Short-course radiation with consolidation chemotherapy does not increase operative morbidity compared to long-course chemoradiation: A retrospective study of the US rectal cancer consortium.

BACKGROUND AND OBJECTIVES: Neoadjuvant short-course radiation and consolidation chemotherapy (SC TNT) remains less widely used for rectal cancer in the United States than long-course chemoradiation (LCRT). SC TNT may improve compliance and downstaging; however, a longer radiation-to-surgery interval may worsen pelvic fibrosis and morbidity with total mesorectal excision (TME). A single, US-center retrospective analysis has shown comparable risk of morbidity after neoadjuvant short-course radiation with consolidation chemotherapy (SC TNT) and long-course chemoradiation (LCRT). Validation by a multi-institutional study is needed. METHODS: The US Rectal Cancer Consortium database (2010-2018) was retrospectively reviewed for patients with nonmetastatic, rectal adenocarcinoma treated with neoadjuvant LCRT or SC TNT before TME. The primary endpoint was severe postoperative morbidity. Cohorts were compared by univariate analysis. Multivariable logistic regression modeled the odds of severe complication. RESULTS: Of 788 included patients, 151 (19%) received SC TNT and 637 (81%) LCRT. The SC TNT group had fewer distal tumors (33.8% vs. 50.2%, p < 0.0001) and more clinical node-positive disease (74.2% vs. 47.6%, p < 0.0001). The intraoperative complication rate was similar (SC TNT 5.3% vs. 4.4%, p = 0.65). There was no difference in overall postoperative morbidity (38.4% vs. 46.3%, p = 0.08). Severe morbidity was similar with low anterior resection (9.1% vs. 15.3%, p = 0.10) and abdominoperineal resection (24.4% vs. 29.7%, p = 0.49). SC TNT did not increase the odds of severe morbidity relative to LCRT on multivariable analysis (OR 0.64, 95% CI 0.37-1.10). CONCLUSIONS: SC TNT does not increase morbidity after TME for rectal cancer relative to LCRT. Concern for surgical complications should not discourage the use of SC TNT when aiming to increase the likelihood of complete clinical response.

Circumferential Resection Margin as Predictor of Nonclinical Complete Response in Nonoperative Management of Rectal Cancer.

