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.

Three-stage versus modified two-stage surgery for ulcerative colitis: a patient-centred treatment trade-off study.

AIM: There is ongoing debate about whether ileal pouch-anal anastomosis needs temporary diversion at the time of construction. Stomas may reduce risk for anastomotic leak (AL) but are also associated with complications, emergency department visits and readmissions. This treatment trade-off study aims to measure patients' preferences by assessing the absolute risk of AL and pouch failure (PF) they are willing to accept to avoid a diverting ileostomy. METHODS: Fifty-two patients with ulcerative colitis, with or without previous pouch surgery, from Mount Sinai Hospital, Toronto, participated in this study. Standardized interviews were conducted using the treatment trade-off threshold technique. An online anonymous survey was used to collect patient demographics. We measured the absolute increased risk in AL and PF that patients would accept to undergo modified two-stage surgery as opposed to traditional three-stage surgery. RESULTS: Thirty-two patients (mean age 38.7 ± 15.3) with previous surgery and 20 patients (mean age 39.5 ± 11.9) with no previous surgery participated. Patients were willing to accept an absolute increased leak rate of 5% (interquartile range 4.5%-15%) to avoid a diverting ileostomy. Similarly, patients were willing to accept an absolute increased PF rate of 5% (interquartile range 2.5%-10%). Younger patients, aged 21-29, had lower tolerance for PF, accepting an absolute increase of only 2% versus 5% for patients older than 30 (P = 0.01). CONCLUSION: Patients were willing to accept a 5% increased AL rate or PF rate to avoid a temporary diverting ileostomy. This should be taken into consideration when deciding between modified two- and three-stage pouch procedures.

Routine diversion following delayed IPAA construction does not reduce the incidence of pouch-related sepsis or failure in patients with ulcerative colitis.

AIM: The aim of this study was to compare modified 2-stage and 3-stage IPAA construction techniques to evaluate the effect of diverting loop ileostomy following completion proctectomy and IPAA for ulcerative colitis. In addition, our overall institutional experience was reviewed to describe long-term outcomes and changes in staging trends over time. METHODS: Our institutional database was searched to identify all cases of IPAA for ulcerative colitis between 1981 and 2018. Patient, pouch and outcome characteristics were abstracted. Primary study outcomes were the incidence of primary pouch failure and pouch-related sepsis. Failure was evaluated by Kaplan-Meier estimates of survival over time. The adjusted effect of pouch stage was evaluated using multivariable Cox and logistic regression models. Exploratory analysis evaluated the effect of stage on failure in the pouch related sepsis subgroup. RESULTS: A total of 2105 patients underwent primary IPAA over the study period. The 5, 10 and 20-year pouch survival probabilities were 95.2%, 92.7% and 86.6%. The incidence of pouch related sepsis was 12.3%. Adjusted analysis demonstrated no difference in pouch failure (HR = 0.64: 95% 0.39-1.07, p = 0.09) or post-operative sepsis (aOR = 0.79: 95% CI 0.53-1.17, p = 0.24) by stage of construction. Among patients experiencing pouch sepsis, there was no difference in Kaplan-Meier estimates of pouch survival by stage (p = 0.90). CONCLUSIONS: Pouch related sepsis and IPAA failure did not differ between modified 2-stage and 3-stage construction techniques. Among the sub-group of patients experiencing pouch related sepsis, there was no difference in failure between groups. The results suggest diverting ileostomy may be safely avoided following delayed pouch reconstruction in appropriately selected patients.

Is extended venous thromboprophylaxis required in patients undergoing ileal pouch procedure for ulcerative colitis?

AIM: Venous thromboembolic events (VTEs) are relatively common adverse surgical complications. Extended VTE prophylaxis for 4 weeks is recommended after colorectal cancer surgery, but its use in inflammatory bowel disease surgery lacks high-quality evidence. This retrospective study aimed to assess and characterize VTEs within the first 30 days after ileal pouch-anal anastomosis (IPAA) procedures and subtotal colectomies (STCs) for ulcerative colitis (UC). METHODS: All patients who underwent IPAA for UC between 1 January 2017 and 31 December 2021 were included. VTE rates after IPAA, in-hospital or at-home occurrences, utilization of in-hospital thromboprophylaxis, and prescribed anticoagulant treatment were evaluated. Retrospectively, the same variables were analysed if patients of the cohort underwent STC before the IPAA construction. RESULTS: In all, 204 patients underwent IPAA (61.8% men, 73% laparoscopic), with an average hospital stay of 6.8 days. Among them, 116 patients underwent STC prior to IPAA. Thirteen patients (6.3%) experienced VTEs after IPAA, with 76.9% (10/13) of cases occurring during hospitalization and under adequate thromboprophylaxis. The VTE rate after STC was 10.3% (12/116), with 58.2% (7/12) occurring in hospital and under appropriate thromboprophylaxis. No reoperations or mortality were attributed to thrombotic events. The type and duration of anticoagulant treatment varied considerably. CONCLUSION: The VTE rate after IPAA for UC was 6.3%, with the majority of events occurring in hospital and under adequate thromboprophylaxis. These findings suggest that routine use of extended VTE prophylaxis in our cohort may not be supported. Further research is needed to clarify the optimal VTE prophylaxis strategy for inflammatory bowel disease surgery.

