Preoperative triage to detect SARS-CoV-2 infection in surgical patients: lessons learned for resuming surgery.

PURPOSE: To define the impact of the COVID-19 outbreak on hospital surgical activity and assess the incidence of perioperative COVID-19 within two protocolized screening pathways for elective and non-elective surgery. METHODS: We conducted a prospective cohort study of adults undergoing surgery during the COVID-19 outbreak. The elective pathway included telephone surveys and a quantitative polymerase-chain-reaction test (RT-PCR) only for patients who were asymptomatic and at low risk of infection. Only patients with negative screening underwent surgery. In the non-elective pathway, preoperative screening was performed during the hospital admission. RESULTS: Among 835 patients considered for the elective pathway, 725 had negative RT-PCR results and underwent surgery. This reflects an 83% reduction in surgical activity from 2019. Moreover, 596 patients underwent non-elective surgery, representing a 28% reduction. Preoperatively, 39 patients (6.5%) tested positive for SARS-CoV-2 and underwent surgery through the non-elective pathway, vs. none in the elective pathway (p < 0.001). Postoperatively, 1.4% of elective surgery patients and 2.2% of non-elective surgery patients tested positive (p > 0.05). Mortality was higher in non-elective surgery (0.6% vs. 2.9%, p < 0.001) and in patients with COVID-19 (0% vs. 14%, p < 0.001). CONCLUSIONS: The low incidence of COVID-19 in elective surgeries during the outbreak demonstrates the importance and effectiveness of preoperative screening, combining surveys and RT-PCR.

Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence.

OBJECTIVE: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. SUMMARY OF BACKGROUND DATA: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. METHODS: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. RESULTS: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. CONCLUSION: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

Quantitative Indocyanine Green Fluorescence Imaging Assessment for Nonmucinous Peritoneal Metastases: Preliminary Results of the ICCP Study.

