Feasibility and Colonoscopy Yield Using the Fecal Immunochemical Test (FIT)-Based Colorectal Cancer Screening in a Latin America Country.

BACKGROUND & AIMS: Organized colorectal cancer (CRC) screening is not widely practiced in Latin America and the results of regional studies may help overcome barriers for implementation of national screening programs. We aimed to describe the implementation and findings of a fecal immunochemical test (FIT)-based program in Brazil. METHODS: In a prospective population-based study, asymptomatic individuals (50-75 years old) from Sao Paulo city were invited to undergo FIT for CRC screening. Participants with positive FIT (≥10 µg Hb/g feces) were referred for colonoscopy. Subjects were classified into groups according to the presence of CRC, precursor lesions, and other benign findings, possibly related to bleeding. RESULTS: Of a total of 9881 subjects, 7.8% had positive FIT and colonoscopy compliance was 68.9% (n = 535). Boston scale was considered adequate in 99% and cecal intubation rate was 99.4%. CRC was diagnosed in 5.9% of the cases, adenoma in 63.2%, advanced adenoma in 31.4%, and advanced neoplasia in 33.0%. Age was positively associated with CRC (P = .03). Higher FIT concentrations were associated with increased detection of CRC (P < .008), advanced adenoma (P < .001), and advanced neoplasia (P < .001). CONCLUSIONS: Implementation of a FIT-based CRC screening program was feasible in a low-resource setting, and there was a high yield for neoplasia in individuals with a positive FIT. This approach could be used as a model to plan and disseminate organized CRC screening more broadly in Brazil and Latin America.

Comparing three-dimensional endorectal ultrasound and magnification chromoendoscopy for early rectal neoplasia invasion depth assessment.

INTRODUCTION: Accurate assessment of invasion depth of early rectal neoplasms is essential for optimal therapy. We aimed to compare three-dimensional endorectal ultrasound (3D-ERUS) with magnification chromoendoscopy (MCE) regarding their accuracy in assessing parietal invasion depth (T). METHODS: Patients with middle and distal rectum neoplasms were prospectively included. Two providers blinded to each other's assessment performed 3D-ERUS and MCE, respectively. The T stage assessed through ERUS was compared to the MCE evaluation. The results were compared to the surgical specimen anatomopathological report. Sensitivity, specificity, accuracy, positive (PPV), and negative (NPV) predictive values were calculated for the T stage and for the final therapy (local excision or radical surgery). RESULTS: In 8 years, 70 patients were enrolled, and all underwent both exams. MCE and ERUS showed an accuracy of 94.3% and 85.7%, sensitivity of 83.7 and 93.3%, specificity of 96.4 and 83.6%, PPV of 86.7 and 60.9%, and NPV of 96.4 and 97.9%, respectively. Kappa for T stage assessed through ERUS was 0.64 and 0.83 for MCE. CONCLUSION: MCE and 3D-ERUS had good diagnostic performance, but the endoscopic method had higher accuracy. Both methods reliably assessed lesion extension, circumferential involvement, and distance from the anal verge.

Brazilian Portuguese Translation and Validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised.

INTRODUCTION AND HYPOTHESIS: Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Brazilian Portuguese and to clinically validate it in a Brazilian Portuguese-speaking population. METHODS: Translation and validation of the PISQ-IR was performed according to the International Urogynecological Association-recommended process and guidelines. For external validity, PISQ-IR subscales were compared with the clinical measures, Pelvic Organ Prolapse Quantification system (POP-Q) stage, pelvic floor muscle tone, and Oxford Grading Scale (Pearson correlations). Descriptive statistics, internal consistency (Cronbach's alpha coefficient), and test-retest reliability (interclass correlation coefficient) were calculated for all PISQ-IR subscales. RESULTS: A total of 120 sexually active and 106 not sexually active women were enrolled in the study between March 2015 and July 2019. Internal consistency was acceptable, with Cronbach's alpha values 0.60-0.80, except for the sexual arousal and orgasm, sexual arousal and partner-related issues, sexual arousal and condition-specific issues, global rating of sexual quality and condition impact subscales. PISQ-IR demonstrated good reliability (α > 0.6, CIC = 0.996). The agreement for each individual questionnaire item also individually presented substantial agreement between the assessments (κ 0.61-0.8). There was a correlation between PISQ-IR and POP, mixed, stress and fecal incontinence diagnosis and a positive correlation with pelvic floor muscle function according to the Oxford Scale in sexually active women. For sexually inactive women there was a correlation between PISQ-IR and mixed urinary symptoms. CONCLUSIONS: The Brazilian Portuguese version of PISQ-IR is a reliable and valid tool that can be easily used for the identification and assessment of sexual function in Brazilian Portuguese-speaking women with pelvic floor disorders.

