AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders.

BACKGROUND & AIMS: Pouchitis is the most common complication after restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. This American Gastroenterological Association (AGA) guideline is intended to support practitioners in the management of pouchitis and inflammatory pouch disorders. METHODS: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, conduct an evidence synthesis, and develop recommendations for the prevention and treatment of pouchitis, Crohn's-like disease of the pouch, and cuffitis. RESULTS: The AGA guideline panel made 9 conditional recommendations. In patients with ulcerative colitis who have undergone ileal pouch-anal anastomosis and experience intermittent symptoms of pouchitis, the AGA suggests using antibiotics for the treatment of pouchitis. In patients who experience recurrent episodes of pouchitis that respond to antibiotics, the AGA suggests using probiotics for the prevention of recurrent pouchitis. In patients who experience recurrent pouchitis that responds to antibiotics but relapses shortly after stopping antibiotics (also known as "chronic antibiotic-dependent pouchitis"), the AGA suggests using chronic antibiotic therapy to prevent recurrent pouchitis; however, in patients who are intolerant to antibiotics or who are concerned about the risks of long-term antibiotic therapy, the AGA suggests using advanced immunosuppressive therapies (eg, biologics and/or oral small molecule drugs) approved for treatment of inflammatory bowel disease. In patients who experience recurrent pouchitis with inadequate response to antibiotics (also known as "chronic antibiotic-refractory pouchitis"), the AGA suggests using advanced immunosuppressive therapies; corticosteroids can also be considered in these patients. In patients who develop symptoms due to Crohn's-like disease of the pouch, the AGA suggests using corticosteroids and advanced immunosuppressive therapies. In patients who experience symptoms due to cuffitis, the AGA suggests using therapies that have been approved for the treatment of ulcerative colitis, starting with topical mesalamine or topical corticosteroids. The panel also proposed key implementation considerations for optimal management of pouchitis and Crohn's-like disease of the pouch and identified several knowledge gaps and areas for future research. CONCLUSIONS: This guideline provides a comprehensive, patient-centered approach to the management of patients with pouchitis and other inflammatory conditions of the pouch.

Sex-Based Differences in IBD Surgical Outcomes.

BACKGROUND: Although there are discrepancies in the development and progression of IBD based on biologic sex, little is known about differences in postoperative outcomes between men and women undergoing surgery for this condition. OBJECTIVE: To compare rates of anastomotic leaks, wound complications, and serious adverse events between men and women undergoing surgery for IBD. DESIGN: This was a retrospective cohort study. SETTINGS: Data were obtained from the American College of Surgeons National Surgical Quality Improvement Program IBD Collaborative database, which includes 15 high-volume IBD surgery centers. PATIENTS: All adult patients undergoing surgery for IBD were included. Participants with missing data for exposure or outcome variables were excluded. MAIN OUTCOME MEASURES: Rates of anastomotic leaks, wound complications, and serious adverse events were compared between women and men. RESULTS: A total of 3143 patients were included. There was a significant association between sex and BMI, IBD type, and preoperative medication use. Women had decreased odds of serious adverse events compared to men (OR 0.73; 95% CI, 0.55-0.96), but there was no significant association between sex and anastomotic leaks or wound complications. IBD type was found to be an effect measure modifier of the relationship between sex and serious adverse events. Among patients with ulcerative colitis, women had a 54% decrease in the odds of serious adverse events compared to men, whereas there was no significant difference between women and men with Crohn's disease. LIMITATIONS: This study was limited by capturing only 30 days of postoperative outcomes. CONCLUSIONS: Women undergoing surgery for ulcerative colitis had decreased odds of serious adverse events compared to men. Understanding sex-based differences in outcomes allows clinicians to make patient-centered decisions regarding surgical planning and perioperative management for patients with IBD. See Video Abstract . DIFERENCIAS BASADAS EN EL SEXO EN LOS RESULTADOS QUIRRGICOS DE LA ENFERMEDAD INFLAMATORIA INTESTINAL: ANTECEDENTES:Aunque existen discrepancias en el desarrollo y la progresión de la enfermedad inflamatoria intestinal según el sexo biológico, se sabe poco sobre las diferencias en los resultados postoperatorios entre hombres y mujeres sometidos a cirugía por esta afección.OBJETIVO:Nuestro objetivo fue comparar las tasas de fugas anastomóticas, complicaciones de las heridas y eventos adversos graves entre hombres y mujeres sometidos a cirugía por enfermedad inflamatoria intestinal.DISEÑO:Este fue un estudio de cohorte retrospectivo.AJUSTES:Los datos se obtuvieron de la base de datos del Programa Nacional de Mejora de la Calidad Quirúrgica del Colegio Americano de Cirujanos para la Enfermedad Inflamatoria Intestinal, que incluye 15 centros de cirugía de enfermedad inflamatoria intestinal de alto volumen.PACIENTES:Se incluyeron todos los pacientes adultos sometidos a cirugía por enfermedad inflamatoria intestinal. Se excluyeron los sujetos a los que les faltaban datos sobre exposición o variables de resultado.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon las tasas de fugas anastomóticas, complicaciones de las heridas y eventos adversos graves entre mujeres y hombres.RESULTADOS:Se incluyeron un total de 3.143 pacientes. Hubo una asociación significativa entre el sexo y el índice de masa corporal, el tipo de enfermedad inflamatoria intestinal y el uso de medicación preoperatoria. Las mujeres tuvieron menores probabilidades de sufrir eventos adversos graves en comparación con los hombres (OR = 0,73; IC del 95 %: 0,55 a 0,96), pero no hubo una relacion significativa entre el sexo y las fugas anastomóticas o las complicaciones de las heridas. Se encontró que el tipo de enfermedad inflamatoria intestinal era un modificador de la medida del efecto de la relación entre el sexo y los eventos adversos graves. Entre los pacientes con colitis ulcerosa, las mujeres tuvieron una disminución del 54 % en las probabilidades de sufrir eventos adversos graves en comparación con los hombres, mientras que no hubo diferencias significativas entre mujeres y hombres con enfermedad de Crohn.LIMITACIONES:Este estudio estuvo limitado al capturar solo 30 días de resultados posoperatorios.CONCLUSIONES:Las mujeres sometidas a cirugía por colitis ulcerosa tuvieron menores probabilidades de sufrir eventos adversos graves en comparación con los hombres. Comprender las diferencias en los resultados basadas en el sexo permite a los médicos tomar decisiones centradas en el paciente con respecto a la planificación quirúrgica y el manejo perioperatorio de los pacientes con enfermedad inflamatoria intestinal. (Traducción-Dr Yolanda Colorado).

