The multispecies microbial cluster of Fusobacterium, Parvimonas, Bacteroides and Faecalibacterium as a precision biomarker for colorectal cancer diagnosis.

The incidence of colorectal cancer (CRC) has increased worldwide, and early diagnosis is crucial to reduce mortality rates. Therefore, new noninvasive biomarkers for CRC are required. Recent studies have revealed an imbalance in the oral and gut microbiomes of patients with CRC, as well as impaired gut vascular barrier function. In the present study, the microbiomes of saliva, crevicular fluid, feces, and non-neoplastic and tumor intestinal tissue samples of 93 CRC patients and 30 healthy individuals without digestive disorders (non-CRC) were analyzed by 16S rRNA metabarcoding procedures. The data revealed that Parvimonas, Fusobacterium, and Bacteroides fragilis were significantly over-represented in stool samples of CRC patients, whereas Faecalibacterium and Blautia were significantly over-abundant in the non-CRC group. Moreover, the tumor samples were enriched in well-known periodontal anaerobes, including Fusobacterium, Parvimonas, Peptostreptococcus, Porphyromonas, and Prevotella. Co-occurrence patterns of these oral microorganisms were observed in the subgingival pocket and in the tumor tissues of CRC patients, where they also correlated with other gut microbes, such as Hungatella. This study provides new evidence that oral pathobionts, normally located in subgingival pockets, can migrate to the colon and probably aggregate with aerobic bacteria, forming synergistic consortia. Furthermore, we suggest that the group composed of Fusobacterium, Parvimonas, Bacteroides, and Faecalibacterium could be used to design an excellent noninvasive fecal test for the early diagnosis of CRC. The combination of these four genera would significantly improve the reliability of a discriminatory test with respect to others that use a single species as a unique CRC biomarker.

Parvimonas micra can translocate from the subgingival sulcus of the human oral cavity to colorectal adenocarcinoma.

Oral and intestinal samples from a cohort of 93 colorectal cancer (CRC) patients and 30 healthy controls (non-CRC) were collected for microbiome analysis. Saliva (28 non-CRC and 94 CRC), feces (30 non-CRC and 97 CRC), subgingival fluid (20 CRC), and tumor tissue samples (20 CRC) were used for 16S metabarcoding and/or RNA sequencing (RNAseq) approaches. A differential analysis of the abundance, performed with the ANCOM-BC package, adjusting the P-values by the Holm-Bonferroni method, revealed that Parvimonas was significantly over-represented in feces from CRC patients (P-value < 0.001) compared to healthy controls. A total of 11 Parvimonas micra isolates were obtained from the oral cavity and adenocarcinoma of CRC patients. Genome analysis identified a pair of isolates from the same patient that shared 99.2% identity, demonstrating that P. micra can translocate from the subgingival cavity to the gut. The data suggest that P. micra could migrate in a synergistic consortium with other periodontal bacteria. Metatranscriptomics confirmed that oral bacteria were more active in tumor than in non-neoplastic tissues. We suggest that P. micra could be considered as a CRC biomarker detected in non-invasive samples such as feces.

Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE).

INTRODUCTION: To date, no pancreatic stump closure technique has been shown to be superior to any other in distal pancreatectomy. Although several studies have shown a trend towards better results in transection using a radiofrequency device (radiofrequency-assisted transection (RFT)), no randomised trial for this purpose has been performed to date. Therefore, we designed a randomised clinical trial, with the hypothesis that this technique used in distal pancreatectomies is superior in reducing clinically relevant postoperative pancreatic fistula (CR-POPF) than mechanical closures. METHODS AND ANALYSIS: TRANSPAIRE is a multicentre randomised controlled trial conducted in seven Spanish pancreatic centres that includes 112 patients undergoing elective distal pancreatectomy for any indication who will be randomly assigned to RFT or classic stapler transections (control group) in a ratio of 1:1. The primary outcome is the CR-POPF percentage. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-ß), expected POPF in control group of 32%, expected POPF in RFT group of 10% and a clinically relevant difference of 22%. Secondary outcomes include postoperative results, complications, radiological evaluation of the pancreatic stump, metabolomic profile of postoperative peritoneal fluid, survival and quality of life. Follow-ups will be carried out in the external consultation at 1, 6 and 12 months postoperatively. ETHICS AND DISSEMINATION: TRANSPAIRE has been approved by the CEIM-PSMAR Ethics Committee. This project is being carried out in accordance with national and international guidelines, the basic principles of protection of human rights and dignity established in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), and in accordance with regulations in studies with biological samples, Law 14/2007 on Biomedical Research will be followed. We have defined a dissemination strategy, whose main objective is the participation of stakeholders and the transfer of knowledge to support the exploitation of activities. REGISTRATION DETAILS: ClinicalTrials.gov Registry (NCT04402346).