Impact of a Routine Colorectal Endoscopic Submucosal Dissection in the Surgical Management of Nonmalignant Colorectal Lesions Treated in a Referral Cancer Center.

BACKGROUND: Recent data show an increasing number of abdominal surgeries being performed for the treatment of nonmalignant colorectal polyps in the West but in settings in which colorectal endoscopic submucosal dissection is not routinely performed. This study evaluated the number of nonmalignant colorectal lesions referred to surgical treatment in a tertiary cancer center that incorporated magnification chromoendoscopy and endoscopic submucosal dissection as part of the standard management of complex colorectal polyps. OBJECTIVE: The study aimed to estimate the number of patients with nonmalignant colorectal lesions referred to surgical resection at our institution after the standardization of routine endoscopic submucosal dissection and to describe outcomes for patients undergoing colorectal endoscopic submucosal dissection. DESIGN: Single-center retrospective study from a prospectively collected database of endoscopic submucosal dissections and colorectal surgeries performed between January 2016 and December 2019. SETTING: Reference cancer center. PATIENTS: Consecutive adult patients with complex nonmalignant colorectal polyps were included. INTERVENTIONS: Patients with nonmalignant colorectal polyps were treated by endoscopic submucosal dissection or surgery (elective colectomy, rectosigmoidectomy, low anterior resection, or proctocolectomy). MAIN OUTCOMES MEASURES: The primary outcome measure was the percentage of patients referred to colorectal surgery for nonmalignant lesions. RESULTS: In the study period, 1.1% of 825 colorectal surgeries were performed for nonmalignant lesions, and 97 complex polyps were endoscopically removed by endoscopic submucosal dissection. The en bloc, R0, and curative resection rates of endoscopic submucosal dissection were 91.7%, 83.5%, and 81.4%, respectively. The mean tumor size was 59 (SD 37.8) mm. Perforations during endoscopic submucosal dissection occurred in 3 cases, all treated with clipping. One patient presented with a delayed perforation 2 days after the endoscopic resection and underwent surgery. The mean follow-up period was 3 years, with no tumor recurrence in this cohort. LIMITATIONS: Single-center retrospective study. CONCLUSIONS: A workflow that includes assessment of the lesions with magnification chromoendoscopy and resection through endoscopic submucosal dissection can lead to a very low rate of abdominal surgery for nonmalignant colorectal lesions. See Video Abstract at http://links.lww.com/DCR/C123 . IMPACTO DE LA DISECCIN SUBMUCOSA ENDOSCPICA COLORRECTAL DE RUTINA EN EL MANEJO QUIRRGICO DE LESIONES COLORRECTALES NO MALIGNAS TRATADAS EN UN CENTRO ONCOLGICO DE REFERENCIA: ANTECEDENTES:Datos recientes muestran un número cada vez mayor de cirugías abdominales realizadas para el tratamiento de pólipos colorrectales no malignos en Occidente, pero no en los entornos donde la disección submucosa endoscópica colorrectal se realiza de forma rutinaria. El estudio evaluó el número de lesiones colorrectales no malignas referidas a tratamiento quirúrgico en un centro oncológico terciario, que incorporó cromoendoscopia de aumento y disección submucosa endoscópica como parte del manejo estándar de pólipos colorrectales complejos.OBJETIVO:Estimar el número de pacientes con lesiones colorrectales no malignas referidos para resección quirúrgica en nuestra institución, después de la estandarización de la disección submucosa endoscópica de rutina y describir los resultados para los pacientes sometidos a disección submucosa endoscópica colorrectal.DISEÑO:Estudio retrospectivo de un solo centro, a partir de una base de datos recolectada prospectivamente de disecciones submucosas endoscópicas y cirugías colorrectales realizadas entre enero de 2016 y diciembre de 2019.AJUSTE:Centro oncológico de referencia.PACIENTES:Pacientes adultos consecutivos con pólipos colorrectales no malignos complejos.INTERVENCIONES:Pacientes con pólipos colorrectales no malignos tratados mediante disección submucosa endoscópica o cirugía (colectomía electiva, rectosigmoidectomía, resección anterior baja o proctocolectomía).PRINCIPALES MEDIDAS DE RESULTADO:La medida de resultado primario fue el porcentaje de pacientes remitidos a cirugía colorrectal por lesiones no malignas.RESULTADOS:En el período, 1,1% de 825 cirugías colorrectales fueron realizadas por lesiones no malignas y 97 pólipos complejos fueron extirpados por. disección submucosa endoscópica. Las tasas de resección en bloque, R0 y curativa de disección submucosa endoscópica fueron 91,7%, 83,5% y 81,4%, respectivamente. El tamaño tumoral medio fue de 59 (DE 37,8) mm. Se produjeron perforaciones durante la disección submucosa endoscópica en 3 casos, todos tratados con clipaje. Un paciente presentó una perforación diferida 2 días después de la resección endoscópica y fue intervenido quirúrgicamente. El seguimiento medio fue de 3 años, sin recurrencia tumoral en esta cohorte.LIMITACIONES:Estudio retrospectivo de un solo centro.CONCLUSIONES:Un flujo de trabajo que incluye la evaluación de las lesiones con cromoendoscopia de aumento y resección a través de disección submucosa endoscópica, puede conducir a una tasa muy baja de cirugía abdominal para lesiones colorrectales no malignas. Consulte Video Resumen en http://links.lww.com/DCR/C123 . (Traducción-Dr. Fidel Ruiz Healy ).