Association of Race and Postoperative Outcomes in Patients with Inflammatory Bowel Disease.

BACKGROUND: Previous literature suggests that rates of postoperative complications following inflammatory bowel disease (IBD) surgery differ based on race. AIMS: The purpose of this study was to examine the association between race and adverse events and wound complications in patients with IBD. METHODS: This was a retrospective cohort study of the American College of Surgeons National Surgery Quality Improvement Program Inflammatory Bowel Disease Collaborative from 2017 to 2022. The data was collected from 15 high-volume IBD centers across the United States. The data was analyzed using crude and multivariable logistic regressions. RESULTS: 4284 patients were included in the study. Overall rates of adverse events and wound complications were 20.3% and 11.3%, respectively, and did not differ based on race on bivariate analysis. Rates of adverse events were 20.0% vs 24.6% vs 22.1%, p = 0.13 for white, black and other minority subjects, respectively. The adjusted odds of adverse events were higher for black subjects (1.46 [95%CI 1.0-2.1], p = 0.03) compared to white subjects. No difference in adverse events was found between other minority subjects and either black or white subjects (1.29 [0.7-2.3], p = 0.58). Race was not associated with likelihood of wound complications in the final analysis. CONCLUSIONS: We found that a subset of black patients with IBD continue to experience more adverse events compared to white patients, primarily driven by a higher need for postoperative blood transfusion. Nonetheless, known risk factors, including comorbid conditions, decreased BMI, open surgery, and emergency surgery have a stronger association with postoperative complications than race alone.

Cancer in Anal Fistulas.

Fistula-associated anal cancer in Crohn's disease (CD) can be challenging to diagnose and treat. Patients with longstanding fistulas in the setting of CD who present with a sudden change in their symptoms should undergo biopsy under anesthesia with extensive sampling, followed by staging imaging. Pelvic magnetic resonance imaging (MRI) can be helpful in identifying the extent of the disease locally. Patients often present in the later stages due to the challenges associated with diagnosing these patients. Two subtypes of this disease include squamous cell carcinoma and adenocarcinoma, and treatment depends on diagnosis. Small sample size and lack of uniform data on treatments make it difficult to say which treatment modalities are optimal, but aggressive combined therapy is likely the best approach for survival. This will include chemotherapy and radiation and often radical resection as well. Despite this, survival is poor, although more recent data suggest that outcomes are improving.

Effectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study.

BACKGROUND & AIMS: There are limited data on outcomes of biologic therapy in Hispanic patients with inflammatory bowel diseases (IBDs). We compared risk of hospitalization, surgery, and serious infections in Hispanic vs non-Hispanic patients with IBD in a multicenter, electronic health record-based cohort of biologic-treated patients. METHODS: We identified adult patients with IBD who were new users of biologic agents (tumor necrosis factor α [TNF-α] antagonists, ustekinumab, vedolizumab) from 5 academic institutions in California between 2010 and 2017. We compared the risk of all-cause hospitalization, IBD-related surgery, and serious infections in Hispanic vs non-Hispanic patients using 1:4 propensity score matching and survival analysis. RESULTS: We compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% TNF-α antagonist-treated; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% TNF-α antagonist-treated; 27% with prior biologic exposure). After propensity score matching, Hispanic patients were younger (37 ± 15 vs 40 ± 16 y; P = .02) and had a higher burden of comorbidities (Elixhauser index, >0; 37% vs 26%; P < .01), without any differences in patterns of medication use, burden of inflammation, and hospitalizations. Within 1 year of biologic initiation, Hispanic patients had higher rates of hospitalizations (31% vs 23%; adjusted hazard ratio [aHR], 1.32; 95% CI, 1.01-1.74) and IBD-related surgery (7.1% vs 4.6%; aHR, 2.00; 95% CI, 1.07-3.72), with a trend toward higher risk of serious infections (8.8% vs 4.9%; aHR, 1.74; 95% CI, 0.99-3.05). CONCLUSIONS: In a multicenter, propensity score-matched cohort of biologic-treated patients with IBD, Hispanic patients experienced higher rates of hospitalization, surgery, and serious infections. Future studies are needed to investigate the biological, social, and environmental drivers of these differences.

Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study.

BACKGROUND & AIMS: We compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn's disease (CD) in a multicenter cohort (CA-IBD). METHODS: We created an electronic health record-based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease-related surgery (effectiveness) between different biologic classes using propensity score (PS) matching. RESULTS: As compared with TNF-α antagonists (n = 1030), 2:1 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20-0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89-1.21) or surgery (HR, 1.08; 95% CI, 0.69-1.70). Compared with vedolizumab (n = 221), 1:1 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07-0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54-1.07) or surgery (HR, 1.42; 95% CI, 0.54-3.72). Compared with TNF-α antagonists (n = 442), 2:1 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84-2.78), hospitalization (HR, 1.32; 95% CI, 0.98-1.77), and surgery (HR, 0.63; 95% CI, 0.27-1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD. CONCLUSION: In a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab.

Conventional Frailty Index Does Not Predict Risk of Postoperative Complications in Patients With IBD: A Multicenter Cohort Study.