BACKGROUND: In selected patients with peritoneal metastases of colorectal origin, complete cytoreduction has been the main single prognostic factor influencing long-term outcomes. In these patients, indocyanine green fluorescence imaging seems to be useful in detecting small subclinical peritoneal implants. However, quantitative fluorescence analysis has not yet been established as standard. OBJECTIVE: This study aimed to evaluate the sensitivity and specificity of quantitative indocyanine green fluorescence assessment in the detection of peritoneal metastases of nonmucinous colorectal origin. DESIGN: This is a single-center, single-arm, low-intervention prospective trial. SETTINGS: A fluorescence assessment device was used for intraoperative fluorescence quantitative assessment. PATIENTS: Consecutive patients diagnosed with peritoneal metastases of colorectal origin who met the inclusion criteria were selected for curative surgery. INTERVENTIONS: Intravenous indocyanine green was administered 12 hours before surgery. Cytoreduction was performed through nodule identification under white light and then under indocyanine green. Finally, ex vivo fluorescence was assessed. MAIN OUTCOME MEASURES: The primary outcomes measured were the sensitivity and specificity of quantitative fluorescence. RESULTS: The first 11 enrolled patients were included in this preliminary analysis. In total, 52 nodules were resected, with 37 (71.1%) being diagnosed as malignant in the histopathological analysis. Of those, 5 (13.5%) were undetectable under white light and were identified only with fluorescence. A total of 15 nonmalignant nodules were detected under white light, 8 (53.3%) of which were fluorescence negative. Fluorescence greater than 181 units might be the threshold of malignancy, with a sensitivity and specificity of 89.0% and 85.0%, whereas uptake less than 100 units appears to correlate with a benign pathology. LIMITATIONS: The limited sample size, the physiological uptake, and excretion of indocyanine green might interfere with the assessment of unnoticed implants in the bowel serosa and liver. CONCLUSIONS: Quantitative indocyanine green seems to be useful for the assessment of nonmucinous colorectal peritoneal metastases. Fluorescence uptake greater than 181 units appears to correlate with malignancy, whereas uptake less than 100 units appears to correlate with a benign pathology. See Video Abstract at http://links.lww.com/DCR/B743. EVALUACIN CUANTITATIVA DE IMGENES DE FLUORESCENCIA CON VERDE DE INDOCIANINA PARA METSTASIS PERITONEALES NO MUCINOSAS RESULTADOS PRELIMINARES DEL ESTUDIO ICCP: ANTECEDENTES:En pacientes seleccionados con metástasis peritoneales de origen colorrectal, la citorreducción com-pleta ha sido el único factor pronóstico principal que influye en el resultado a largo plazo. En estos pacientes, las imágenes de fluorescencia con verde de indocianina parecen ser útiles para detectar pequeños implantes peritoneales subclínicos. Sin embargo, el análisis cuantitativo de fluorescencia aún no se ha establecido como estándar.OBJETIVO:Evaluar la sensibilidad y especificidad de la evaluación cuantitativa de fluorescencia verde de indo-cianina, en la detección de metástasis peritoneales de origen colorrectal no mucinoso.DISEÑO:Ensayo prospectivo de intervención baja de un solo brazo y un solo centro.ENTORNO CLINICO:El dispositivo se utilizó para la evaluación cuantitativa de fluorescencia intraoperatoria.PACIENTES:Pacientes consecutivos diagnosticados con metástasis peritoneales de origen colorrectal, selecciona-dos para cirugía curativa y que cumplieron con los criterios de inclusión.INTERVENCIONES:Se administró verde de indocianina por vía intravenosa 12 h antes de la cirugía. La citorreducción se realizó mediante identificación de nódulos con luz blanca y luego con verde de indocianina. Final-mente, se evaluó la fluorescencia ex vivo.PRINCIPALES MEDIDAS DE VALORACION:Sensibilidad y especificidad cuantitativa de la fluorescencia.RESULTADOS:Los primeros 11 pacientes fueron incluidos en este análisis preliminar. En total se resecaron 52 nódu-los, siendo 37 (71,1%) diagnosticados como malignos en el análisis histopatológico. De ellos, 5 (13,5%) eran indetectables bajo luz blanca y solamente se identificaron con fluorescencia. Se detec-taron un total de 15 nódulos no malignos bajo luz blanca, de los cuales 8 (53,3%) fueron fluorescen-tes negativos. La fluorescencia superior a 181 unidades podría ser el umbral de malignidad, con una sensibilidad y especificidad del 89,0% y el 85,0% respectivamente; mientras que la captación por debajo de 100 unidades parece correlacionarse con una patología benigna.LIMITACIONES:El tamaño limitado de la muestra; la captación fisiológica y la excreción de verde de indocianina pueden interferir con la evaluación de implantes inadvertidos en la serosa intestinal y el hígado.CONCLUSIONES:La cuantificación del verde de indocianina, parece ser útil en la evaluación de metástasis peritonea-les colorrectales no mucinosas. La captación de fluorescencia por encima de 181 unidades parece correlacionarse con la malignidad, mientras que la captación por debajo de 100 unidades parece co-rrelacionarse con una patología benigna. Consulte Video Resumen en http://links.lww.com/DCR/B743. (Traducción - Dr. Fidel Ruiz Healy).

Functional Outcomes and Quality of Life After Transanal Total Mesorectal Excision for Rectal Cancer: A Prospective Observational Study.

