Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials.

PURPOSE: Chemotherapy is established as primary treatment in patients with stage IV colorectal cancer and unresectable metastases. Data from nonrandomized clinical trials have fueled persistent uncertainty if primary tumor resection (PTR) before chemotherapy prolongs survival. We investigated the prognostic value of PTR in patients with newly diagnosed stage IV colon cancer who were not amenable to curative treatment. PATIENTS AND METHODS: Patients enrolled in the multicenter, randomized SYNCHRONOUS and CCRe-IV trials were included in the analysis. Patients with colon cancer with synchronous unresectable metastases were randomly assigned at 100 sites in Austria, Germany, and Spain to undergo PTR or up-front chemotherapy (No PTR group). The chemotherapy regimen was left at discretion of the local team. Patients with tumor-related symptoms, inability to tolerate surgery and/or systemic chemotherapy, and history of another cancer were excluded. The primary end point was overall survival (OS), and the analyses were performed with intention-to-treat. RESULTS: A total of 393 patients were randomly assigned to undergo PTR (n = 187) or no PTR (n = 206) between November 2011 and March 2017. Chemotherapy was not administered to 6.4% in the No PTR group and 24.1% in the PTR group. The median follow-up time was 36.7 months (95% CI, 36.6 to 37.3). The median OS was 16.7 months (95% CI, 13.2 to 19.2) in the PTR group and 18.6 months (95% CI, 16.2 to 22.3) in the No PTR group (P = .191). Comparable OS between the study groups was further confirmed on multivariate analysis (hazard ratio, 0.944 [95% CI, 0.738 to 1.209], P = .65) and across all subgroups. Patients with serious adverse events were more common in the No PTR group (10.2% v 18.0%; P = .027). CONCLUSION: Among patients with colon cancer and synchronous unresectable metastases, PTR before systemic chemotherapy was not associated with prolonged OS.

Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: The SANLARS Randomized Clinical Trial.

BACKGROUND: Sacral neuromodulation might be effective to palliate low anterior resection syndrome after rectal cancer surgery, but robust evidence is not available. OBJECTIVE: To assess the impact of sacral neuromodulation on low anterior resection syndrome symptoms as measured by validated scores and bowel diaries. DESIGN: Randomized, double-blind, 2-phased, controlled, multicenter crossover trial (NCT02517853). SETTINGS: Three tertiary hospitals. PATIENTS: Patients with major low anterior resection syndrome 12 months after transit reconstruction after rectal resection who had failed conservative treatment. INTERVENTIONS: Patients underwent an advanced test phase by stimulation for 3 weeks and received the pulse generator implant if a 50% reduction in low anterior resection syndrome score was achieved. These patients entered the randomized phase in which the generator was left active or inactive for 4 weeks. After a 2-week washout, the sequence was changed. After the crossover, all generators were left activated. MAIN OUTCOME MEASURES: The primary outcome was low anterior resection syndrome score reduction. Secondary outcomes included continence and bowel symptoms. RESULTS: After testing, 35 of 46 patients (78%) had a 50% or greater reduction in low anterior resection syndrome score. During the crossover phase, all patients showed a reduction in scores and improved symptoms, with better performance if the generator was active. At 6- and 12-month follow-up, the mean reduction in low anterior resection syndrome score was -6.2 (95% CI -8.97 to -3.43; p < 0.001) and -6.97 (95% CI -9.74 to -4.2; p < 0.001), with St. Mark's continence score -7.57 (95% CI -9.19 to -5.95, p < 0.001) and -8.29 (95% CI -9.91 to -6.66; p < 0.001). Urgency, bowel emptiness sensation, and clustering episodes decreased in association with quality-of-life improvement at 6- and 12-month follow-up. LIMITATIONS: The decrease in low anterior resection syndrome score with neuromodulation was underestimated because of an unspecific measuring instrument. There was a possible carryover effect in sham stimulation sequence. CONCLUSIONS: Neuromodulation provides symptoms and quality-of-life amelioration, supporting its use in low anterior resection syndrome. See Video Abstract . NEUROMODULACIN SACRA EN PACIENTES CON SNDROME DE RESECCIN ANTERIOR BAJA ENSAYO CLNICO ALEATORIZADO SANLARS: ANTECEDENTES:La neuromodulación sacra podría ser eficaz para paliar el síndrome de resección anterior baja después de la cirugía de cáncer de recto, pero no hay pruebas sólidas disponibles.OBJETIVO:Evaluar el impacto de la neuromodulación sacra en los síntomas del síndrome de resección anterior baja, medido mediante puntuaciones validadas y diarios intestinales.DISEÑO:Ensayo cruzado multicéntrico, controlado, aleatorizado, doble ciego, de dos fases (NCT02517853).LUGARES:Tres hospitales terciarios.PACIENTES:Pacientes con puntuación de resección anterior baja importante, 12 meses después de la reconstrucción del tránsito después de la resección rectal en quienes había fracasado el tratamiento conservador.INTERVENCIONES:Los pacientes se sometieron a una fase de prueba avanzada mediante estimulación durante tres semanas y se les implantó el generador de impulsos si se lograba una reducción del 50% en la puntuación del síndrome de resección anterior baja, ingresando a la fase aleatorizada en la que el generador se dejaba activo o inactivo durante cuatro semanas. Después de observar por 2 semanas, se cambió la secuencia. Después del cruce, todos los generadores quedaron activados.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la reducción de la puntuación del síndrome de resección anterior baja. Los resultados secundarios incluyeron continencia y síntomas intestinales.RESULTADOS:Después de las pruebas, 35 de 46 pacientes (78%) tuvieron una reducción ≥50% en la puntuación del síndrome de resección anterior baja. Durante el cruce, todos los pacientes mostraron una reducción en las puntuaciones y una mejora de los síntomas, con un mejor rendimiento si el generador estaba activo. A los 6 y 12 meses de seguimiento, la reducción media en la puntuación del síndrome de resección anterior baja fue -6,2 (-8,97; -3,43; p < 0,001) y -6,97 (-9,74; -4,2; p < 0,001), con Puntuación de continencia de St. Mark's -7,57 (-9,19; -5,95, p < 0,001) y -8,29 (-9,91; -6,66; p < 0,001). La urgencia, la sensación de vacío intestinal y los episodios de agrupamiento disminuyeron en asociación con una mejora en la calidad de vida a los 6 y 12 meses de seguimiento.LIMITACIONES:La disminución en la puntuación del síndrome de resección anterior baja con neuromodulación se subestimó debido a un instrumento de medición no específico. Posible efecto de arrastre en la secuencia de estimulación simulada.CONCLUSIONES:La neuromodulación mejora los síntomas y la calidad de vida, lo que respalda su uso en el síndrome de resección anterior baja. (Traducción-Dr. Mauricio Santamaria ).

Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision.

OBJECTIVE: To assess the effect of high inferior mesenteric artery tie on defecatory, urinary, and sexual function after surgery for sigmoid colon cancer. Performing a sigmoidectomy poses a notable risk of causing injury to the preaortic sympathetic nerves during the high ligation of the inferior mesenteric artery, as well as to the superior hypogastric plexus during dissection at the level of the sacral promontory. Postoperative defecatory and genitourinary dysfunction after sigmoid colon resection are often underestimated and underreported. METHODS: This study is a secondary research of a multicenter, single-blind, randomized clinical trial. The trial involved patients with sigmoid cancer who underwent either extended complete mesocolic excision (e-CME) or standard CME (s-CME). Patients completed questionnaires to assess defecatory, urinary, and sexual function before, 1 month after surgery, and 1 year after surgery. Multivariate analysis was conducted to identify factors associated with functional dysfunction. RESULTS: Seventy-nine patients completed functional assessments before and 1 year after surgery. One year after sigmoidectomy with a high tie of the inferior mesenteric artery, 15.2% of patients had minor low anterior resection syndrome (LARS) and 12.7% had major LARS; 22.2% of males and 29.4% of females had urinary dysfunction; and 43.8% of males and 27.3% of females had sexual dysfunction. After multivariate analysis, no significant associations were found between clinical and surgical factors and gastrointestinal or urinary dysfunction after 1 year of surgery. Age was identified as the only factor linked to sexual dysfunction in both sexes (women, ß = - 0.54, p = 0.002; men ß = - 0.38, p = 0.010). Regarding recovery outcomes, diabetes mellitus was identified as a contributing factor to suboptimal gastrointestinal recovery (p = 0.033) and urinary recovery in women (p = 0.039). Furthermore, the treatment arm was found to be significantly associated with the recovery of erectile function after 1 year of surgery (p = 0.046). CONCLUSIONS: A high tie of the inferior mesenteric artery during sigmoidectomy is associated with a high incidence of defecatory and genitourinary dysfunction. Age was identified as a significant factor associated with sexual dysfunction 1 year after sigmoid colon resection in both sexes. TRIAL REGISTRATION: Clinical trials NCT03083951 HIGHLIGHTS: • One year after high-tie sigmoidectomy, 27.9% of patients had LARS; 22.2% of the men and 29.4% of the women had urinary dysfunction; and 43.8% of the men and 27.3% of the women had sexual dysfunction. • e-CME is associated with a high rate of urinary dysfunction in men 1 year after surgery. However, after multivariate analysis, no association was found between e-CME and urinary dysfunction in men. • Age was correlated with the recovery of sexual function in both sexes 1 year after surgery. Furthermore, diabetes mellitus was identified as the factor associated with poorer recovery of urinary function in females.

