Influence of the COVID-19 pandemic on the defined daily dose of antimicrobials in patients requiring elective and emergency surgical procedures.

BACKGROUND: The COVID-19 pandemic has resulted in great incertitude and overwhelming changes in healthcare that have had a direct impact on antibiotic prescription. However, the influence of this pandemic on antibiotic consumption in patients undergoing surgery has not yet been analysed. The goal of this study was to analyse antimicrobial consumption and prescription in the same period of 2019 (pre-COVID-19), 2020 (beginning of the COVID-19 pandemic) and 2021 (established COVID-19) according to the DDD system in surgical patients at a tertiary-level hospital. METHODS: A prospectively maintained database was analysed. All patients who underwent elective or emergency gastrointestinal surgery during the same period (2019, 2020 and 2021) were included. Those who received at least 1 of the 10 most frequently prescribed antimicrobials during those periods were analysed. RESULTS: A total of 2975 patients were included in this study. In 2020, the number of procedures performed decreased significantly (653 versus 1154 and 1168 in 2020 versus 2019 and 2021, respectively; P = 0.005). Of all patients who underwent surgery during these periods, 45.08% received at least one of the antimicrobials studied (45.8% in 2020 versus 22.9% and 22.97% in 2019 and 2021, respectively; P = 0.005). Of these, 22.97% of the patients received a combination of these antimicrobials, with ceftriaxone/metronidazole being the most frequent. Hepato-Pancreato-Biliary and Liver Transplant, Emergency Surgery and Colorectal Surgery units had higher antibiotic consumption. CONCLUSIONS: The COVID-19 pandemic has resulted in a significant decrease in surgical activity and higher post-operative antimicrobial prescription compared with previous and subsequent years.

Observational Prospective Study to Determine the Efficacy of 'Non-Slip Socks' vs. 'Adequate Footwear' Regarding the Number of Falls Observed among Admitted Patients.

BACKGROUND: Fall prevention is an important indicator of the quality of patient care. Prevention includes the use of adequate footwear. Our objective is to determine the differences in the number of falls between patients with "adequate footwear" and "non slip socks", and their associated consequences, to support their use in the prevention of falls among hospitalized patients. METHODS: This is an observational prospective study on inpatient falls. Patient characteristics, fall circumstances, and injuries were collected through Clinical Report Forms, a review of fall reports, and medical records. Admitted patients over 18 years old were recruited from Geriatric and Internal Medicine Units over a brief period of 3 months. RESULTS: A total of 158 hospitalized patients were recruited. In total, 77 patients (48.73%) were assigned to the non-slip socks group, and 81 (51.27%) were assigned to the adequate footwear group. There were 21 falls during the study period, all of which were experienced by the adequate footwear group (p < 0.0001). The mean age of the patients who fell was 83.14 (range 60-100) years old. The most frequent reasons for admission among the patients who fell were COVID-19 infection (19%) and oncological complications (19%). Overall, 61.9% of patients had a high risk of falling. Most falls (76.1%) occurred in patient rooms, and most of these occurred while wandering around. The most frequent reason for falls was slipping (14/21). For 16 of 21 patients, falls did not have immediate consequences, while 5 had contusions and 1 suffered a wound. Nobody needed to be admitted to the ER or suffered external hemorrhages or loss of consciousness. CONCLUSIONS: Non-slip socks represent an adequate alternative to well-fitting rubber-soled footwear. It seems that non-slip socks could prevent falls among hospitalized patients; nevertheless, further studies are necessary to clarify their role in preventing hospital falls and reducing injury rates.

Freelite and Kloneus assays in free light chain measurements in patients with renal impairment.