BACKGROUND: Few studies have addressed the functional impact after transanal total mesorectal excision. OBJECTIVE: This study aimed to evaluate function and health-related quality of life among patients with rectal cancer treated with transanal total mesorectal excision. DESIGN: Consecutive patients treated between 2016 and 2018 were selected. Their function and quality of life were studied preoperatively and at 3 and 12 months after surgery. SETTING: This is a prospective case series. PATIENTS: Patients were eligible if they had primary anastomosis, their diverting stoma had been reversed, and they did not have anastomotic leakage. Forty-five patients were finally included. A total of 31 (68.8%) and 32 patients (71.1%) completed the 3- and 12-month surveys. INTERVENTIONS: Standard transanal total mesorectal excision was performed. MAIN OUTCOME MEASURES: The primary end point was functional and quality-of-life outcomes using validated questionnaires. Secondary end points included values obtained with endoanal ultrasounds, anorectal manometries, and rectal sensation testing. RESULTS: Wexner and Low Anterior Resection Syndrome scores significantly increased 3 months after surgery but returned to baseline values at 12 months. The rate of "major low anterior resection syndrome" at the end of follow-up was 25.0% (+11.7% compared with baseline, p = 0.314). Sexual and urinary functions remained stable throughout the study, although a meaningful clinical improvement was detected in male sexual interest. Among quality-of-life domains, all deteriorations returned to baseline values 12 months after surgery, except worsening of flatulence symptoms, and improvement in insomnia and constipation. At 12 months, an expected decrease in the mean width of the internal sphincter, the anal resting pressure, and the tenesmus threshold volume was found. LIMITATIONS: This study was limited by its small sample size, the absence of a comparative group, and significant missing data in female sexual difficulty and in ultrasounds and manometries at 3 months. CONCLUSIONS: Patients undergoing transanal total mesorectal excision report acceptable quality-of-life and functional outcomes 12 months after surgery. See Video Abstract at http://links.lww.com/DCR/B541. RESULTADOS FUNCIONALES Y CALIDAD DE VIDA DE LOS PACIENTES DESPUS DE LA ESCISIN MESORRECTAL TOTAL TRANSANAL PARA CNCER DE RECTO UN ESTUDIO PROSPECTIVO OBSERVACIONAL: ANTECEDENTES:Pocos estudios han abordado el impacto funcional después de la escisión mesorrectal total transanal.OBJETIVO:Evaluar la función y la calidad de vida relacionada con la salud en pacientes con cáncer de recto tratados con escisión mesorrectal total transanal.DISEÑO:Se seleccionaron pacientes consecutivos tratados entre 2016 y 2018. Se estudió su función y calidad de vida, en la etapa preoperatoria, a los tres y doce meses postoperatorios.METODO:Serie de casos prospectivos.PACIENTES:Los pacientes eran incluidos en presencia de anastomosis primaria, cierre del estoma de derivación y en ausencia de fuga anastomótica. Finalmente se incluyeron cuarenta y cinco pacientes. Un total de 31 (68,8%) y 32 pacientes (71,1%) completaron las encuestas de tres y doce meses, respectivamente.INTERVENCIONES:Escisión mesorrectal total transanal estándar.PRINCIPALES MEDIDAS DE RESULTADO:Los criterio de evaluación principal fueron los resultados funcionales y de calidad de vida mediante cuestionarios previamente validados. Los criterios de evaluación secundarios incluyeron los valores obtenidos con ecografía endoanal, manometría anorrectal y prueba de sensibilidad rectal.RESULTADOS:La escala de Wexner y el síndrome de resección anterior baja aumentaron significativamente tres meses después de la cirugía, pero volvieron a los valores iniciales a los doce meses. La tasa de "síndrome de resección anterior inferior grave" al final del seguimiento fue del 25,0% (+ 11,7% en comparación con el valor inicial, p = 0,314). La función sexual y urinaria se mantuvo estable durante todo el estudio, aunque se detectó una mejora clínica significativa en la libido masculina. Entre los criterios que evalúan la calidad de vida, todas las alteraciones en la misma volvieron a los valores iniciales, doce meses después de la cirugía, excepto el aumento de flatulencia, la mejoría del insomnio y el estreñimiento. A los doce meses, se encontró una disminución esperada en el grosor medio del esfínter interno, la presión anal en reposo y el volumen umbral para la presencia de tenesmo.LIMITACIONES:Tamaño de muestra limitado, ausencia de un grupo comparativo, falta significativa de datos para identificar la dificultad para la actividad sexual femenina y el efectuar ecografía y manometría a los tres meses.CONCLUSIONES:Los pacientes sometidos a escisión mesorrectal total transanal refieren una calidad de vida y resultados funcionales aceptables a los doce meses después de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/B541.

Transanal Total Mesorectal Excision Versus Anterior Total Mesorectal Excision for Rectal Cancer: A Propensity Score Matched, Population-Based Study in Catalonia, Spain.