Lessons learnt from the implementation of a colorectal cancer screening programme for lynch syndrome in a tertiary public hospital.

BACKGROUND: Lynch syndrome (LS) is the first cause of inherited colorectal cancer (CRC), being responsible for 2-4% of all diagnoses. Identification of affected individuals is important as they have an increased lifetime risk of multiple CRC and other neoplasms, however, LS is consistently underdiagnosed at the population level. We aimed to evaluate the yield of LS screening in CRC in a single-referral centre and to identify the barriers to its effective implementation. METHODS: LS screening programme included individuals with CRC < 70 years, multiple CRC, or endometrial cancer at any age. Mismatch repair (MMR) protein immunohistochemistry (IHC) analysis was performed in routine practice on the surgical specimen and, if MLH1 IHC was altered, MLH1 gene promoter methylation was analysed. Results were collected in the CRC multidisciplinary board database. LS suspected individuals (altered MMR IHC without MLH1 promoter methylation) were referred to the Cancer Genetic Counselling Unit (CGCU). If accepted, a genetic study was performed. Two checkpoints were included: review of the pathology data and verification of patient referral by a genetic counsellor. RESULTS: Between 2016 and 2019, 381 individuals were included. MMR IHC analysis was performed in 374/381 (98.2 %) CRC cases and MLH1 promoter methylation in 18/21 (85.7 %). Seventeen of the 20 LS suspected individuals were invited for referral at the CGCU. Two cases were not invited and the remaining patient died of cancer before completion of tumour screening. Fifteen individuals attended and a genetic analysis was performed in 15/20 (75 %) LS suspected individuals. Ten individuals were diagnosed with LS, in concordance with the IHC profile (2.7 % of the total cohort). This led to cascade testing in 58/75 (77.3 %) of the available adult relatives at risk, identifying 26 individuals with LS. CONCLUSIONS: Establishing a standardized institutional LS screening programme with checkpoints in the workflow is key to increasing the yield of LS identification.

Prognostic Value of the Circumferential Resection Margin After Curative Surgery for Rectal Cancer: A Multicenter Propensity Score-Matched Analysis.