BACKGROUND: Serum free light chain (FLC) quantification is a diagnostic criterion for monoclonal gammopathy and its values in patients with renal impairment are different from those in healthy subjects. The aim of this study was to evaluate Freelite and Kloneus assays in these patients. METHODS: In this retrospective study, serum samples from 226 patients with chronic kidney disease (CKD) of stages 2-5 were measured with a Freelite assay on the Optilite system and with a Kloneus assay on the AU5800 system and compared with controls without renal impairment. RESULTS: Both kappa FLC (K-FLC) and lambda FLC (L-FLC) concentrations increased with Kloneus and Freelite assays with each increment in CKD stage. In patients with CKD, Kloneus detected lower concentrations of K-FLC (median: 20.4 mg/L; 95% range: 9.8-57.2) than Freelite (median: 36.5 mg/L; 95% range: 16.5-137.7) and higher concentrations of L-FLC (median: 32.2 mg/L; 95% range: 14.4-96.7) than Freelite (median: 25.4 mg/L; 95% range: 11.9-86.0). This resulted in significantly different kappa/lambda ratios (K/L-FLC) in patients with CKD for the two tests. The Freelite K/L-FLC in the CKD group (median: 1.50; min-max: 0.66-3.45) was significantly increased compared with healthy controls, and the Kloneus K/L-FLC in the CKD group (median: 0.63; 95 % min-max: 0.34-1.01) was slightly lower. CONCLUSIONS: These findings demonstrate that Freelite and Kloneus assays provide higher but not parallel values when FLCs are measured in patients with CKD, so an increase in K/L-FLC was observed in the case of Freelite, and we found a slight decrease in the case of Kloneus.

A Systematic Review on Food Recommender Systems for Diabetic Patients.

Recommender systems are currently a relevant tool for facilitating access for online users, to information items in search spaces overloaded with possible options. With this goal in mind, they have been used in diverse domains such as e-commerce, e-learning, e-tourism, e-health, etc. Specifically, in the case of the e-health scenario, the computer science community has been focused on building recommender systems tools for supporting personalized nutrition by delivering user-tailored foods and menu recommendations, incorporating the health-aware dimension to a larger or lesser extent. However, it has been also identified the lack of a comprehensive analysis of the recent advances specifically focused on food recommendations for the domain of diabetic patients. This topic is particularly relevant, considering that in 2021 it was estimated that 537 million adults were living with diabetes, being unhealthy diets a major risk factor that leads to such an issue. This paper is centered on presenting a survey of food recommender systems for diabetic patients, supported by the PRISMA 2020 framework, and focused on characterizing the strengths and weaknesses of the research developed in this direction. The paper also introduces future directions that can be followed in the next future, for guaranteeing progress in this necessary research area.

Immediate adverse reactions in the chemotherapy treatment of patients with cancer at an oncology day hospital.

A descriptive and cross-sectional study was performed to characterize the degree of immediate adverse reaction and the type of causative antineoplastic drug presented by 371 different patients treated for cancer at the oncology day hospital unit of the San Carlos Clinical Hospital (Madrid, Spain), during the period between January 2015 and December 2019. In the case series, 488 immediate adverse reactions secondary to chemotherapy toxicity were detected. The dominating factors were: Female sex, age from 51-70 years old, skin melanoma and the use of vinca alkaloids and analogs. Among the most frequent adverse reactions, the following stood out: Disorders of the nervous and musculoskeletal systems and of the connective tissue. There was a higher number of moderate adverse reactions (grade 2 according to the Common Terminology Criteria for Adverse Events Version 4.0) between the first and third chemotherapy cycles, with a latency period of between 6 and 15 min., generally lasting less than 30 min. Association with the degree of immediate adverse reaction (grade) has been observed in male subjects over 71 years of age, with soft tissue neoplasm type and monoclonal antibodies therapeutic group.

Deep Learning-Based Model for Identifying Tumors in Endoscopic Images From Patients With Locally Advanced Rectal Cancer Treated With Total Neoadjuvant Therapy.