BACKGROUND: Frailty has been associated with adverse outcomes in patients with IBD. OBJECTIVE: This study aimed to evaluate the association between health deficit-defined frailty (using the 5-factor modified frailty index) and postoperative outcomes in patients with IBD. DESIGN: Prospective cohort study. SETTING: American College of Surgeons National Surgical Quality Improvement Program, Inflammatory Bowel Diseases Module. PATIENTS: The included patients had IBD and underwent major abdominal surgery between 2016 and 2019. Patients were classified as frail (modified frailty index ≥2), prefrail (modified frailty index = 1), or normal (modified frailty index = 0) based on a validated, 5-factor modified frailty index. MAIN OUTCOME MEASURES: The association was evaluated between frailty and risk of 30-day severe postoperative complications, prolonged hospital stay, and risk of readmission using multivariable logistic regression. RESULTS: Of 3172 patients with IBD who underwent major abdominal surgery (42.7 ± 16.4 y, 49.3% female, 57.7% with Crohn's disease, 43.9% on biologics), 116 (3.7%) were classified as frail and 477 as prefrail (15%). After adjustment for age, sex, race/ethnicity, smoking, BMI, type of surgery, corticosteroid use, and biologic and immunomodulator use, frailty was not associated with increased risk for severe postoperative complications (adjusted OR, 1.24; 95% CI, 0.81-1.90), mortality (adjusted OR, 1.38 [0.44-3.6]), or 30-day readmission (adjusted OR, 1.35 [0.77-2.30]). Nonelective surgery, significant weight loss, corticosteroid use, and need for ileostomy were associated with increased risk of severe postoperative complications. LIMITATIONS: Limited information regarding IBD-specific characteristics. CONCLUSIONS: In patients with IBD undergoing major abdominal surgery, frailty measured by a conventional abbreviated health deficits index is not predictive of adverse postoperative outcomes. Biologic and functional measures of frailty may better risk-stratify surgical candidacy in patients with IBDs. See Video Abstract at http://links.lww.com/DCR/C108 . EL NDICE DE FRAGILIDAD CONVENCIONAL NO PREDICE EL RIESGO DE COMPLICACIONES POSOPERATORIAS EN PACIENTES CON ENFERMEDADES INFLAMATORIAS DEL INTESTINO UN ESTUDIO DE COHORTE MULTICNTRICO: ANTECEDENTES:La fragilidad se ha asociado con resultados adversos en pacientes con enfermedades inflamatorias del intestino.OBJETIVO:Examinamos la asociación entre la fragilidad definida por déficit de salud (utilizando el índice de fragilidad modificado de 5 factores) y los resultados postoperatorios en pacientes con enfermedades inflamatorias del intestino.DISEÑO:Estudio de cohorte prospective.ESCENARIO:Programa Nacional de Mejoramiento de la Calidad Quirúrgica del Colegio Estadounidense de Cirujanos, Módulo de Enfermedades Inflamatorias del Intestino.PACIENTES:Pacientes con enfermedades inflamatorias intestinales inscritos en la cohorte que se sometieron a cirugía abdominal mayor entre 2016-19.EXPOSICIÓN:Los pacientes se clasificaron como frágiles (índice de fragilidad modificado ≥2), prefrágiles (índice de fragilidad modificado = 1) o normales (índice de fragilidad modificado = 0) según un índice de fragilidad modificado de 5 factores validado.PRINCIPALES MEDIDAS DE RESULTADO:Examinamos la asociación entre la fragilidad y el riesgo de complicaciones postoperatorias graves a los 30 días, la estancia hospitalaria prolongada y el riesgo de reingreso, mediante regresión logística multivariable.RESULTADOS:De 3172 pacientes con enfermedades inflamatorias intestinales que se sometieron a cirugía abdominal mayor (42,7 ± 16,4 años, 49,3% mujeres, 57,7% con enfermedad de Crohn, 43,9% con biológicos), 116 (3,7%) fueron clasificados como frágiles y 477 como pre- frágil (15%). Después de ajustar por edad, sexo, raza/origen étnico, tabaquismo, índice de masa corporal, tipo de cirugía, uso de corticosteroides, uso de biológicos e inmunomoduladores, la fragilidad no se asoció con un mayor riesgo de complicaciones postoperatorias graves (odds ratio ajustado, 1,24; 95 % de confianza intervalos, 0,81-1,90), mortalidad (odds ratio ajustado, 1,38 [0,44-3,6]) o reingreso a los 30 días (odds ratio ajustado, 1,35 [0,77-2,30]). La cirugía no electiva, la pérdida de peso significativa, el uso de corticosteroides y la necesidad de ileostomía se asociaron con un mayor riesgo de complicaciones posoperatorias graves.LIMITACIONES:Información limitada sobre las características específicas de la enfermedad inflamatoria intestinal.CONCLUSIONES:En pacientes con enfermedades inflamatorias del intestino sometidos a cirugía abdominal mayor, la fragilidad medida por un índice de déficit de salud abreviado convencional no es predictivo de resultados postoperatorios adversos. Las medidas biológicas y funcionales de fragilidad pueden estratificar mejor la candidatura quirúrgica en pacientes con enfermedades inflamatorias del intestino. Consulte el Video Resumen en http://links.lww.com/DCR/C108 . (Traducción-Yesenia Rojas-Khalil ).

Effect of Obesity on Risk of Hospitalization, Surgery, and Serious Infection in Biologic-Treated Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study.

