mediano de satisfacción laboral. Las correlaciones permiten concluir que a mayor percepción de las variables de Satisfacción laboral y mayor Control sobre el trabajo, se logra reducir el grado de estrés. Además la dimensión de Apoyo Social Laboral Global aumenta la Satisfacción Laboral, permitiendo disminuir el estrés.

Abstract: The objective of this research is to analyze the relationship between work stress and job satisfaction in a Charity Institution in the Province of Concepción. A cross-sectional, descriptive, correlational empirical study was developed, with a study universe consisting of 184 workers, divided into five groups. The self-administered and anonymous questionnaire with 71 items divided into 3 sections: general information, work stress and job satisfaction. The reliability analysis of the questionnaire presented values of Cronbach's alpha, for Labor Satisfaction between 0.656 and 0.923, for Labor Stress between 0.635 and 0.927, the reliability being acceptable in both. In general, with respect to stress, all work groups are located in the low tension, low psychological demand, high labor control and high global support quadrant. Regarding Job Satisfaction, the general average in the evaluated work lines is 3.8 points, which denotes a medium level of job satisfaction. The correlations allow us to conclude that the greater the perception of the variables of job satisfaction and greater control over work, the reduction of the degree of stress is achieved. In addition, the dimen sion of Global Labor Social Support increases the Labor Satisfaction, allowing to reduce stress.

Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial.

BACKGROUND: Accurate identification of sentinel lymph nodes in patients with cancer improves detection of metastatic disease and decreases surgical morbidity. We sought to establish whether indocyanine green fluorescent dye is non-inferior to isosulfan blue dye in detecting sentinel lymph nodes in women with cervical and uterine cancers. METHODS: In this non-inferiority, within-patient comparison study, patients aged 18 years or older with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with isosulfan blue dye (visualised by white light) followed by indocyanine green (visualised by near-infrared imaging), or indocyanine green followed by isosulfan blue dye. Permuted block randomisation with stratification by study site was done with a computerised random number generator. All participants were masked to their randomisation assignment until after the procedure; however, investigators were not masked to the procedure used. Laparoscopic surgery with the PINPOINT near-infrared fluorescence imaging system (Stryker, Kalamazoo, MI, USA) was used in all cases. The primary outcome was efficacy of intraoperative indocyanine green with near-infrared fluorescence imaging versus that of isosulfan blue dye in the identification of lymph nodes, defined as the number of lymph nodes identified by indocyanine green and isosulfan blue dye, respectively (and confirmed as lymphoid tissue by histology), divided by the number of lymph nodes identified intraoperatively and excised. The study had a 5% non-inferiority margin needed to show non-inferiority of the frequency of lymph node detection with indocyanine green to that with isosulfan blue dye with 80% power at a 5% two-sided significance level. Analyses were done in both per-protocol and modified intention-to-treat populations. The trial was registered with ClinicalTrials.gov, number NCT02209532, and is completed and closed. FINDINGS: Between Dec 21, 2015, and June 19, 2017, 180 patients were enrolled and randomly assigned to the two groups (90 to each group); 176 patients received the intervention and were evaluable (modified intention-to-treat population). 13 patients with major protocol violations were subsequently excluded from the per-protocol population. 517 sentinel nodes were identified in the per-protocol population (n=163), of which 478 (92%) were confirmed to be lymph nodes on pathological processing: 219 (92%) of 238 nodes that were both blue and green, all seven nodes that were blue only, and 252 (95%) of 265 nodes that were green only (p=0·33). Seven sentinel lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. In total, 471 (97%) of 485 lymph nodes were identified with the green dye and 226 (47%) with the blue dye (difference 50%, 95% CI 39-62; p<0·0001). In the modified intention-to-treat population (n=176), 545 nodes were identified, of which 513 (94%) were confirmed to be lymph nodes on pathological processing: 229 (92%) of 248 nodes that were both blue and green, all nine nodes that were blue only, and 266 (95%) of 279 nodes that were green only (p=0·30). Nine sentinal lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. 495 (96%) of 513 nodes were identified with the green dye and 238 (46%) with the blue dye (50%, 39-61; p<0·0001). INTERPRETATION: Indocyanine green dye with near-infrared fluorescence imaging identified more sentinel nodes than isosulfan blue dye in women with cervical and uterine cancers, with no difference in the pathological confirmation of nodal tissue between the two mapping substances. FUNDING: Novadaq.