BACKGROUND: A barrier to the widespread adoption of watch-and-wait management for locally advanced rectal cancer is the inaccuracy and variability of identifying tumor response endoscopically in patients who have completed total neoadjuvant therapy (chemoradiotherapy and systemic chemotherapy). OBJECTIVE: This study aimed to develop a novel method of identifying the presence or absence of a tumor in endoscopic images using deep convolutional neural network-based automatic classification and to assess the accuracy of the method. DESIGN: In this prospective pilot study, endoscopic images obtained before, during, and after total neoadjuvant therapy were grouped on the basis of tumor presence. A convolutional neural network was modified for probabilistic classification of tumor versus no tumor and trained with an endoscopic image set. After training, a testing endoscopic imaging set was applied to the network. SETTINGS: The study was conducted at a comprehensive cancer center. PATIENTS: Images were analyzed from 109 patients who were diagnosed with locally advanced rectal cancer between December 2012 and July 2017 and who underwent total neoadjuvant therapy. MAIN OUTCOME MEASURES: The main outcomes were accuracy of identifying tumor presence or absence in endoscopic images measured as area under the receiver operating characteristic for the training and testing image sets. RESULTS: A total of 1392 images were included; 1099 images (468 of no tumor and 631 of tumor) were for training and 293 images (151 of no tumor and 142 of tumor) for testing. The area under the receiver operating characteristic for training and testing was 0.83. LIMITATIONS: The study had a limited number of images in each set and was conducted at a single institution. CONCLUSIONS: The convolutional neural network method is moderately accurate in distinguishing tumor from no tumor. Further research should focus on validating the convolutional neural network on a large image set. See Video Abstract at http://links.lww.com/DCR/B959 . MODELO BASADO EN APRENDIZAJE PROFUNDO PARA IDENTIFICAR TUMORES EN IMGENES ENDOSCPICAS DE PACIENTES CON CNCER DE RECTO LOCALMENTE AVANZADO TRATADOS CON TERAPIA NEOADYUVANTE TOTAL: ANTECEDENTES:Una barrera para la aceptación generalizada del tratamiento de Observar y Esperar para el cáncer de recto localmente avanzado, es la imprecisión y la variabilidad en la identificación de la respuesta tumoral endoscópica, en pacientes que completaron la terapia neoadyuvante total (quimiorradioterapia y quimioterapia sistémica).OBJETIVO:Desarrollar un método novedoso para identificar la presencia o ausencia de un tumor en imágenes endoscópicas utilizando una clasificación automática basada en redes neuronales convolucionales profundas y evaluar la precisión del método.DISEÑO:Las imágenes endoscópicas obtenidas antes, durante y después de la terapia neoadyuvante total se agruparon en base de la presencia del tumor. Se modificó una red neuronal convolucional para la clasificación probabilística de tumor versus no tumor y se entrenó con un conjunto de imágenes endoscópicas. Después del entrenamiento, se aplicó a la red un conjunto de imágenes endoscópicas de prueba.ENTORNO CLINICO:El estudio se realizó en un centro oncológico integral.PACIENTES:Analizamos imágenes de 109 pacientes que fueron diagnosticados de cáncer de recto localmente avanzado entre diciembre de 2012 y julio de 2017 y que se sometieron a terapia neoadyuvante total.PRINCIPALES MEDIDAS DE VALORACION:La precisión en la identificación de la presencia o ausencia de tumores en imágenes endoscópicas medidas como el área bajo la curva de funcionamiento del receptor para los conjuntos de imágenes de entrenamiento y prueba.RESULTADOS:Se incluyeron mil trescientas noventa y dos imágenes: 1099 (468 sin tumor y 631 con tumor) para entrenamiento y 293 (151 sin tumor y 142 con tumor) para prueba. El área bajo la curva operativa del receptor para entrenamiento y prueba fue de 0,83.LIMITACIONES:El estudio tuvo un número limitado de imágenes en cada conjunto y se realizó en una sola institución.CONCLUSIÓN:El método de la red neuronal convolucional es moderadamente preciso para distinguir el tumor de ningún tumor. La investigación adicional debería centrarse en validar la red neuronal convolucional en un conjunto de imágenes mayor. Consulte Video Resumen en http://links.lww.com/DCR/B959 . (Traducción -Dr. Fidel Ruiz Healy ).

Use of sponge-assisted endoluminal vacuum therapy for the treatment of colorectal anastomotic leaks: expert panel consensus.

