Nonoperative management protocol for locally advanced rectal cancer.

AIM: The standard treatment for low rectal cancer is preoperative chemoradiotherapy followed by surgery with low anterior resection with diverting ileostomy or abdominoperineal resection, both of which have significant long-term effects on bowel and sexual function. Due to the high morbidity of surgery, there has been increasing interest in nonoperative management for low rectal cancer. The aim of this work is to conduct a pan-Canadian Phase II trial assessing the safety of nonoperative management for low rectal cancer. METHOD: Patients with Stage II or III low rectal cancer completing chemoradiotherapy according to standard of care at participating centres will be assessed for complete clinical response 8-14 weeks following completion of chemoradiotherapy. Subjects achieving a clinical complete response will undergo active surveillance including endoscopy, imaging and bloodwork at regular intervals for 24 months. The primary outcome will be the rate of local regrowth 2 years after chemoradiotherapy. Nonoperative management will be considered safe (i.e. as effective as surgery to achieve local control) if the rate of local regrowth is ≤30% and surgical salvage is possible for all local regrowths. Secondary outcomes will include disease-free and overall survival. CONCLUSION: The results will be highly clinically relevant, as it is expected that nonoperative management will be safe and lead to widespread adoption of nonoperative management in Canada. This change in practice has the potential to decrease the number of patients requiring surgery and the costs associated with surgery and long-term surgical morbidity.

Is mechanical bowel preparation necessary to reduce surgical site infection following colon surgery? Protocol for a multicentre Canadian randomized controlled trial.

AIM: There is significant practice variation with respect to the use of bowel preparation to reduce surgical site infection (SSI) following colon surgery. Although intravenous antibiotics + mechanical bowel preparation + oral antibiotics (IVA + MBP + OA) has been shown to be superior to IVA + MBP and IVA, there are insufficient high-quality data from randomized controlled trails (RCTs) that directly compare these options. This is an important question, because if IVA + OA has similar effectiveness to IVA + MBP + OA, mechanical bowel preparation can be safely omitted, and the associated side effects avoided. The aim of this work is to compare rates of SSI following IVA + OA + MBP (MBP) versus IVA + OA (OA) for elective colon surgery. METHOD: This is a multicentre, parallel, two-arm, noninferiority RCT comparing IVA + OA + MBP versus IVA + OA. The primary outcome is the overall rate of SSI 30 days following surgery. Secondary outcomes are length of stay and 30-day emergency room visit and readmission rates. The planned sample size is 1062 subjects with four participating high-volume centres. Overall SSI rates 30 days following surgery between the treatment groups will be compared using a general linear model. Secondary outcomes will be analysed with linear regression for continuous outcomes, logistic regression for binary outcomes and modified Poisson regression for count data. CONCLUSION: It is expected that IVA + OA will work similarly to IVA + MBP + OA and that this work will provide definitive evidence showing that MBP is not necessary to reduce SSI. This is highly relevant to both patients and physicians as it will have the potential to significantly change practice and outcomes following colon surgery in Canada and beyond.

Tumor Budding Assessment in Colorectal Carcinoma: Normalization Revisited.

Tumor budding (TB) is a powerful prognostic factor in colorectal cancer (CRC). An internationally standardized method for its assessment (International Tumor Budding Consensus Conference [ITBCC] method) has been adopted by most CRC pathology protocols. This method requires that TB counts are reported by field area (0.785 mm 2 ) rather than objective lens and a normalization factor is applied for this purpose. However, the validity of this approach is yet to be tested. We sought to validate the ITBCC method with a particular emphasis on normalization as a tool for standardization. In a cohort of 365 stage I-III CRC, both normalized and non-normalized TB were significantly associated with disease-specific survival and recurrence-free survival ( P <0.0001). Examining both 0.95 and 0.785 mm 2 field areas in a subset of patients (n=200), we found that normalization markedly overcorrects TB counts: Counts obtained in a 0.95 mm 2 hotspot field were reduced by an average of 17.5% following normalization compared with only 3.8% when counts were performed in an actual 0.785 mm 2 field. This resulted in 45 (11.3%) cases being downgraded using ITBCC grading criteria following normalization, compared with only 5 cases (1.3%, P =0.0007) downgraded when a true 0.785 mm 2 field was examined. In summary, the prognostic value of TB was retained regardless of whether TB counts in a 0.95 mm 2 field were normalized. Normalization resulted in overcorrecting TB counts with consequent downgrading of most borderline cases. This has implications for risk stratification and adjuvant treatment decisions, and suggests the need to re-evaluate the role of normalization in TB assessment.

Laparoscopic Versus Transanal IPAA for Ulcerative Colitis: A Patient-Centered Treatment Trade-Off Study.