Fluorescence-based bowel anastomosis perfusion evaluation: results from the IHU-IRCAD-EAES EURO-FIGS registry.

BACKGROUND: Anastomotic leakage (AL) is one of the dreaded complications following surgery in the digestive tract. Near-infrared fluorescence (NIRF) imaging is a means to intraoperatively visualize anastomotic perfusion, facilitating fluorescence image-guided surgery (FIGS) with the purpose to reduce the incidence of AL. The aim of this study was to analyze the current practices and results of NIRF imaging of the anastomosis in digestive tract surgery through the EURO-FIGS registry. METHODS: Analysis of data prospectively collected by the registry members provided patient and procedural data along with the ICG dose, timing, and consequences of NIRF imaging. Among the included upper-GI, colorectal, and bariatric surgeries, subgroup analysis was performed to identify risk factors associated with complications. RESULTS: A total of 1240 patients were included in the study. The included patients, 74.8% of whom were operated on for cancer, originated from 8 European countries and 30 hospitals. A total of 54 surgeons performed the procedures. In 83.8% of cases, a pre-anastomotic ICG dose was administered, and in 60.1% of cases, a post-anastomotic ICG dose was administered. A significant difference (p < 0.001) was found in the ICG dose given in the four pathology groups registered (range: 0.013-0.89 mg/kg) and a significant (p < 0.001) negative correlation was found between the ICG dose and BMI. In 27.3% of the procedures, the choice of the anastomotic level was guided by means of NIRF imaging which means that in these cases NIRF imaging changed the level of anastomosis which was first decided based on visual findings in conventional white light imaging. In 98.7% of the procedures, the use of ICG partly or strongly provided a sense of confidence about the anastomosis. A total of 133 complications occurred, without any statistical significance in the incidence of complications in the anastomoses, whether they were ICG-guided or not. CONCLUSION: The EURO-FIGS registry provides an insight into the current clinical practice across Europe with respect to NIRF imaging of anastomotic perfusion during digestive tract surgery.

Beneficial Effects of Bariatric Surgery-Induced by Weight Loss on the Proteome of Abdominal Subcutaneous Adipose Tissue.

Bariatric surgery (BS) is the most effective treatment for obesity and has a positive impact on cardiometabolic risk and in the remission of type 2 diabetes. Following BS, the majority of fat mass is lost from the subcutaneous adipose tissue depot (SAT). However, the changes in this depot and functions and as well as its relative contribution to the beneficial effects of this surgery are still controversial. With the aim of studying altered proteins and molecular pathways in abdominal SAT (aSAT) after body weight normalization induced by BS, we carried out a proteomic approach sequential window acquisition of all theoretical mass spectra (SWATH-MS) analysis. These results were complemented by Western blot, electron microscopy and RT-qPCR. With all of the working tools mentioned, we confirmed that after BS, up-regulated proteins were associated with metabolism, the citric acid cycle and respiratory electron transport, triglyceride catabolism and metabolism, formation of ATP, pyruvate metabolism, glycolysis/gluconeogenesis and thermogenesis among others. In contrast, proteins with decreased values are part of the biological pathways related to the immune system. We also confirmed that obesity caused a significant decrease in mitochondrial density and coverage, which was corrected by BS. Together, these findings reveal specific molecular mechanisms, genes and proteins that improve adipose tissue function after BS characterized by lower inflammation, increased glucose uptake, higher insulin sensitivity, higher de novo lipogenesis, increased mitochondrial function and decreased adipocyte size.