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.

Transabdominal IPAA Revision: Does Indication Dictate Outcome?

BACKGROUND: Following IPAA failure, select patients are eligible for IPAA revision. Presently, there is limited evidence describing long-term revision outcomes and predictors of revision failure. This represents an important knowledge gap when selecting and counseling patients. OBJECTIVE: This study aimed to define long-term IPAA survival outcomes after transabdominal IPAA revision and identify preoperative clinical factors associated with revision failure. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted at a tertiary referral center. PATIENTS: This study included all patients who underwent revisional IPAA surgery between 1982 and 2017 for pouch failure. INTERVENTION: Transabdominal IPAA revision was included. MAIN OUTCOME MEASURES: The primary outcome was pouch failure, defined as pouch excision or permanent pouch diversion, after IPAA revision. RESULTS: A total of 159 patients (64.2% women) were included with a median age of 36 years (interquartile range, 28.5-46.5) at revision. Eighty percent of patients had a primary diagnosis of ulcerative colitis. The most common indication for revision was leak/pelvic sepsis, representing 41% of the cohort, followed by pouch-vaginal fistula (22.2%), mechanical factors (20.4%), and poor pouch function (14.6%). During the study period, 56 patients (35.2%) experienced pouch failure. The 3-year pouch survival probability was 82.3% (95% CI, 75.5%-87.5%), 5-year pouch survival probability was 77.2% (95% CI, 69.8%-83.0%), and 10-year pouch survival probability was 70.6% (95% CI, 62.6%-77.2%). Compared to mechanical factors, pouch failure was significantly associated with pelvic sepsis (HR, 4.25; 95% CI, 1.50-12.0) and pouch-vaginal fistula (HR, 4.37; 95% CI, 1.47-12.99). No significant association was found between revision failure and previous revision, redo ileoanal anastomosis, or new pouch construction. LIMITATIONS: This study is limited by its retrospective design. CONCLUSIONS: Revisional IPAA can be undertaken with favorable long-term outcomes at high-volume centers. Consideration should be given to indication for revision when counseling patients regarding the risk of failure. Further research on risk stratifying patients before revision is required. See Video Abstract at http://links.lww.com/DCR/B966 . REVISIN DE LA ANASTOMOSIS ANAL DE LA BOLSA ILEAL TRANSABDOMINAL LA INDICACIN DICTA EL RESULTADO: ANTECEDENTES:Después de la falla en la anastomosis del reservorio ileoanal, los pacientes seleccionados son elegibles para la revisión de la anastomosis del reservorio ileoanal. Actualmente, hay evidencias limitadas que describen los resultados de la revisión a largo plazo y los predictores del fracaso de la revisión. Esto representa un importante vacío de investigación a la hora de seleccionar y asesorar a los pacientes.OBJETIVO:Definir los resultados de supervivencia a largo plazo de la IPAA después de la revisión de la anastomosis del reservorio ileoanal transabdominal e identificar los factores clínicos preoperatorios asociados con el fracaso de la revisión.DISEÑO:Este fue un estudio de cohorte retrospectivo.ENTORNO CLINICO:Este estudio se realizó en un centro de referencia terciario.PARTICIPANTES:Todos los pacientes que se sometieron a una cirugía de revisión de la anastomosis ileoanal del reservorio entre 1982 y 2017, por falla del reservorio.INTERVENCIÓN:Revisión de la anastomosis de reservorio ileoanal transabdominal.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario es el fracaso del reservorio, definido como escisión del reservorio o derivación permanente del reservorio, después de la revisión de la anastomosis del reservorio ileoanal.RESULTADOS:Se incluyeron un total de 159 pacientes (64,2% mujeres) con una mediana de edad a la revisión de 36 años (RIC: 28,5-46,5). El ochenta por ciento tenía un diagnóstico primario de colitis ulcerosa. La indicación más común para la revisión fue la fuga/sepsis pélvica, que representó el 41 % de la cohorte, seguida de la fístula vaginal del reservorio (22,2 %), factores mecánicos (20,4 %) y mala función del reservorio 14,6 %. Durante el período de estudio, 56 pacientes (35,2 %) experimentaron fallas en la bolsa. Las probabilidades de supervivencia de la bolsa a los 3, 5 y 10 años fueron del 82,3% (IC del 95%: 75,5%-87,5%), del 77,2% (IC del 95%: 69,8%-83,0%) y del 70,6% (IC del 95%: 62,6%- 77,2%), respectivamente. En comparación con los factores mecánicos, la falla de la bolsa se asoció significativamente con sepsis pélvica (HR = 4,25, IC del 95 %: 1,50 a 12,0) y fístula vaginal de la bolsa (HR = 4,37, IC del 95 %: 1,47 a 12,99). No hubo una asociación significativa entre el fracaso de la revisión y la revisión previa, el rehacer la anastomosis ileoanal o la construcción de una nueva bolsa.LIMITACIONES:El estudio está limitado por su diseño retrospectivo.CONCLUSIONES:La revisión de la anastomosis del reservorio ileoanal se puede realizar con resultados favorables a largo plazo en centros de alto volumen. Se debe considerar la indicación de revisión al asesorar a los pacientes sobre el riesgo de fracaso. Se requiere investigación adicional sobre la estratificación del riesgo de los pacientes antes de la revisión. Consulte Video Resumen en http://links.lww.com/DCR/B966 . (Traducción - Dr. Fidel Ruiz Healy ).