BACKGROUND: Transanal IPAA is a relatively new technique aiming to reduce surgical invasiveness while providing better access to the pelvis in patients with ulcerative colitis. Currently, patients' preference for a surgical approach has never been investigated. OBJECTIVE: To observe patient preference between transanal and laparoscopic IPAA by measuring the potential risk, expressed in pouch function reduction, patients are willing to take to undergo transanal surgery. DESIGN: We conducted standardized interviews of patients using the threshold technique. SETTINGS: Patients from Mount Sinai Hospital in Toronto were included. PATIENTS: Fifty-two patients with ulcerative colitis participated in this study. INTERVENTION: Patients with ulcerative colitis, with or without previous pouch surgery, were submitted to standardized interviews using the threshold technique. MAIN OUTCOME MEASURES: We measured the absolute increase in bowel frequency, bowel urgency, and fecal incontinence that patients would accept if undergoing transanal IPAA. RESULTS: Thirty-two patients (mean age: 38.7 ± 15.3 years) with previous surgery and 20 patients (mean age: 39.5 ± 11.9 years) with no previous surgery participated in this study. Patients accepted an absolute increase of 2 bowel movements per day and 1 episode of fecal incontinence per month to undergo transanal IPAA. They also accepted 10 minutes of worsening bowel urgency (ie, decrease of 10 minutes in "holding time") for transanal surgery. Younger patients aged 21 to 29 years only accepted an absolute decrease of 5 minutes in "holding time" ( p = 0.02). LIMITATIONS: Biases inherent to study design. CONCLUSIONS: Patients were willing to accept a potential reduction in pouch function to receive the less invasive method of transanal IPAA. More studies evaluating long-term functional outcomes after transanal IPAA are required to help patients make educated surgical decisions. See Video Abstract. ANASTOMOSIS LAPAROSCPICA VERSUS TRANSANAL ILEALBOLSA ANAL PARA LA COLITIS ULCEROSA UN ESTUDIO DE COMPENSACIN DE TRATAMIENTO CENTRADO EN EL PACIENTE: ANTECEDENTES:La anastomosis anal transanal con reservorio ileal es una técnica relativamente nueva que tiene como objetivo reducir la invasividad quirúrgica y al mismo tiempo proporcionar un mejor acceso a la pelvis en pacientes con colitis ulcerosa. Actualmente, nunca se ha investigado la preferencia de los pacientes sobre el abordaje quirúrgico.OBJETIVO:Observar la preferencia de los pacientes entre la anastomosis ileoanal con reservorio transanal y laparoscópica midiendo el riesgo potencial, expresado en la reducción de la función del reservorio, que los pacientes están dispuestos a someterse a una cirugía transanal.DISEÑO:Realizamos entrevistas estandarizadas de pacientes utilizando la técnica del umbral.AJUSTES:Se incluyeron pacientes del Hospital Mount Sinai en Toronto.PACIENTES:Cincuenta y dos pacientes con colitis ulcerosa participaron en este estudio.INTERVENCIÓN(ES):Los pacientes con colitis ulcerosa, con o sin cirugía previa de reservorio fueron sometidos a entrevistas estandarizadas utilizando la técnica del umbral.MEDIDAS DE RESULTADO PRINCIPALES:Medimos el aumento absoluto en la frecuencia intestinal, la urgencia intestinal y la incontinencia fecal que los pacientes aceptarían si se sometieran a una anastomosis transanal con bolsa ileal.RESULTADOS:Treinta y dos pacientes (edad media: 38,7 ± 15,3) con cirugía previa y 20 pacientes (edad media: 39,5 ± 11,9) sin cirugía previa participaron en este estudio. Los pacientes aceptaron un aumento absoluto de 2 deposiciones por día y un episodio de incontinencia fecal por mes para someterse a una anastomosis transanal ileoanal con reservorio. También aceptaron 10 minutos de empeoramiento de la urgencia intestinal (es decir, disminución de 10 minutos del "tiempo de espera") para la cirugía transanal. Los pacientes más jóvenes de 21 a 29 años solo aceptaron una disminución absoluta de 5 minutos en el "tiempo de espera" ( P = 0,02).LIMITACIONES:Sesgos inherentes al diseño del estudio.CONCLUSIONES:Los pacientes estaban dispuestos a aceptar una reducción potencial en la función del reservorio para recibir el método menos invasivo de anastomosis transanal ileoanal con reservorio. Se requieren más estudios que evalúen los resultados funcionales a largo plazo después de la anastomosis transanal ileoanal con reservorio para ayudar a los pacientes a tomar decisiones quirúrgicas informadas. (Traducción-Yesenia Rojas-Khalil ).

Surgeon factors but not hospital factors associated with length of stay after colorectal surgery - A population based study.

