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 ).

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.

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.

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.

Promising Practices Observed in High-Throughput COVID-19 Vaccination Sites in the United States, February-May 2021.

Objectives. To identify promising practices for implementing COVID-19 vaccination sites. Methods. The Centers for Disease Control and Prevention (CDC) and Federal Emergency Management Agency (FEMA) assessed high-throughput COVID-19 vaccination sites across the United States, including Puerto Rico, after COVID-19 vaccinations began. Site assessors conducted site observations and interviews with site staff. Qualitative data were compiled and thematically analyzed. Results. CDC and FEMA conducted 134 assessments of high-throughput vaccination sites in 25 states and Puerto Rico from February 12 to May 28, 2021. Promising practices were identified across facility, clinical, and cross-cutting operational areas and related to 6 main themes: addressing health equity, leveraging partnerships, optimizing site design and flow, communicating through visual cues, using quick response codes, and prioritizing risk management and quality control. Conclusions. These practices might help planning and implementation of future vaccination operations for COVID-19, influenza, and other vaccine-preventable diseases. Public Health Implications. These practices can be considered by vaccination planners and providers to strengthen their vaccination site plans and implementation of future high-throughput vaccination sites. (Am J Public Health. 2023;113(8):909-918. https://doi.org/10.2105/AJPH.2023.307331).

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.

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).

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.

Etiology of Severe Acute Respiratory Infections, Bangladesh, 2017.

In April 2017, surveillance detected a surge in severe acute respiratory infections (SARI) in Bangladesh. We collected specimens from SARI patients and asymptomatic controls for analysis with multipathogen diagnostic tests. Influenza A(H1N1)pdm09 was associated with the SARI epidemic, suggesting that introducing vaccines and empiric antiviral drugs could be beneficial.

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.

Association of Biosecurity and Hygiene Practices with Environmental Contamination with Influenza A Viruses in Live Bird Markets, Bangladesh.

In Bangladesh, live bird market environments are frequently contaminated with avian influenza viruses. Shop-level biosecurity practices might increase risk for environmental contamination. We sought to determine which shop-level biosecurity practices were associated with environmental contamination. We surveyed 800 poultry shops to describe biosecurity practices and collect environmental samples. Samples from 205 (26%) shops were positive for influenza A viral RNA, 108 (14%) for H9, and 60 (8%) for H5. Shops that slaughtered poultry, kept poultry overnight, remained open without rest days, had uneven muddy floors, held poultry on the floor, and housed sick and healthy poultry together were more frequently positive for influenza A viruses. Reported monthly cleaning seemed protective, but disinfection practices were not otherwise associated with influenza A virus detection. Slaughtering, keeping poultry overnight, weekly rest days, infrastructure, and disinfection practices could be targets for interventions to reduce environmental contamination.

COVID-19 Outbreak Among Employees at a Meat Processing Facility - South Dakota, March-April 2020.

On March 24, 2020, the South Dakota Department of Health (SDDOH) was notified of a case of coronavirus disease 2019 (COVID-19) in an employee at a meat processing facility (facility A) and initiated an investigation to isolate the employee and identify and quarantine contacts. On April 2, when 19 cases had been confirmed among facility A employees, enhanced testing for SARS-CoV-2, the virus that causes COVID-19, was implemented, so that any employee with a COVID-19-compatible sign or symptom (e.g., fever, cough, or shortness of breath) could receive a test from a local health care facility. By April 11, 369 COVID-19 cases had been confirmed among facility A employees; on April 12, facility A began a phased closure* and did not reopen during the period of investigation (March 16-April 25, 2020). At the request of SDDOH, a CDC team arrived on April 15 to assist with the investigation. During March 16-April 25, a total of 929 (25.6%) laboratory-confirmed COVID-19 cases were diagnosed among 3,635 facility A employees. At the outbreak's peak, an average of 67 cases per day occurred. An additional 210 (8.7%) cases were identified among 2,403 contacts of employees with diagnosed COVID-19. Overall, 48 COVID-19 patients were hospitalized, including 39 employees and nine contacts. Two employees died; no contacts died. Attack rates were highest among department-groups where employees tended to work in proximity (i.e., <6 feet [2 meters]) to one another on the production line. Cases among employees and their contacts declined to approximately 10 per day within 7 days of facility closure. SARS-CoV-2 can spread rapidly in meat processing facilities because of the close proximity of workstations and prolonged contact between employees (1,2). Facilities can reduce this risk by implementing a robust mitigation program, including engineering and administrative controls, consistent with published guidelines (1).