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.

Indications and Surgical Technique for Transanal Proctectomy and Ileal Pouch-Anal Anastomosis for Inflammatory Bowel Disease.

Surgical management of inflammatory bowel disease has advanced significantly over the years. One particular focus of its evolution has been to minimize invasiveness. Transanal surgery has given the contemporary surgeon an alternate approach to access the low rectum situated in the confines of the deep pelvis. In benign disease, combining transanal surgery with laparoscopy has allowed for the development of novel techniques to create ileal pouch-anal anastomoses, perform intersphincteric Crohn's proctectomies, manage complications from pelvic surgery, and facilitate redo pelvic surgery. We aim to review the indications for transanal surgery in benign disease, describe an approach to transanal pouch surgery in detail, and discuss the potential benefits, pitfalls, and contentious issues surrounding this approach.

Patients Undergoing Ileoanal Pouch Surgery Experience a Constellation of Symptoms and Consequences Representing a Unique Syndrome: A Report from the Patient-Reported Outcomes After Pouch Surgery (PROPS) Delphi Consensus Study.

BACKGROUND: Functional outcomes after ileoanal pouch creation have been studied; however, there is great variability in how relevant outcomes are defined and reported. More importantly, the perspective of patients has not been represented in deciding which outcomes should be the focus of research. OBJECTIVE: The primary aim was to create a patient-centered definition of core symptoms that should be included in future studies of pouch function. DESIGN: This was a Delphi consensus study. SETTING: Three rounds of surveys were used to select high-priority items. Survey voting was followed by a series of online patient consultation meetings used to clarify voting trends. A final online consensus meeting with representation from all 3 expert panels was held to finalize a consensus statement. PATIENTS: Expert stakeholders were chosen to correlate with the clinical scenario of the multidisciplinary team that cares for pouch patients, including patients, colorectal surgeons, and gastroenterologists or other clinicians. MAIN OUTCOME MEASURES: A consensus statement was the main outcome. RESULTS: patients, 62 colorectal surgeons, and 48 gastroenterologists or nurse specialists completed all 3 Delphi rounds. Fifty-three patients participated in online focus groups. One hundred sixty-one stakeholders participated in the final consensus meeting. On conclusion of the consensus meeting, 7 bowel symptoms and 7 consequences of undergoing ileoanal pouch surgery were included in the final consensus statement. LIMITATIONS: The study was limited by online recruitment bias. CONCLUSIONS: This study is the first to identify key functional outcomes after pouch surgery with direct input from a large panel of ileoanal pouch patients. The inclusion of patients in all stages of the consensus process allowed for a true patient-centered approach in defining the core domains that should be focused on in future studies of pouch function. See Video Abstract at http://links.lww.com/DCR/B571. LOS PACIENTES SOMETIDOS A CIRUGA DE RESERVORIO ILEOANAL EXPERIMENTAN UNA CONSTELACIN DE SNTOMAS Y CONSECUENCIAS QUE REPRESENTAN UN SNDROME UNICO: Un Informe de los Resultados Reportados por los Pacientes Posterior a la Cirugía de Reservorio (PROPS) Estudio de Consenso DelphiANTECEDENTES:Los resultados funcionales después de la creación del reservorio ileoanal han sido estudiados; sin embargo, existe una gran variabilidad en la forma en que se definen y reportan los resultados relevantes. Más importante aún, la perspectiva de los pacientes