Postoperative Oral Rehydration and Regimented Follow-up Decrease Readmissions After Colorectal Surgery That Includes Ileostomies.

BACKGROUND: Ileostomies constitute 15% to 43% of readmissions after colorectal surgery, often due to dehydration and acute kidney injury. Prior institutional interventions decreased readmissions but not among patients who underwent new ileostomies. OBJECTIVE: To evaluate readmissions among patients who underwent new ileostomies after postoperative oral rehydration solution and standardized clinic visits. DESIGN: Retrospective analysis of prospective database. SETTINGS: Enhanced recovery colorectal surgery service. PATIENTS: Patients who underwent new ileostomy before and after intervention. INTERVENTIONS: Postoperative oral rehydration solution and postdischarge clinic visits with review of inputs/outputs, antimotility and appliance needs, and trained nurse reeducation 4 to 7 days after discharge, 30 days postoperatively, and every 1 to 2 weeks thereafter as needed. MAIN OUTCOME MEASURES: Readmission rate due to dehydration/acute kidney injury (primary), emergency department visits, and readmission rates overall and for specific diagnoses. Analysis used univariate and weighted techniques. RESULTS: A total of 312 patients (199 preintervention; 113 postintervention) were included, with a mean age of 59.0 years. Patients were predominantly White (94.9%) and evenly split between men and women. The most common diagnosis was diverticulitis (43.3%). The most common procedure was high anterior resection (38.8%), followed by low anterior resection (16.35%). Patient and procedure characteristics were well matched between groups. Multivariate analysis demonstrated that readmission rate due to dehydration/acute kidney injury significantly decreased between pre- and postintervention study groups (45.7% vs 16.5%, p = 0.039). Emergency department visits due to dehydration/acute kidney injury (12.0% vs 1.7%, p < 0.001) and readmissions from all causes (24.33% vs 10.6%, p = 0.005) also significantly decreased. Other complications were not significantly different between groups. Average stoma output 24 hours before (776 vs 625 mL, p = 0.005) and after (993 vs 890 mL, p = 0.025) discharge was significantly decreased in the postintervention group. LIMITATIONS: Retrospective single-center study. CONCLUSIONS: An oral rehydration solution and frequent standardized postdischarge visits led by trained nursing staff decreased readmissions and emergency department visits among patients who underwent new ileostomies after colorectal surgery. See Video Abstract . LA REHIDRATACIN ORAL POSOPERATORIA Y EL SEGUIMIENTO REGLAMENTADO REDUCEN LOS REINGRESOS EN PACIENTES DE CIRUGA COLORRECTAL CON ILEOSTOMAS: ANTECEDENTES:Las ileostomías constituyen del 15 al 43% de los reingresos después de la cirugía colorrectal, a menudo debido a la deshidratación y la lesión renal aguda. Las intervenciones institucionales previas redujeron los reingresos, pero no entre los pacientes con nuevas ileostomías.OBJETIVO:Evaluar los reingresos entre pacientes con nuevas ileostomías después del uso de solución de rehidratación oral postoperatoria y visitas clínicas estandarizadas.DISEÑO:Análisis retrospectivo de base de datos prospectiva.AJUSTES:Servicio de cirugía colorrectal de recuperación mejorada.PACIENTES:Pacientes con ileostomía nueva antes y después de la intervención.INTERVENCIÓN(ES):Solución de rehidratación oral posoperatoria y visitas clínicas posteriores al alta con revisión de entradas/salidas, antimotilidad y necesidades de aparatos, y reeducación de enfermeras capacitadas 4-7 días después del alta, 30 días después de la operación y cada 1-2 semanas después, según sea necesario.PRINCIPALES MEDIDAS DE RESULTADO:Tasa de readmisión debido a deshidratación/lesión renal aguda (primaria), tasa de urgencias y de readmisión en general y para diagnósticos específicos. El análisis utilizó técnicas univariadas y ponderadas.RESULTADOS:Se incluyeron un total de 312 pacientes (199 preintervención; 113 postintervención), con una edad media de 59,0 años. Los pacientes eran predominantemente blancos (94,9%) y se dividieron equitativamente entre hombres y mujeres. El diagnóstico más frecuente fue diverticulitis (43,3%). El procedimiento más común fue la resección anterior alta (38,8 %) seguida de la resección anterior baja (16,35 %). Las características del paciente y del procedimiento coincidieron bien entre los grupos. El análisis multivariante demostró que la tasa de reingreso debido a deshidratación/lesión renal aguda disminuyó significativamente entre los grupos de estudio antes y después de la intervención (45,7 % frente a 16,5 %, p = 0,039). Las visitas a urgencias por deshidratación/insuficiencia renal aguda (12,0 % frente a 1,7 %, p < 0,001) y los reingresos por todas las causas (24,33 % frente a 10,6 %, p = 0,005) también disminuyeron significativamente. Otras complicaciones no fueron significativamente diferentes entre los grupos. El gasto medio del estoma 24 horas antes (776 ml frente a 625 ml, p = 0,005) y después (993 ml frente a 890 ml, p = 0,025) del alta disminuyó significativamente en el grupo posterior a la intervención.LIMITACIONES:Estudio retrospectivo de centro único.CONCLUSIONES:Una solución de rehidratación oral y frecuentes visitas estandarizadas posteriores al alta dirigidas por personal de enfermería capacitado redujeron los reingresos y las visitas al servicio de urgencias entre los pacientes con nuevas ileostomías después de la cirugía colorrectal. ( Traducción-Dr. Yolanda Colorado ).