BACKGROUND: Short-course radiation therapy and consolidation chemotherapy with nonoperative intent has emerged as a novel treatment paradigm for patients with rectal cancer, but there are no data on the predictors of clinical complete response. OBJECTIVE: Evaluate the predictors of clinical complete response and survival. DESIGN: Retrospective cohort. SETTINGS: National Cancer Institute-designated cancer center. PATIENTS: Patients with stage I to III rectal adenocarcinoma treated between January 2018 and May 2019 (n = 86). INTERVENTIONS: Short-course radiation therapy followed by consolidation chemotherapy. MAIN OUTCOME MEASURES: Logistic regression was performed to assess for predictors of clinical complete response. The end points included local regrowth-free survival, regional control, distant metastasis-free survival, and overall survival. RESULTS: A positive (+) circumferential resection margin by MRI at diagnosis was a significant predictor of nonclinical complete response (OR: 4.1, p = 0.009) when adjusting for CEA level and primary tumor size. Compared to patients with a negative (-) pathologic circumferential resection margin, patients with a positive (+) pathologic circumferential resection margin had inferior local regrowth-free survival (29% vs 87%, p < 0.001), regional control (57% vs 94%, p < 0.001), distant metastasis-free survival (43% vs 95%, p < 0.001), and overall survival (86% vs 95%, p < 0.001) at 2 years. However, the (+) and (-) circumferential resection margin by MRI subgroups in patients who had a clinical complete response both had similar regional control, distant metastasis-free survival, and overall survival of more than 90% at 2 years. LIMITATIONS: Retrospective design, modest sample size, short follow-up, and the heterogeneity of treatments. CONCLUSIONS: Circumferential resection margin involvement by MRI at diagnosis is a strong predictor of nonclinical complete response. However, patients who achieve a clinical complete response after short-course radiation therapy and consolidation chemotherapy with nonoperative intent have excellent clinical outcomes regardless of the initial circumferential resection margin status. See Video Abstract at http://links.lww.com/DCR/C190 . EL MARGEN DE RESECCIN CIRCUNFERENCIAL COMO PREDICTOR NO CLNICO DE RESPUESTA COMPLETA EN EL MANEJO CONSERVADOR DEL CNCER DE RECTO: ANTECEDENTES:La radioterapia de corta duración y la quimioterapia de consolidación en el manejo conservador, han surgido como un nuevo paradigma de tratamiento, para los pacientes con cáncer de recto, lastimosamente no hay datos definitivos sobre los predictores de una respuesta clínica completa.OBJETIVO:Evaluar los predictores de respuesta clínica completa y de la sobrevida.DISEÑO:Estudio retrospectivo de cohortes.AJUSTES:Centro oncológico designado por el NCI.PACIENTES:Adenocarcinomas de recto estadio I-III tratados entre 01/2018 y 05/2019 (n = 86).INTERVENCIONES:Radioterapia de corta duración seguida de quimioterapia de consolidación.PRINCIPALES MEDIDAS DE RESULTADO:Se realizó una regresión logística para evaluar los predictores de respuesta clínica completa. Los criterios de valoración incluyeron la sobrevida libre de recidiva local, el control regional, la sobrevida libre de metástasis a distancia y la sobrevida general.RESULTADOS:Un margen de resección circunferencial positivo (+) evaluado por imagenes de resonancia magnética nuclear en el momento del diagnóstico fue un predictor no clínico muy significativo de respuesta completa (razón de probabilidades/ OR: 4,1, p = 0,009) al ajustar el nivel de antígeno carcinoembrionario y el tamaño del tumor primario. Comparando con los pacientes que presetaban un margen de resección circunferencial patológico negativo (-), los pacientes con un margen de resección circunferencial patológico positivo (+) tuvieron una sobrevida libre de recidiva local (29% frente a 87%, p < 0,001), un control regional (57% frente a 94%, p < 0,001), una sobrevida libre de metástasis a distancia (43% frente a 95%, p < 0,001) y una sobrevida global (86% frente a 95%, p < 0,001) inferior en 2 años de seguimiento. Sin embargo, los subgrupos de margen de resección circunferencial (+) y (-) evaluados por imágenes de resonancia magnética nuclear en pacientes que tuvieron una respuesta clínica completa tuvieron un control regional similar, una sobrevida libre de metástasis a distancia y una sobrevida general >90% en 2 años de seguimiento.LIMITACIONES:Diseño retrospectivo, tamaño modesto de la muestra, seguimiento corto y heterogeneidad de tratamientos.CONCLUSIONES:La afectación del margen de resección circunferencial evaluado por resonancia magnética nuclear al momento del diagnóstico es un fuerte factor predictivo no clínico de respuesta completa. Sin embargo, los pacientes que logran una respuesta clínica completa después de un curso corto de radioterapia y quimioterapia de consolidación como manejo conservador tienen excelentes resultados clínicos independientemente del estado del margen de resección circunferencial inicial. Consulte Video Resumen en http://links.lww.com/DCR/C190 . (Traducción-Dr. Xavier Delgadillo ).

Discharge Prescribing Protocol Decreases Opioids in Circulation and Does Not Increase Refills After Colorectal Surgery.