no se ha representado a la hora de decidir qué resultados deberían ser el foco de investigación.OBJETIVO:El objetivo principal era crear en el paciente una definición centrada de los síntomas principales que debería incluirse en los estudios futuros de la función del reservorio.DISEÑO:Estudio de consenso Delphi.ENTORNO CLINICO:Se emplearon tres rondas de encuestas para seleccionar elementos de alta prioridad. La votación de la encuesta fue seguida por una serie de reuniones de consulta de pacientes en línea que se utilizan para aclarar las tendencias de votación. Se realizo una reunión de consenso final en línea con representación de los tres paneles de expertos para finalizar una declaración de consenso.PACIENTES:Se eligieron partes interesadas expertas para correlacionar con el escenario clínico del equipo multidisciplinario que atiende a los pacientes con reservorio: pacientes, cirujanos colorrectales, gastroenterólogos / otros médicos.PRINCIPALES MEDIDAS DE VALORACION:Declaración de consenso.RESULTADOS:Ciento noventa y cinco pacientes, 62 cirujanos colorrectales y 48 gastroenterólogos / enfermeras especialistas completaron las tres rondas Delphi. 53 pacientes participaron en grupos focales en línea. 161 interesados participaron en la reunión de consenso final. Al concluir la reunión de consenso, siete síntomas intestinales y siete consecuencias de someterse a una cirugía de reservorio ileoanal se incluyeron en la declaración de consenso final.LIMITACIONES:Sesgo de reclutamiento en línea.CONCLUSIONES:Este estudio es el primero en identificar resultados funcionales claves después de la cirugía de reservorio con información directa de un gran panel de pacientes con reservorio ileoanal. La inclusión de pacientes en todas las etapas del proceso de consenso permitió un verdadero enfoque centrado en el paciente para definir los dominios principales en los que debería centrarse los estudios futuros de la función del reservorio. Consulte Video Resumen en http://links.lww.com/DCR/B571.

Low-dose amikacin in the treatment of Multidrug-resistant Tuberculosis (MDR-TB).

BACKGROUND: The World Health Organization recommends intravenous amikacin for the treatment of MDR-TB at a dose of 15 mg/kg. However, higher doses are associated with significant toxicity. METHODS: Patients with MDR-TB treated at our institution receive amikacin at 8-10 mg/kg, with dose adjustment based on therapeutic drug monitoring. We conducted a retrospective cohort study of patients with MDR-TB who received amikacin between 2010 and 2016. RESULTS: Forty-nine patients were included in the study. The median starting dose of amikacin was 8.9 mg/kg (IQR 8, 10), and target therapeutic drug levels were achieved at a median of 12 days (IQR 5, 26). The median duration of amikacin treatment was 7.2 months (IQR 5.7, 8), and median time to sputum culture conversion was 1 month (IQR 1,2). Six patients (12.2%) experienced hearing loss based on formal audiometry testing (95% CI 4.6-24.8%); 22.2% had subjective hearing loss (95% CI 11.2-37.1%) and 31.9% subjective tinnitus (95% CI 19.1-47.1%). Ten patients (23%) had a significant rise in serum creatinine (95% CI 11.8-38.6%), but only 5 patients had a GFR < 60 at treatment completion. 84% of patients had a successful treatment outcome (95% CI 84-99%). CONCLUSIONS: Low dose amikacin is associated with relatively low rates of aminoglycoside-related adverse events. We hypothesize that low-dose amikacin can be used as a safe and effective treatment for MDR-TB in situations where an adequate regimen cannot be constructed with Group A and B drugs, and where careful monitoring for adverse events is feasible.

Colonic disease recurrence following proctectomy with end colostomy for anorectal Crohn's disease.