Lack of Complete Pretreatment Staging Is Associated With Omission of Neoadjuvant Therapy for Rectal Cancer: A Statewide Study.

BACKGROUND: Standardized local staging and neoadjuvant therapy are rectal cancer management quality measures supported by the Commission on Cancer and National Accreditation Program for Rectal Cancer for the management of rectal cancer. Previous studies suggested that up to 25% of patients with stage II/III rectal cancer patients do not receive neoadjuvant therapy. We hypothesized that failure to receive neoadjuvant therapy may be caused by failure to properly stage patients before surgery. OBJECTIVE: This study aimed to determine whether lack of local rectal cancer staging is associated with underutilization of neoadjuvant therapy and to determine risk factors for omission of neoadjuvant therapy. DESIGN: Retrospective cohort study. Bivariate and multivariable analyses were performed on patient, tumor, and 30-day outcome factors associated with neoadjuvant therapy and staging. SETTINGS: hospitals participated in the Michigan Surgical Quality Collaborative Colorectal Cancer Project from January 2014 to December 2019. PATIENTS: Elective, clinical stage II/III, mid-to-low rectal cancer resections. Patients with upper rectal cancer were excluded. MAIN OUTCOME MEASURES: Percentage of patients receiving neoadjuvant therapy. RESULTS: The final cohort included 350 patients with clinical stage II/III mid or low rectal cancer-80.9% of patients who had received neoadjuvant therapy and 83.2% of patients who had MRI and/or endoscopic ultrasound. A significant association was found between receiving neoadjuvant therapy and MRI/endorectal ultrasound staging ( p < 0.0001). Eighty-seven percent of patients who had MRI/endorectal ultrasound received neoadjuvant chemoradiotherapy; 49% of patients who did not have MRI/endorectal ultrasound staging received neoadjuvant chemoradiotherapy. Multivariate analysis revealed that risk factors for the omission of neoadjuvant therapy were older age and incomplete staging. LIMITATIONS: Observational study with the possibility of unmeasured confounding variables. CONCLUSIONS: Neoadjuvant therapy is underused in patients with stage II/III rectal cancer. Omission of pretreatment staging with MRI/endorectal ultrasound is associated with omission of neoadjuvant therapy. These data suggest the need for regional and national quality improvement strategies to standardize the multidisciplinary management of rectal cancer. See Video Abstract at http://links.lww.com/DCR/B923 . LA FALTA DE ESTADIFICACIN COMPLETA PREVIA AL TRATAMIENTO SE ASOCIA CON LA OMISIN DE LA TERAPIA NEOADYUVANTE PARA EL CNCER DE RECTO UN ESTUDIO ESTATAL: ANTECEDENTES: La estadificación local estandarizada y la terapia neoadyuvante son medidas de calidad de la Comisión sobre el Cáncer y el Programa Nacional de Acreditación para el Cáncer de Recto para el tratamiento del cáncer de recto. Estudios previos sugirieron que hasta el 25% de los pacientes con cáncer de recto en estadio II/III no reciben terapia neoadyuvante. Planteamos la hipótesis de que la falla en recibir la terapia neoadyuvante puede deberse a la falla en la estadificación adecuada de los pacientes antes de la cirugía.OBJETIVO: El propósito de este estudio es determinar si la falta de estadificación local del cáncer de recto está asociada con la infrautilización de la terapia neoadyuvante y determinar los factores de riesgo para la omisión de la terapia neoadyuvante.DISEÑO: Estudio de cohorte retrospectivo. Se realizaron análisis bivariados y multivariados sobre el paciente, el tumor y los factores de resultado a los 30 días asociados con la terapia neoadyuvante y la estadificación.AJUSTE: Un total de 31 hospitales que participaron en el Proyecto Quirugico Colaborativo de Cáncer Colorrectal de Calidad de Michigan desde enero de 2014 hasta diciembre de 2019.PACIENTES: Resecciones electivas, en estadio clínico II/III, de cáncer de recto medio a bajo. Se excluyeron los pacientes con cáncer de recto superior.MEDIDA DE RESULTADO PRINCIPAL: Porcentaje de pacientes que reciben terapia neoadyuvante. Porcentaje de pacientes que reciben terapia neoadyuvante.RESULTADOS: La cohorte final fue de 350 casos con cáncer de recto medio o bajo en estadio clínico II/III. El 80,9% tenía terapia neoadyuvante y el 83,2%, resonancia magnética y/o ultrasonido endoscópico. Hubo una asociación significativa entre recibir terapia neoadyuvante y la estadificación MRI/ERUS ( p < 0,0001). El 87% de los pacientes a los que se les realizaron imágenes con MRI/ERUS recibieron NT, mientras que el 49% de los pacientes a los que no se les realizó la estadificación con MRI/ERUS tuvieron NT. El análisis multivariante reveló que los factores de riesgo para la omisión de la terapia neoadyuvante fueron la edad avanzada y la estadificación incompleta.LIMITACIONES: Estudio observacional con posibilidad de confusión de variables no medidas.CONCLUSIONES: La terapia neoadyuvante está infrautilizada en pacientes con cáncer de recto en estadio II/III. La omisión de la estadificación previa al tratamiento con MRI/ERUS se asocia con la omisión de la terapia neoadyuvante. Estos datos sugieren la necesidad de estrategias regionales y nacionales de mejora de la calidad para estandarizar el manejo multidisciplinario del cáncer de recto. Consulte Video Resumen en http://links.lww.com/DCR/B923 . (Traducción-Dr Yolanda Colorado ).