Multivisceral resection compared to standard gastrectomy for gastric adenocarcinoma: A propensity score-matching analysis.

BACKGROUND: Multivisceral resection (MVR) in locally advanced gastric cancer (GC) is a morbid procedure. However, the precise impact of removing additional organs remains controversial. This study aimed to compare the outcomes of MVR versus standard gastrectomy (SG) in an unbiased cohort. METHODS: Patients who underwent curative-intent surgery for gastric adenocarcinoma were considered. Those submitted to SG were compared to the ones who received MVR using Propensity Score Matching (PSM) analysis. RESULTS: A total of 685 GC patients were included (621 SG and 64 MVR). Groups were distinct concerning the extent of the gastrectomy, tumor size, pTNM, R0, postoperative complications, and 90-day mortality. After PSM, 57 patients were matched in each group. All variables assigned in the score were well matched. Postoperative complication, 90-day mortality, and overall survival (OS) became similar among groups. Age >65 years old and resection of two or more organs, besides the stomach, were factors associated with 90-day mortality. R1 and not received multimodal therapy were independent prognostic factors for worse OS. CONCLUSIONS: After PSM, the difference in morbidity, mortality, and survival of MVR compared to SG was no longer statistically significant, suggesting that MVR is an acceptable therapeutic strategy to patients with advanced GC.

Preoperative inflammatory markers as prognostic predictors after hepatocellular carcinoma resection: data from a western referral center.