BACKGROUND: Up to 10% of patients develop new, persistent opioid use after surgery. We aimed to assess our prescribing practices and patient utilization of opioids after colorectal surgery. OBJECTIVE: This study aimed to implement an opioid-prescribing protocol that will minimize the number of postoperative opioids to decrease community circulation and persistent use by patients. DESIGN: This was a single-institution, prospective study based on questionnaires of postoperative patients in 2019 and 2020 to determine opioid prescribing and usage patterns. Based on these preliminary results, a protocol was implemented in which patients were discharged with 5 or 15 oxycodone 5 mg equivalents based on opioid usage in the 24 hours before discharge. Patients were surveyed after protocol implementation. SETTINGS: Our institution is a large referral center for surgical treatment of colorectal disease. PATIENTS: Adults who underwent inpatient abdominal colorectal procedures. MAIN OUTCOME MEASURES: End points included the number of opioids prescribed, number of prescribed opioids taken, and refill rate. Nonparametric testing was used. RESULTS: Of 77 eligible patients, 61 were opioid naive. Preprotocol, opioid-naive patients (n = 29) were prescribed a median of 30 (interquartile range [IQR], 30-45) tablets but took only 10 (IQR, 0-10; p < 0.0001). Eighty-three percent took 20 or fewer tablets. After protocol implementation, opioid-naive patients (n = 32) were prescribed fewer tablets (median 15; IQR, 7-15; p < 0.0001) but took a similar number of tablets as the preprotocol group (median 10; IQR, 0-10; p = 0.21). The refill rate remained similar (13.8% vs 18.8%; p = 0.60). Protocol adherence was 90.6%. LIMITATIONS: This study is limited by sample size, cohort heterogeneity, and generalizability. CONCLUSIONS: Patients took significantly fewer opioids than were prescribed. Our protocol limited overprescribing and resulted in fewer opioids in the community without opportunity costs such as increased refills. Long-term studies are needed to assess the effects of persistent opioid use after surgery. See Video Abstract at http://links.lww.com/DCR/C93 .

ANTECEDENTES: Hasta el 10% de los pacientes desarrollan un nuevo uso persistente de opioides después de la cirugía. Nuestro objetivo fue evaluar nuestras prácticas de prescripción y la utilización de opioides por parte de los pacientes después de la cirugía colorrectal. OBJETIVO: Nuestro objetivo es implementar un protocolo de prescripción de opioides que minimice la cantidad de opioides posoperatorios para disminuir la circulación en la comunidad y el uso persistente por parte de los pacientes. DISEÑO: Estudio prospectivo, de una sola institución, basado en cuestionarios de pacientes postoperatorios en 2019 y 2020 para determinar los patrones de prescripción y uso de opioides. Con base en estos resultados preliminares, se implementó un protocolo en el que los pacientes eran dados de alta con 5 o 15 equivalentes de oxicodona de 5 mg según el uso de opioides en las 24 horas previas al alta. Los pacientes fueron encuestados después de la implementación del protocolo. AJUSTES: Nuestra institución es un gran centro de referencia para el tratamiento quirúrgico de la enfermedad colorrectal. PACIENTES: Adultos que se sometieron a procedimientos colorrectales abdominales con hospitalización. PRINCIPALES MEDIDAS DE RESULTADO: Los criterios de valoración incluyeron el número de opioides recetados, el número de opioides recetados tomados y la tasa de reabastecimiento. Se utilizaron pruebas no paramétricas. RESULTADOS: De 77 pacientes elegibles, 61 no habian recibido opioides. A los pacientes sin tratamiento previo con opioides antes del protocolo (n = 29) se les prescribió una mediana de 30 (rango intercuartilico [RIC] 30­45) comprimidos, pero solo tomaron 10 (RIC 0.10, p < 0,0001). El ochenta y tres por ciento tomo ≤20 comprimidos. Despues de la implementacion del protocolo, a los pacientes sin tratamiento previo con opioides (n = 32) se les prescribieron menos comprimidos (15; RIC 7.15, p < 0,0001), pero tomaron un numero similar antes de la intervención (10; RIC 0­10, p = 0,21). La tasa de reabastecimiento se mantuvo similar (13,8% frente a 18,8%, p = 0,60). La adherencia al protocolo fue del 90,6%. LIMITACIONES: Este estudio está limitado por el tamaño de la muestra, la heterogeneidad de la cohorte y la generalización. CONCLUSIONES: Los pacientes tomaron significativamente menos opioides de los prescritos. Nuestro protocolo limitó la prescripción excesiva y dio como resultados menos opioides en la comunidad sin costos de oportunidad, como el aumento de reabastecimiento. Se necesitan estudios a largo plazo para evaluar los efectos sobre el uso persistente de opioides después de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/C93 . (Traducción­Dr. Francisco M. Abarca-Rendon).