Laser Angiography to Assess the Vaginal Cuff During Robotic Hysterectomy.

BACKGROUND AND OBJECTIVES: Vaginal cuff dehiscence may be a vascular-mediated event, and reports show a higher incidence after robot-assisted total laparoscopic hysterectomy (RATLH), when compared with other surgical routes. This study was conducted to determine the feasibility of using laser angiography to assess vaginal cuff perfusion during RATLH. METHODS: This was a pilot feasibility trial incorporating 20 women who underwent RATLH for benign disease. Colpotomy was made with ultrasonic or monopolar instruments, whereas barbed or nonbarbed suture was used for cuff closure. Time of instrument activation during colpotomy was recorded. Images were captured of vaginal cuff perfusion before and after cuff closure. Reviewers evaluated these images and determined areas of adequate cuff perfusion. RESULTS: Indocyanine green (ICG) was visible at the vaginal cuff in all participants. Optimal dosage was determined to be 7.5 mg of ICG per intravenous dose. Mean time to appearance for ICG was 18.4 ± 7.3 s (mean ± SD) before closure and 19.0 ± 8.7 s after closure. No significant difference (P = .19) was noted in judged perfusion in open cuffs after colpotomy with a monopolar (48.9 ± 26.0%; mean ± SD) or ultrasonic (40.2 ± 14.1%) device. No difference was seen after cuff closure (P = .36) when a monopolar (70.9 ± 21.1%) or ultrasonic (70.5 ± 20.5%) device was used. The use of barbed (74.1 ± 20.1%) or nonbarbed (66.4 ± 20.9%) sutures did not significantly affect estimated closed cuff perfusion (P = .19). Decreased cuff perfusion was observed with longer instrument activation times in open cuffs (R2 = 0.3175). CONCLUSION: Laser angiography during RATLH allows visualization of vascular perfusion of the vaginal cuff. The technology remains limited by the lack of quantifiable fluorescence and knowledge of clinically significant levels of fluorescence.

Single-port laparoscopy in gynecologic oncology: seven years of experience at a single institution.