COVID-19 Among Workers in Meat and Poultry Processing Facilities - 19 States, April 2020.

Congregate work and residential locations are at increased risk for infectious disease transmission including respiratory illness outbreaks. SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is primarily spread person to person through respiratory droplets. Nationwide, the meat and poultry processing industry, an essential component of the U.S. food infrastructure, employs approximately 500,000 persons, many of whom work in proximity to other workers (1). Because of reports of initial cases of COVID-19, in some meat processing facilities, states were asked to provide aggregated data concerning the number of meat and poultry processing facilities affected by COVID-19 and the number of workers with COVID-19 in these facilities, including COVID-19-related deaths. Qualitative data gathered by CDC during on-site and remote assessments were analyzed and summarized. During April 9-27, aggregate data on COVID-19 cases among 115 meat or poultry processing facilities in 19 states were reported to CDC. Among these facilities, COVID-19 was diagnosed in 4,913 (approximately 3%) workers, and 20 COVID-19-related deaths were reported. Facility barriers to effective prevention and control of COVID-19 included difficulty distancing workers at least 6 feet (2 meters) from one another (2) and in implementing COVID-19-specific disinfection guidelines.* Among workers, socioeconomic challenges might contribute to working while feeling ill, particularly if there are management practices such as bonuses that incentivize attendance. Methods to decrease transmission within the facility include worker symptom screening programs, policies to discourage working while experiencing symptoms compatible with COVID-19, and social distancing by workers. Source control measures (e.g., the use of cloth face covers) as well as increased disinfection of high-touch surfaces are also important means of preventing SARS-CoV-2 exposure. Mitigation efforts to reduce transmission in the community should also be considered. Many of these measures might also reduce asymptomatic and presymptomatic transmission (3). Implementation of these public health strategies will help protect workers from COVID-19 in this industry and assist in preserving the critical meat and poultry production infrastructure (4).

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.

Laparoscopic Versus Open Resection for Rectal Cancer: A Noninferiority Meta-analysis of Quality of Surgical Resection Outcomes.

OBJECTIVE: To determine whether laparoscopic surgery is noninferior to open surgery for rectal cancer in terms of quality of surgical resection outcomes. BACKGROUND: Randomized clinical trials (RCTs) have evaluated the oncologic safety of laparoscopic versus open surgery for rectal cancer with conflicting results. Prior meta-analyses comparing these operative approaches in terms of quality of surgical resection aimed to demonstrate if one approach was superior. However, this method is not appropriate and potentially misleading when noninferiority RCTs are included. METHODS: MEDLINE, EMBASE, and Cochrane were searched to identify RCTs comparing these operative approaches. Risk differences (RDs) were pooled using random-effects meta-analyses. One-sided Z tests were used to determine noninferiority. Noninferiority margins (ΔNI) for circumferential resection margin (CRM), plane of mesorectal excision (PME), distal resection margin (DRM), and a composite outcome ("successful resection") were based on the consensus of 58 worldwide experts. RESULTS: Fourteen RCTs were included. Laparoscopic resection was noninferior compared with open resection for the rate of positive CRM [RD 0.79%, 90% confidence interval (CI) -0.46 to 2.04, ΔNI = 2.33%, PNI = 0.026], incomplete PME (RD 1.16%, 90% CI -0.27 to 2.59, ΔNI = 2.85%, PNI = 0.025), and positive DRM (RD 0.15%, 90% CI -0.58 to 0.87, ΔNI = 1.28%, PNI = 0.005). For the rate of "successful resection" (RD 6.16%, 90% CI 2.30-10.02), the comparison was inconclusive when using the ΔNI generated by experts (ΔNI = 2.71%, PNI = 0.07), although no consensus was achieved for this ΔNI. CONCLUSIONS: Laparoscopy was noninferior to open surgery for rectal cancer in terms of individual quality of surgical resection outcomes. These findings are concordant with RCTs demonstrating noninferiority for long-term oncologic outcomes between the 2 approaches.