Total Neoadjuvant Therapy in Rectal Cancer: Multi-center Comparison of Induction Chemotherapy and Long-Course Chemoradiation Versus Short-Course Radiation and Consolidative Chemotherapy.

BACKGROUND: Total neoadjuvant therapy for locally advanced rectal cancer may include induction chemotherapy and chemoradiation or short-course radiotherapy and consolidative chemotherapy. METHODS: Patients with clinical stage 2 or 3 rectal cancer who received induction chemotherapy followed by long-course chemoradiation at the University of Colorado (2016-2020) or short-course radiotherapy followed by consolidative chemotherapy at Washington University (2017-2020) were assessed. RESULTS: Eighty-four patients received induction chemotherapy and chemoradiation and 83 received short-course radiotherapy and consolidative chemotherapy. Among patients with complete re-staging evaluation, clinical complete response rates were similar, 49% (18/37) and 53% (44/83), respectively (p = 0.659). In the induction chemotherapy and chemoradiation group, 80% (n = 67) underwent surgery and 28% (n = 19) achieved a pathologic complete response. In the short-course radiotherapy and consolidative chemotherapy group, 44 (53%) patients underwent surgery and 11% (n = 5) had a pathologic complete response. Overall, a complete response was observed in 43% (n = 36) of patients who received induction chemotherapy and chemoradiation compared to 53% (n = 44) who received short-course radiotherapy and consolidative chemotherapy (p = 0.189). Perioperative outcomes were similar in patients who received induction chemotherapy and chemoradiation compared to short-course radiotherapy and consolidative chemotherapy: intraoperative complications (2% vs 7%), complete mesorectal specimen (85% vs 84%), anastomotic leak (9% vs 7%), organ/space infection (9% vs 5%), readmission (19% vs 21%), and reoperation (8% vs 9%), respectively (all p > 0.05). CONCLUSIONS: In patients with clinical stage 2 or 3 rectal cancer, total neoadjuvant therapy with either induction chemotherapy and chemoradiation or short-course radiotherapy followed by consolidative chemotherapy were associated with similar perioperative morbidity and complete response rates.

FDG-PET/MRI for Nonoperative Management of Rectal Cancer: A Prospective Pilot Study.

Nonoperative management (NOM) is increasingly utilized for rectal cancer patients with a clinical complete response (cCR) following total neoadjuvant therapy (TNT). The objective of this pilot study was to determine whether FDG-PET/MRI alters clinical response assessments among stage I-III rectal cancer patients undergoing TNT followed by NOM, relative to MRI alone. This prospective study included 14 subjects with new rectal cancer diagnoses. Imaging consisted of FDG-PET/MRI for initial staging, post-TNT restaging, and surveillance during NOM. Two independent readers assessed treatment response on MRI followed by FDG-PET/MRI. Inter-reader differences were resolved by consensus review. The reference standard for post-TNT restaging consisted of surgical pathology or clinical follow-up. 7/14 subjects completed post-TNT restaging FDG-PET/MRIs. 5/7 subjects had evidence of residual disease and underwent total mesorectal excision; 2/7 subjects had initial cCR with no evidence of disease after 12 months of NOM. FDG-PET/MRI assessments of cCR status at post-TNT restaging had an accuracy of 100%, compared with 71% for MRI alone, as FDG-PET detected residual tumor in 2 more subjects. Inter-reader agreement for cCR status on FDG-PET/MRI was moderate (kappa, 0.56). FDG-PET provided added value in 82% (9/11) of restaging/surveillance scans. Our preliminary data indicate that FDG-PET/MRI can detect more residual disease after TNT than MRI alone, with the FDG-PET component providing added value in most restaging/surveillance scans.