BACKGROUND: Single-port laparoscopy has gained popularity within minimally invasive gynecologic surgery for its feasibility, cosmetic outcomes, and safety. However, within gynecologic oncology, there are limited data regarding short-term adverse outcomes and long-term hernia risk in patients undergoing single-port laparoscopic surgery. OBJECTIVE: The objective of the study was to describe short-term outcomes and hernia rates in patients after single-port laparoscopy in a gynecologic oncology practice. STUDY DESIGN: A retrospective, single-institution study was performed for patients who underwent single-port laparoscopy from 2009 to 2015. A univariate analysis was performed with χ2 tests and Student t tests; Kaplan-Meier and Cox proportional hazards determined time to hernia development. RESULTS: A total of 898 patients underwent 908 surgeries with a median follow-up of 37.2 months. The mean age and body mass index were 55.7 years and 29.6 kg/m2, respectively. The majority were white (87.9%) and American Society of Anesthesiologists class II/III (95.5%). The majority of patients underwent surgery for adnexal masses (36.9%) and endometrial hyperplasia/cancer (37.3%). Most women underwent hysterectomy (62.7%) and removal of 1 or both fallopian tubes and/or ovaries (86%). Rate of adverse outcomes within 30 days, including reoperation (0.1%), intraoperative injury (1.4%), intensive care unit admission (0.4%), venous thromboembolism (0.3%), and blood transfusion, were low (0.8%). The rate of urinary tract infection was 2.8%; higher body mass index (P = .02), longer operative time (P = .02), smoking (P = .01), hysterectomy (P = .01), and cystoscopy (P = .02) increased the risk. The rate of incisional cellulitis was 3.5%. Increased estimated blood loss (P = .03) and endometrial cancer (P = .02) were independent predictors of incisional cellulitis. The rate for surgical readmissions was 3.4%; higher estimated blood loss (P = .03), longer operative time (P = .02), chemotherapy alone (P = .03), and combined chemotherapy and radiation (P < .05) increased risk. The rate of incisional hernia rate was 5.5% (n = 50) with a mean occurrence at 570.2 ± 553.3 days. Higher American Society of Anesthesiologists class (P = .04), diabetes (P < .001), hypertension (P = .043), increasing age (P = .017; hazard ratio [HR], 1.03), and body mass index (P < .001; HR, 1.08) were independent predictors for incisional hernia development. Previous abdominal surgeries (P = .24) and hand assist (P = .64) were not associated with increased risk for incisional hernia. Patients with American Society of Anesthesiologists class III/IV had a 3 year hernia rate of 12.8% (HR, 1.81). Patients with diabetes mellitus had a 3 year hernia rate of 23.0% (HR, 3.60). CONCLUSION: In this large cohort of patients undergoing single-port laparoscopy, the incidence of short-term adverse outcomes is low. While the rate of incisional hernia was 5.5%, incidence reached 23.0% at 3 years in high-risk groups. Previous studies with short follow-up duration may underestimate the risk of hernia, especially in patients with significant comorbidities.

Uterine viability in the baboon after ligation of uterine vasculature: a pilot study to assess alternative perfusion and venous return for uterine transplantation.

OBJECTIVE: To assess, in two separate groups of baboons, uterine viability after ligation of the uterine veins and uterine viability after ligation of both the uterine arteries and veins, respectively. DESIGN: Prospective, observational study. SETTING: Baboon breeding colony. ANIMAL(S): Six naïve female Papio hamadryas baboons with indicators of normal reproductive function. INTERVENTION(S): Three baboons underwent surgical interruption of the uterine veins bilaterally, and three baboons underwent surgical interruption of the uterine arteries and the uterine veins bilaterally. All baboons also underwent colpotomy, cervico-vaginal reanastomosis, and intraoperative near-infrared fluorescence imaging after vessel ligation. In the postoperative period, transabdominal sonography, vaginoscopy, and endocervical biopsy were performed on all animals. MAIN OUTCOME MEASURE(S): Postoperative uterine and ovarian viability. RESULT(S): Near-infrared imaging confirmed intraoperative perfusion of the uterus and cervico-vaginal anastomosis in all cases. In all subjects, sonography revealed normal uteri, and vaginoscopy revealed well-healed anastomoses. Endocervical biopsies (five of six) demonstrated pathologically normal endocervical tissue without evidence of necrosis. Cyclical sex skin turgescence and menstruation were unanimously observed. CONCLUSION(S): Disruption of bilateral uterine vessels does not affect uterine or ovarian viability in the baboon. Bilateral uterine artery and vein ligation furthers development of a minimally invasive approach to donor hysterectomy.

Laser Angiography with Indocyanine Green to Assess Vaginal Cuff Perfusion during Total Laparoscopic Hysterectomy: A Pilot Study.