AIM: In patients with anorectal Crohn's disease, it remains uncertain whether a total proctocolectomy with end ileostomy or proctectomy with end colostomy should be recommended due to the unknown rate of disease recurrence in the remaining colon. METHODS: A retrospective review of all patients with a known diagnosis of Crohn's disease who underwent a proctectomy with end colostomy for distal Crohn's disease between January 1, 2010 and January 1, 2019 at two IBD referral centres was conducted. Data collected included patient demographics, surgical variables at the time of proctectomy, and postoperative clinical, endoscopic and surgical recurrence rates. RESULTS: A total of 63 patients were included; mean age was 47 years (SD 15 years) and 32 (50.8%) were female. The majority of patients underwent a proctectomy with end colostomy (n = 56; 88.9%) while the remaining seven patients (11.1%) underwent a proctectomy with end colostomy and concurrent ileocectomy. A total of 55 patients (87.3%) had proctitis, 51 (81%) had perianal fistulating disease, and 34 (54%) had anal canal stenosis or ulceration. Most patients had medically refractory disease (n = 54; 85.7%) versus neoplasia (n = 9; 14.3%). The median length of long-term follow-up was 17.7 months (IQR: 4.72, 38.7 months). During that time, 14 (22.2%) experienced clinical recurrence, 10 of 34 evaluated (29.4%) had endoscopic recurrence, and 3 (4.76%) required a completion total abdominal colectomy for recurrent medically refractory disease in the colon. CONCLUSION: Colonic recurrence remains low following proctectomy and descending colostomy suggesting this operative management strategy is reasonable in Crohn's patients with distal disease.

An Optimal Diagnostic Strategy for Tuberculosis in Hospitalized HIV-Infected Patients Using GeneXpert MTB/RIF and Alere Determine TB LAM Ag.

The diagnosis of tuberculosis (TB) in HIV-infected patients is challenging. Both a urinary lipoarabinomannan (LAM) test (Alere TB LAM) and GeneXpert-MTB/RIF (Xpert) are useful for the diagnosis of TB. However, how to optimally integrate Xpert and LAM tests into clinical practice algorithms remain unclear. We performed a post hoc analysis of 561 HIV-infected sputum-expectorating patients (median CD4 count of 130 cells/ml) from a previously published randomized controlled trial evaluating the LAM test in hospitalized HIV-infected patients with suspected TB. We evaluated 5 different diagnostic strategies using sputum culture as a reference standard (Xpert alone, LAM alone, sequential Xpert followed by LAM and vice versa [LAM in Xpert-negative patients and Xpert in LAM-negative patients], and both tests concurrently [LAM + Xpert]). A cost-consequence analysis was performed. Strategy-specific sensitivity and specificity, using culture as a reference, were similar with the Xpert-only and sequential and concurrent strategies. However, when any positive TB-specific test was used as a reference, the incremental yield of LAM over Xpert was 29.6% (45/152) and that of Xpert over LAM was 75% (84/11). The incremental yield of LAM increased with decreasing CD4 count. The costs per TB case diagnosed were similar for the sequential and concurrent strategies ($1,617 to $1,626). In sputum-expectorating hospitalized patients with advanced HIV and access to both tests, concurrent testing with Xpert and LAM may be the best strategy for diagnosing TB. These data inform clinical practice in settings where TB and HIV are endemic.

Ileorectal Anastomosis Versus IPAA for the Surgical Treatment of Ulcerative Colitis: A Markov Decision Analysis.

