Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST).

BACKGROUND: The impact of method of anastomosis and minimally invasive surgical technique on surgical and clinical outcomes after right hemicolectomy is uncertain. The aim of the MIRCAST study was to compare intracorporeal and extracorporeal anastomosis (ICA and ECA respectively), each using either a laparoscopic approach or robot-assisted surgery during right hemicolectomies for benign or malignant tumours. METHODS: This was an international, multicentre, prospective, observational, monitored, non-randomized, parallel, four-cohort study (laparoscopic ECA; laparoscopic ICA; robot-assisted ECA; robot-assisted ICA). High-volume surgeons (at least 30 minimally invasive right colectomy procedures/year) from 59 hospitals across 12 European countries treated patients over a 3-year interval The primary composite endpoint was 30-day success, defined by two measures of efficacy-absence of surgical wound infection and of any major complication within the first 30 days after surgery. Secondary outcomes were: overall complications, conversion rate, duration of operation, and number of lymph nodes harvested. Propensity score analysis was used for comparison of ICA with ECA, and robot-assisted surgery with laparoscopy. RESULTS: Some 1320 patients were included in an intention-to-treat analysis (laparoscopic ECA, 555; laparoscopic ICA, 356; robot-assisted ECA, 88; robot-assisted ICA, 321). No differences in the co-primary endpoint at 30 days after surgery were observed between cohorts (7.2 and 7.6 per cent in ECA and ICA groups respectively; 7.8 and 6.6 per cent in laparoscopic and robot-assisted groups). Lower overall complication rates were observed after ICA, specifically less ileus, and nausea and vomiting after robot-assisted procedures. CONCLUSION: No difference in the composite outcome of surgical wound infections and severe postoperative complications was found between intracorporeal versus extracorporeal anastomosis or laparoscopy versus robot-assisted surgery.

Robotic surgery for locally advanced T4 rectal cancer: feasibility and oncological quality.

For T4 rectal tumours and local recurrences (LR) of rectal cancer, a radical resection beyond TME, sometimes by multi-visceral resection, is important to obtain safe margins and improve survival. The use of the laparoscopic approach (LA) for these cases is still controversial and associated with a high rate of conversion. However, robotic surgery might offer some advantages that can overcome some of the limitations of LA. Therefore, we aimed to analyse the postoperative outcomes and medium-term oncological results of robotic surgery for locally advanced rectal cancer (pathological T4) and LR. A retrospective analysis was performed including patients who had undergone robotic rectal resection in a single institution over an 11-year period, and had a T4 tumour confirmed in the pathological report. Primary endpoint was to analyse postoperative complications (30-day) and the rate of conversion. Secondary endpoints include pathological assessment of the quality of the specimen, local recurrence and survival [2-year disease-free survival (DFS) and overall survival (OS)]. A total of 41 patients were analysed, including a total of 24 patients (60%) that required a multivisceral resection. The median distance from the tumour to the anorectal junction was 7 (4-12) cm. Conversion to open surgery was necessary in 2 cases (5%). The overall morbidity rate was 78% (n = 32), with 37% of major complications, most of them urinary (n = 7). Median length of hospital stay (LOS) was 13 (7-27) days. The 30-day mortality rate was 7% (n = 3). An R0 resection was achieved in 85.4% of the cases (n = 35) due to 6 cases of the positive circumferential resection margin. 2-year disease-free survival (DFS) and overall survival (OS) for the T4 tumours were 72% and 85%, respectively. There were 8 cases of local recurrence (22.2%); 6 of them met the selection criteria for salvage surgery. Robotic surgery for locally advanced T4 rectal cancer and multi-visceral resections is safe and feasible, with a low rate of conversion and an acceptable rate of postoperative morbidity in this subgroup of patients. Oncological results have shown to be comparable with the laparoscopic series published, preserving a good quality of the resected specimen. However, comparative studies and a longer follow-up period is needed to confirm the oncologic findings and to support the general adoption of the robotic system for these complex interventions.

Intraoperative robotic-assisted low anterior rectal resection performance assessment using procedure-specific binary metrics and a global rating scale.