AIM: Length of stay (LOS) after colorectal surgery (CRS) is a significant driver of healthcare utilization and adverse patient outcomes. To date, there is little high-quality evidence in the literature examining how individual surgeon and hospital factors independently impact LOS. We aimed to identify and quantify the independent impact of surgeon and hospital factors on LOS after CRS. METHODS: A retrospective population-based cohort study was conducted using validated health administrative databases, encompassing all patients from the province of Ontario, Canada. All patients from 121 hospitals in Ontario who underwent elective CRS between 2008 and 2019 in Ontario were included, and factors pertaining to these patients and their treating surgeon and hospital were assessed. A negative binomial regression model was used to assess the independent effect of surgeon and hospital factors on LOS, accounting for a comprehensive collection of determinants of LOS. To minimize unmeasured confounding, the analysis was repeated in a subgroup comprising patients undergoing lower-complexity CRS without postoperative complications. RESULTS: A total of 90,517 CRS patients were analysed. Independent of patient and procedural factors, low surgeon volume (lowest volume quartile) was associated with a 20% increase in LOS (95% CI: 12-29, p < 0.0001) compared to high surgeon volume (highest volume quartile). In the 22,639 patients undergoing uncomplicated lower-complexity surgeries, a 43% longer LOS was seen in the lowest volume surgeon quartile (95% CI: 26-61, p < 0.0001). In both models, more years-in-practice was associated with a small increase in LOS (RR 1.02, 95% CI: 1.02-1.03, p < 0.0001). Hospital factors were not significantly associated with increased LOS. CONCLUSIONS: Surgeon factors, including low surgeon volume and increasing years-in-practice, were strongly and independently associated with longer LOS, whereas hospital factors did not have an independent impact. This suggests that LOS is driven primarily by surgeon-mediated care processes and may provide actionable targets for provider-level interventions to reduce LOS after CRS.

Clinical tools to assess functional capacity before elective non-cardiac surgery: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to map the evidence on clinical tools to assess functional capacity prior to elective non-cardiac surgery. INTRODUCTION: Functional capacity is a strong prognostic indicator before surgery, which can be used to identify patients at elevated risk of postoperative complications, yet, there is no consensus on which clinical tools should be used to assess functional capacity in patients prior to non-cardiac surgery. INCLUSION CRITERIA: This review will consider any randomized or non-randomized studies that evaluate the performance of a functional capacity assessment tool in adults (≥18 years) prior to non-cardiac surgery. For studies to be included, the tool must be used clinically for risk stratification. We will exclude studies on lung and liver transplant surgery, as well as ambulatory procedures performed under local anesthesia. METHODS: The review will be conducted in line with the JBI methodology for scoping reviews. A peer-reviewed search strategy will be used to query relevant databases (ie, MEDLINE, Embase, EBM Reviews). Additional sources of evidence will include databases of non-peer-reviewed literature and the reference lists of included studies. Two independent reviewers will identify eligible studies in 2 stages: stage 1, based on titles and abstracts; and stage 2, based on full texts. Information on study details, measurement properties, pragmatic qualities, and/or clinical utility metrics will be charted in duplicate onto standardized data collection forms. The results will be presented using descriptive summaries, frequency tables, and visual plots that highlight the extent of evidence and remaining gaps in the validation process of each tool. REVIEW REGISTRATION: Open Science Framework https://osf.io/6nfht.

Home to Stay: A Randomized Controlled Trial Evaluating the Effect of a Postdischarge Mobile App to Reduce 30-Day Readmission Following Elective Colorectal Surgery.

OBJECTIVE: A randomized controlled trial was conducted to evaluate the effect of a postdischarge app on 30-day readmissions and patient-reported outcomes following colorectal surgery. BACKGROUND: Patients undergoing colorectal surgery are particularly vulnerable during their transition from hospital-to-home. There has been increasing interest in e-health to provide cost-effective transitional care. An integrated discharge monitoring program using a mobile app platform was developed to support patients after surgery. METHODS: A 2 arm, superiority randomized control trial was conducted at an academic tertiary care center with patients undergoing elective colorectal surgery. The intervention group received usual postoperative care and postdischarge monitoring with the app. The primary outcome was 30-day readmissions following hospital discharge. RESULTS: Two hundred eighty-two participants were randomized. The majority were young, had inflammatory bowel disease and underwent laparoscopic surgery. Intention to treat analysis showed no difference between groups for 30-day readmission (14.8% vs 17.6%, P =0.55), ER visits (25.0% vs 28.8%, P =0.49), primary care visits (12.5% vs 8.8%, P =0.34) or unplanned healthcare visits (34.4% vs 35.2%, P =0.89). All patient reported outcomes were significantly improved with median scores higher with the app for satisfaction [9, interquartile range (IQR): 8-10 vs 8, IQR: 7-9, P =0.001], well-being (7, IQR: 6-8 vs 6, IQR: 5-7, P =0.001) and significantly lower for anxiety (3, IQR: 2-5 vs 5, IQR: 3-6, P =0.001). CONCLUSIONS: Although the app did not show a significant reduction in 30-day readmission or ER visits, it did lead to significant improvements in patient-reported outcomes. The app may be an important tool to support patients following colorectal surgery.

Home to Stay: A randomized controlled trial protocol to assess use of a mobile app to reduce readmissions following colorectal surgery.