Total Neoadjuvant Therapy With Short-Course Radiation: US Experience of a Neoadjuvant Rectal Cancer Therapy.

BACKGROUND: Short-course radiation followed by chemotherapy as total neoadjuvant therapy has been investigated primarily in Europe and Australia with increasing global acceptance. There are limited data on this regimen's use in the United States, however, potentially delaying implementation. OBJECTIVE: This study aimed to compare clinical performance and oncologic outcomes of 2 rectal cancer neoadjuvant treatment modalities: short-course total neoadjuvant therapy versus standard chemoradiation. DESIGN: This is a retrospective cohort study. SETTING: This study was performed at a National Cancer Institute-designated cancer center. PATIENTS: A total of 413 patients had locally advanced rectal cancers diagnosed from June 2009 to May 2018 and received either short-course total neoadjuvant therapy or standard chemoradiation. INTERVENTIONS: There were 187 patients treated with short-course total neoadjuvant therapy (5 × 5 Gy radiation followed by consolidation oxaliplatin-based chemotherapy) compared with 226 chemoradiation recipients (approximately 50.4 Gy radiation in 28 fractions with concurrent fluorouracil equivalent). MAIN OUTCOME MEASURES: Primary end points were tumor downstaging, measured by complete response and "low" neoadjuvant rectal score rates, and progression-free survival. Secondary analyses included treatment characteristics and completion, sphincter preservation, and recurrence rates. RESULTS: Short-course total neoadjuvant therapy was associated with higher rates of complete response (26.2% vs 17.3%; p = 0.03) and "low" neoadjuvant rectal scores (40.1% vs 25.7%; p < 0.01) despite a higher burden of node-positive disease (78.6% vs 68.9%; p = 0.03). Short-course recipients also completed trimodal treatment more frequently (88.4% vs 50.4%; p < 0.01) and had fewer months with temporary stomas (4.8 vs 7.0; p < 0.01). Both regimens achieved comparable local control (local recurrence: 2.7% short-course total neoadjuvant therapy vs 2.2% chemoradiation, p = 0.76) and 2-year progression-free survival (88.2% short-course total neoadjuvant therapy (95% CI, 82.9-93.5) vs 85.6% chemoradiation (95% CI, 80.5-90.7)). LIMITATIONS: Retrospective design, unbalanced disease severity, and variable dosing of neoadjuvant consolidation chemotherapy were limitations of this study. CONCLUSIONS: Short-course total neoadjuvant therapy was associated with improved downstaging and similar progression-free survival compared with chemoradiation. These results were achieved with shortened radiation courses, improved treatment completion, and less time with diverting ostomies. Short-course total neoadjuvant therapy is an optimal regimen for locally advanced rectal cancer. See Video Abstract at http://links.lww.com/DCR/B724.TERAPIA NEOADYUVANTE TOTAL CON RADIACIÓN DE CORTA DURACIÓN: EXPERIENCIA ESTADOUNIDENSE DE UNA TERAPIA NEOADYUVANTE CONTRA EL CÁNCER DE RECTO. ANTECEDENTES: La radiación de corta duración seguida de quimioterapia como terapia neoadyuvante total se ha investigado principalmente en Europa y Australia con una aceptación mundial cada vez mayor. Sin embargo, datos limitados sobre el uso de este régimen en los Estados Unidos, han potencialmente retrasando su implementación. OBJETIVO: Comparar el desempeño clínico y los resultados oncológicos de dos modalidades de tratamiento neoadyuvante del cáncer de recto: terapia neoadyuvante total de corta duración versus quimioradiación. estándar. DISEO: Cohorte retrospectivo. AJUSTE: Centro oncológico designado por el NCI. PACIENTES: Un total de 413 cánceres rectales localmente avanzados diagnosticados entre junio de 2009 y mayo de 2018 que recibieron cualquiera de los regímenes neoadyuvantes. INTERVENCIONES: Hubo 187 pacientes tratados con terapia neoadyuvante total de ciclo corto (radiación 5 × 5 Gy seguida de quimioterapia de consolidación basada en oxaliplatino) en comparación con 226 pacientes de quimiorradiación (aproximadamente 50,4 Gy de radiación en 28 fracciones con equivalente de fluorouracilo concurrente). PRINCIPALES MEDIDAS DE RESULTADO: Los criterios primarios de valoración fueron la disminución del estadio del tumor, medido por la respuesta completa y las tasas de puntuación rectal neoadyuvante "baja", y la supervivencia libre de progresión. Los análisis secundarios incluyeron las características del tratamiento y las tasas de finalización, conservación del esfínter y recurrencia. RESULTADOS: La terapia neoadyuvante total de corta duración, se asoció con tasas más altas de respuesta completa (26,2% versus 17,3%, p = 0,03) y puntuaciones rectales neoadyuvantes "bajas" (40,1% versus 25,7%, p < 0,01) a pesar de una mayor carga de enfermedad con ganglios positivos (78,6% versus 68,9%, p = 0,03). Los pacientes de ciclo corto también completaron el tratamiento trimodal con mayor frecuencia (88,4% versus 50,4%, p < 0,01) y tuvieron menos meses con estomas temporales (4,8 versus 7,0, p < 0,01). Ambos regímenes lograron un control local comparable (recidiva local: 2,7% de SC-TNT versus 2,2% de TRC, p = 0,76) y supervivencia libre de progresión a 2 años (88,2% de SC-TNT [IC: 82,9 - 93,5] versus 85,6% CRT [CI: 80,5 - 90,7]). LIMITACIONES: Diseño retrospectivo, gravedad de la enfermedad desequilibrada y dosificación variable de quimioterapia neoadyuvante de consolidación. CONCLUSIONES: La terapia neoadyuvante total de ciclo corto se asoció con una mejora en la reducción del estadio y una supervivencia libre de progresión similar en comparación con la quimioradiación. Estos resultados se lograron con ciclos de radiación más cortos, tratamientos mejor finalizados y menos tiempo en ostomías de derivación. La terapia neoadyuvante total de corta duración es un régimen óptimo para el cáncer de recto localmente avanzado. Consulte Video Resumen en http://links.lww.com/DCR/B724. (Traducción- Dr. Fidel Ruiz Healy).