BACKGROUND: This study aimed to evaluate the use of binary metric-based (proficiency-based progression; PBP) performance assessments and global evaluative assessment of robotic skills (GEARS) of a robotic-assisted low anterior rectal resection (RA-LAR) procedure. METHOD: A prospective study of video analysis of RA-LAR procedures was carried out using the PBP metrics with binary parameters previously developed, and GEARS. Recordings were collected from five novice surgeons (≤30 RA-LAR previously performed) and seven experienced surgeons (>30 RA-LAR previously performed). Two consultant colorectal surgeons were trained to be assessors in the use of PBP binary parameters to evaluate the procedure phases, surgical steps, errors, and critical errors in male and female patients and GEARS scores. Novice and experienced surgeons were categorized and assessed using PBP metrics and GEARS; mean scores obtained were compared for statistical purpose. Also, the inter-rater reliability (IRR) of these assessment tools was evaluated. RESULTS: Twenty unedited recordings of RA-LAR procedures were blindly assessed. Overall, using PBP metric-based assessment, a subgroup of experienced surgeons made more errors (20 versus 16, P = 0.158) and critical errors (9.2 versus 7.8, P = 0.417) than the novice group, although not significantly. However, during the critical phase of RA-LAR, experienced surgeons made significantly fewer errors than the novice group (95% CI of the difference, Lower = 0.104 - Upper = 5.155, df = 11.9, t = 2.23, p = 0.042), and a similar pattern was observed for critical errors. The PBP metric and GEARS assessment tools distinguished between the objectively assessed performance of experienced and novice colorectal surgeons performing RA-LAR (total error scores with PBP metrics, P = 0.019-0.008; GEARS scores, P = 0.029-0.025). GEARS demonstrated poor IRR (mean IRR 0.49) and weaker discrimination between groups (15-41 per cent difference). PBP binary metrics demonstrated good IRR (mean 0.94) and robust discrimination particularly for total error scores (58-64 per cent). CONCLUSIONS: PBP binary metrics seem to be useful for metric-based training for surgeons learning RA-LAR procedures.

Implementation of an enhanced recovery after surgery program with robotic surgery in high-risk patients obtains optimal results after colorectal resections.

Enhanced recovery after surgery programs reduce postoperative complications and length of stay after laparoscopic colorectal surgery, but are still under evaluation after robotic colorectal surgery. To evaluate potential benefits in terms of length of stay and complications of an Enhanced recovery after surgery program in colorectal surgery. A subanalysis was performed to assess what combination of surgical approach and perioperative care had better outcomes. Prospective observational cohort study. 300 consecutive colorectal surgery patients: 150 were prospectively included in the enhanced recovery after Surgery program group and 150 retrospectively in the traditional care group, and subdivided according to the type of surgery, in Hospital Marques de Valdecilla, between 2013 and 2016. Postoperative complications decreased significantly (p = 0.002) from 46 to 28% (traditional care vs program group). The length of stay was decreased by 2 days (p < 0.001). Multivariate analysis indicated similar effect sizes after adjusting for age, gender, Charlson score, and type of surgery. Type of surgery was an independent predictive factor for postoperative complications and length of stay. Compared to open surgery, postoperative complications decreased by 50% (p < 0.001) after robotic surgery and by 40% (p = 0.01) after laparoscopic surgery, while the median length of stay decreased by three days (p < 0.001) after minimally invasive surgery. Enhanced recovery after surgery program and minimally invasive surgery were associated with decreased morbidity and length of stay after colorectal surgery compared to open surgery and traditional care. An enhanced recovery after surgery program with robotic surgery in high-risk patients might be beneficial.

Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu.

BACKGROUND: The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. AIMS: To evaluate the impact of biologics on the risk of PC. METHODS: A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered "exposed". The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. RESULTS: A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5; 95% CI: 1.2-2.0), urgent surgery (OR: 1.6; 95% CI: 1.2-2.2), laparotomy approach (OR: 1.5; 95% CI: 1.1-1.9) and severe anaemia (OR: 1.8; 95% CI: 1.3-2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2; 95% CI: 0.97-1.58), although it could be a risk factor for postoperative infections (OR 1.5; 95% CI: 1.03-2.27). CONCLUSIONS: Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.