BACKGROUND: Recently, positive circumferential resection margin has been found to be an indicator of advanced disease with a high risk of distant recurrence rather than local recurrence. OBJECTIVE: The study aimed to analyze the prognostic impact of the circumferential resection margin on long-term oncological outcomes in patients with rectal cancer. DESIGN: This was a multicenter, propensity score-matched (2:1) analysis comparing the positive and negative circumferential resection margins. SETTINGS: The study was conducted at 5 high-volume centers in Spain. PATIENTS: Patients who underwent total mesorectal excision with curative intent for middle-low rectal cancer between 2006 and 2014 were included. MAIN OUTCOME MEASURES: The main outcomes were local recurrence, distant recurrence, overall survival, and disease-free survival. RESULTS: The unmatched initial cohort consisted of 1599 patients, of whom 4.9% had a positive circumferential resection margin. After matching, 234 patients were included (156 with a negative circumferential margin and 78 with a positive circumferential margin). The median follow-up period was 52.5 (22.0-69.5) months. Local recurrence was significantly higher in patients with a positive circumferential margin (33.3% vs 11.5%; p < 0.001). Distant recurrence was similar in both groups (46.2% vs 42.3%; p = 0.651). There were no statistically significant differences in 5-year overall survival (48.6% vs 43.6%; p = 0.14). Disease-free survival was lower in patients with a positive circumferential margin (36.1% vs 52.3%; p = 0.026). LIMITATIONS: This study was limited by its retrospective design. The different neoadjuvant treatment options were not included in the propensity score. CONCLUSIONS: The positive circumferential resection margin was associated with a higher local recurrence rate and worse disease-free survival in comparison with the negative circumferential resection margin. However, the positive circumferential resection margin was not a prognostic indicator of distant recurrence and overall survival. See Video Abstract at http://links.lww.com/DCR/B950 . VALOR PRONSTICO DEL MARGEN DE RESECCIN CIRCUNFERENCIAL DESPUS DE LA CIRUGA CURATIVA PARA EL CNCER DE RECTO UN ANLISIS MULTICNTRICO EMPAREJADO POR PUNTAJE DE PROPENSIN: ANTECEDENTES:En los últimos años, se ha encontrado que el margen de resección circunferencial positivo es un indicador de enfermedad avanzada con alto riesgo de recurrencia a distancia más que de recurrencia local.OBJETIVO:El objetivo fue analizar el impacto pronóstico del margen de resección circunferencial sobre la recidiva local, a distancia y las tasas de supervivencia en pacientes con cáncer de recto.DISEÑO:Este fue un análisis multicéntrico emparejado por puntaje de propensión 2: 1 que comparó el margen de resección circunferencial positivo y negativo.AJUSTES:El estudio se realizó en 5 centros Españoles de alto volumen.PACIENTES:Se incluyeron pacientes sometidos a escisión total de mesorrecto con intención curativa por cáncer de recto medio-bajo entre 2006-2014. Las características clínicas e histológicas se utilizaron para el emparejamiento.PRINCIPALES MEDIDAS DE RESULTADO:Los resultadoes principales fueron la recurrencia local, la recurrencia a distancia, la supervivencia global y libre de enfermedad.RESULTADOS:La cohorte inicial no emparejada consistió en 1599 pacientes; El 4,9% tuvo un margen de resección circunferencial positivo. Tras el emparejamiento se incluyeron 234 pacientes (156 con margen circunferencial negativo y 78 con margen circunferencial positivo). La mediana del período de seguimiento fue de 52,5 meses (22,0-69,5). La recurrencia local fue significativamente mayor en pacientes con margen circunferencial positivo, 33,3% vs 11,5% [HR 3,2; IC 95%: 1,83-5,43; p < 0,001]. La recidiva a distancia fue similar en ambos grupos (46,2 % frente a 42,3 %) [HR 1,09, IC 95 %: 0,78-1,90; p = 0,651]. No hubo diferencias significativas en la supervivencia global a 5 años (48,6 % frente a 43,6 %) [HR 1,09, IC 95 %: 0,92-1,78; p = 0,14]; La supervivencia libre de enfermedad fue menor en pacientes con margen circunferencial positivo, 36,1% vs 52,3% [HR 1,5; IC 95%: 1,05-2,06; p = 0,026].LIMITACIONES:Este estudio estuvo limitado por el diseño retrospectivo. Las diferentes opciones de tratamientos neoadyuvantes no se han incluido en la puntuación de propensión.CONCLUSIONES:El margen de resección circunferencial positivo se asocia con una mayor tasa de recurrencia local y peor supervivencia libre de enfermedad en comparación con el margen de resección circunferencial negativo. Sin embargo, el margen de resección circunferencial positivo no fue un indicador pronóstico de recidiva a distancia ni de supervivencia global. Consulte el Video del Resumen en http://links.lww.com/DCR/B950 . (Traducción- Dr. Yesenia Rojas-Khalil ).

Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Vessel-Sealing Device Hemorrhoidectomy for Grade III to IV Hemorrhoids: Long-term Outcomes From the THDLIGA Randomized Controlled Trial.