Perioperative Complications After Proctectomy for Rectal Cancer: Does Neoadjuvant Regimen Matter?

OBJECTIVE: Investigate the association between neoadjuvant treatment strategy and perioperative complications in patients undergoing proctectomy for nonmetastatic rectal cancer. SUMMARY OF BACKGROUND DATA: Neoadjuvant SC-TNT is an alternative to neoadjuvant CRT for rectal cancer. Some have argued that short-course radiation and extended radiation-to-surgery intervals increase operative difficulty and complication risk. However, the association between SC-TNT and surgical complications has not been previously investigated. METHODS: This single-center retrospective cohort study included patients undergoing total mesorectal excision for nonmetastatic rectal cancer after SC-TNT or CRT between 2010 and 2018. Univariate analysis of severe POM and multiple secondary outcomes, including overall POM, intraoperative complications, and resection margins, was performed. Logistic regression of severe POM was also performed. RESULTS: Of 415 included patients, 156 (38%) received SC-TNT and 259 (62%) received CRT. The cohorts were largely similar, though patients with higher tumors (69.9% vs 47.5%, P < 0.0001) or node-positive disease (76.9% vs 62.6%, P = 0.004) were more likely to receive SC-TNT. We found no difference in incidence of severe POM (9.6% SC-TNT vs 12.0% CRT, P = 0.46) or overall POM (39.7% SC-TNT vs 37.5% CRT, P = 0.64) between cohorts. Neoadjuvant regimen was also not associated with a difference in severe POM (odds ratio 0.42, 95% confidence interval 0.04-4.70, P = 0.48) in multivariate analysis. There was no significant association between neoadjuvant regimen and any secondary outcome. CONCLUSION: In rectal cancer patients treated with SC-TNT and proctectomy, we found no significant association with POM compared to patients undergoing CRT. SC-TNT does not significantly increase the risk of POM compared to CRT.