Computational Inference of Gene Co-Expression Networks for the identification of Lung Carcinoma Biomarkers: An Ensemble Approach.

Gene Networks (GN), have emerged as an useful tool in recent years for the analysis of different diseases in the field of biomedicine. In particular, GNs have been widely applied for the study and analysis of different types of cancer. In this context, Lung carcinoma is among the most common cancer types and its short life expectancy is partly due to late diagnosis. For this reason, lung cancer biomarkers that can be easily measured are highly demanded in biomedical research. In this work, we present an application of gene co-expression networks in the modelling of lung cancer gene regulatory networks, which ultimately served to the discovery of new biomarkers. For this, a robust GN inference was performed from microarray data concomitantly using three different co-expression measures. Results identified a major cluster of genes involved in SRP-dependent co-translational protein target to membrane, as well as a set of 28 genes that were exclusively found in networks generated from cancer samples. Amongst potential biomarkers, genes N C K A P 1 L and D M D are highlighted due to their implications in a considerable portion of lung and bronchus primary carcinomas. These findings demonstrate the potential of GN reconstruction in the rational prediction of biomarkers.

AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome.

Serum Anti-Müllerian hormone (AMH) level could be useful for the diagnosis of polycystic ovary syndrome (PCOS). We evaluated the hormonal status in women for the diagnosis of PCOS. A total of 77 PCOS women and 106 healthy women were enrolled in this study. Serum AMH, gonadotropins [luteinising hormone (LH) and follicle-stimulating hormone (FSH)], oestradiol, testosterone (total and free), 4-androstenedione (ANDST), dehydroepiandrosterone sulphate, sex hormone binding globulin (SHBG), prolactin, thyroid-stimulating hormone and insulin levels were measured in all enrolled women. Our data showed that insulin, LH, testosterone, ANDST and AHM levels were significantly higher in the PCOS group and FSH and SHBG levels were lower in the PCOS group. In Receiver operating characteristic analysis, the combination of AMH with SHBG showed higher area under curves (AUC) for PCOS diagnosis with an AUC of 0.843 and a specificity of 81.1% and a sensitivity of 72.7%. Our results suggest that a combination of serum AMH and SHBG levels could be used as a diagnostic biomarker of PCOS. Impact statement What is already known on this subject? Women with PCOS have an increased risk of hypertension, altered glucose metabolism and probably an increased lifetime risk of cardiovascular diseases. There is no consensus on the diagnostic criteria for PCOS. This leads to many patients with PCOS are being undiagnosed. It is known that AMH plays a role in the follicular status of PCOS and serum AMH level is increased significantly in women with PCOS compared with normo-ovulatory women. This is why several studies have suggested the inclusion of AMH as a diagnostic criterion in PCOS. What do the results of this study add? Extensive epidemiological data is available which demonstrates an association between higher AMH levels and PCOS, but there was no information available about the combination of AMH level with other hormones and PCOS. This is the first study that has investigated the association of AMH and SHBG, together, with PCOS. Our results suggest that serum AMH and SHBG level in combination could represent a useful and practical test to screen the general population for PCOS. What are the implications of these findings for clinical practice and/or further research? Many PCOS women in the general population are undiagnosed due to lack of consensus in diagnostic criteria. Therefore, the importance of identifying women with PCOS due to the need for follow-up in short and long-term health risk.

Laparoscopic colorectal cancer resection with natural orifice specimen extraction: a prospective study / Ressecção laparoscópica do câncer colorretal com extração de espécime em orifício natural: um estudo prospectivo

ABSTRACT Introduction: Laparoscopic colorectal resection is more and more being employed in the daily oncology practice. Natural orifice techniques to obviate the need for a specimen extraction incision are evolving. Materials and methods: We studied transanal and transvaginal specimen extraction after laparoscopic colorectal resections prospectively in 16 patients. Results: The technique was successfully implemented in 75% of the cases. The site of the tumour and the patient age were the significant predictors of the technique success. Conclusion: The technique is reproducible and can be more widely adopted.