BACKGROUND: Ileorectal anastomosis in patients with ulcerative colitis results in decreased postoperative morbidity and better functional outcome but leads to increased risk for rectal cancer compared with IPAA. OBJECTIVE: This study aims to compare ileorectal anastomosis with IPAA in ulcerative colitis by using a decision model. DESIGN: A Markov simulation model was designed to simulate clinical events of ileorectal anastomosis and IPAA over a time horizon of 40 years with time cycles of 1 year. All probabilities and utilities were derived from observational studies, identified after a systematic literature search using MEDLINE. Primary outcomes were life-years and quality-adjusted life-years. Deterministic and probabilistic sensitivity analyses were performed. SETTINGS: A decision model using Markov simulation was designed. PATIENTS: The base case was a 35-year-old patient with ulcerative colitis and a relatively preserved rectum. MAIN OUTCOMES MEASURES: The primary outcome measures were (quality-adjusted) life-years. RESULTS: The model resulted in lower life-years (36.22 vs 37.02) and higher quality-adjusted life-years (33.42 vs 31.57) for ileorectal anastomosis. This was confirmed after probabilistic sensitivity analysis. The model was sensitive to the utility of ileorectal anastomosis, IPAA, and end-ileostomy. A higher proportion of patients with ileorectal anastomosis will develop rectal cancer (7.6% vs 3.2%) and 43.5% of all patients with ileorectal anastomosis will end with an ileostomy as opposed to 23.0% of all patients with IPAA. LIMITATIONS: The study was limited by characteristics inherent to modeling studies, including assumptions necessary to build the model, data input based on best available but often limited evidence, and unavoidable extra- and interpolation of data. CONCLUSIONS: Ileorectal anastomosis was the preferred treatment option when quality-adjusted life-years were the outcome, with higher life-years for IPAA. This model highlights that both surgical strategies are useful in patients who have ulcerative colitis with a relatively spared rectum. See Video Abstract at http://links.lww.com/DCR/B249. ANASTOMOSIS ILEORRECTAL VERSUS ANASTOMOSIS ANAL CON RESERVORIO ILEAL EN EL TRATAMIENTO QUIRÚRGICO DE LA COLITIS ULCEROSA: ANÁLISIS DE DECISIÓN DE MARKOV: Las anastomosis ileorrectales en pacientes con colitis ulcerosa se encuentran asociadas con la disminución de la morbilidad postoperatoria y un mejor resultado funcional, pero conducen a un mayor riesgo de cáncer de recto cuando se las compara con casos de confección de un reservorio íleo-anal.Comparar las anastomosis ileorrectales con la anastomosis de un reservorio íleo-anal en casos de colitis ulcerosa, utilizando un modelo de procesos de decisión.Se diseñó un modelo de proceso de Markov para simular eventos clínicos en casos de anastomosis ileorrectales y anastomosis de reservorios íleo-anales en un horizonte temporal de 40 años comprendiendo ciclos temporales de 1 año. Todas las probabilidades y utilidades se derivaron de estudios observacionales, identificados después de una búsqueda sistemática de literatura usando MEDLINE. Los resultados primarios fueron años de vida y los años ajustados a la calidad de vida. Se realizaron los análisis de sensibilidad determinada y de probabilística.Se diseñó un modelo de decisión utilizando el proceso de simulación de Markov.El caso base fue el de un paciente de 35 años con colitis ulcerosa y con un recto relativamente sano.El resultado principal fué la medida de los años de vida (con ajuste en la calidad de vida).El modelo resultó en menos años de vida (36.22 frente a 37.02) y años de vida de menor calidad (33.42 frente a 31.57) para los casos de anastomosis ileorrectales. Esto se confirmó después del análisis de sensibilidad probabilística. El modelo era sensible a la utilidad de la anastomosis ileorrectal, la anastomosis del reservorio íleo-anal y la ileostomía terminal. Una mayor proporción de pacientes con anastomosis ileorectales desarrollarán cáncer de recto (7,6% frente a 3,2%) y el 43,5% de todos los pacientes con anastomosis ileorrectales terminarán con una ileostomía en comparación con el 23,0% de todos los pacientes con un reservorio íleo-anal.El analisis estuvo limitado por las características inherentes a los estudios de modelado, incluidas las suposiciones necesarias para construir el modelo, la entrada de datos basada en la mejor evidencia disponible pero a menudo limitada y la extrapolación e interpolación inevitable de datos.Las anastomosis ileorrectales fueron la opción de tratamiento preferida cuando el resultado fue ajustado en años con calidad de vida, con años de vida más larga para la anastomosis de reservorios íleo-anales. Este modelo destaca que ambas estrategias quirúrgicas son útiles en pacientes con colitis ulcerosa con rectos relativamente sanos. Consulte Video Resumen en http://links.lww.com/DCR/B249.

Association Between Preoperative Oral Antibiotics and the Incidence of Postoperative Clostridium difficile Infection in Adults Undergoing Elective Colorectal Resection: A Systematic Review and Meta-analysis.