Single-Dose Study of a Corticotropin-Releasing Factor Receptor-1 Antagonist in Women With 21-Hydroxylase Deficiency.

CONTEXT: Treatment of 21-hydroxylase deficiency (21OHD) is difficult to optimize. Normalization of excessive ACTH and adrenal steroid production commonly requires supraphysiologic doses of glucocorticoids. OBJECTIVES: We evaluated the safety and tolerability of the selective corticotropin releasing factor type 1 (CRF1) receptor antagonist NBI-77860 in women with classic 21OHD and tested the hypothesis that CRF1 receptor blockade decreases early-morning ACTH and 17α-hydroxyprogesterone (17OHP) in these patients. PARTICIPANTS: The study enrolled eight classic 21OHD females, ages 18-58 years, seen at a single tertiary referral university setting. DESIGN: This was a phase Ib, single-blind, placebo-controlled, fixed-sequence, single-dose trial. During three treatment periods separated by 3-week washout intervals, patients sequentially received placebo, NBI-77860 300 mg, and NBI-77860 600 mg at 10 pm; glucocorticoid therapy was withheld for 20 hours. We evaluated ACTH, 17OHP, androstenedione, and testosterone as well as NBI-77860 pharmacokinetics over 24 hours. RESULTS: Dose-dependent reductions of ACTH and/or 17OHP were observed in six of eight subjects. Relative to placebo, NBI-77860 led to an ACTH and 17OHP reduction by a mean of 43% and 0.7% for the 300 mg dose, respectively, and by 41% and 27% for the 600 mg dose, respectively. Both NBI-77860 doses were well tolerated. CONCLUSION: The meaningful reductions in ACTH and 17OHP following NBI-77860 dosing in 21OHD patients demonstrate target engagement and proof of principle in this disorder. These promising data provide a rationale for additional investigations of CRF1 receptor antagonists added to physiologic doses of hydrocortisone and fludrocortisone acetate for the treatment of classic 21OHD.

The combination of insulin-like growth factor receptor 1 (IGF1R) antibody cixutumumab and mitotane as a first-line therapy for patients with recurrent/metastatic adrenocortical carcinoma: a multi-institutional NCI-sponsored trial.

Adrenocortical carcinoma (ACC) is an aggressive malignancy, which lacks an effective systemic treatment. Abnormal activation of insulin-like growth factor receptor 1 (IGF1R) has been frequently observed. Preclinical studies demonstrated that pharmacological inhibition of IGF1R signaling in ACC has antiproliferative effects. A previous phase I trial with an IGF1R inhibitor has demonstrated biological activity against ACC. The objective of this study is to assess the efficacy of the combination of the IGF1R inhibitor cixutumumab (IMC-A12) in association with mitotane as a first-line treatment for advanced/metastatic ACC. We conducted a multicenter, randomized double-arm phase II trial in patients with irresectable recurrent/metastatic ACC. The original protocol included two treatment groups: IMC-A12 + mitotane and mitotane as a single agent, after an initial single-arm phase for safety evaluation with IMC-A12 + mitotane. IMC-A12 was dosed at 10 mg/kg intravenously every 2 weeks. The starting dose for mitotane was 2 g daily, subsequently adjusted according to serum levels/symptoms. The primary endpoint was progression-free survival (PFS) according to RECIST (Response Evaluation Criteria in Solid Tumors). This study was terminated before the randomization phase due to slow accrual and limited efficacy. Twenty patients (13 males, 7 females) with a median age of 50.2 years (range 21.9-79.6) were enrolled for the single-arm phase. Therapeutic effects were observed in 8/20 patients, including one partial response and seven stable diseases. The median PFS was 6 weeks (range 2.66-48). Toxic events included two grade 4 (hyperglycemia and hyponatremia) and one grade 5 (multiorgan failure). Although the regimen demonstrated activity in some patients, the relatively low therapeutic efficacy precluded further studies with this combination of drugs.