STUDY OBJECTIVE: To determine feasibility of using laser angiography with indocyanine green (ICG) to assess vaginal cuff vascular perfusion during total laparoscopic hysterectomy (TLH). DESIGN: Pilot feasibility trial (Canadian Task Force classification II-2). SETTING: Academic-affiliated hospital. PATIENTS: Twenty women undergoing TLH for benign disease. INTERVENTIONS: Participants underwent 1:1 randomization of energy method used for colpotomy (ultrasonic vs monopolar) and vaginal cuff closure suture (barbed vs nonbarbed). After intravenous administration of ICG, laser angiography was used to capture images of the vaginal cuff before and after closure. Three reviewers analyzed fluorescent images of vaginal cuffs to determine percent of cuff perimeter with adequate perfusion when open and length of vaginal cuff adequately perfused when closed. MEASUREMENTS AND MAIN RESULTS: ICG fluorescence was visible at the vaginal cuff in all participants. Mean time to appearance of ICG in the pelvis after administration was 19.8 ± 6.8 seconds (mean ± SD) preclosure, and 26.0 ± 22.2 seconds postclosure. With ultrasonic energy 67.5% ± 17.4% of open cuff perimeter and 74.4% ± 20.5% of closed cuff length were adequately perfused, whereas with monopolar energy use 59.1% ± 17.4% of the open cuff perimeter and 66.3% ± 15.4% of closed cuff length were adequately perfused. Cuffs closed with barbed suture showed adequate perfusion along 71.5% ± 15.1% of the length, whereas those closed with nonbarbed suture showed 68.9% ± 20.9% adequate perfusion. When normalized to cervical cup circumference, ultrasonic energy required 1.0 ± .2 s/mm, whereas monopolar energy required .8 ± .3 s/mm (p = .162). Linear regression showed no association of normalized time of energy activation to percentage of perimeter of open cuff (R2 = .007) or length of closed cuff (R2 = .005) with adequate perfusion. No complications related to intravenous ICG administration occurred. CONCLUSION: Laser angiography with ICG allows evaluation of vascular perfusion at the vaginal cuff during TLH. This technique may facilitate future prospective studies examining causes for vaginal cuff dehiscence, a complication with potential for severe morbidity.

Bowel injury in robotic gynecologic surgery: risk factors and management options. A systematic review.

OBJECTIVE: We sought to analyze the published literature on bowel injuries in patients undergoing gynecologic robotic surgery with the aim to determine its incidence, predisposing factors, and treatment options. DATA SOURCES: Studies included in this analysis were identified by searching PubMed Central, OVID Medline, EMBASE, Cochrane, and ClinicalTrials.gov databases. References for all studies were also reviewed. Time frame for data analysis spanned from November 2001 through December 2014. STUDY ELIGIBILITY CRITERIA: All English-language studies reporting the incidence of bowel injury or complications during robotic gynecologic surgery were included. Studies with data duplication, not in English, case reports, or studies that did not explicitly define bowel injury incidence were excluded. STUDY APPRAISAL AND SYNTHESIS METHODS: The Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies were used to complete the systematic review with the exception of scoring study quality and a single primary reviewer. RESULTS: In all, 370 full-text articles were reviewed and 144 met the inclusion criteria. There were 84 bowel injuries recorded in 13,444 patients for an incidence of 1 in 160 (0.62%; 95% confidence interval, 0.50-0.76%). There were no significant differences in incidence of bowel injury by procedure type. The anatomic location of injury, etiology, and management were rarely reported. Of the bowel injuries, 87% were recognized intraoperatively and the majority (58%) managed via a minimally invasive approach. Of 13,444 patients, 3 (0.02%) (95% confidence interval, 0.01-0.07%) died in the immediate postoperative period and no deaths were a result of a bowel injury. CONCLUSION: The overall incidence of bowel injury in robotic-assisted gynecologic surgery is 1 in 160. When the location of bowel injuries were specified, they most commonly occurred in the colon and rectum and most were managed via a minimally invasive approach.

Coaxial robot-assisted laparoendoscopic single-site myomectomy.