BACKGROUND: Recent studies from eastern centers have demonstrate an association between inflammatory response and long-term outcomes after hepatocellular carcinoma (HCC) resection. However, the prognostic impact of inflammatory markers in western patients, with distinct tumor and epidemiologic features, is still unknown. AIM: To evaluate the prognostic impact of preoperative neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR), as well as their impact according to tumor size (< 5 cm, 5-10 cm, > 10 cm) in patients undergoing HCC resection with curative intent. METHODS: Optimal cut-off values for NLR, PLR, and MLR were determined by plotting the receiver operator curves. Overall survival (OS) and disease-free survival (DFS) curves were calculated using the Kaplan-Meier method and compared using the log-rank test. The Cox method was used to identify independent predictors of OS and DFS. RESULTS: In total, 161 consecutive adult patients were included. A high NLR (> 1.715) was associated with worse OS (P = 0.018). High NLR (> 2.475; P = 0.047) and PLR (> 100.25; P = 0.028) were predictors of short DFS. In HCC < 5 cm, MLR (> 1.715) was associated with worse OS (P = 0.047). In the multivariate analysis, high PLR was an independent predictor of worse DFS [hazard ratio (HR) 3.029; 95%CI 1.499-6.121; P = 0.002]. CONCLUSION: Inflammatory markers are useful tools to predict long-term outcomes after liver resection in western patients, high NLR was able to stratify subgroups of patients with short OS and DFS, an increased PLR was an independent predictor of short DFS, while high MLR was associated with short OS in patients with early HCC.

Cytotoxic T-lymphocyte-associated protein 4 in gastric cancer: Prognosis and association with PD-L1 expression.

BACKGROUND: Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) is one of the most studied immune checkpoint in gastric cancer (GC). However, the prognostic role of CTLA-4 expression in GC is poorly described. This study aimed to evaluate CTLA-4 expression in GC and its impact on survival, including patients treated with standard platinum-based chemotherapy (CMT), and association with PD-L1 expression. METHODS: All GC patients who underwent D2-gastrectomy were investigated retrospectively. Tumor samples were examined for CTLA-4 and PD-L1 by immunohistochemistry. Tumor-infiltrating inflammatory cells, including CD4 + and CD8 + , were also examined. RESULTS: Among the 284 GC patients included, 159 (56%) were CTLA-4 positive and the remaining 125 (44%) were classified as negative. CTLA-4 positive GC was associated with increased inflammatory cell infiltration (p < 0.001), high CD8 + T cells (p = 0.016) and PD-L1 expression (p = 0.026). Considering GC referred for treatment, CTLA-4 negative patients who received CMT had a significant improvement in disease-free survival compared to untreated CLTA-4 negative (p = 0.028). In multivariate analysis, GC positive for both CTLA-4 and PD-L1 had a prognostic impact on survival. CONCLUSION: CTLA-4 positive was associated with PD-L1 expression and a high tumor-infiltrating CD8 + T cells. Accordingly, positivity for both CTLA-4 and PD-L1 was an independent factor associated to better survival in GC patients.

Long-term outcomes of endoscopic submucosal dissection and transanal endoscopic microsurgery for the treatment of rectal tumors.

BACKGROUND AND AIM: Endoscopic submucosal dissection and transanal endoscopic microsurgery are good options for the treatment of rectal adenomas and early rectal carcinomas, but whether long-term outcomes of these procedures are comparable is not known. The aim of this study was to address this question. METHODS: A retrospective single-center study evaluating 98 consecutive procedures between June 2008 and December 2017 was performed in a tertiary cancer center. Consecutive patients who had undergone either endoscopic submucosal resection or transanal endoscopic microsurgery for rectal adenomas and early rectal carcinomas were evaluated, and long-term recurrence and complication rates were compared. RESULTS: Both groups were similar regarding sex, age, preoperative surgical risk, and en bloc resection rate (95.7% in the endoscopic and 100% in the surgical group, P = 0.81). Mean follow-up period was 37.6 months. Lesions resected endoscopically were significantly larger (68.5 mm) than those resected by transanal resection (44.5 mm), P = 0.003. Curative resections occurred in 97.2% of endoscopic resections and 85.2% of the surgical ones (P = 0.04). Comparing resections that fulfilled histologic curative criteria, there were no recurrences in the endoscopic group (out of 69 cases) and two recurrences in the transanal group (8.3% of 24 cases), P = 0.06. Late complications occurred in 12.7% of endoscopic procedures and 25.9% of surgical procedures (P = 0.13). CONCLUSIONS: In our experience, endoscopic submucosal resection seems to have advantages over transanal endoscopic microsurgery, with similar en bloc resection rate and lower rate of late complications and recurrences. Multicenter randomized controlled trials are needed to support our findings.