BACKGROUND: Both transanal hemorrhoidal dearterialization and vessel-sealing device hemorrhoidectomy are safe for grade III to IV hemorrhoid treatment. Whether one of them is superior regarding long-term results remains unclear. OBJECTIVE: To compare long-term results after transanal hemorrhoidal dearterialization and vessel-sealing device hemorrhoidectomy. DESIGN: Multicenter randomized controlled trial. SETTINGS: This study was conducted at 6 centers. PATIENTS: Patients ≥18 years of age with grade III to IV hemorrhoids were included in the study. INTERVENTIONS: Patients were randomly assigned to transanal hemorrhoidal dearterialization (n = 39) or vessel-sealing device hemorrhoidectomy (n = 41). MAIN OUTCOME MEASURES: The primary outcome was hemorrhoid symptom recurrence assessed by a specific questionnaire 2 years postoperatively. Secondary outcomes included long-term complications, reoperations, fecal continence, and patient satisfaction and quality of life. RESULTS: Five of the 80 patients included in the study were lost to follow-up. Thirty-six patients randomly assigned to transanal hemorrhoidal dearterialization and 39 patients randomly assigned to vessel-sealing device hemorrhoidectomy were included in the long-term analysis. The differences between mean baseline and mean 2-year score in the 2 groups were similar (-11.0, SD 3.8 vs -12.5, SD 3.6; p = 0.080). Three patients in the transanal hemorrhoidal dearterialization group underwent supplementary procedures for hemorrhoid symptoms, compared with none in the vessel-sealing device hemorrhoidectomy group ( p = 0.106). Four patients in the vessel-sealing hemorrhoidectomy group and none in the transanal hemorrhoidal dearterialization group experienced chronic opened wound ( p = 0.116). LIMITATIONS: Lack of stratification for hemorrhoid grade and power calculation based on the main outcome trial but not on the end point of this long-term study. CONCLUSIONS: Transanal hemorrhoidal dearterialization with mucopexy is associated with hemorrhoid symptom recurrence similar to vessel-sealing device hemorrhoidectomy at 2 years. See Video Abstract at http://links.lww.com/DCR/B933 . REGISTRATION: Clinicaltrials.gov ; ID: NCT02654249. DESARTERIALIZACIN HEMORROIDAL TRANSANAL CON MUCOPEXIA VERSUS HEMORROIDECTOMA CON DISPOSITIVO DE SELLADO DE VASOS PARA HEMORROIDES DE GRADO IIIIV RESULTADOS A LARGO PLAZO DEL ENSAYO CLNICO ALEATORIZADO THDLIGARCT: ANTECEDENTES:Tanto la desarterialización hemorroidal transanal como la hemorroidectomía con dispositivo de sellado de vasos son seguras y bien toleradas para el tratamiento de las hemorroides de grado III-IV. La primera se asocia con una necesidad más breve de analgesia posoperatoria que la hemorroidectomía con dispositivo de sellado de vasos. No está claro si uno de ellos es superior con respecto a los resultados a largo plazo.OBJETIVO:El objetivo fue comparar los resultados a largo plazo después de la desarterialización hemorroidal transanal y la hemorroidectomía con dispositivo de sellado de vasos.DISEÑO:Se realizó un ensayo clínico aleatorizado multicéntrico.AJUSTE:Este estudio se realizó en 6 centros.PACIENTES:Se incluyeron en el estudio pacientes de ≥18 años con hemorroides de grado III-IV.INTERVENCIONES:Los pacientes fueron asignados al azar a desarterialización hemorroidal transanal (n = 39) o hemorroidectomía con dispositivo de sellado de vasos (n = 41).PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la recurrencia de los síntomas de hemorroides evaluada mediante un cuestionario específico 2 años después de la operación. Los resultados secundarios incluyeron complicaciones a largo plazo, reoperaciones, continencia fecal, satisfacción del paciente y calidad de vida.RESULTADOS:Cinco de los 80 pacientes incluidos en el estudio se perdieron durante el seguimiento. En el análisis a largo plazo se incluyeron 36 pacientes aleatorizados a desarterialización hemorroidal transanal y 39 aleatorizados a hemorroidectomía con dispositivo de sellado de vasos. Las diferencias entre la puntuación inicial media y la puntuación media a los 2 años en los dos grupos fueron similares (-11,0, DE 3,8 frente a -12,5, DE 3,6; p = 0,080). Tres pacientes en el grupo de desarterialización hemorroidal transanal se sometieron a procedimientos complementarios por síntomas de hemorroides, en comparación con ninguno en el grupo de hemorroidectomía con dispositivo de sellado de vasos (p = 0,106). Cuatro pacientes en el grupo de hemorroidectomía con sellado de vasos y ninguno en el grupo de desarterialización hemorroidal transanal experimentaron herida abierta crónica (p = 0,116). No se encontraron diferencias en cuanto a continencia fecal (p = 0,657), satisfacción del paciente (p = 0,483) y calidad de vida.LIMITACIONES:No hay estratificación para el grado de hemorroides ni el cálculo del poder basado en el resultado principal del ensayo, pero no en el criterio de valoración de este estudio a largo plazo.CONCLUSIONES:La desarterialización hemorroidal transanal con mucopexia se asocia con una recurrencia de síntomas de hemorroides similar a la hemorroidectomía con dispositivo de sellado de vasos a los dos años. See Video Abstract at http://links.lww.com/DCR/B933 . (Traducción- Dr. Francisco M. Abarca-Rendon )REGISTRO DE PRUEBA:Clinicaltrials.gov (NCT02654249).

Upfront surgery versus self-expanding metallic stent as bridge to surgery in left-sided colonic cancer obstruction: A multicenter observational study.