Clinical Complete Response in Patients With Rectal Adenocarcinoma Treated With Short-Course Radiation Therapy and Nonoperative Management.

PURPOSE: This study aimed to determine the clinical efficacy and safety of nonoperative management (NOM) for patients with rectal cancer with a clinical complete response (cCR) after short-course radiation therapy and consolidation chemotherapy. METHODS AND MATERIALS: Patients with stage I-III rectal adenocarcinoma underwent short-course radiation therapy followed by consolidation chemotherapy between January 2018 and May 2019 (n = 90). Clinical response was assessed by digital rectal examination, pelvic magnetic resonance imaging, and endoscopy. Of the patients with an evaluable initial response, those with a cCR (n = 43) underwent NOM, and those with a non-cCR (n = 43) underwent surgery. The clinical endpoints included local regrowth-free survival, regional control, distant metastasis-free survival, disease-free survival, and overall survival. RESULTS: Compared with patients with an initial cCR, patients with initial non-cCR had more advanced T and N stage (P = .05), larger primary tumors (P = .002), and more circumferential resection margin involvement on diagnostic magnetic resonance imaging (P < .001). With a median follow-up of 30.1 months, the persistent cCR rate was 79% (30 of 38 patients) in the NOM cohort. The 2-year local regrowth-free survival was 81% (95% confidence interval [CI], 70%-94%) in the initial cCR group, and all patients with local regrowth were successfully salvaged. Compared with those with a non-cCR, patients with a cCR had improved 2-year regional control (98% [95% CI, 93%-100%] vs 85% [95% CI, 74%-97%], P = .02), distant metastasis-free survival (100% [95% CI, 100%-100%] vs 80% [95% CI, 69%-94%], P < .01), disease-free survival (98% [95% CI, 93%-100%] vs 71% [95% CI, 59%-87%], P < .01), and overall survival (100% [95% CI, 100%-100%] vs 88% [95% CI, 79%-98%], P = .02). No late grade 3+ gastrointestinal or genitourinary toxicities were observed in the patients who underwent continued NOM. CONCLUSIONS: Short-course radiation therapy followed by consolidation chemotherapy may be a feasible organ preservation strategy in rectal cancer. Additional prospective studies are necessary to evaluate the safety and efficacy of this approach.

What's the magic number? Impact of time to initiation of treatment for rectal cancer.