BACKGROUND: Anastomotic leaks represent one of the most significant complications of colorectal surgery and are the primary cause of postoperative mortality and morbidity. Sponge-assisted endoluminal vacuum therapy (EVT) has emerged as a minimally invasive technique for the management of anastomotic leaks; however, there are questions regarding patient selection due to the heterogeneous nature of anastomotic leaks and the application of sponge-assisted EVT by surgeons. METHOD: Seven colorectal surgical experts participated in a modified nominal group technique to establish consensus regarding key questions that arose from existing gaps in scientific evidence and the variability in clinical practice. After a bibliographic search to identify the available evidence and sequential meetings with participants, a series of recommendations and statements were formulated and agreed upon. RESULTS: Thirty-seven recommendations and statements on the optimal use of sponge-assisted EVT were elaborated on and unanimously agreed upon by the group of experts. The statements and recommendations answer 10 key questions about the indications, benefits, and definition of the success rate of sponge-assisted EVT for the management of anastomotic leaks. CONCLUSION: Although further research is needed to resolve clinical and technical issues associated with sponge-assisted EVT, the recommendations and statements produced from this project summarize critical aspects to consider when using sponge-assisted EVT and to assist those involved in the management of patients with colorectal anastomotic leaks.

Factors associated with recruitment success in the phase 2a study of aztreonam-avibactam development programme: a descriptive qualitative analysis among sites in Spain.

OBJECTIVE: Successful clinical trials are subject to recruitment. Recently, the REJUVENATE trial, a prospective phase 2a open-label, single-arm interventional clinical trial conducted within the Innovative Medicines Initiative-supported Combatting Bacterial Resistance in Europe-Carbapenem Resistance project, was published, with 85% of the recruitment performed in Spain. We analysed the recruitment success in this trial by establishing a model of recruitment practice. METHODS: A descriptive qualitative study was performed from May 2016 to October 2017 at 10 participating Spanish centres. Data were extracted from: (1) feasibility questionnaires to assess the centre's potential for patient enrolment; (2) delegation of responsibility records; (3) pre-screening records including an anonymised list of potentially eligible and (4) screening and enrolment records. A descriptive analysis of the features was performed by the participating centre. Pearson's and Spearman's correlation coefficients were calculated to determine factors of recruitment success. RESULTS: The highest recruitment rate was observed in Hospitals 3 and 6 (58.8 and 47.0 patients per month, respectively). All the study teams were multidisciplinary with a median of 15 members (range: 7-22). Only Hospitals 3, 5 and 6 had dedicated nursing staff appointed exclusively to this study. Moreover, in those three hospitals and in Hospital 9, the study coordinator performed exclusive functions as a research planner, and did not assume these functions for the other hospitals. The univariate analysis showed a significant association between recruitment success and months of recruitment (p=0.024), number of staff (p<0.001), higher number of pharmacists (p=0.005), infectious disease specialists (p<0.001), the presence of microbiologist in the research team (p=0.018) and specifically dedicated nursing staff (p=0.036). CONCLUSIONS: The existence of broad multidisciplinary teams with staff dedicated exclusively to the study as well as the implementation of a well-designed local patient assessment strategy were the essential optimisation factors for recruitment success in Spain. TRIAL REGISTRATION NUMBER: NCT02655419; EudraCT 2015-002726-39; analysis of pre-screened patients.

Adoption of Organ Preservation and Surgeon Variability for Patients with Rectal Cancer Does Not Correlate with Worse Survival.

BACKGROUND AND OBJECTIVES: Watch-and-wait is variably adopted by surgeons and the impact of this on outcomes is unknown. We compared the disease-free survival and organ preservation rates of locally advanced rectal cancer patients treated by expert colorectal surgeons at a comprehensive cancer center. METHODS: This study included retrospective data on patients diagnosed with stage II/III rectal adenocarcinoma from January 2013 to June 2017 who initiated neoadjuvant therapy (either with chemoradiation, chemotherapy, or a combination of both) and were treated by an expert colorectal surgeon. RESULTS: Overall, 444 locally advanced rectal cancer patients managed by five surgeons were included. Tumor distance from the anal verge, type of neoadjuvant therapy, and organ preservation rates varied by treating surgeon. There was no difference in disease-free survival after stratifying by the treating surgeon (p = 0.2). On multivariable analysis, neither the type of neoadjuvant therapy nor the treating surgeon was associated with disease-free survival. CONCLUSIONS: While neoadjuvant therapy type and organ preservation rates varied among surgeons, there were no meaningful differences in disease-free survival. These data suggest that among expert colorectal surgeons, differing thresholds for selecting patients for watch-and-wait do not affect survival.