BACKGROUND: Oncological outcomes of self-expanding metallic stent used as a bridge to surgery in potential curative patients with left-sided colonic cancer obstruction remain unclear. The aim of this study was to investigate perioperative and mid-term oncological outcomes of 2 of the currently most commonly performed treatments in left-sided colonic cancer obstruction. METHODS: This is a retrospective multicenter study including patients with left-sided colonic cancer obstruction treated with curative intent between 2013 and 2017. The presence of metastasis at diagnosis was an exclusion criterion. The primary outcome was to evaluate the noninferiority, in terms of overall survival, of bridge to surgery strategy compared with emergency colonic resection. The secondary outcomes were perioperative morbimortality, disease free survival, local recurrence, and distant recurrence. RESULTS: A total of 564 patients were included, 320 in the emergency colonic resection group and 244 in the bridge to surgery group. Twenty-seven patients of the bridge-to-surgery group needed urgent operation. Postoperative morbidity rates were statistically higher in the emergency colonic resection group (odds ratio [95% confidence interval] 0.37 [0.24-0.55], P < .001). There was no difference in 90-day mortality between groups (odds ratio [95% confidence interval] 0.85 [0.36-1.99], P = .702). The median follow-up was 3.80 years (2.29-4.92). The results show the noninferiority of bridge to surgery versus emergency colonic resection in terms of overall survival (hazard ratio [95% confidence interval) 0.78 [0.56-1.07], P = .127). There were no differences in disease free survival, distant recurrence, and local recurrence rates between bridge to surgery and emergency colonic resection groups. CONCLUSION: Self-expanding metallic stent as bridge to surgery might not lead to a negative impact on the long-term prognosis of the tumor compared with emergency colonic resection in expert hands and selected patients.

Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate whether extended complete mesocolic excision (e-CME) for sigmoid colon cancer improves oncological outcomes without compromising morbidity or functional results. BACKGROUND: In surgery for cancer of the sigmoid colon and upper rectum, s-CME removes the lymphofatty tissue surrounding the inferior mesenteric artery (IMA), but not the lymphofatty tissue surrounding the portion of the inferior mesenteric vein that does not run parallel to the IMA. Evidence about the safety and efficacy of extending CME to include this tissue is lacking. METHODS: This single-blind study randomized sigmoid cancer patients at 4 centers to undergo e-CME or s-CME. The primary outcome was the total number of lymph nodes harvested. Secondary outcomes included disease-free and overall survival at 2 years, morbidity, and bowel and genitourinary function. Clinicaltrials.gov: NCT03107650. RESULTS: We analyzed 93 patients (46 e-CME and 47 s-CME). Perioperative outcomes were similar between groups. No differences between groups were found in the total number of lymph nodes harvested [21 (interquartile range, IQR, 14-29) in e-CME vs 20 (IQR, 15-27) in s-CME, P = 0.873], morbidity (P = 0.829), disease-free survival (P = 0.926), or overall survival (P = 0.564). The extended specimen yielded a median of 1 lymph node (range, 0-6), none of which were positive.Bowel function recovery was similar between arms at all timepoints. Males undergoing e-CME had worse recovery of urinary function (P = 0.026). CONCLUSION: Extending lymphadenectomy to include the IMV territory did not increase the number of lymph nodes or improve local recurrence or survival rates.

Combined endoscopic-laparoscopic surgery (CELS) can avoid segmental colectomy in endoscopically unremovable colonic polyps: a cohort study over 10 years.

BACKGROUND: Combined-Endoscopic-Laparoscopic-Surgery (CELS) was developed for benign colonic polyps, endoscopically unresectable, to avoid segmental colectomy. This observational study aims to compare surgical outcomes of endoscopically unresectable colonic polyps treated laparoscopically before and since the institutional introduction of CELS. Primary endpoint was postoperative morbidity and mortality; secondary endpoints were time of hospitalization and histopathological findings. METHODS: Charts of all patients with preoperative diagnosis of benign colonic tumors, treated laparoscopically at our institution from 1/2010 to 2/2020 were reviewed. Patients with polyps (1) affecting ileocecal valve, (2) occupying > 50% of the circumference, (3) ≥ 3 endoscopically unresectable polyps, (4) inflammatory bowel disease, (5) polyps within diverticular area post diverticulitis, (6) rectal polyps (7) foreseen impossibility of laparoscopy (8) preoperatively biopsy proven invasive adenocarcinoma were excluded. Group I consists of all patients potentially treatable by CELS but operated by laparoscopic colonic resection as CELS was not yet institutionally established. Group II includes all patients treated with CELS (since 11/2017). RESULTS: One hundred-fifteen consecutive patients were reviewed. Applying exclusion criteria, twenty-three patients form group I and twenty-three group II (female 30.4%, median age 68 years). Groups distributed homogenously for age, BMI (body mass index) and polyps´ localization with most polyps (60.4%) localized in right colon; group II patients had significantly higher American Society of Anesthesiologists (ASA) score. Median operating time, hospital stay and morbidity were significantly less in group II. Postoperative morbidity occurred overall in 14 patients (30.4%), mostly Clavien-Dindo class I-II (26.1%) and significantly less in group II (p = 0.017), Clavien-Dindo III-IV distributed equally (one patient each group) without postoperative mortality. Definitive histopathology showed invasive adenocarcinoma in 8.3% without differences between groups. Two patients with invasive adenocarcinoma after CELS were advised for oncological resection. CONCLUSION: CELS is safe and efficient to treat complex, benign colonic polyps by a complete minimal invasive laparoscopic approach. CELS showed better surgical outcomes with less morbidity, no mortality and appropriate pathological results avoiding unnecessary laparoscopic surgery with intestinal anastomosis.