Validation of the Brazilian Portuguese version of the pelvic floor bother questionnaire.

INTRODUCTION AND HYPOTHESIS: The Pelvic Floor Bother Questionnaire (PFBQ) was designed to identify the presence and degree of bother associated with common pelvic floor symptoms. The PFBQ can be used in clinical practice and for research purposes, but it is not available in Brazilian Portuguese. We aimed to validate a cross-culturally adapted Brazilian Portuguese version of the PFBQ. METHODS: A pilot-tested version of the PFBQ translated from English was evaluated with Brazilian patients suffering from pelvic floor disorders. Internal reliability, test-retest reliability, validity, and responsiveness to change were assessed. RESULTS: A total of 147 patients (mean age, 60.49 years) were enrolled in the study. The Brazilian Portuguese version of the PFBQ demonstrated good reliability (α = 0.625; ICC = 0.981). There was strong agreement beyond chance for each item (κ = 0.895-1.00). The PFBQ correlated with stage of prolapse (p < 0.01), number of urinary (ρ = 0.791, p < 0.001) and fecal (ρ = 0.78, p < 0.001) incontinence episodes, and obstructed defecation (ρ = 0.875, p < 0.001). CONCLUSIONS: The Brazilian Portuguese version of the PFBQ is a reliable, valid, and user-friendly instrument that can be used for assessing the presence and severity of pelvic floor symptoms in clinical and research settings in Brazil.

T≤2N0 TRG1-2 in Post-Chemoradiation Therapy MRI: What can it Predict?

BACKGROUND: Total mesorectal excision is the standard radical operation after neoadjuvant chemoradiotherapy for patients with middle/low locally advanced rectal cancer. However, it carries significant rates of morbidity, sexual/urinary dysfunction, fecal impairment and permanent stoma. The ability to identify patients with a complete or nearly-complete response could help steer patients to less-invasive surgery or a watch-and-wait strategy. OBJECTIVE: To assess the ability to predict good responders and a favorable prognosis among rectal cancer patients by post-chemoradiation therapy MRI. PATIENTS: Consecutive patients stage T3-4N0M0 or T(any)N+M0 located within 10cm from the anal verge were enrolled. Patients were staged and re-staged 8.8 weeks after the completion of chemoradiation by digital exam, colonoscopy, pelvic-MRI, and thorax and abdominal CT scans. All patients underwent total mesorectal excision with curative intent. RESULTS: Of the total 309 patients, 275 were eligible, and 199 (72.4%) of these were stage III. Restaging-MRI identified 59 (21.4%) T=2N0/TRG1-2. Specimen pathologic evaluation revealed 43 (15.6%) patients with a complete pathologic response. Estimates of the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of MRIyT=2N0/TRG1-2 for the identification of ypT0N0 were 79.7%, 84.5%, 53.5%, 39%, and 90.7%, respectively. Estimates for the identification of ypN0 were 48.4%, 27.8%, 92%, 88.1%, and 48.4%, respectively. In a multivariate analysis, the only pre-CRT/MRI variables that were associated with an increased risk of lymph node involvement at the specimen were N+ (OR=2.22) and extramural vascular invasion (OR=2.28). MRI yT=2N0/TRG1-2 patients showed improved estimated 5-year disease-free survival, but no difference in estimated 5-year survival. CONCLUSION: Although MRIyT=2N0/TRG1-2 cannot predict all cases of a complete pathologic response, it can effectively predict a low rate of lymph node involvement and a better prognosis in patients who undergo total mesorectal excision.