Organ Preservation in Patients with Rectal Cancer Treated with Total Neoadjuvant Therapy.

BACKGROUND: Retrospective studies suggest that watch-and-wait is a safe alternative to total mesorectal excision in selected patients with a clinical complete response after chemoradiotherapy. OBJECTIVE: This study aimed to determine the proportion of patients with rectal cancer who may benefit from watch-and-wait. DESIGN: This study is a retrospective analysis of data from prospectively maintained databases. SETTING: This study was conducted at a comprehensive cancer center. PATIENTS: Consecutive patients with stage II or III rectal adenocarcinoma who were treated with total neoadjuvant therapy using induction chemotherapy between 2012 and 2019 under the care of the same surgeon were included. INTERVENTION: Induction-type total neoadjuvant therapy consisted of 8 cycles of leucovorin-fluorouracil-oxaliplatin or 5 cycles of capecitabine-oxaliplatin before chemoradiotherapy. Patients with a clinical complete response were offered watch-and-wait, and patients with residual tumor were offered total mesorectal excision. MAIN OUTCOMES AND MEASURES: Tumor response was assessed with a digital rectal examination, endoscopy, and MRI. Patient characteristics and recurrence-free survival were compared between the watch-and-wait group and the total mesorectal excision group. RESULTS: A total of 88 patients were included in the analysis. One (1%) died during neoadjuvant therapy. Fifty-five patients (62.5%) had an incomplete clinical response and underwent surgery, 10 (18%) of the 55 developed distant metastasis, and 3 (5%) developed local recurrence. The remaining 32 patients (36.3%) had a clinical complete response and underwent watch-and-wait. On average, patients in the watch-and-wait group were older and had smaller, more distal tumors compared with patients in the surgery group. The median radiation dose, number of chemotherapy cycles, rate of adverse events, and length of follow-up did not differ substantively between the total mesorectal excision group and the watch-and-wait group. In the watch-and-wait group, 2 (6%) patients developed tumor regrowth, and one of them had distant metastasis. Recurrence-free survival was significantly higher in the watch-and-wait group. LIMITATIONS: Generalizability, sample size, and follow-up duration were limitations of this study. CONCLUSIONS: Approximately one-third of patients with stage II or III rectal cancer can benefit from a watch-and-wait approach with the aim of preserving the rectum if treated with induction-type total neoadjuvant therapy and followed by an experienced multidisciplinary team. See Video Abstract at http://links.lww.com/DCR/B688. CONSERVACIN DE RGANOS EN PACIENTES CON CNCER DE RECTO TRATADOS CON TERAPIA NEOADYUVANTE TOTAL: ANTECEDENTES:Estudios retrospectivos sugieren que observar y esperar es una alternativa segura a la escisión mesorrectal total en pacientes seleccionados con una respuesta clínica completa después de la quimiorradioterapia.OBJETIVO:Determinar la proporción de pacientes con cáncer de recto que pueden beneficiarse de observar y esperar.DISEÑO:Análisis retrospectivo de datos de bases de datos mantenidas de forma prospectiva.ESCENARIO:Centro Oncológico Integral.PACIENTES:Pacientes consecutivos con adenocarcinoma de recto en estadio II o III tratados con TNT utilizando quimioterapia de inducción entre 2012 y 2019 bajo el cuidado del mismo cirujano.INTERVENCIÓN:La terapia neoadyuvante total de tipo inducción consistió en ocho ciclos de leucovorín-fluorouracilo-oxaliplatino o cinco ciclos de capecitabina-oxaliplatino antes de la quimiorradioterapia. A los pacientes con una respuesta clínica completa se les ofreció observar y esperar, y a los pacientes con tumor residual se les ofreció la escisión mesorrectal total.PRINCIPALES RESULTADOS Y MEDIDAS:La respuesta del tumor se evaluó con un tacto rectal, endoscopia y resonancia magnética. Se compararon las características de los pacientes y la supervivencia libre de recurrencia entre el grupo de observación y espera y el grupo de escisión mesorrectal total.RESULTADOS:Se incluyó en el análisis a un total de 88 pacientes. Uno (1%) murió durante la terapia neoadyuvante. Cincuenta y cinco pacientes (62.5%) tuvieron una respuesta clínica incompleta y se sometieron a cirugía; 10 (18%) de los 55 desarrollaron metástasis a distancia y 3 (5%) desarrollaron recidiva local. Los 32 pacientes restantes (36.3%) tuvieron una cCR (respuesta clínica completa) y se sometieron a observar y esperar. En promedio, los pacientes del grupo de observación y espera eran mayores y tenían tumores más pequeños y distales en comparación con el grupo de cirugía. La dosis mediana de radiación, el número de ciclos de quimioterapia, la tasa de eventos adversos y la duración del seguimiento no difirieron sustancialmente entre el grupo de escisión mesorrectal total y el grupo de observación y espera. En el grupo de observación y espera, 2 (6%) pacientes desarrollaron recrecimiento del tumor y uno de ellos tuvo metástasis a distancia. La supervivencia libre de recurrencia fue significativamente mayor en el grupo de observación y espera.LIMITACIONES:Generalizabilidad, tamaño de la muestra, duración del seguimiento.CONCLUSIONES:Aproximadamente un tercio de los pacientes con cáncer de recto en estadio II o III pueden beneficiarse de un abordaje de observación y espera con el objetivo de preservar el recto si se tratan con terapia neoadyuvante total de tipo inducción y son seguidos por un equipo multidisciplinario experimentado. Consulte Video Resumen en http://links.lww.com/DCR/B688.