Correction: Dueñas et al. Assessing Effectiveness of Colonic and Gynecological Risk Reducing Surgery in Lynch Syndrome Individuals. Cancers 2020, 12, 3419.

In the original article, there was a mistake in Figure 3 as published [...].

Post-operative and oncological 3-year follow-up outcomes in stage 2 colonic cancer in the emergency and elective setting: a cohort study.

BACKGROUND: Stage 2 colonic cancer comprises a heterogeneous group of patients with a spectrum of disease, from invasion of the sub-serosa to tumour perforation into visceral peritoneum/adjacent organs. This study evaluates the post-operative outcomes and prognostic factors of patients with both emergency and elective presentations of stage 2 colonic cancer treated with curative intent. METHODS: Retrospective analysis of a prospectively maintained database of adult patients (emergency and elective) who underwent curative surgery for stage 2 colonic cancer in a single tertiary referral centre between 2007 and 2016 was conducted. Multivariate analysis was performed to identify prognostic factors. Measured variables included demographics, complications, histology, disease-free survival and overall survival (OS). RESULTS: A total of 428 patients with stage 2 colonic cancer received curative surgical resection, and negative resection margins were achieved in all cases: T3 group (stage 2A): 316 (73.8%); T4a group (stage 2B): 78 patients (18.2%); and T4b group (stage 2C): 34 (8%). There were 187 (45.7%) post-operative complications, 32 (7.5%) anastomotic leaks and eight (1.9%) 30-day mortalities. Eighty patients (19.3%) died during the follow-up. During the follow-up period, 45 patients developed recurrence (all distant). Multivariate analysis identified age >70 years, American Society of Anesthesiologists grades III-IV and male gender as factors associated with poor OS, while recurrence was higher in those aged over 70 years and with stages 2B-2C disease. CONCLUSION: Surgical morbidity in patients with stage 2 colonic cancer who have undergone curative surgery is high. Older and more co-morbid patients have poorer OS. Stages 2B and 2C colon cancer patients have worse prognosis than those with stage 2A regarding recurrence. Future larger data sets are required to determine the role of transmural spread as a prognostic factor.

Assessing Effectiveness of Colonic and Gynecological Risk Reducing Surgery in Lynch Syndrome Individuals.

BACKGROUND: Colorectal (CRC) and endometrial cancer (EC) are the most common types of cancer in Lynch syndrome (LS). Risk reducing surgeries (RRS) might impact cancer incidence and mortality. Our objectives were to evaluate cumulative incidences of CRC, gynecological cancer and all-cause mortality after RRS in LS individuals. METHODS: Retrospective analysis of 976 LS carriers from a single-institution registry. Primary endpoints were cumulative incidence at 75 years of cancer (metachronous CRC in 425 individuals; EC and ovarian cancer (OC) in 531 individuals) and all-cause mortality cumulative incidence, comparing extended (ES) vs. segmental surgery (SS) in the CRC cohort and risk reducing gynecological surgery (RRGS) vs. surveillance in the gynecological cohort. RESULTS: Cumulative incidence at 75 years of metachronous CRC was 12.5% vs. 44.7% (p = 0.04) and all-cause mortality cumulative incidence was 38.6% vs. 55.3% (p = 0.31), for ES and SS, respectively. Cumulative, incidence at 75 years was 11.2% vs. 46.3% for EC (p = 0.001) and 0% vs. 12.7% for OC (p N/A) and all-cause mortality cumulative incidence was 0% vs. 52.7% (p N/A), for RRGS vs. surveillance, respectively. CONCLUSIONS: RRS in LS reduces the incidence of metachronous CRC and gynecological neoplasms, also indicating a reduction in all-cause mortality cumulative incidence in females undergoing RRGS.

Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial.