INTRODUCTION: Obesity is variably associated with treatment response in biologic-treated patients with inflammatory bowel diseases (IBD). We evaluated the association between obesity and risk of hospitalization, surgery, or serious infections in patients with IBD in new users of biologic agents in a large, multicenter, electronic health record (EHR)-based cohort (CA-IBD). METHODS: We created an EHR-based cohort of adult patients with IBD who were new users of biologic agents (tumor necrosis factor [TNF-α] antagonists, ustekinumab, and vedolizumab) between January 1, 2010, and June 30, 2017, from 5 health systems in California. Patients were classified as those with normal body mass index (BMI), overweight, or obese based on the World Health Organization classification. We compared the risk of all-cause hospitalization, IBD-related surgery, or serious infections among patients with obesity vs those overweight vs those with normal BMI, using Cox proportional hazard analyses, adjusting for baseline demographic, disease, and treatment characteristics. RESULTS: Of 3,038 biologic-treated patients with IBD (69% with Crohn's disease and 76% on TNF-α antagonists), 28.2% (n = 858) were overweight, and 13.7% (n = 416) were obese. On a follow-up after biologic initiation, obesity was not associated with an increased risk of hospitalization (adjusted hazard ratio [aHR] vs normal BMI, 0.90; [95% confidence interval, 0.72-1.13]); IBD-related surgery (aHR, 0.62 [0.31-1.22]); or serious infection (aHR, 1.11 [0.73-1.71]). Similar results were observed on stratified analysis by disease phenotype (Crohn's disease vs ulcerative colitis) and index biologic therapy (TNF-α antagonists vs non-TNF-α antagonists). DISCUSSION: In a multicenter, EHR-based cohort of biologic-treated patients with IBD, obesity was not associated with hospitalization, surgery, or serious infections. Further studies examining the effect of visceral obesity on patient-reported and endoscopic outcomes are needed.

Cost Effectiveness of Watch and Wait Versus Resection in Rectal Cancer Patients with Complete Clinical Response to Neoadjuvant Chemoradiation.

BACKGROUND: Watch and wait (WW) protocols have gained increasing popularity for patients diagnosed with locally advanced rectal cancer and presumed complete clinical response after neoadjuvant chemoradiation. While studies have demonstrated comparable survival and recurrence rates between WW and radical surgery, the decision to undergo surgery has significant effects on patient quality of life. We sought to conduct a cost-effectiveness analysis comparing WW with abdominoperineal resection (APR) and low anterior resection (LAR) among patients with stage II/III rectal cancer. METHODS: In this comparative-effectiveness study, we built Markov microsimulation models to simulate disease progression, death, costs, and quality-adjusted life-years (QALYs) for WW or APR/LAR. We assessed cost effectiveness using the incremental cost-effectiveness ratio (ICER), with ICERs under $100,000/QALY considered cost effective. Probabilities of disease progression, death, and health utilities were extracted from published, peer-reviewed literature. We assessed costs from the payer perspective. RESULTS: WW dominated both LAR and APR at a willingness to pay (WTP) threshold of $100,000. Our model was most sensitive to rates of distant recurrence and regrowth after WW. Probabilistic sensitivity analysis demonstrated that WW was the dominant strategy over both APR and LAR over 100% of iterations across a range of WTP thresholds from $0-250,000. CONCLUSIONS: Our study suggests WW could reduce overall costs and increase effectiveness compared with either LAR or APR. Additional clinical research is needed to confirm the clinical efficacy and cost effectiveness of WW compared with surgery in rectal cancer.

Current trends in nonoperative management for rectal adenocarcinoma: An unequal playing field?

BACKGROUND AND OBJECTIVES: Increasing evidence suggests patient-oriented benefits of nonoperative management (NOM) for rectal cancer. However, vigilant surveillance requires excellent access to care. We sought to examine patient, socioeconomic, and facility-level factors associated with NOM over time. METHODS: Using the National Cancer Database (2006-2017), we examined patients with Stage II-III rectal adenocarcinoma, who received neoadjuvant chemoradiation and received NOM versus surgery. Factors associated with NOM were assessed using multivariable logistic regression with backward stepwise selection. RESULTS: There were 59,196 surgical and 8520 NOM patients identified. NOM use increased from 12.9% to 15.9% between 2006 and 2017. Patients who were Black (adjusted odds ratio [aOR]: 1.36, 95% confidence interval [CI]: 1.26-1.47), treated at community cancer centers (aOR: 1.22, 95% CI: 1.12-1.30), without insurance (aOR: 1.87, 95% CI: 1.68-2.09), and with less education (aOR: 1.53, 95% CI: 1.42-1.65) exhibited higher odds of NOM. Patients treated at high-volume centers (aOR: 0.79, 95% CI: 0.74-0.84) and those who traveled >25.6 miles for care (aOR: 0.59, 95% CI: 0.55-0.64) had lower odds of NOM. CONCLUSIONS: Vulnerable groups who traditionally have difficulty accessing comprehensive cancer care were more likely to receive NOM, suggesting that healthcare disparities may be driving utilization. More research is needed to understand NOM decision-making in rectal cancer treatment.