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.

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.

A review of factors affecting patient fertility preservation discussions & decision-making from the perspectives of patients and providers.

Women undergoing cancer treatments and their healthcare providers encounter challenges in fertility preservation (FP) discussions and decision-making. A systematic review of qualitative research was conducted to gain in-depth understanding of factors influencing FP discussions and decision-making. Major bibliographic databases and grey literature in English from 1994 to 2016 were searched for qualitative research exploring patient/provider perspectives on barriers and facilitators to FP decision-making. Two researchers screened article titles, abstracts and full-texts. Verbatim data on research questions, study methodology, participants, findings and discussions of findings were extracted. Quality assessment and thematic analysis were conducted. The search yielded 74 studies dating from 2007 onwards; 29 met the inclusion criteria. Analysis revealed three types of barriers: (a) FP knowledge, skills and information deficits contributed to discomfort for providers and discontent for patients; (b) psychosocial factors and clinical issues influenced providers' practices around FP discussions and patients' decision-making; and (c) material, social and structural factors (e.g., lack of resources and accessibility) posed challenges to FP discussions. Potential facilitators to FP discussions and decision-making were also identified. A discussion of ways to improve physician's knowledge and facilitate women's decision-making and access to FP is presented, along with areas for policy development and further research.

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.

Patient and Physician Preferences for Nonoperative Management for Low Rectal Cancer: Is It a Reasonable Treatment Option?

BACKGROUND: Although the body of evidence supporting nonoperative management for rectal cancer has been accumulating, there has been little systematic investigation to explore how physicians and patients value the tradeoffs between oncologic and functional outcomes after abdominal perineal resection and nonoperative management. OBJECTIVE: The purpose of this study was to elicit patient and physician preferences for nonoperative management relative to abdominal perineal resection in the setting of low rectal cancer. DESIGN: We conducted a standardized interviews of patients and a cross-sectional survey of physicians. SETTINGS: Patients from 1 tertiary care center and physicians from across Canada were included. PATIENTS: The study involved 50 patients who were previously treated for rectal cancer and 363 physicians who treat rectal cancer. INTERVENTIONS: Interventions included standardized interviews using the threshold technique with patients and surveys mailed to physicians. MAIN OUTCOMES MEASURES: We measured absolute increase risk in local regrowth and absolute decrease in overall survival that patients and physicians would accept with nonoperative management relative to abdominal perineal resection. RESULTS: Patients were willing to accept a 20% absolute increase for local regrowth (ie, from 0% to 20%) and a 20% absolute decrease in overall survival (ie, from 80% to 60%) with nonoperative management relative to abdominal perineal resection, whereas physicians were willing to accept a 5% absolute increase for local regrowth (ie, from 0% to 5%) and a 5% absolute decrease in overall survival (ie, from 80% to 75%) with nonoperative management relative to abdominal perineal resection. LIMITATIONS: Data were subject to response bias and generalizable to only a select group of patients with low rectal cancer. CONCLUSIONS: Offering nonoperative management as an option to patients, even if oncologic outcomes are not equivalent, may be more consistent with the values of patients in this setting. See Video Abstract at http://links.lww.com/DCR/A688.