Lymph Node Yield After Neoadjuvant Chemoradiotherapy in Rectal Cancer Specimens: A Randomized Trial Comparing Two Fixatives.

BACKGROUND: It is widely reported that neoadjuvant chemoradiation reduces lymph node yield in rectal cancer specimens. Some have questioned the adequacy of finding ≥12 lymph nodes for accurate staging, and fewer nodes were correlated with good response. Others reported that low lymph node count raises the chance for understaging and correlates with worse survival. In addition, a few studies demonstrated that diligent specimen analysis increases lymph node count. OBJECTIVE: The aim of this study was to compare Carnoy's solution and formalin concerning lymph node yield in specimens of patients with rectal cancer after neoadjuvant chemoradiation. DESIGN: This is a prospective randomized trial that was conducted from 2012 to 2015. SETTINGS: This study was performed in a reference cancer center in Brazil. PATIENTS: Patients who underwent low anterior resection with total mesorectal excision after neoadjuvant chemoradiation for rectal adenocarcinoma were included. INTERVENTION: Rectosigmoid specimens were randomized for fixation with Carnoy's solution or formalin. MAIN OUTCOME MEASURES: A total of 130 specimens were randomized. After dissection, the residual fat from the formalin group was immersed in Carnoy's solution in search for missed lymph nodes (Revision). RESULTS: The Carnoy's solution group had superior lymph node count (24.0 vs 16.3, p < 0.01) and fewer cases with <12 lymph nodes (6 vs 22, p = 0.001). The Revision group found lymph nodes in all cases (mean, 11.1), retrieving metastatic lymph nodes in 6 patients. It reduced the formalin cases with <12 lymph nodes from 33.8% to 4.6% and upstaged 2 patients. Tumor response to neoadjuvant chemoradiotherapy was not associated with lymph node count. LIMITATIONS: This was a unicentric study. CONCLUSIONS: Compared with formalin, the Carnoy's solution increases lymph node count and reduces the cases with <12 lymph nodes. Harvested lymph nodes are missed following routine analysis and this is clinically relevant. Finding <12 lymph nodes is not a sign of good response to neoadjuvant chemoradiation (www.clinicaltrials.gov. Unique identifier: NCT02629315). See Video Abstract at http://links.lww.com/DCR/A694.

Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms.

BACKGROUND: Adequate oncologic staging of rectal neoplasia is important for treatment and prognostic evaluation of the disease. Diagnostic methods such as endorectal ultrasound can assess rectal wall invasion and lymph node involvement. OBJECTIVE: The purpose of this study was to correlate findings of 3-dimensional endorectal ultrasound and pathologic diagnosis of extraperitoneal rectal tumors with regard to depth of rectal wall invasion, lymph node involvement, percentage of rectal circumference involvement, and tumor extension. DESIGN: Consecutive patients with extraperitoneal rectal tumors were prospectively assessed by 3-dimensional endorectal ultrasound blind to other staging methods and pathologic diagnosis. PATIENTS: Patients who underwent endorectal ultrasound followed by surgery were included in the study. SETTINGS: The study was conducted at a single academic institution. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values, area under curve, and κ coefficient between 3-dimensional endorectal ultrasound and pathologic diagnosis were determined. Intraclass correlation coefficient was calculated for tumor extension and percentage of rectal wall involvement. RESULTS: Forty-four patients (27 women; mean age = 63.5 years) were evaluated between September 2010 and June 2014. Most lesions were malignant (72.7%). For depth of submucosal invasion, 3-dimensional endorectal ultrasound showed sensitivity of 77.3%, specificity of 86.4%, positive predictive value of 85.0%, a negative predictive value of 79.2%, and an area under curve of 0.82. The weighted κ coefficient for depth of rectal wall invasion staging was 0.67, and there was no agreement between 3-dimensional endorectal ultrasound and pathologic diagnosis for lymph node involvement (κ = -0.164). Intraclass correlation coefficient for lesion extension and percentage of rectal circumference involvement were 0.45 and 0.66. A better correlation between 3-dimensional endorectal ultrasound and pathologic diagnosis was observed in tumors <5 cm and with <50% of rectal wall involvement. LIMITATIONS: The relatively small sample size of patients with early rectal lesions referred directly for surgery could represent a potential selection bias. CONCLUSIONS: Three-dimensional endorectal ultrasound was effective for determining rectal wall invasion and lesion extension in tumors <5 cm and with <50% of rectal wall invasion but was limited for detecting lymph node involvement in early rectal lesions.