Type of recurrence is associated with disease-free survival after salvage surgery for locally recurrent rectal cancer.

PURPOSE: To compare the characteristics and outcomes of rectal cancer patients with local recurrence at a perianastomotic site (PA), a surgical field (SF) site, or in lateral lymph nodes (LLN). METHODS: A total of 114 consecutive patients who underwent surgery for recurrent, non-metastatic rectal cancer at a single comprehensive cancer center between 1997 and 2012 were grouped on the basis of radiographic assessment of type of recurrence: PA, 76 (67%) patients; SF, 25 (22%) patients; LLN, 13 (11%) patients. Demographic, clinical, and pathological features were compared between the three groups, as were disease-free survival (DFS) and overall survival (OS). RESULTS: Recurrence type was associated with positive circumferential margin in the primary resection (PA, 4 [6%]; SF, 4 [19%]; LLN, 3 [25%]; P = 0.027), prior neoadjuvant therapy for the primary tumor (PA, 57 [75%]; SF, 18 [72%]; LLN, 4 [31%]; P = 0.007), and location of the primary tumor in the upper rectum (PA, 33 [45%]; SF, 5 [23%]; LLN, 1 [8%]; P < 0.001). Patients with PA had longer median DFS (PA, 5.1 years; SF, 1.5 years; LLN, 1.2 years; P = 0.036). There was a non-significant trend toward longer OS and higher rates of R0 resection for PA. CONCLUSION: Type of recurrence after salvage surgery for locally recurrent rectal cancer is associated with longer DFS in patients with PA recurrence.

Special surgical approaches during peri-COVID-19 pandemic: Robotic and transanal minimally invasive surgery.

During the peri-coronavirus disease 2019 pandemic, the need of special care has raised, not only for our patients but also for health care workers. These needs are different regarding the procedure and the approach performed. This is a dynamic review in the use of robotics and transanal approaches for colorectal diseases. We searched PubMed and KSREvidence.com for studies related to coronavirus disease and robotic surgery/transanal mesorectal excision/transanal surgery (primary and systematic reviews). From 147 results in PubMed, 11 were selected for full text screening, and 11 were included in this paper. From 3 results in KSREvidence, no relevant systematic reviews were identified. We also checked the references in identified papers for further relevant studies. European Society of Coloproctology guidelines were including as part of the recommendations available. Robotic and transanal MIS can be performed safely during the pandemic, but particular characteristics of these procedure need to be taken into consideration.