RESUMO Introdução: A ressecção colorretal laparoscópica está sendo cada vez mais empregada na prática diária de oncologia. Observa-se uma evolução nas técnicas que usam orifícios naturais de modo a evitar a necessidade de uma incisão para extração de espécimes. Materiais e métodos: O estudo avaliou prospectivamente a extração transanal e transvaginal de espécimes após ressecções colorretais laparoscópicas em 16 pacientes. Resultados: A técnica foi implementada com sucesso em 75% dos casos. A localização do tumor e a idade do paciente foram preditores significativos de sucesso da técnica. Conclusão: A técnica é reprodutível e pode ser mais amplamente adotada.

Servidor de Terminología Médica para el Hospital de Clínicas de Paraguay utilizando Apache Lucene / Medical Terminology Server for the Hospital de Clínicas de Paraguay using Apache Lucene

Introducción: En el Hospital de Clínicas de Paraguay, el proceso actual de búsqueda de terminologías para la codificación médica en estándares de salud toma mucho tiempo ya que se realiza manualmente. Se propone, optimizar el proceso actual de búsqueda a través de la implementación de un servidor de terminología médica utilizando servicios web y una librería de motor de búsqueda de texto. Método: Se propone una arquitectura cliente - servidor de tres capas (también conocida como arquitectura multi-nivel), organizada de la siguiente manera: capa de presentación, de negocios y capa de datos. Se eligió utilizar este patrón por la independencia entre las capas y la clara definición de cada una de ellas en cuanto al objetivo que persigue. El servidor de terminología se encuentra representado en la capa de negocios. Está compuesta por un conjunto de servicios web de tipo REST y una librería de motor de búsqueda de texto, denominada Apache Lucene. Experimentos y Resultados: Fueron realizados dos experimentos acordes a los objetivos específicos mencionados anteriormente. El servidor de terminología implementado responde hasta 19 veces más rápido que el proceso actual de búsqueda y resultó ser bastante competitivo contra Metamorphosys. Si bien ambas herramientas presentan un tiempo de respuesta promedio similar, el servidor de terminología es hasta 5 veces más rápido que Metamorphosys en sus valores atípicos. Conclusiones: El servidor de terminología implementado reduce el tiempo de búsqueda del proceso actual siendo más rápido que el proceso actual de búsqueda. Finalmente, ante la comparación del servidor implementado contra el buscador Metamorphosys, el servidor implementado se muestra competitivo contra dicho buscador ya que tienen tiempos de respuesta similares(AU)

Introduction: In the Hospital Clínicas of Paraguay, the current process of searching for terminologies for medical coding in health standards takes a long time since it is done manually. It is proposed to optimize the current search process through the implementation of a medical terminology server using web services and a text search engine library. Method: Three layer client-server architecture is proposed (also known as multilevel architecture), organized as follows: presentation layer, business layer and data layer. The use of this pattern was due to its contribution to the independence between the layers and the clear definition of them in terms of the objective pursued. The terminology server is represented in the business layer. It is composed of a set of REST web services and a text search engine library, called Apache Lucene. Experiments and Results: Two experiments were carried out according to the objective mentioned above. The implemented terminology server responds up to 19 times faster than the current search process and proved to be quite competitive against Metamorphosys. While both tools have a similar average response time, the terminology server is up to 5 times faster than Metamorphosys in their outliers. Conclusions: The terminology server implemented reduces the search time of the current process being faster than the current search process. Finally, before the comparison of the server implemented against the Metamorphosys search engine, the implemented server is competitive since they have similar response times(AU).

Redo transanal total mesorectal excision (Re-TaTME) after initial TaTME; is it possible?