A probabilistic model for the prediction of intra-abdominal infection after colorectal surgery.

AIM: Predicting intra-abdominal infections (IAI) after colorectal surgery by means of clinical signs is challenging. A naïve logistic regression modeling approach has some limitations, for which reason we study two potential alternatives: the use of Bayesian networks, and that of logistic regression model. METHODS: Data from patients that had undergone colorectal procedures between 2010 and 2017 were used. The dataset was split into two subsets: (i) that for training the models and (ii) that for testing them. The predictive ability of the models proposed was tested (i) by comparing the ROC curves from days 1 and 3 with all the subjects in the test set and (ii) by studying the evolution of the abovementioned predictive ability from day 1 to day 5. RESULTS: In day 3, the predictive ability of the logistic regression model achieved an AUC of 0.812, 95% CI = (0.746, 0.877), whereas that of the Bayesian network was 0.768, 95% CI = (0.695, 0.840), with a p-value for their comparison of 0.097. The ability of the Bayesian network model to predict IAI does present significant difference in predictive ability from days 3 to 5: AUC(Day 3) = 0.761, 95% CI = (0.680, 0.841) and AUC(Day 5) = 0.837, 95% CI = (0.769, 0.904), with a p-value for their comparison of 0.006. CONCLUSIONS: Whereas at postoperative day 3, a logistic regression model with imputed data should be used to predict IAI; at day 5, when the predictive ability is almost identical, the Bayesian network model should be used.

Robotic surgery for colorectal cancer.

Minimally invasive surgery has demonstrated many benefits in general surgery, particularly in colon and rectal procedures. On the other hand, it has some limitations that must be taken into account, especially technical drawback. Robotic surgery has incorporated many improvements to overcome this disadvantage, such as 3D visualization, articulating instruments assisting complex and precise movements. As a result, robotic colorectal surgery shows less intraoperative blood loss, shorter time to oral tolerance and initial flatus (particularly associated with "Enhanced Recovery After Surgery" protocol), less conversion rate to open surgery, shortened hospital stay, and longer distal margins compared to laparoscopic and open surgery. This approach also shows a shorter learning curve. Some studies suggest that it could decrease perioperatively or 30 days after the intervention's mortality, raise overall survival, reduce wound infection, and improve functional results, while others show no significant difference. However, it lengthens surgical time. Otherwise, the studies included do not show statistically significant changes in the number of resected lymph nodes and anastomotic leaks. Economic costs remain one of the major concerns, although to date there are no large-scale studies that have evaluated this aspect from a global point of view. Robotic surgery represents a qualitative leap in surgical instruments and, although there is no strong evidence in favor of the use of robotic surgery over laparoscopic or open surgery, there is enough evidence to support its use in colorectal surgery, with potential advantages for patients.

Applied diagnostics in liver cancer. Efficient combinations of sorafenib with targeted inhibitors blocking AKT/mTOR.

Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related deaths worldwide. There is increasing interest in developing specific markers to serve as predictors of response to sorafenib and to guide targeted therapy. Using a sequencing platform designed to study somatic mutations in a selection of 112 genes (HepatoExome), we aimed to characterize lesions from HCC patients and cell lines, and to use the data to study the biological and mechanistic effects of case-specific targeted therapies used alone or in combination with sorafenib. We characterized 331 HCC cases in silico and 32 paired samples obtained prospectively from primary tumors of HCC patients. Each case was analyzed in a time compatible with the requirements of the clinic (within 15 days). In 53% of the discovery cohort cases, we detected unique mutational signatures, with up to 34% of them carrying mutated genes with the potential to guide therapy. In a panel of HCC cell lines, each characterized by a specific mutational signature, sorafenib elicited heterogeneous mechanistic and biological responses, whereas targeted therapy provoked the robust inhibition of cell proliferation and DNA synthesis along with the blockage of AKT/mTOR signaling. The combination of sorafenib with targeted therapies exhibited synergistic anti-HCC biological activity concomitantly with highly effective inhibition of MAPK and AKT/mTOR signaling. Thus, somatic mutations may lead to identify case-specific mechanisms of disease in HCC lesions arising from multiple etiologies. Moreover, targeted therapies guided by molecular characterization, used alone or in combination with sorafenib, can effectively block important HCC disease mechanisms.