AIM: Patients undergoing colorectal surgery face high rates of emergency room visits and readmission to hospital. These unplanned hospital visits lead to both increased patient anxiety and health care costs. The aim of this study is to evaluate the use of mobile application to support patients undergoing colorectal surgery following discharge from hospital. METHOD: This study is a randomized controlled trial in which the control group will receive standard follow-up care following discharge after surgery and the intervention group will receive standard follow-up care in addition to the mobile application. The primary outcome is the proportion of patients with unplanned hospital visits within 30 days of discharge. The secondary outcomes are patient-reported outcomes on validated scales evaluating their quality of recovery following discharge. A sample size of 670 subjects is planned. For the primary outcome, the control and intervention groups will be compared using a generalized linear model to account for clustering of patients within centres. For the secondary outcomes, the overall scores on the Quality of Recovery 15 and Patient Activation Measure will be analysed using a linear regression model. RESULTS: It is expected that the results of this study will show that the mobile app will lead to significant improvements in unplanned hospital visits as well as improved quality of recovery for patients. CONCLUSION: If the trial is successful, the mobile app can be easily adopted more widely into clinical practice to support patients at home following surgery.

Anal Adenocarcinoma: A Rare Entity in Need of Multidisciplinary Management.

BACKGROUND: Anal adenocarcinoma is a rare clinical entity for which the optimal management is not defined. OBJECTIVE: This study aimed to describe the multidisciplinary management and outcomes of patients with anal adenocarcinoma. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at a quaternary cancer center. PATIENTS: Men and women with anal adenocarcinoma treated between 1995 and 2016 were selected. INTERVENTIONS: Fifty-two patients were treated with either chemoradiotherapy or trimodality therapy including radiation therapy, chemotherapy, and surgical resection. MAIN OUTCOME MEASURES: Local failure, regional failure, and distant metastasis rates were estimated using the cumulative incidence method. The Kaplan-Meier method was used to estimate progression-free survival and overall survival. The multivariable Cox proportional hazards model was used to evaluate the clinical predictors of outcome. RESULTS: There was a higher 5-year rate of local failure in patients treated with chemoradiotherapy compared with trimodality therapy (53% vs 10%; p < 0.01). The 5-year incidence of distant metastases was 29% (trimodality therapy) versus 30% (chemoradiotherapy; p = 0.9); adjuvant chemotherapy did not reduce the incidence of distant metastases (p = 0.8). Five-year overall survival was 73% (trimodality therapy) versus 49.4% (chemoradiotherapy; p = 0.1). On multivariable analysis, factors associated with worse overall survival were treatment with chemoradiotherapy, cT3-4 category disease, and node-positive disease. LIMITATIONS: This study is limited by its small sample size and retrospective nature. CONCLUSIONS: Although treatment may continue to be tailored to individual patients, better outcomes with a trimodality therapy approach were observed. See Video Abstract at http://links.lww.com/DCR/B708.ADENOCARCINOMA ANAL: UNA ENTIDAD POCO FRECUENTE EN NECESIDAD DE UN MANEJO MULTIDISCIPLINARIO. ANTECEDENTES: El adenocarcinoma anal es una entidad clínica poco frecuente por lo que aún no se define el manejo óptimo. OBJETIVO: Describir el manejo multidisciplinario y los resultados de los pacientes con adenocarcinoma anal. DISEO: Estudio de cohorte retrospectivo. ENTORNO CLINICO: Centro de cáncer cuaternario. PACIENTES: Hombres y mujeres con adenocarcinoma anal tratados entre 1995 y 2016. INTERVENCIONES: Cincuenta y dos pacientes fueron tratados con quimiorradioterapia o terapia trimodal que incluyó: radioterapia, quimioterapia y resección quirúrgica. PRINCIPALES MEDIDAS DE VALORACION: Se estimaron las tasas de falla local, falla regional y metástasis a distancia mediante el método de incidencia acumulada. Se utilizó el método de Kaplan-Meier para estimar la supervivencia libre de progresión y la supervivencia global. Los riesgos proporcionales de multivariable Cox se utilizaron para evaluar los predictores clínicos de los resultados. RESULTADOS: Hubo una mayor tasa de falla local a cinco años en pacientes tratados con quimiorradioterapia en comparación con terapia trimodal (53% vs 10%; p < 0,01). La incidencia a cinco años de metástasis a distancia fue del 29% (terapia trimodal) versus 30% (quimiorradioterapia) (p = 0,9); la quimioterapia adyuvante no redujo la incidencia de metástasis a distancia (p = 0,8). La supervivencia global a cinco años fue del 73% (terapia trimodal) versus 49,4% (quimiorradioterapia); p = 0,1. En el análisis multivariable, los factores asociados con una peor supervivencia general fueron el tratamiento con quimiorradioterapia, enfermedad de categoría cT3-4 y enfermedad con ganglios positivos. LIMITACIONES: Este estudio está limitado por su pequeño tamaño de muestra y su naturaleza retrospectiva. CONCLUSIONES: Aunque el tratamiento puede seguir adaptándose a pacientes individuales, se observaron mejores resultados con un enfoque TTM. Conslute Video Resumen en http://links.lww.com/DCR/B708. (Traducción- Dr. Francisco M. Abarca-Rendon).