BACKGROUND: The clinical value of transanal total mesorectal excision is debated. OBJECTIVE: This study aimed to compare short- and medium-term effects of transanal versus anterior total mesorectal excision for rectal cancer. DESIGN: This was a multicenter retrospective cohort study. SETTING: The study included all Catalonian public hospitals. PATIENTS: All patients receiving transanal or anterior total mesorectal excision (open or laparoscopic) for nonmetastatic primary rectal cancer in 2015 to 2016 were included. MAIN OUTCOME MEASURES: Data on vital status were collected to March 2019. Between-group differences were minimized by applying propensity score matching to baseline patient characteristics. Competing risk models were used to assess systemic and local recurrence along with death at 2 years, and multivariable Cox regression was used to assess 2-year disease-free survival. Results are expressed with their 95% CIs. RESULTS: The final subsample was 537 patients receiving total mesorectal excision (transanal approach: n = 145; anterior approach: n = 392). Median follow-up was 39.2 months (interquartile range, 33.0-45.8). Accounting for death as a competing event, there was no association between transanal total mesorectal excision and local recurrence (matched subhazard ratio 1.28, 95% CI 0.55-2.96). There were no statistical differences in the comparative rate of local recurrence (transanal: 1.77 per 100 person-years, 95% CI 0.76-3.34; anterior: 1.37 per 100 person-years, 95% CI 0.8-2.15) or mortality (transanal: 3.98 per 100 person-years, 95% CI 2.36-6.16; anterior: 2.99 per 100 person-years, 95% CI 2.1-4.07). Groups presented similar 2-year cumulative incidence of local recurrence (4.83% versus 3.57%) and disease-free survival (HR, 1.33; 95% CI 0.92-1.92). LIMITATIONS: We used data only from the public system, the study is retrospective, and data on individual surgeons are not reported. CONCLUSION: These population-based results support the use of either the transanal, open, or laparoscopic approach for rectal cancer in Catalonia. See Video Abstract at http://links.lww.com/DCR/B744.ESCISIÓN MESORRECTAL TOTAL TRANSANAL VERSUS ESCISIÓN MESORRECTAL TOTAL ANTERIOR PARA EL CÁNCER DE RECTO: UN ESTUDIO POBLACIONAL CON EMPAREJAMIENTO DE PUNTAJE DE PROPENSIÓN EN CATALUÑA, ESPAÑA. ANTECEDENTES: Se debate el valor clínico de la escisión mesorrectal total transanal. OBJETIVO: Comparar los efectos a corto y mediano plazo de la escisión mesorrectal total transanal versus anterior para el cáncer de recto. DISEO: Este fue un estudio de cohorte retrospectivo multicéntrico. AJUSTE: El estudio incluyó a todos los hospitales públicos de Cataluña. PACIENTES: Todos los pacientes no metastásicos que recibieron escisión mesorrectal total anterior o transanal (abierta o laparoscópica) por cáncer de recto primario en 2015-16. PRINCIPALES MEDIDAS DE VALORACION: Los datos sobre el estado vital se recopilaron hasta marzo de 2019. Las diferencias entre los grupos se minimizaron aplicando el emparejamiento de puntajes de propensión a las características iniciales del paciente. Se utilizaron modelos de riesgo competitivo para evaluar la recurrencia sistémica y local junto con la muerte a los dos años, y la regresión de Cox multivariable para evaluar la supervivencia libre de enfermedad a dos años. Los resultados se expresan con sus intervalos de confianza del 95%. RESULTADOS: La submuestra final fue de 537 pacientes que recibieron escisión mesorrectal total (abordaje transanal: n = 145; abordaje anterior: n = 392). La mediana de seguimiento fue de 39,2 meses (rango intercuartílico 33,0-45,8). Teniendo en cuenta la muerte como un evento competitivo, no hubo asociación entre la escisión mesorrectal total transanal y la recurrencia local (cociente de subriesgo apareado 1,28, 0,55-2,96). No hubo diferencias estadísticas en la tasa comparativa de recurrencia local (transanal: 1,77 por 100 personas-año, 0,76-3,34; anterior: 1,37 por 100 personas-año, 0,8-2,15) o mortalidad (transanal: 3,98 por 100 personas-año, 2,36-6,16; anterior: 2,99 por 100 personas-año, 2,1-4,07). Los grupos presentaron una incidencia acumulada de dos años similar de recidiva local (4,83% frente a 3,57%, respectivamente) y supervivencia libre de enfermedad (índice de riesgo 1,33, 0,92-1,92). LIMITACIONES: Utilizamos datos solo del sistema público, el estudio es retrospectivo y no se informan datos sobre cirujanos individuales. CONCLUSIONES: Estos resultados poblacionales apoyan el uso del abordaje transanal, abierto o laparoscópico para el cáncer de recto en Cataluña. Consulte. Video Resumen en http://links.lww.com/DCR/B744. (Traducción- Dr. Francisco M. Abarca-Rendon).

Transanal total mesorectal excision for stage II or III rectal cancer: pattern of local recurrence in a tertiary referral center.