Endoscopic colostomy with percutaneous colopexy: an animal feasibility study.

BACKGROUND: Indications for colostomy in colorectal diseases are obstruction of the large bowel, such as in cancer, diverticular disease in the acute phase, post-radiotherapy enteritis, complex perirectal fistulas, anorectal trauma and severe anal incontinence. Some critically ill patients cannot tolerate an exploratory laparotomy, and laparoscopic assisted colostomy also requires general anesthesia. OBJECTIVE: To evaluate the feasibility, safety and efficacy of performing colostomy assisted by colonoscopy and percutaneous colopexy. MATERIALS AND METHODS: Five pigs underwent endoscopic assisted colostomy with percutaneous colopexy. Animals were evaluated in post-operative days 1, 2, 5 and 7 for feeding acceptance and colostomy characteristics. On day 7 full colonoscopy was performed on animals followed by exploratory laparotomy. RESULTS: Average procedure time was 27 minutes (21-54 min). Postoperative mobility and feeding of animals were immediate after anesthesia recovery. Position of the colostomy, edges color, appearance of periostomal area, as well as its function was satisfactory in four animals. Retraction of colostomy was present in one pig. The colonoscopy and laparotomy control on the seventh day were considered as normal. A bladder perforation that was successfully repaired through the colostomy incision occurred in one pig. The main limitation of this study is its experimental nature. CONCLUSION: Endoscopic assisted colostomy with percutaneous colopexy proves to be a safe and effective method with low morbidity for performing colostomy in experimental animals, with possible clinical application in humans.

Pathologic Complete Response in Rectal Cancer: Can We Detect It? Lessons Learned From a Proposed Randomized Trial of Watch-and-Wait Treatment of Rectal Cancer.

BACKGROUND: Chemoradiotherapy has the potential to downsize and downstage tumors before surgery, decrease locoregional recurrence, and induce a complete sterilization of tumor cells for middle and low locally advanced rectal cancer. A watch-and-wait tactic has been proposed for patients with clinical complete response. OBJECTIVE: The purpose of this study was to verify our ability to identify complete clinical response in patients with rectal cancer based on clinical and radiologic criteria. DESIGN: This was a prospective study. SETTINGS: The study was conducted at a single institution, in the setting of a watch-and-wait randomized trial. PATIENTS: Consecutive patients with stage T3 to T4N0M0 or T(any)N+M0 cancer located within 10 cm from anal verge or T2N0 within 7 cm from anal verge were included in the study. Patients were staged and restaged 8 weeks after completion of chemoradiation (5-fluorouracil, 5040 cGy) by digital examination, colonoscopy, pelvic MRI, and thorax and abdominal CT scans. MAIN OUTCOME MEASURES: Clinical and radiologic judgments of tumor response were compared with pathologic response of patients treated by total mesorectal excision or clinical follow-up of patients selected for nonoperative treatment. RESULTS: A total of 118 patients were treated. Six patients were considered clinic complete responders (2 randomly assigned for surgery (1 ypT0N0 and 1 ypT2N0) and 4 patients randomly assigned for observation (3 sustained clinic complete response and 1 had tumor regrowth)). The 112 clinic incomplete responders underwent total mesorectal excision, and 18 revealed pathologic complete response. These 18 patients were not considered complete responders at restaging because they presented at least 1 of the following conditions: mucosal ulceration and/or deformity and/or substenosis of rectal lumen at digital rectal examination and colonoscopy (n = 16), ymrT1 to T4 (n = 16), ymrN+ (n = 2), involvement of circumferential resection margin on MRI (n = 3), extramural vascular invasion on MRI (n = 4), MRI tumor response grade 2 to 4 (n = 15), and pelvic side wall lymph node involvement on MRI (n = 1). Sensitivity for identification of ypT0N0 or sustained clinic complete response was 18.2%. LIMITATIONS: This study has a short follow-up and small sample size. Radiologists who reviewed the restaging examination were not blinded to the pretreatment stage. Only 1 radiologist read the images of each patient. CONCLUSIONS: Evaluation of clinic complete response according to current adopted criteria has low sensitivity because pathologic complete response more frequently presented as clinic incomplete response (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A221).