BACKGROUND: The risk of postoperative Clostridium difficile infection in patients receiving preoperative oral antibiotics remains controversial and a potential barrier for implementation. OBJECTIVE: The purpose of this study was to determine the association between preoperative oral antibiotics and the incidence of postoperative C difficile infection in patients undergoing colorectal surgery. DATA SOURCES: Medline, PubMed (not Medline), Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science were searched for articles published up to September 2018. STUDY SELECTION: Randomized controlled trials and observational studies that compared bowel preparation regimens in adult patients who underwent colorectal surgery were selected. MAIN OUTCOME MEASURE: The incidence of postoperative C difficile infection in adults receiving oral antibiotics versus no oral antibiotics was used as the primary outcome. ORs were pooled using generalized linear/mixed effects models. RESULTS: Fourteen randomized controlled trials and 13 cohort studies comparing bowel preparation with oral antibiotics to those without oral antibiotics were identified. The pooled OR from 4 eligible randomized controlled trials was suggestive of a greater odds of C difficile infection in the oral antibiotic group (OR = 4.46 (95% CI, 0.96-20.66)); however, the absolute incidence of C difficile infection was extremely low (total 11 events among 2753 patients). The pooled OR from 6 eligible cohort studies did not demonstrate a significant difference in the odds of C difficile infection (OR = 0.88 (95% CI, 0.51-1.52)); again, a very low absolute incidence of C difficile infection was identified (total 830 events among 59,960 patients). LIMITATIONS: This meta-analysis was limited by the low incidence of C difficile infection reported in the studies and the low number of randomized controlled trials included. CONCLUSIONS: The incidence of C difficile infection in patients who undergo colorectal surgery is very low, regardless of bowel preparation regimen used. Considering the beneficial role of oral antibiotics in reducing surgical site infection, the fear for C difficile infection is not sufficient to omit oral antibiotics in this setting. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO - IDCRD42018092148.

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.

Does intra-operative margin assessment improve margin status and re-excision rates? A population-based analysis of outcomes in breast-conserving surgery for ductal carcinoma in situ.

BACKGROUND AND OBJECTIVES: Using a 2 mm margin criteria, we evaluated the effect of intra-operative margin assessment on margin status and re-excisions following breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). METHODS: We identified patients undergoing BCS for DCIS from a prospective, population-based database. Multivariable logistic regression was used to determine the effect of specimen mammography, ultrasound and macroscopic assessment by a pathologist on margins and re-excision rates. RESULTS: In 588 patients, 52% (95% confidence interval [CI], 48%-56%) had positive margins (<2 mm), 39% (95% CI, 35%-43%) had a re-excision and 15% (95% CI, 12%-18%) had completion mastectomy. There were few re-excisions for margins ≥2 mm (2%). Adjusting for confounders, any margin assessment versus wire localization alone did not reduce positive margins (odds ratio [OR], 0.75; P = 0.202) or re-excisions (OR, 1.14; P = 0.564), however both outcomes varied by type of technique ( P < 0.001). Individually, only macroscopic assessment by pathologist reduced positive margins (OR, 0.54; P = 0.002) and re-excisions (OR, 0.61; P = 0.036). CONCLUSIONS: Despite adherence to a 2 mm margin criteria, re-excision rates remain high following BCS for DCIS, with 39% converted to mastectomy when re-excision is required. Intra-operative margin assessment does not appear to reduce re-excisions; in particular, surgeons should be aware of the limitations of specimen mammography for margin assessment in DCIS.

Diagnosing tuberculosis in hospitalized HIV-infected individuals who cannot produce sputum: is urine lipoarabinomannan testing the answer?

BACKGROUND: Up to one third of HIV-infected individuals with suspected TB are sputum-scarce. The Alere Determine™ TB LAM Ag lateral flow strip test can be used to diagnose TB in HIV-infected patients with advanced immunosuppression. However, how urine LAM testing should be incorporated into testing algorithms and in the context of specific patient sub-groups remains unclear. METHODS: This study represents a post hoc sub-group analysis of data from a randomized multi-center parent study. The study population consisted of hospitalized HIV-infected patients with suspected TB who were unable to produce sputum and who underwent urine LAM testing. The diagnostic utility of urine LAM for TB in this group was compared to the performance of urine LAM in patients who did produce a sputum sample in the parent study. RESULTS: There were a total of 187 and 2341 patients in the sputum-scarce and sputum-producing cohorts, respectively. 80 of the sputum-scarce patients underwent testing with urine LAM. In comparison to those who did produce sputum, sputum-scarce patients had a younger age, a lower Karnofsky performance score, and a lower weight and BMI at admission. A greater proportion of sputum-scarce patients were urine LAM positive, compared to those who were able to produce sputum (31% vs. 21%, p = 0.04). A higher proportion of sputum-scarce patients died within 8 weeks of admission (32% vs. 24%, p = 0.013). We inferred that 19% of HIV-infected sputum-scarce patients suspected of TB were diagnosed with tuberculosis by urine LAM testing, with an estimated positive predictive value of 63% (95% CI 43-82%). CONCLUSIONS: Urine LAM testing can effectively identify tuberculosis in HIV-infected patients who are at a higher risk of mortality yet are unable to generate a sputum sample for diagnostic testing. Our findings support the use of urine LAM testing in sputum-scarce hospitalized HIV-infected patients, and its incorporation into diagnostic algorithms for this patient population.