Routine Elastin Staining in Surgically Resected Colorectal Cancer: Impact on Venous Invasion Detection and its Association With Oncologic Outcomes.

Venous invasion (VI) is a powerful yet underreported prognostic factor in colorectal cancer (CRC). Its detection can be improved with an elastin stain. We evaluated the impact of routine elastin staining on VI detection in resected CRC and its relationship with oncologic outcomes. Pathology reports from the year before (n=145) and the year following (n=128) the implementation of routine elastin staining at our institution were reviewed for established prognostic factors, including VI. A second review, using elastin stains, documented the presence/absence, location, number, and size of VI foci. The relationship between VI and oncologic outcomes was evaluated for original and review assessments. VI detection rates increased from 21% to 45% following implementation of routine elastin staining (odds ratio [OR]=3.1; 95% confidence interval [CI]: 1.8-5.3; P<0.0001). The second review revealed a lower VI miss rate postimplementation than preimplementation (22% vs. 48%, respectively; P=0.007); this difference was even greater for extramural VI-positive cases (9% vs. 38%, respectively; P=0.0003). Missed VI cases postimplementation had fewer VI foci per missed case (P=0.02) and a trend towards less extramural VI than those missed preimplementation. VI assessed with an elastin stain was significantly associated with recurrence-free survival (P=0.003), and cancer-specific survival (P=0.01) in contrast to VI assessed on hematoxylin and eosin alone (P=0.053 and 0.1, respectively). The association between VI and hematogenous metastasis was far stronger for elastin-detected VI (OR=11.5; 95% CI: 3.4-37.1; P<0.0001) than for hematoxylin and eosin-detected VI (OR=3.7; 95% CI: 1.4-9.9; P=0.01). Routine elastin staining enhances VI detection and its ability to stratify risk in CRC and should be considered for evaluation of CRC resection specimens.

Evaluation of a multiparametric MRI scoring system for histopathologic treatment response following preoperative chemoradiotherapy for rectal cancer.

PURPOSE: To evaluate the performance of a multiparametric (mp) MRI scoring system for assessment of tumour response in patients with locally advanced rectal cancer (LARC) after neoadjuvant chemoradiotherapy (CRT). METHOD: Fifty-nine consecutive patients with LARC who had rectal MRI before and after CRT followed by surgery were included. Two radiologists retrospectively assessed tumour response using a proposed mpMRI scoring system. Treatment response was classified as complete, near complete, partial or poor. Accuracy, sensitivity, specificity, positive predictive value and negative predictive values were calculated and inter-reader agreements were assessed. Pathologic tumour regression grade (pTRG) was the reference standard. RESULTS: Treatment response was correctly predicted by both readers in 32.2%-40.7% of patients. Overestimation was more common than underestimation. Sensitivity, specificity, PPV and NPV for pathologic complete response (pCR) among both readers was 16.7-33.0 %, 88.7-94.2 %, 14.3-40.0 % and 92.5-94.2 % respectively. Sensitivity and PPV for both readers improved to 56.0-60.0 % and 53.6-66.7 % respectively when complete response and near complete response categories (good responders) were combined. Inter-reader agreement using the scoring system was fair (κ = 0.383). Agreement between mpMRI score and pathological tumour response was poor to fair for both readers (κ = 0.050 to 0.258) but improved when complete and near complete response categories (good responders) were combined (κ = 0.214 to 0.362). CONCLUSIONS: Despite low agreement between radiological tumour response and pTRG, the proposed mpMRI-based scoring system appears useful in identifying good responders who may benefit from nonoperative management strategies.

Quality indicator selection for the Canadian Partnership against Cancer rectal cancer project: A modified Delphi study.

AIM: It is well established that (i) magnetic resonance imaging, (ii) multidisciplinary cancer conference (MCCs), (iii) preoperative radiotherapy, (iv) total mesorectal excision surgery and (v) pathological assessment as described by Quirke are key processes necessary for high quality, rectal cancer care. The objective was to select a set of multidisciplinary quality indicators to measure the uptake of these clinical processes in clinical practice. METHOD: A multidisciplinary panel was convened and a modified two-phase Delphi method was used to select a set of quality indicators. Phase 1 included a literature review with written feedback from the panel. Phase 2 included an in-person workshop with anonymous voting. The selection criteria for the indicators were strength of evidence, ease of capture and usability. Indicators for which ≥90% of the panel members voted 'to keep' were selected as the final set of indicators. RESULTS: During phase 1, 68 potential indicators were generated from the literature and an additional four indicators were recommended by the panel. During phase 2, these 72 indicators were discussed; 48 indicators met the 90% inclusion threshold and included eight pathology, five radiology, 11 surgical, six radiation oncology and 18 MCC indicators. CONCLUSION: A modified Delphi method was used to select 48 multidisciplinary quality indicators to specifically measure the uptake of key processes necessary for high quality care of patients with rectal cancer. These quality indicators will be used in future work to identify and address gaps in care in the uptake of these clinical processes.