BACKGROUND: For mid and low rectal cancer, transanal total mesorectal excision (TaTME) has been established as an alternative approach to laparoscopic surgery. However, there are concerns about an unexpected pattern of local recurrence. This study aimed to analyze the pattern of local recurrence for patients treated with TaTME in a tertiary referral center. METHODS: A retrospective single-center analysis was performed. Since 2011, all patients with rectal cancer undergoing TaTME with curative intent were prospectively included in a standardized database. Patients with tumors within 12 cm, clinical stage II or III were included. The primary endpoint of the study was the overall local recurrence rate, together with a critical analysis of the patterns of local failures. RESULTS: Two hundred and five patients were included in this analysis. At the time of surgery, patients had a mean age of 67.1 years (SD 12.3), and 66.8% were male. Neoadjuvant therapy was administered in 73.7%. Mesorectal specimen quality was complete or near-complete in 98.5%, while circumferential resection margin was ≤ 1 mm (including T4 tumors) in 11.8%. After a median follow-up of 34.3 months (95% CI 30.1-38.5), 3.4% (n = 7) presented with local recurrent disease. Six out of the seven patients were also diagnosed with hematogenous metastases. Of the seven patients, three presented with at least one of the following risk factors: T4 tumor, N2 disease, incomplete mesorectal specimen, or positive CRM. Local failure was noted posteriorly (n = 3), laterally (n = 2), anteriorly (n = 1), and in the axial compartment (n = 1). Median time to relapse was 31.5 months (10.3-40.9). The median follow-up after local recurrence was 7.9 (95% CI 6.7-9.1) months, with an overall survival of 85.7%. CONCLUSIONS: TaTME provided satisfactory local recurrence outcomes, and the most common patterns of failure were in the central pelvis.

Impact of pneumoperitoneum on intra-abdominal microcirculation blood flow: an experimental randomized controlled study of two insufflator models during transanal total mesorectal excision : An experimental randomized multi-arm trial with parallel treatment design.

OBJECTIVE: To compare changes in microcirculation blood flow (MCBF) between pulsatile and continuous flow insufflation. Transanal total mesorectal excision (TaTME) was developed to improve the quality of the resection in rectal cancer surgery. The AirSeal IFS® insufflator facilitates the pelvic dissection, although evidence on the effects that continuous flow insufflation has on MCBF is scarce. METHODS: Thirty-two pigs were randomly assigned to undergo a two-team TaTME procedure with continuous (n = 16) or pulsatile insufflation (n = 16). Each group was stratified according to two different pressure levels in both the abdominal and the transanal fields, 10 mmHg or 14 mmHg. A generalized estimating equations (GEE) model was used. RESULTS: At an intra-abdominal pressure (IAP) of 10 mmHg, continuous insufflation was associated with a significantly lower MCBF reduction in colon mucosa [13% (IQR 11;14) vs. 21% (IQR 17;24) at 60 min], colon serosa [14% (IQR 9.2;18) vs. 25% (IQR 22;30) at 60 min], jejunal mucosa [13% (IQR 11;14) vs. 20% (IQR 20;22) at 60 min], renal cortex [18% (IQR 15;20) vs. 26% (IQR 26;29) at 60 min], and renal medulla [15% (IQR 11;20) vs. 20% (IQR 19;21) at 90 min]. At an IAP of 14 mmHg, MCBF in colon mucosa decreased 23% (IQR 14;27) in the continuous group and 28% (IQR 26;31) in the pulsatile group (p = 0.034). CONCLUSION: TaTME using continuous flow insufflation was associated with a lower MCBF reduction in colon mucosa and serosa, jejunal mucosa, renal cortex, and renal medulla compared to pulsatile insufflation.

Transanal Total Mesorectal Excision: Description of the Technique.

Surgery remains the gold standard for the treatment of locally advanced rectal cancer. The most effective approach to reduce locoregional recurrence is total mesorectal excision (TME). However, obtaining an optimal TME is demanding, especially in low rectal tumors and anatomically unfavorable pelvis. Transanal TME (taTME) was developed to facilitate low pelvis dissection and potentially provide optimal outcomes for oncologic resection. Current studies have reported satisfactory short-term outcomes. However, taTME is a technically challenging procedure and must be learned in an appropriate training process to allow for a safe implementation. Previous experience in laparoscopic and transanal surgery is strongly recommended. In this work, we provide a detailed discussion of the technique, based on the realization of more than 400 taTME interventions.

Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II).

OBJECTIVE: The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer. SUMMARY BACKGROUND DATA: Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery. METHODS: Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years. Primary endpoint was local recurrence at 3-year follow-up. Secondary endpoints included bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints. RESULTS: All 1044 patients included in the COLOR II trial were analyzed. There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer. CONCLUSION: Based on long-term morbidity outcomes, laparoscopic surgery for rectal cancer could be considered a routine technique as there are no differences with open surgery.

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

The current state of the transanal approach to the ileal pouch-anal anastomosis.

BACKGROUND: The transanal approach to pelvic dissection has gained considerable traction and utilization continues to expand, fueled by the transanal total mesorectal excision (TaTME) for rectal cancer. The same principles and benefits of transanal pelvic dissection may apply to the transanal restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA)-the TaPouch procedure. Our goal was to review the literature to date on the development and current state of the TaPouch. MATERIALS AND METHODS: We performed a PubMed database search for original articles on transanal pelvic dissections, IPAA, and the TaPouch procedure, with a manual search from relevant citations in the reference list. The main outcomes were the technical aspects of the TaPouch, clinical and functional outcomes, and potential advantages, drawbacks, and future direction for the procedure. RESULTS: The conduct of the procedure has been defined, with the safety and feasibility demonstrated in small series. The reported rates of conversion and anastomotic leakage are low. There are no randomized trials or large-scale comparative studies available for comparative effectiveness compared to the traditional IPAA. CONCLUSIONS: The transanal approach to ileal pouch-anal anastomosis is an exciting adaption of the transanal total mesorectal excision for refining the technical steps of a complex operation. Additional experience is needed for comparative outcomes and defining the ideal training and implementation pathways.

Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial.

OBJECTIVE: The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery. SUMMARY BACKGROUND DATA: Prehabilitation, including endurance exercise training and promotion of physical activity, in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications. However, the existing studies provide controversial results and show a clear bias toward low-risk patients. METHODS: This was a randomized blinded controlled trial. Eligible candidates accepting to participate were blindly randomized (1:1 ratio) to control (standard care) or intervention (standard care + prehabilitation) groups. Inclusion criteria were: i) age >70 years; and/or, ii) American Society of Anesthesiologists score III/IV. Prehabilitation covered 3 actions: i) motivational interview; ii) high-intensity endurance training; and promotion of physical activity. The main study outcome was the proportion of patients suffering postoperative complications. Secondary outcomes included the endurance time (ET) during cycle-ergometer exercise. RESULTS: We randomized 71 patients to the control arm and 73 to intervention. After excluding 19 patients because of changes in the surgical plan, 63 controls and 62 intervention patients were included in the intention-to-treat analysis. The intervention group enhanced aerobic capacity [ΔET 135 (218) %; P < 0.001), reduced the number of patients with postoperative complications by 51% (relative risk 0.5; 95% confidence interval, 0.3-0.8; P = 0.001) and the rate of complications [1.4 (1.6) and 0.5 (1.0) (P =  0.001)] as compared with controls. CONCLUSION: Prehabilitation enhanced postoperative clinical outcomes in high-risk candidates for elective major abdominal surgery, which can be explained by the increased aerobic capacity.

A randomized trial of laparoscopic versus open surgery for rectal cancer.

BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. RESULTS: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). CONCLUSIONS: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).

Metabolic and Bariatric Surgery for Obesity.

Metabolic and bariatric surgery (MBS) leads to weight loss in obese individuals and reduces comorbidities such as type 2 diabetes. MBS is superior to medical therapy in reducing hyperglycemia in persons with type 2 diabetes, and has been associated with reduced mortality and incidences of cardiovascular events and cancer in obese individuals. New guidelines have been proposed for the use of MBS in persons with type 2 diabetes. We review the use of MBS as a treatment for obesity and obesity-related conditions and, based on recent evidence, propose that health care systems make the appropriate changes to increase accessibility for eligible patients.

Transanal total mesorectal excision: pathological results of 186 patients with mid and low rectal cancer.