Rectal cancer is one of the commonest human malignancies. Treatment of this serious disease conventionally involves resection with/without anastomosis. Anastomotic site stenosis is a serious complication of rectal resection for which treatment is still evolving. We report a male patient treated with minimally invasive abdominal and anal approach for stenosis after initial transanal total mesorectal excision (TaTME) for rectal cancer. Surgeons are encouraged to put this technique in their mind while treating similar cases.

Transanal Total Mesorectal Excision for Rectal Cancer: Short Term Outcomes from Two Centers.

BACKGROUND: Rectal cancer is now an increasing problem in both developed and developing countries. In the last 7 years, minimally invasive surgery for this disease has entered a new era of transanal resection with/without laparoscopic assistance. MATERIALS AND METHODS: We present here a prospective study done in Egypt (probably the earliest experience) and Spain on the feasibility of hybrid NOTES in rectal cancer. RESULTS: From September 2015 till November 2017, 18 cases underwent transanal total mesorectal excision with no detected mortality and with morbidities in 44% of cases, from which 5 were class III on Clavien-Dindo scale requiring intervention. Good quality total mesorectal excision was obtained in more than three quarters of our patients. CONCLUSIONS: In our experience, the technique was technically demanding with a long learning curve; however, the short term results were very good in alliance with other few similar reports.

Validation of the three web quality dimensions of a minimally invasive surgery e-learning platform.

INTRODUCTION: E-learning web environments, including the new TELMA platform, are increasingly being used to provide cognitive training in minimally invasive surgery (MIS) to surgeons. A complete validation of this MIS e-learning platform has been performed to determine whether it complies with the three web quality dimensions: usability, content and functionality. METHODS: 21 Surgeons participated in the validation trials. They performed a set of tasks in the TELMA platform, where an e-MIS validity approach was followed. Subjective (questionnaires and checklists) and objective (web analytics) metrics were analysed to achieve the complete validation of usability, content and functionality. RESULTS: The TELMA platform allowed access to didactic content with easy and intuitive navigation. Surgeons performed all tasks with a close-to-ideal number of clicks and amount of time. They considered the design of the website to be consistent (95.24%), organised (90.48%) and attractive (85.71%). Moreover, they gave the content a high score (4.06 out of 5) and considered it adequate for teaching purposes. The surgeons scored the professional language and content (4.35), logo (4.24) and recommendations (4.20) the highest. Regarding functionality, the TELMA platform received an acceptance of 95.24% for navigation and 90.48% for interactivity. CONCLUSIONS: According to the study, it seems that TELMA had an attractive design, innovative content and interactive navigation, which are three key features of an e-learning platform. TELMA successfully met the three criteria necessary for consideration as a website of quality by achieving more than 70% of agreements regarding all usability, content and functionality items validated; this constitutes a preliminary requirement for an effective e-learning platform. However, the content completeness, authoring tool and registration process required improvement. Finally, the e-MIS validity methodology used to measure the three dimensions of web quality in this work can be applied to other clinical areas or training fields.

Dysregulated cholinergic network as a novel biomarker of poor prognostic in patients with head and neck squamous cell carcinoma.

BACKGROUND: In airways, a proliferative effect is played directly by cholinergic agonists through nicotinic and muscarinic receptors activation. How tumors respond to aberrantly activated cholinergic signalling is a key question in smoking-related cancer. This research was addressed to explore a possible link of cholinergic signalling changes with cancer biology. METHODS: Fifty-seven paired pieces of head and neck squamous cell carcinoma (HNSCC) and adjacent non-cancerous tissue (ANCT) were compared for their mRNA levels for ACh-related proteins and ACh-hydrolyzing activity. RESULTS: The measurement in ANCT of acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) activities (5.416 ± 0.501 mU/mg protein and 6.350 ± 0.599 mU/mg protein, respectively) demonstrated that upper respiratory tract is capable of controlling the availability of ACh. In HNSCC, AChE and BChE activities dropped to 3.584 ± 0.599 mU/mg protein (p = 0.002) and 3.965 ± 0.423 mU/mg protein (p < 0.001). Moreover, tumours with low AChE activity and high BChE activity were associated with shorter patient overall survival. ANCT and HNSCC differed in mRNA levels for AChE-T, α3, α5, α9 and ß2 for nAChR subunits. Tobacco exposure had a great impact on the expression of both AChE-H and AChE-T mRNAs. Unaffected and cancerous pieces contained principal AChE dimers and BChE tetramers. The lack of nerve-born PRiMA-linked AChE agreed with pathological findings on nerve terminal remodelling and loss in HNSCC. CONCLUSIONS: Our results suggest that the low AChE activity in HNSCC can be used to predict survival in patients with head and neck cancer. So, the ChE activity level can be used as a reliable prognostic marker.