Polipectomía transanal asistida por robot: ¿tiene alguna indicación? / Robotic Assisted Transanal Polypectomies: Is There Any Indication?

Objetivos: La polipectomía transanal asistida por robot puede tener ventajas respecto a la cirugía laparoscópica transanal convencional. Evaluamos la seguridad, factibilidad y ventajas potenciales de esta técnica. Métodos: Entre febrero de 2014 y octubre de 2015, se realizaron un total de 9 polipectomías transanales en nuestro centro. Realizamos un estudio retrospectivo de datos recogidos prospectivamente referentes a las características de los pacientes, tumores tratados, resultados perioperatorios, informe anatomopatológico y morbimortalidad. Resultados: Fueron tratados 5 hombres y 4 mujeres mediante polipectomía robótica transanal. Las lesiones se encontraban a una distancia media de 6,2 cm respecto al margen anal. La superficie media de las lesiones fue de 15,8 cm2. Todos los procedimientos fueron realizados en posición de litotomía, independientemente de la localización de la lesión. Se realizó cierre del defecto en todos los casos. El sangrado intraoperatorio medio fue de 39,8 mL. El tiempo quirúrgico medio fue de 71,9 min. No se objetivaron complicaciones graves postoperatorias ni reingresos y la estancia mediana fue de 2,5 días. Conclusiones: La polipectomía transanal asistida por robot es útil para tratar lesiones rectales complejas o voluminosas. Nuestra plataforma de acceso transanal permitió un amplio rango de movimientos con los pacientes en litotomía (AU)

Objectives: Robotic assisted transanal polipectomy may have advantages compared with the conventional transanal minimally invasive surgery technique. We evaluate the safety, feasibility and advantages of this technique. Methods: Between February 2014 and October 2015, 9 patients underwent robotic transanal polypectomy. We performed a retrospective study in which we analyse prospectively collected data regarding patient and tumor characteristics, perioperative outcomes, pathological report, morbidity and mortality. Results: A total of 5 male and 4 female patients underwent robotic TAMIS. Lesions were 6,22 cm from the anal verge. Mean size was 15,8 cm2. All procedures were performed in the lithotomy position. Closure of the defect was performed in all cases. Mean blood loss was 39,8 ml. Mean operative time was 71,9 min. No severe postoperative complications or readmissions occured. Median hospital stay was 2,5 days. Conclusions: Robotic TAMIS is useful to treat complex rectal lesions. Our transanal platform allowed a wider range of movements of the robotic arms and to perform all procedures in the lithotomy position (AU)

Robotic Assisted Transanal Polypectomies: Is There Any Indication? / Polipectomía transanal asistida por robot: ¿tiene alguna indicación?

OBJECTIVES: Robotic assisted transanal polipectomy may have advantages compared with the conventional transanal minimally invasive surgery technique. We evaluate the safety, feasibility and advantages of this technique. METHODS: Between February 2014 and October 2015, 9patients underwent robotic transanal polypectomy. We performed a retrospective study in which we analyse prospectively collected data regarding patient and tumor characteristics, perioperative outcomes, pathological report, morbidity and mortality. RESULTS: A total of 5 male and 4 female patients underwent robotic TAMIS. Lesions were 6,22cm from the anal verge. Mean size was 15,8cm2. All procedures were performed in the lithotomy position. Closure of the defect was performed in all cases. Mean blood loss was 39,8ml. Mean operative time was 71,9min. No severe postoperative complications or readmissions occured. Median hospital stay was 2,5 days. CONCLUSIONS: Robotic TAMIS is useful to treat complex rectal lesions. Our transanal platform allowed a wider range of movements of the robotic arms and to perform all procedures in the lithotomy position.