Importance: Two-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis seems to provide benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal in patients operated on for low rectal cancer. Objective: To compare 30-day postoperative and 1-year follow-up results of Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection for rectal cancer. Design, Setting, and Participants: Multicenter randomized clinical trial. Neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero e Cura a Carattere Scientifico in Italy. Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis were randomly assigned to 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy. Data were analyzed between June 2012 and October 2018. Interventions: All patients underwent ultralow anterior resection. Patients assigned to the 2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal and, after 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis was performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation. Closure of the ileostomy was planned after 6 to 8 months. Main Outcomes and Measures: Primary outcome was 30-day postoperative morbidity. For the standard hand-sewn coloanal anastomosis with diverting ileostomy group, overall postoperative morbidity includes 30-day postoperative complications of the ileostomy closure. Results: Ninety-two white patients, 72 men and 20 women, with a median age of 62 years, were randomized and included in the analysis. Forty-six patients received standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis. Seven patients (15.2%) in the standard hand-sewn coloanal anastomosis group did not undergo reversal ileostomy, and 1 patient (2.2%) in the 2-stage pull-through hand-sewn coloanal anastomosis group did not undergo delayed coloanal anastomosis. The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P = .40), with a difference of -10.9 (95% CI, -29.5 to 8.9). Conclusions and Relevance: The 2-stage pull-through hand-sewn coloanal anastomosis after ultralow anterior resection for low rectal cancer is safe and does not increase the postoperative morbidity rate compared with standard coloanal anastomosis with covering ileostomy followed by ileostomy closure. Trial Registration: ClinicalTrials.gov Identifier: NCT01766661.

Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.

BACKGROUND: Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections. METHODS: In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual. FINDINGS: Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications. INTERPRETATION: The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery. FUNDING: Fundación Asociación Española de Coloproctología.

Risk factors for ileocolic anastomosis dehiscence; a cohort study.

BACKGROUND: Anastomotic leak (AL) after ileocolic anastomosis influences morbidity, mortality, length of hospitalization and costs. This study analyzes risk and protective factors for AL on ileocolic anastomoses. METHODS: We retrospectively analyzed our single institution patients' series undergoing elective ileocolic anastomosis for AL between 1/2008-12/2017. AL grade A/B (antibiotic treatment and/or radiological drainage) were summarized as mild, grade C (surgical re-intervention) corresponds to severe AL. RESULTS: We included 470 patients (mean age 70.8 years, 43.2% females). Overall AL rate was 9.4% (44 patients) with 6.0% severe and 3.4% mild AL. There was no difference in AL between hand sewn and stapled anastomoses. Multivariate analysis revealed preoperative serum albumin (p = 0.004), smoking habits (p = 0.005) and perioperative blood transfusion (p = 0.038) as risk factors for AL. Suture oversewing as anastomotic reinforcement resulted as independent protective factor (p < 0.001). CONCLUSION: Poor nutritional status, smoking habits and perioperative blood transfusion are negative factors influencing on AL. Suture oversewing as anastomotic reinforcement associates with significantly less AL.

Emergency surgery for obstructing and perforated colon cancer: patterns of recurrence and prognostic factors.

BACKGROUND: The aim of this study was to analyze the incidence, patterns and prognostic factors of recurrence in patients with complicated colon cancer who had emergency surgery within 24 h of admission. METHODS: A retrospective observational study was performed on patients with obstructing or perforated colon cancer having resection with curative intent between 1996 and 2014 at a single center. Data were obtained from a prospectively maintained database. Patients who had rectal cancer, iatrogenic endoscopic perforation, stage IV disease, palliative surgery, a colonic stent or decompressive colostomy were excluded. RESULTS: The study included 393 patients. Obstruction was observed in 320 patients (81.4%) and perforation in 73 (18.6%). Hartmann's procedure was more frequently performed by general surgeons (7.5% vs 23.3%; p = 0.023). 30-day postoperative mortality was 13.5% (53/393), including 47 (14.7%) obstructed and 6 (8.2%) perforated patients. Postoperative complications (Clavien-Dindo III-IV) occurred in 87 patients (22.1%), including 68 (21.2%) of obstructed and 19 (26.0%) of perforated patients. Anastomotic dehiscence was diagnosed in 52 of 329 (15.8%) patients with primary anastomosis and was higher in the obstructing group than in the perforated group (17.4% vs 7.6%). There was a significantly higher anastomotic dehiscence rate after procedures performed by general surgeons when compared with those performed by colorectal surgeons (10.3% vs 21.3%; p = 0.005; OR 2.81, 95% CI 1.4-5.9). With a median follow-up of 6 years, the recurrence rate was 30.1% (67.4% distant, 22.8% local, 9.8% both). Overall and cancer-related survivals were 68.7% and 77.8%, respectively. The presence of positive nodes, male gender, anastomotic dehiscence and diffuse peritonitis were independent predictors for local recurrence while type of surgeon (general) was an independent factor for distant recurrence. CONCLUSIONS: Male gender, diffuse peritonitis, positive lymph nodes, type of surgeon and postoperative anastomotic dehiscence significantly influence recurrence of colorectal cancer in this series.