Postoperative complications in the treatment of rectal neoplasia by transanal endoscopic microsurgery: a prospective study of risk factors and time course.

PURPOSE: Transanal endoscopic microsurgery (TEM) is a safe and efficient minimally invasive treatment for rectal benign and early malignant neoplasia, but postoperative complications may be severe. We aimed to evaluate the risk factors related to the incidence, severity, and time course of postoperative complications of TEM. METHODS: This is a prospective study of postoperative complications in 53 patients (>18 years old) with benign or early rectal neoplasia who underwent TEM with curative intention or, for higher stages, palliation. Outcome measures included age, sex, American Society of Anesthesiologists score, neoadjuvant chemoradiotherapy, lesion height and size, pathologic margins, tumor histology, and suture type. RESULTS: Overall morbidity was 50 %. Temporary fecal incontinence was the most frequent complication (17.3 %). Complication rates of Clavien-Dindo grades I and II were 21.1 % and those of grades III and IV 3.8 %. Of patients with complications, more had lesions under the first rectal valve than over the first valve (61.54 % vs 38.46 %, p = 0.04). Patients submitted to chemoradiotherapy had a 24-fold greater chance of presenting grade II complications (p = 0.002). When the surgical defect was treated using the TEM device to perform the suture, the chance of having grade III complications was reduced 16-fold (p = 0.04). Fifty-three percent of complications occurred in the first 10 days and 95 % within 20 days. CONCLUSIONS: Postoperative complications after transanal endoscopic microsurgery for the treatment of rectal neoplasia are frequent, acceptable, and usually controllable with pharmacologic treatment. Over time the nature of complications is continuous, centered on the first 20 days after surgery.

Carnoy's solution is an adequate tissue fixative for routine surgical pathology, preserving cell morphology and molecular integrity.

AIMS: To compare Carnoy's solution (CS) and 10% neutral buffered formalin solution (NBF) as tissue fixatives in colorectal cancer specimens. METHODS AND RESULTS: Surgical specimens from patients with colorectal cancer were analysed. Three groups were studied, as follows: group 1 consisted of 16 paired samples fixed in CS and NBF; and groups 2 and 3 consisted of 14 prospective and 80 retrospective samples, respectively, both randomized for fixation in CS or NBF. Groups 1 and 2 were analysed for amount, quality and integrity of DNA. Morphological analysis, including some of the usual special stains and polymerase chain reaction (PCR), were also performed for group 1, and Sanger sequencing for group 2. Immunohistochemical (IHC) reactions for mismatch repair proteins were studied in groups 1 and 3. Fixative performances were similar for morphology, special stains, and IHC reactions, as well as for the amount, quality and integrity of extracted DNA. PCR amplification was not possible in two cases from CS group 1. Sanger sequencing gave conclusive results for the CS samples tested. CONCLUSIONS: Carnoy's solution and NBF are equivalent fixatives for colorectal cancer specimens and are adequate for routine utilization in surgical and molecular pathology.