Early Discharge Programme on Hospital-at-Home Evaluation for Patients with Immediate Postoperative Course after Laparoscopic Colorectal Surgery.

BACKGROUND: To audit the safety of the early hospital discharge care model offered by a Hospital-at-home (HAH) unit during early postoperative follow-up of these patients, and to determine whether this care model is more efficient compared to the traditional care model. METHODS: A prospective study of 50 patients included consecutively for 1 year in an early discharge programme after laparoscopic colorectal surgery was performed. As of day 3 after surgery, if the patient met the relevant inclusion criteria they were transferred to the HAH unit. The domiciliary protocol consists of daily clinical follow-up and a series of analytical controls with the purpose of early detection of postoperative complications. If the clinical course was favourable on day 7 after the postoperative period the patient was discharged. RESULTS: A total of 66% were males, and the mean age was 60.6 years. The surgical procedure most commonly performed was sigmoidectomy. The mean stay was 5.5 days. There were no deaths during follow-up. The average estimated cost per day of stay in a HAH system was EUR 174.29 whilst the same average cost on a surgery ward stood at EUR 1,032.42. CONCLUSIONS: For patients undergoing major colorectal surgery with minimally invasive surgical technique, an early hospital discharge care programme by means of referral to a HAH unit is a safe and efficient care model which entails a significant cost saving for the public healthcare system.

Nueva técnica de proctectomía trasanal con escisión total del mesorrecto totalmente robótica en el tratamiento del cáncer de recto / New technique of transanal proctectomy with completely robotic total mesorrectal excision for rectal cancer

La resección anterior con escisión total mesorrectal es el tratamiento estándar para el cáncer de recto. Este tratamiento sigue siendo técnicamente dificultoso en los tumores localizados en el recto medio e inferior. Presentamos un caso de escisión total mesorrectal robótica transanal con asistencia robó tica en un varón de 57 años e IMC 32 kg/m2 con un adenocarcinoma T2N1M0 a 5 cm de línea pectínea tras tratamiento neoadyuvante. El tiempo quirúrgico fue de 420 min. La estancia postoperatoria fue de 6 días, sin objetivarse complicaciones. El estudio anatomopatológico demostró una pieza de 33 cm, una tumoración ypT2N0 con margen distal de 2 cm, margen circunferencial libre y buena calidad del mesorrecto. La tecnología robótica puede disminuir la dificultad inherente a las plataformas TEO/TEM o SILS para la realización de este tipo de procedimientos. La realización de ensayos clínicos es necesaria para la completa evaluación de esta técnica

Anterior resection with total mesorectal excision is the standard method of rectal cancer resection. However, this procedure remains technically difficult in mid and low rectal cancer. A robotic transanal proctectomy with total mesorectal excision and laparoscopic assistance is reported in a 57 year old male with BMI 32 kg/m2 and rectal adenocarcinoma T2N1M0 at 5 cm from the dentate line. Operating time was 420 min. Postoperative hospital stay was 6 days and no complications were observed. Pathological report showed a 33 cm specimen with ypT2N0 adenocarcinoma at 2 cm from the distal margin, complete TME and non affected circumferential resection margin. Robotic technology might reduce some technical difficulties associated with TEM/TEO or SILS platforms in transanal total mesorectal excision. Further clinical trials will be necessary to assess this technique

New technique of transanal proctectomy with completely robotic total mesorrectal excision for rectal cancer.

Anterior resection with total mesorectal excision is the standard method of rectal cancer resection. However, this procedure remains technically difficult in mid and low rectal cancer. A robotic transanal proctectomy with total mesorectal excision and laparoscopic assistance is reported in a 57 year old male with BMI 32 kg/m2 and rectal adenocarcinoma T2N1M0 at 5 cm from the dentate line. Operating time was 420 min. Postoperative hospital stay was 6 days and no complications were observed. Pathological report showed a 33 cm specimen with ypT2N0 adenocarcinoma at 2 cm from the distal margin, complete TME and non affected circumferential resection margin. Robotic technology might reduce some technical difficulties associated with TEM/TEO or SILS platforms in transanal total mesorectal excision. Further clinical trials will be necessary to assess this technique.