Interactive effects of early and later nutritional conditions on the adult antioxidant defence system in zebra finches.

In vertebrates, antioxidant defences comprise a mixture of endogenously produced components and exogenously obtained antioxidants that are derived mostly from the diet. It has been suggested that early-life micronutritional conditions might influence the way in which the antioxidant defence system operates, which could enable individuals to adjust the activity of the endogenous and exogenous components in line with their expected intake of dietary antioxidants if the future environment resembles the past. We investigated this possibility by experimentally manipulating the micronutrient content of the diet during different periods of postnatal development in the zebra finch (Taeniopygia guttata). Birds that had a low micronutrient diet during the growth phase initially had a lower total antioxidant capacity (TAC) than those reared under a high micronutrient diet, but then showed a compensatory response, so that by the end of the growth phase, the TAC of the two groups was the same. Interestingly, we found an interactive effect of micronutrient intake early and late in development: only those birds that continued with the same dietary treatment (low or high) throughout development showed a significant increase in their TAC during the period of sexual maturation. A similar effect was also found in the level of enzymatic antioxidant defences (glutathione peroxidase; GPx). No significant effects were found in the level of oxidative damage in lipids [malondialdehyde (MDA) levels]. These findings demonstrate the importance of early and late developmental conditions in shaping multiple aspects of the antioxidant system. Furthermore, they suggest that young birds may adjust their antioxidant defences to enable them to 'thrive' on diets rich or poor in micronutrients later in life.

Unbalanced acetylcholinesterase activity in larynx squamous cell carcinoma.

Previous reports have demonstrated that a non-neuronal cholinergic system is expressed aberrantly in airways. A proliferative effect is exerted directly by cholinergic agonists through the activation of nicotinic and muscarinic receptors. In cancer, particularly those related with smoking, the mechanism through which tumour cells respond to aberrantly activated cholinergic signalling is a key question. Fifty paired pieces of larynx squamous cell carcinoma and adjacent non-cancerous tissue were compared in terms of their acetylcholinesterase activity (AChE). The AChE activity in non-cancerous tissues (0.248 ± 0.030 milliunits per milligram of wet tissue; mU/mg) demonstrates that upper respiratory tissues express sufficient AChE activity for controlling the level of acetylcholine (ACh). In larynx carcinomas, the AChE activity decreased to 0.157 ± 0.024 mU/mg (p=0.009). Larynx cancer patients exhibiting low ACh-degrading enzymatic activity had a significantly shorter overall survival (p=0.031). Differences in the mRNA levels of alternatively spliced AChE isoforms and molecular compositions were noted between glottic and supraglottic cancers. Our results suggest that the low AChE activity observed in larynx squamous cell carcinoma may be useful for predicting the outcome of patients.

Screening for hazardous drinking in migrant workers in southeastern Spain.