Short-term and Long-term Outcomes Following Pelvic Pouch Excision: The Mount Sinai Hospital Experience.

BACKGROUND: Few studies have reported surgical outcomes following pouch excision and fewer have described the long-term sequelae. Given the debate regarding optimal surgical management following pouch failure, an accurate estimation of the morbidity associated with this procedure addresses a critical knowledge gap. OBJECTIVE: The objective of this study was to review our institutional experience with pouch excision with a focus on indications, short-term outcomes, and long-term reintervention rates. DESIGN: This was a retrospective cohort study. SETTING: This study was conducted at Mount Sinai Hospital, Toronto, Ontario Canada. PARTICIPANTS: Adult patients registered in the prospectively maintained IBD database with a diagnosis of pelvic pouch failure between 1991 and 2018 were selected. INTERVENTION: The patients had undergone pelvic pouch excision was measured. MAIN OUTCOMES AND MEASURES: Indications for excision, incidence of short-term and long-term complications, and long-term surgical reintervention were the primary outcomes. In addition, multivariable logistic regression models were fitted to identify predictors of chronic perineal wound complications and the effect of preoperative diversion. The positive predictive value of a clinical suspicion of Crohn's disease of the pouch was also evaluated. RESULTS: One hundred forty cases were identified. Fifty-nine percent of patients experienced short-term complications and 49.3% experienced delayed morbidity. Overall, one-third of patients required long-term reoperation related to perineal wound, stoma, and hernia complications. On multivariable regression, immunosuppression was associated with increased odds of perineal wound complications, and preoperative diversion was not associated with perineal wound healing. Crohn's disease was suspected in 24 patients preoperatively but confirmed on histopathology in only 6 patients. LIMITATIONS: This is a retrospective chart review of a single institution's experience, whereby complication rates may be underestimates of the true event rates. CONCLUSIONS: Pouch excision is associated with high postoperative morbidity and long-term reintervention due to nonhealing perineal wounds, stoma complications, and hernias. Further study is required to clarify risk reduction strategies to limit perineal wound complications and the appropriate selection of patients for diversion alone vs pouch excision in IPAA failure. See Video Abstract at http://links.lww.com/DCR/B348. RESULTADOS A CORTO Y LARGO PLAZO DESPUÉS DE LA EXTIRPACIÓN DE LA BOLSA PéLVICA: LA EXPERIENCIA DEL HOSPITAL MOUNT SINAÍ: Pocos estudios han informado resultados quirúrgicos después de la escisión de bolsa pélvica (reservorio ileoanal) y menos han descrito las secuelas a largo plazo. Dado el debate sobre el manejo quirúrgico óptimo después de la falla de la bolsa, una estimación precisa de la morbilidad asociada con este procedimiento aborda una brecha crítica de conocimiento.El objetivo de este estudio fue revisar nuestra experiencia institucional con la extirpación de la bolsa con un enfoque en las indicaciones, los resultados a corto plazo y las tasas de reintervención a largo plazo.Estudio de cohorte retrospectivo.Hospital Mt Sinaí, Toronto, Ontario, Canadá.Pacientes adultos registrados en la base de datos de EII mantenida prospectivamente con un diagnóstico de falla de la bolsa pélvica entre 1991 y 2018.Escisión de bolsa pélvica.Las indicaciones para la escisión, la incidencia de complicaciones a corto y largo plazo y la reintervención quirúrgica a largo plazo fueron los resultados primarios valorados. Además, se ajustaron modelos de regresión logística multivariable para identificar predictores de complicaciones de la herida perineal crónica y el efecto de la derivación preoperatoria. También se evaluó el valor predictivo positivo de una sospecha clínica de enfermedad de Crohn de la bolsa.Se identificaron 140 casos. El 59% de los pacientes desarrollaron complicaciones a corto plazo y el 49,3% con morbilidad tardía. En general, 1/3 de los pacientes requirieron una reoperación a largo plazo relacionada con complicaciones de herida perineal, estoma y hernia. En la regresión multivariable, la inmunosupresión se asoció con mayores probabilidades de complicaciones de la herida perineal y la derivación preoperatoria no se asoció con la cicatrización de la herida perineal. La enfermedad de Crohn se sospechó en 24 pacientes antes de la operación, pero se confirmó por histopatología en solo 6 pacientes.Revisión retrospectiva del cuadro de la experiencia de una sola institución por la cual las tasas de complicaciones pueden ser subestimadas de las tasas de eventos reales.La escisión de la bolsa se asocia con una alta morbilidad postoperatoria y una reintervención a largo plazo debido a complicaciones de heridas perineales, complicaciones del estoma y hernias. Se requieren más estudios para aclarar las estrategias de reducción de riesgos para limitar las complicaciones de la herida perineal y la selección adecuada de pacientes para la derivación sola versus la escisión de la bolsa en caso de falla de reservorio ileoanal. Consulte Video Resumen en http://links.lww.com/DCR/B348.

Real-world outcomes of FOLFIRINOX vs gemcitabine and nab-paclitaxel in advanced pancreatic cancer: A population-based propensity score-weighted analysis.