Intraoperative Margin Assessment in Wire-Localized Breast-Conserving Surgery for Invasive Cancer: A Population-Level Comparison of Techniques.

BACKGROUND: Various intraoperative margin assessment techniques have been shown to improve margin status in breast-conserving surgery (BCS) for cancer. Our study sought to evaluate multiple margin assessment techniques on a population level and determine their effects on margin status. METHODS: Patients undergoing wire-localized BCS for invasive cancer in Alberta, Canada, were assessed using a prospectively entered database of patient and tumor characteristics. Margin status was obtained from chart review. Four margin assessment techniques were studied: specimen mammography (SM), intraoperative ultrasound (US), gross assessment by pathologist (GP), and frozen section analysis (FS). Multivariable logistic regression adjusting for confounders was used to assess effect of any technique on margin status, with secondary analysis evaluating effects of individual techniques. RESULTS: Margin assessment was performed in 1165 of 1649 patients (71 %). The overall positive margin rate was 20.8 %. Adjusting for confounders, we found no difference in the odds of a positive margin with any margin assessment technique versus wire localization alone (OR 0.79, p = 0.22, 95 % CI 0.54-1.16). Individually, both GP and FS reduced the risk of a positive margin (GP-OR 0.56, p = 0.002, 95 % CI 0.39-0.81; FS-OR 0.43, p = 0.046, 95 % CI 0.19-0.98), whereas SM and US showed no effect (SM-OR 1.23, p = 0.29, 95 % CI 0.84-1.81; US-OR 1.09, p = 0.83, 95 % CI 0.50-2.37). CONCLUSIONS: Use of any margin assessment technique did not improve margin status compared to wire localization alone. Gross assessment by pathologist and frozen section analysis improved margin status compared to imaging-alone techniques. Further exploration is required to refine optimal margin assessment methods.

Neoadjuvant Chemotherapy for Breast Cancer, Is Practice Changing? A Population-Based Review of Current Surgical Trends.

INTRODUCTION: Neoadjuvant chemotherapy in breast cancer is used to downstage locally advanced and inoperable tumors. Expanded benefits of neoadjuvant chemotherapy include downstaging of tumors to allow breast-conserving surgery (BCS) and assessment of in vivo tumor response. We sought to identify patterns and predictors of neoadjuvant chemotherapy use to determine if this has translated into population-level clinical practice. METHODS: All patients undergoing surgery for invasive breast cancer between January 2012 and June 2014 were identified from our provincial synoptic operating room database. Data regarding patient demographics, hospital, operating surgeon, preoperative tumor characteristics, neoadjuvant treatment, and type of surgery performed were collected. Descriptive statistics and multivariable analysis were used to identify predictors of neoadjuvant chemotherapy. RESULTS: A total of 4186 patients were identified, 363 (8.53%) of whom underwent neoadjuvant chemotherapy. A significant increase was seen in the use of neoadjuvant chemotherapy over time. In multivariable analysis, neoadjuvant chemotherapy was associated with prechemotherapy tumor size, multicentricity, lymph node positivity, and decreasing patient age. In addition, there was significant variability in neoadjuvant chemotherapy use between operating surgeons. Of those patients who underwent neoadjuvant chemotherapy, 68.9% were not pretreatment candidates for BCS. At the time of definitive surgery, 72.1% had mastectomy, with 18.7% opting for contralateral prophylactic mastectomy. As reported, this was due to the tumor being advanced/too large (50.4%), patient preference (12.6%), multicentricity (8.8%) and margins, genetics, and previous radiotherapy (4%). CONCLUSIONS: A significant increase in the use of neoadjuvant chemotherapy over time was identified, and treatment with mastectomy as definitive surgical management remained high. There was significant variability in neoadjuvant chemotherapy use by the operating surgeons, in addition to factors generally associated with more locally advanced/aggressive tumors.