Comparing outcomes of robotic versus open mesorectal excision for rectal cancer.

BACKGROUND: The outcomes of robot-assisted mesorectal excision for rectal cancer, compared with open resection, have not been fully characterized. METHODS: A retrospective analysis of pathologic, short-term, and long-term outcomes in patients with rectal adenocarcinoma who underwent total or tumour-specific mesorectal excision at a high-volume cancer centre between 2008 and 2017 was conducted. Outcomes after robotic and open surgery were compared on an intention-to-treat basis. RESULTS: Out of 1048 resections performed, 1018 patients were reviewed, with 638 who underwent robotic surgery and 380 open surgery. Robotic surgery was converted to the open approach in 17 (2.7 per cent) patients. Patients who underwent robotic surgery were younger (median 54 (range 22-91) years versus median 58 (range 18-97) years; P < 0.001), had higher tumours (median 80 (range 0-150) mm from the anal verge versus median 70 (0-150) mm; P = 0.001), and were less likely to have received neoadjuvant therapy (64 per cent versus 73 per cent; P = 0.003). For patients who underwent a robotic total mesorectal excision, the operating time was longer (median 283.5 (range 117-712) min versus median 249 (range 70-661) min; P < 0.001). However, the rate of complications was lower (29 per cent versus 45 per cent; P < 0.001) and length of hospital stay was shorter (median 5 (range 1-32) days versus median 7 (range 0-137) days; P < 0.001). Median follow-up of survivors was 2.9 years. The proportion of patients with a positive circumferential resection margin did not differ between the groups, nor did the rate of local recurrence (robotic versus open: 3.7 per cent, 95 per cent c.i. 1.9 to 5.6 versus 2.8 per cent, 95 per cent c.i. 1.0 to 4.6; P = 0.400), systemic recurrence (robotic versus open: 11.7 per cent, 95 per cent c.i. 8.5 to 14.8 versus 13.0 per cent, 95 per cent c.i. 9.2 to 16.5; P = 0.300), or overall survival (robotic versus open: 97.8 per cent, 95 per cent c.i. 96.3 to 99.3 versus 93.5 per cent, 95 per cent c.i. 90.8 to 96.2; P = 0.050). The same results were documented in a subanalysis of 370 matched patients, including 185 who underwent robotic surgery and 185 open surgery, for the overall incidence of any postoperative complications, overall survival, disease-free survival, local recurrence, and systemic recurrence. CONCLUSION: In patients with rectal cancer who are candidates for curative resection, robotic mesorectal excision is associated with lower complication rates, shorter length of stay, and equivalent oncologic outcomes, compared with open mesorectal excision.

Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study.

BACKGROUND: Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. MATERIALS AND METHODS: Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). RESULTS: A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. CONCLUSION: The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.

Quantitative assessment of tumor-infiltrating lymphocytes in mismatch repair proficient colon cancer.

Tumor infiltrating lymphocytes (TIL), which represent host adaptive response to the tumor, were first identified at scanning magnification to select areas with the highest counts on hematoxylin and eosin slides, quantitated per high-power field (HPF), and analyzed for association with recurrence-free survival (RFS) in 848 patients. Highest TIL in a single HPF was analyzed as a continuous and categorical variable, and optimal cutoff analysis was performed to predict RFS. Highest TIL count in a single HPF ranged from 0 to 45, and the optimal cutoff for TIL high vs TIL low was determined to be ≥ 3 vs < 3 with a concordance probability estimate of 0.74. In the entire cohort, 5-year RFS was 90.2% (95% CI = 83.7-94.2) in TIL high compared to 78.9% (95% CI = 74.1-82.9) in TIL low (log rank P < .0001). TIL remained significant in the mismatch repair-proficient (pMMR) cohort where 5-year RFS was 94.6% (95% CI = 88.3-97.5) in TIL high compared to 77.9% (95% CI = 69.2-84.4) in TIL low (P = .008). On multivariable analysis, TIL and AJCC Stage were independently associated with RFS in the pMMR cohort. Qualitatively in the pMMR cohort, RFS in Stage II TIL high patients was similar to that in Stage I patients and RFS in Stage III TIL high was similar to that in Stage II TIL low patients. Assessment of TIL in a single HPF using standard H&E slides provides important prognostic information independent of MMR status and AJCC stage.