BACKGROUND: In Ontario, FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GnP) have been publicly funded for first-line unresectable locally advanced pancreatic cancer (uLAPC) or metastatic pancreatic cancer (mPC) since April 2015. We examined the real-world effectiveness and safety of FFX vs GnP for advanced pancreatic cancer, and in uLAPC and mPC. METHODS: Patients receiving first-line FFX or GnP from April 2015 to March 2017 were identified in the New Drug Funding Program database. Baseline characteristics and outcomes were obtained through the Ontario Cancer Registry and other population-based databases. Overall survival (OS) was assessed using Kaplan-Meier and weighted Cox proportional hazard models, weighted by the inverse propensity score adjusting for baseline characteristics. Weighted odds ratio (OR) for hospitalization and emergency department visits (EDV) were estimated from weighted logistic regression models. RESULTS: For 1130 patients (632 FFX, 498 GnP), crude median OS was 9.6 and 6.1 months for FFX and GnP, respectively. Weighted OS was improved for FFX vs GnP (HR = 0.77, 0.70-0.85). Less frequent EDV and hospitalization were observed in FFX (EDV: 67.8%; Hospitalization: 49.2%) than GnP (EDV: 77.7%; Hospitalization: 59.3%). More frequent febrile neutropenia-related hospitalization was observed in FFX (5.8%) than GnP (3.3%). Risk of EDV and hospitalization were significantly lower for FFX vs GnP (EDV: OR = 0.68, P = .0001; Hospitalization: OR = 0.76, P = .002), whereas the risk of febrile neutropenia-related hospitalization was significantly higher (OR = 2.12, P = .001). Outcomes for uLAPC and mPC were similar. CONCLUSION: In the real world, FFX had longer OS, less frequent all-cause EDV and all-cause hospitalization, but more febrile neutropenia-related hospitalization compared to GnP.

The "Begin Exploring Fertility Options, Risks and Expectations" (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients.

BACKGROUND: Premenopausal breast cancer patients are at risk of treatment-related infertility. Many patients do not receive sufficient fertility information before treatment. As such, our team developed and alpha tested the Begin Exploring Fertility Options, Risks, and Expectations decision aid (BEFORE DA). METHODS: The BEFORE DA development process was guided by the International Patient Decision Aids Standards and the Ottawa Decision Support Framework. Our team used integrated knowledge translation by collaborating with multiple stakeholders throughout the development process including breast cancer survivors, multi-disciplinary health care providers (HCPs), advocates, and cancer organization representatives. Based on previously conducted literature reviews and a needs assessment by our team - we developed a paper prototype. The paper prototype was finalized at an engagement meeting with stakeholders and created into a graphically designed paper and mirrored online decision aid. Alpha testing was conducted with new and previously engaged stakeholders through a questionnaire, telephone interviews, or focus group. Iterative reviews followed each step in the development process to ensure a wide range of stakeholder input. RESULTS: Our team developed an 18-page paper prototype containing information deemed valuable by stakeholders for fertility decision-making. The engagement meeting brought together 28 stakeholders to finalize the prototype. Alpha testing of the paper and online BEFORE DA occurred with 17 participants. Participants found the BEFORE DA usable, acceptable, and most provided enthusiastic support for its use with premenopausal breast cancer patients facing a fertility decision. Participants also identified areas for improvement including clarifying content/messages and modifying the design/photos. The final BEFORE DA is a 32-page paper and mirrored online decision aid ( https://fertilityaid.rethinkbreastcancer.com ). The BEFORE DA includes information on fertility, fertility options before/after treatment, values clarification, question list, next steps, glossary and reference list, and tailored information on the cost of fertility preservation and additional resources by geographic location. CONCLUSION: The BEFORE DA, designed in collaboration with stakeholders, is a new tool for premenopausal breast cancer patients and HCPs to assist with fertility discussions and decision-making. The BEFORE DA helps to fill the information gap as it is a tool that HCPs can refer patients to for supplementary information surrounding fertility.

Striving to Do No Harm and Yet Respect Patient Autonomy: Plastic Surgeons' Perspectives of the Consultation for Breast Reconstruction with Women Who Have Early-Stage Breast Cancer.

BACKGROUND: Rates of contralateral prophylactic mastectomy (CPM) have doubled over the last decade among women considered low risk for developing contralateral breast cancer. Despite the strong association between CPM and breast reconstruction, little is known about the clinical encounter between patients and plastic surgeons. A qualitative study was performed to understand how plastic surgeons describe their roles in the treatment decision-making process through their consultations with women who have unilateral early-stage breast cancer. METHODS: Semi-structured interviews with Ontario plastic surgeons were conducted. An inductive and interpretive thematic approach was initially used to analyze the data. The four principles of biomedical ethics then served as the conceptual lens to interpret the findings. RESULTS: The participants in this study were 18 plastic surgeons, and data saturation was reached. Four themes were identified: maintaining non-maleficence, supporting patient autonomy, delivering (un)equal health care, and providing care to enhance well-being. The ongoing push-pull between competing ethical principles was the overarching theme, specifically, striving to balance parallel responsibilities to do no harm while also respecting patients' rights to make their own healthcare decisions. CONCLUSIONS: In this patient-centric climate, it is important to acknowledge that patients may value outcomes such as achieving greater peace of mind above other clinical factors and are willing to incur additional risks to achieve these goals. Shared decision-making will help to reveal the rationale underlying each individual's treatment choice, which in turn will allow physicians to appropriately weigh patient requests with the best available medical evidence when counseling women on decision-making for breast cancer care.