We report our experience with coaxial robot-assisted laparoendoscopic single-site (RA-LESS) myomectomy, including a detailed description of the technique and outcomes from our first 21 cases. This was a retrospective cohort study carried out at the reproductive endocrinology and gynecologic oncology divisions at two academic medical centers. RA-LESS myomectomy was performed with the da Vinci Si Surgical System (Intuitive Surgical, Inc, Sunnyvale, CA, USA) employing standard rigid 8 or 5 mm instrumentation in a coaxial arrangement through a standard laparoendoscopic single-site (LESS) port (GelPOINT Advanced Access Platform, Applied Medical, Rancho Santa Margarita, CA, USA). Cases were completed between October 2011 and November 2013. Twenty-one patients underwent surgery. Mean age (±SD) was 38.1 ± 5.8 years, and mean BMI was 29.4 ± 4.7 kg/m2. Menorrhagia, pelvic pressure, and urinary frequency were the main presenting symptoms. Mean diameter of the largest tumor was 5.7 ± 1.9 cm (median 5.9 cm, range 2.1-9.5 cm), while mean number of tumors removed was 2.2 ± 1.8, ranging from 1 to 8 per surgery. Mean operative time was 154.2 ± 55.2 min (median 152 min, range 85-290 min). Mean blood loss was 57.9 ± 53.7 cc (median 50 cc, range 5-200 cc) and length of hospital stay ranged between 0 and 3 days (median 0). All procedures were successfully performed without conversion to conventional LESS surgery, multi-port laparoscopy or laparotomy. RA-LESS myomectomy with coaxial use of standard rigid instrumentation is a safe and reproducible addition to the minimally invasive surgeons' armamentarium, with excellent cosmetic and postoperative outcomes in selected patients. Further investigation is needed to define the patient groups that will most benefit from it.

Inflammation Thread Runs across Medical Laboratory Specialities.

We work on the assumption that four major specialities or sectors of medical laboratory assays, comprising clinical chemistry, haematology, immunology, and microbiology, embraced by genome sequencing techniques, are routinely in use. Medical laboratory markers for inflammation serve as model: they are allotted to most fields of medical lab assays including genomics. Incessant coding of assays aligns each of them in the long lists of big data. As exemplified with the complement gene family, containing C2, C3, C8A, C8B, CFH, CFI, and ITGB2, heritability patterns/risk factors associated with diseases with genetic glitch of complement components are unfolding. The C4 component serum levels depend on sufficient vitamin D whilst low vitamin D is inversely related to IgG1, IgA, and C3 linking vitamin sufficiency to innate immunity. Whole genome sequencing of microbial organisms may distinguish virulent from nonvirulent and antibiotic resistant from nonresistant varieties of the same species and thus can be listed in personal big data banks including microbiological pathology; the big data warehouse continues to grow.

Utility of indocyanine green (ICG) intra-operative angiography to determine uterine vascular perfusion at the time of radical trachelectomy.

OBJECTIVES: The aim of our study was to measure and analyze uterine perfusion utilizing laser angiography with ICG during uterine artery sparing and non-sparing radical trachelectomy. METHODS: Data were collected from all patients diagnosed with early-stage cervical cancer that underwent laser angiography with ICG during open or laparoscopic radical trachelectomy from June 2012 to December 2015. Regression analysis was use to determine the p values and R-squares on fluorescence, surgical time, hospital stay, age and BMI; a p-value<0.05 was considered statistically significant. RESULTS: A total of 20 patients met the inclusion criteria and were included in this study. Ten patients underwent uterine artery-sparing surgery, and ten patients underwent uterine artery non-sparing surgery. The most frequent stage for the entire cohort was IA2 (55%), and the most common histologic subtype was squamous cell carcinoma (49%). Lymph-vascular invasion was noted in 30% of the patients. There was no statistical significance difference in the mean ICG fundal fluorescence intensity between the uterine artery-sparing group 162.5 (range, 137-188) and the uterine artery non-sparing group 160.5 (range, 135-186), p=0.22. In both groups, 100% of the patients regained their menstrual function by postoperative week 8. A total of 4 (40%) pregnancies have occurred in the uterine artery-sparing group and 3 (30%) in the non-uterine artery-sparing group. CONCLUSIONS: Based on our real-time intraoperative angiography observations, there is no need to preserve the uterine artery during radical trachelectomy to maintain uterine viability.