Patient-Reported Bowel Function in Patients With Rectal Cancer Managed by a Watch-and-Wait Strategy After Neoadjuvant Therapy: A Case-Control Study.

BACKGROUND: A watch-and-wait strategy is a nonoperative alternative to sphincter-preserving surgery for patients with locally advanced rectal cancer who achieve a clinical complete response after neoadjuvant therapy. There are limited data about bowel function for patients undergoing this organ-preservation approach. OBJECTIVE: The purpose of this study was to compare bowel function in patients with rectal cancer managed with a watch-and-wait approach with bowel function in patients who underwent sphincter-preserving surgery (total mesorectal excision). DESIGN: This was a retrospective case-control study using patient-reported outcomes. SETTINGS: The study was conducted at a comprehensive cancer center. PATIENTS: Twenty-one patients underwent a watch-and-wait approach and were matched 1:1 with 21 patients from a pool of 190 patients who underwent sphincter-preserving surgery, based on age, sex, and tumor distance from the anal verge. MAIN OUTCOME MEASURES: Bowel function was measured using the Memorial Sloan Kettering Cancer Center Bowel Function Instrument. RESULTS: Patients in the watch-and-wait arm had better bowel function on the overall scale (median total score, 76 vs 55; p < 0.001) and on all of the subscales, with the greatest difference on the urgency/soilage subscale (median score, 20 vs 12; p < 0.001). LIMITATIONS: The study was limited by its retrospective design, small sample size, and temporal variability between surgery and time of questionnaire completion. CONCLUSIONS: A watch-and-wait strategy correlated with overall better bowel function when compared with sphincter-preserving surgery using a comprehensive validated bowel dysfunction tool. See Video Abstract at http://links.lww.com/DCR/B218. FUNCIÓN EVACUATORIA INFORMADA POR PACIENTES EN CÁNCER RECTAL MANEJADO CON UNA ESTRATEGIA DE OBSERVAR Y ESPERAR DESPUÉS DE LA TERAPIA NEOADYUVANTE: UN ESTUDIO DE CASOS Y CONTROLES: Observar y esperar es una alternativa no operativa a la cirugía de preservación del esfínter para pacientes con cáncer rectal localmente avanzado que logran una respuesta clínica completa después de la terapia neoadyuvante. Hay datos limitados sobre la función evacuatoria en pacientes sometidos a este abordaje para preservación de órganos.Evaluar la función evacuatoria en pacientes con cáncer rectal manejados con observar y esperar comparado a pacientes sometidos a cirugía de preservación de esfínteres (escisión mesorrectal total).Estudio retrospectivo de casos y controles utilizando resultados reportados por pacientes.Centro especializado oncológico.21 pacientes se sometieron a observar y esperar y se compararon con 21 pacientes de un grupo de 190 pacientes que se sometieron a cirugía de preservación de esfínteres controlando por edad, sexo y la distancia del tumor al borde anal.Función evacuatoria utilizando un instrumento de valoración del Centro de Cáncer Memorial Sloan Kettering.Los pacientes de observar y esperar demostraron mejor función evacuatoria en la escala general (puntuación total media, 76 versus 55; p <0,001) y en todas las subescalas, con la mayor diferencia en la subescala de urgencia / ensuciamiento fecal (puntuación media, 20 versus 12; p <0,001).Diseño retrospectivo, numero de muestra pequeño y variabilidad temporal entre la cirugía y el tiempo de finalización del cuestionario.Observar y esperar se correlacionó con mejor función evacuatoria en general en comparación con la cirugía de preservación del esfínter utilizando una herramienta integral validada para la disfunción evacuatoria. Consulte Video Resumen en http://links.lww.com/DCR/B218. (Traducción-Dr. Adrián Ortega).