BACKGROUND: Transanal total mesorectal excision (TaTME) seems to be a valid alternative to the open or laparoscopic TME. Quality of the TME specimen is the most important prognostic factor in rectal cancer. This study shows the pathological results of the largest single-institution series published on TaTME in patients with mid and low rectal cancer. METHODS: We conducted a retrospective cohort study of all consecutive patients with rectal cancer, treated by TaTME between November 2011 and June 2016. Patient data were prospectively included in a standardized database. Patients with all TNM stages of mid (5-10 cm from the anal verge) and low (0-5 cm from the anal verge) rectal cancer were included. RESULTS: A total of 186 patients were included. Tumor was in the mid and low rectum in, respectively, 62.9 and 37.1%. Neoadjuvant chemoradiotherapy was given in 62.4%, only radiotherapy in 3.2%, and only chemotherapy in 2.2%. Preoperative staging showed T1 in 3.2%, T2 in 20.4%, T3 in 67.7%, and T4 in 7.5%. Mesorectal resection quality was complete in 95.7% (n = 178), almost complete in 1.6% (n = 3), and incomplete in 1.1% (n = 2). Overall positive CRM (≤ 1 mm) and DRM (≤ 1 mm) were 8.1% (n = 15) and 3.2% (n = 6), respectively. The composite of complete mesorectal excision, negative CRM, and negative DRM was achieved in 88.1% (n = 155) of the patients. The median number of lymph nodes found per specimen was 14.0 (IQR 11-18). CONCLUSIONS: The present study showed good rates regarding total mesorectal excision, negative circumferential, and distal resection margins. As the specimen quality is a surrogate marker for survival, TaTME can be regarded as a safe method to treat patients with rectal cancer, from an oncological point of view.

The Future of Rectal Cancer Surgery: A Narrative Review of an International Symposium.

Surgery remains the mainstay of curative treatment for primary rectal cancer. For mid and low rectal tumors, optimal oncologic surgery requires total mesorectal excision (TME) to ensure the tumor and locoregional lymph nodes are removed. Adequacy of surgery is directly linked to survival outcomes and, in particular, local recurrence. From a technical perspective, the more distal the tumor, the more challenging the surgery and consequently, the risk for oncologically incomplete surgery is higher. TME can be performed by an open, laparoscopic, robotic or transanal approach. There is a lack of consensus on the "gold standard" approach with each of these options offering specific advantages. The International Symposium on the Future of Rectal Cancer Surgery was convened to discuss the current challenges and future pathways of the 4 approaches for TME. This article reviews the findings and discussion from an expert, international panel.

Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity.

OBJECTIVE: To construct and validate a scoring system for evidence-based selection of bariatric and metabolic surgery procedures according to severity of type 2 diabetes (T2DM). BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM. METHODS: A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005-2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied. RESULTS: At median postoperative follow-up of 7 years (range 5-12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ≤25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional ß-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided. CONCLUSIONS: This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.

Transanal Hartmann's colostomy reversal assisted by laparoscopy: outcomes of the first 10 patients.

INTRODUCTION: Restoration of intestinal continuity after Hartmann's procedure is a technically difficult surgery associated with significant morbidity and mortality. This study presents the short-term results of a new approach: a transanal Hartmann's colostomy reversal assisted by laparoscopy. METHOD: This is a retrospective analysis of data collected in one tertiary hospital, from October 2013 to November 2015. RESULTS: During the study period, there were ten cases of transanal Hartmann's reversal. Reasons for Hartmann's procedure were: complicated diverticulitis (4), anastomotic leak (3), and recto-sigmoid cancer (3). Rectal stump length was 10.4 ± 4.5 cm. Reconstruction was achieved in all patients. One low colorectal anastomosis was hand-sewn, the other 9 were stapled. Mean operative time was 204 ± 65 min. Diverting loop ileostomies were created in five patients and all were closed during the following year. One case required hand-assistance but there was no conversion to open surgery. Iatrogenic laparoscopic enterotomies occurred in four patients and all were repaired primarily without consequences. Three patients had a total of four post-operative complications: ileus (2), abdominal abscess and wound infection (1). None required reoperation. Mean length of stay was 7.2 ± 4.3 days. One required readmission. CONCLUSION: A transanal Hartmann's reversal assisted by laparoscopy is a new approach for a difficult surgery. It has the potential to be an additional tool in the case of hostile pelvises or with a rectal stump difficult to identify. The surgery remains challenging and indications need to be clarified.