Safety and Feasibility of Using Magnetic Resonance Imaging Criteria to Identify Patients With "Good Prognosis" Rectal Cancer Eligible for Primary Surgery: The Phase 2 Nonrandomized QuickSilver Clinical Trial.

IMPORTANCE: Chemoradiotherapy (CRT), followed by surgery, is the recommended approach for stage II and III rectal cancer. While CRT decreases the risk of local recurrence, it does not improve survival and leads to poorer functional outcomes than surgery alone. Therefore, new approaches to better select patients for CRT are important. OBJECTIVE: To conduct a phase 2 study to evaluate the safety and feasibility of using magnetic resonance imaging (MRI) criteria to select patients with "good prognosis" rectal tumors for primary surgery. DESIGN, SETTING, AND PARTICIPANTS: Prospective nonrandomized phase 2 study at 12 high-volume colorectal surgery centers across Canada. From September 30, 2014, to October 21, 2016, a total of 82 patients were recruited for the study. Participants were patients newly diagnosed as having rectal cancer with MRI-predicted good prognosis rectal cancer. The MRI criteria for good prognosis tumors included distance to the mesorectal fascia greater than 1 mm; definite T2, T2/early T3, or definite T3 with less than 5 mm of extramural depth of invasion; and absent or equivocal extramural venous invasion. INTERVENTIONS: Patients with rectal cancer with MRI-predicted good prognosis tumors underwent primary surgery. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients with a positive circumferential resection margin (CRM) rate. Assuming a 10% baseline probability of a positive CRM, a sample size of 75 was estimated to yield a 95% CI of ±6.7%. RESULTS: Eighty-two patients (74% male) participated in the study. The median age at the time of surgery was 66 years (range, 37-89 years). Based on MRI, most tumors were midrectal (65% [n = 53]), T2/early T3 (60% [n = 49]), with no suspicious lymph nodes (63% [n = 52]). On final pathology, 91% (n = 75) of tumors were T2 or greater, 29% (n = 24) were node positive, and 59% (n = 48) were stage II or III. The positive CRM rate was 4 of 82 (4.9%; 95% CI, 0.2%-9.6%). CONCLUSIONS AND RELEVANCE: The use of MRI criteria to select patients with good prognosis rectal cancer for primary surgery results in a low rate of positive CRM and suggests that CRT may not be necessary for all patients with stage II and III rectal cancer. TRIAL REGISTRATION: ISRCTN.com identifier: ISRCTN05107772.

Extramural venous invasion in rectal cancer: overview of imaging, histopathology, and clinical implications.

OBJECTIVE: Extramural venous invasion (EMVI) is an independent prognostic factor for prediction of overall unfavorable outcomes in rectal cancer. While EMVI has traditionally been detected in postoperative pathologic specimens, MRI can provide this important piece of information preoperatively. This article reviews the methods of EMVI detection and their clinical implications for treatment and outcomes of rectal cancer. CONCLUSION: EMVI has fundamental implications for rectal cancer prognosis and long-term outcomes. Since MRI has the advantage of preoperative detection of EMVI, it has been suggested that MRI-detected EMVI be incorporated for preoperative chemoradiotherapy (CRT) treatment stratification of rectal cancer for better patient triage and outcomes.

A framework to build capacity for a reflex-testing program for Lynch syndrome.

PURPOSE: Lynch syndrome (LS) is the most common inherited cause of colorectal cancer. Although testing all colorectal tumors for LS is recommended, the uptake of reflex-testing programs within health systems has been limited. This multipronged study describes the design of a provincial program for reflex testing in Ontario, Canada. METHODS: We recruited key stakeholders to participate in qualitative interviews to explore the barriers and facilitators to the implementation of a reflex-testing program. Data were analyzed in an iterative manner, key themes identified, and a framework for a proposed program developed. RESULTS: Twenty-six key informants participated in our interviews, and several themes were identified. These included providing education for stakeholders (patients, primary care providers, surgeons); challenges with sustaining various resources (laboratory costs, increased workload for pathologists); ensuring consistency of reporting test results; and developing a plan to measure program success. Using these themes, a framework for the reflex-testing program was developed. At a subsequent stakeholder meeting, the framework was refined, and recommendations were identified. CONCLUSIONS: This study identifies factors to ensure the effective implementation of a population-level program for reflex LS testing. The final product is a prototype that can be utilized in other jurisdictions, taking into account local environmental considerations.