OBJECTIVES: Despite the great impact the migration has had in economic, social and health-related fields, and the repercussions of alcohol consumption on them, few data exist concerning the extent of alcohol consumption in migrant workers. The aims of this study were to identify workers with a hazardous drinking problem by means of a self-reported questionnaire (Alcohol Use Disorders Identification Test-AUDIT) and a biomarker (carbohydrate-deficient transferrin-CDT) and to ascertain associated risk factors. METHODS: A cross-sectional survey was conducted using a random sample of 385 migrant workers, undergoing a routine health examination as part of occupational health services. RESULTS: The results showed that 13.8% (n=53) of the workers were screened as positive with the AUDIT (≥8) and/or CDT (>2.6) and identified as hazardous drinkers and that 53.8% (n=207) were teetotallers. Being a man (OR: 2.0), working in the construction industry (OR: 2.8) or agriculture (OR: 2.2), being resident in Spain for more than 7 years (OR: 2.3) and sharing a house with friends were the factors most closely associated with hazardous drinking. CONCLUSIONS: Prevention-orientated programs, adjusted to the characteristics of each country and the origin of the migrants themselves, should be instituted to modify the drinking habits of migrant workers considered at risk.

Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study.

BACKGROUND: Natural orifice transumbilical endoscopic surgery (NOTES) is a technique still in experimental development that requires clinical trials to assess its safety and efficacy. We present a pilot prospective, randomized, three-arm clinical trial of 1-year duration that was conducted as a noninferiority trial comparing single-incision laparoscopic surgery (SILS) and flexible single-incision surgery (FSIS) with conventional laparoscopy for elective cholecystectomy (NCT01558414). METHODS: Sixty patients between aged 18 and 65 years who were eligible for elective cholecystectomy were randomly assigned in a 1:1:1 ratio (n = 20 per group): group A (SILS), single-incision endoscopic surgery using a transumbilical SILS™ device; group B (FSIS), single-incision transumbilical surgery using a flexible endoscope; and group C (CL), conventional laparoscopy. The main outcome variable of the study was "parietal complications" (wound infection, bleeding, and ventral hernia). The analysis was by intention to treat and attritions were not replaced. RESULTS: Cholecystectomy was performed in 100 % of the cases; perioperative complications occurred in only 1.6 % of the cases, and umbilical surgical wound infection in 3.33 %, with no differences between groups. After a minimum follow-up of 1 year, no differences were noted in the frequency of parietal complications and no ventral hernias occurred. Postoperative pain, hospital length of stay, and downtime from work were similar in all three groups. Surgical time was longer in cases in which a single-incision transumbilical approach was used (58.95 min for SILS and 54.15 for FSIS vs. 49.21 for laparoscopy). CONCLUSIONS: Single-incision transumbilical approaches are not inferior for safety or effectiveness compared with conventional laparoscopy. The transumbilical approach using a flexible endoscope is just as effective and safe as the other two procedures and is a promising single-incision approach.

The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report.

BACKGROUND: The EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2 years of the ECR. METHODS: The ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way. RESULTS: A total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8% of patients, addition of a single trocar in 5.3%, and conversions to laparoscopy in 0.5%. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7% of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5%), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0%), but none needing further treatment. CONCLUSIONS: Five years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.

TELMA: Technology-enhanced learning environment for minimally invasive surgery.

BACKGROUND: Cognitive skills training for minimally invasive surgery has traditionally relied upon diverse tools, such as seminars or lectures. Web technologies for e-learning have been adopted to provide ubiquitous training and serve as structured repositories for the vast amount of laparoscopic video sources available. However, these technologies fail to offer such features as formative and summative evaluation, guided learning, or collaborative interaction between users. METHODOLOGY: The "TELMA" environment is presented as a new technology-enhanced learning platform that increases the user's experience using a four-pillared architecture: (1) an authoring tool for the creation of didactic contents; (2) a learning content and knowledge management system that incorporates a modular and scalable system to capture, catalogue, search, and retrieve multimedia content; (3) an evaluation module that provides learning feedback to users; and (4) a professional network for collaborative learning between users. Face validation of the environment and the authoring tool are presented. RESULTS: Face validation of TELMA reveals the positive perception of surgeons regarding the implementation of TELMA and their willingness to use it as a cognitive skills training tool. Preliminary validation data also reflect the importance of providing an easy-to-use, functional authoring tool to create didactic content. CONCLUSION: The TELMA environment is currently installed and used at the Jesús Usón Minimally Invasive Surgery Centre and several other Spanish hospitals. Face validation results ascertain the acceptance and usefulness of this new minimally invasive surgery training environment.