BACKGROUND: National guidelines, including the National Accreditation Program for Rectal Cancer, recommend initiation of rectal cancer treatment within 60 days of diagnosis; however, the effect of timely treatment initiation on oncologic outcomes is unclear. The purpose of this study was to evaluate the impact on oncologic outcomes of initiation of rectal cancer treatment within 60 days of diagnosis. METHODS: This was a retrospective review of stage II/III rectal cancer patients performed using the United States Rectal Cancer Consortium, a collaboration of 6 academic medical centers. Patients with clinical stage II/III rectal cancer who underwent radical resection between January 1, 2010 and December 31, 2018 were included. The primary exposure was treatment initiation, defined as either resection or initiation of chemotherapy or chemoradiotherapy, within 60 days of diagnosis. The primary outcome was disease recurrence, and the secondary outcome was all-cause mortality. RESULTS: A total of 1,031 patients meeting inclusion criteria were included in the analysis. Treatment was initiated within 60 days of diagnosis in 830 patients (80.5%) and after 60 days in 201 patients (20.3%). In multivariable logistic regression, older age, non-White race, and residence greater than 100 miles from the treatment center were significantly associated with delay in treatment beyond 60 days. In survival analysis, 167 patients (16.2%) experienced recurrent disease, and 127 patients (12.3%) died of any cause. In an adjusted model accounting for pathologic staging, treatment sequence, distance to care, age, comorbidities, treatment center, and receipt of adjuvant chemotherapy, neither progression-free survival nor all-cause mortality was significantly associated with timely initiation of therapy with hazard ratios of 1.09 (0.70, 1.69) and 1.03 (0.63, 1.66), respectively. CONCLUSION: This study found no difference in oncologic outcomes with initiation of treatment beyond 60 days.

Perioperative Blood Transfusions Are Associated With Worse Overall Survival But Not Disease-Free Survival After Curative Rectal Cancer Resection: A Propensity Score-Matched Analysis.

BACKGROUND: The effects of blood transfusions on oncologic outcomes after surgery remain inconclusive. Thus, we examined the association between receiving a perioperative blood transfusion and oncologic outcomes in patients undergoing curative rectal cancer resection. OBJECTIVE: The purpose of this study was to assess the association between receiving a perioperative blood transfusion with disease-free and overall survival in patients undergoing curative resection of clinical stage I to III rectal cancer. We hypothesized that blood transfusion is associated with worse disease-free and overall survival in this patient cohort. DESIGN: This was a retrospective cohort study using a propensity score-matched analysis. SETTINGS: The study involved 6 tertiary academic medical centers in the United States contributing to the United States Rectal Cancer Consortium. PATIENTS: Patients who underwent curative resection for rectal cancer from 2010 to 2018 were included. MAIN OUTCOME MEASURES: The primary outcome was disease-free survival. The secondary outcomes were overall survival, intensive care unit length of stay, hospital length of stay, surgical site infection, and readmission. RESULTS: Of the 924 patients eligible for matching, 312 patients were matched, including 100 patients who received a transfusion and 212 who did not. In a propensity score-matched analysis, receiving a perioperative blood transfusion was not associated with worse 5-year disease-free survival (transfused, 78%; not transfused, 83%; p = 0.32) but was associated with worse 5-year overall survival (transfused 65% vs not transfused 86%; p < 0.001) and increased hospital length of stay (transfused, 9.9 d; not transfused, 7.6 d; p = 0.001). LIMITATIONS: Despite propensity matching, confounding may remain. Propensity matching may limit the power to detect a difference in disease-free survival. CONCLUSIONS: Receiving a perioperative blood transfusion is not associated with worse disease-free survival but is associated with worse overall survival. Such findings are important for clinicians and patients to understand when considering perioperative blood transfusions. See Video Abstract at http://links.lww.com/DCR/B531. LAS TRANSFUSIONES DE SANGRE PERIOPERATORIAS SE ASOCIAN CON UNA PEOR SOBREVIDA GLOBAL, PERO NO CON LA SOBREVIDA LIBRE DE ENFERMEDAD POSTERIOR A LA RESECCIN CURATIVA DEL CNCER DE RECTO UN PUNTAJE DE PROPENSIN POR ANLISIS DE CONCORDANCIA: ANTECEDENTES:El impacto de las transfusiones de sangre en los resultados oncológicos posteriores a la cirugía no son concluyentes. Por lo anterior, estudiamos la asociación entre recibir una transfusión de sangre perioperatoria y los resultados oncológicos en pacientes llevados a resección curativa de cáncer de recto.OBJETIVO:El propósito de este estudio fue evaluar la asociación entre recibir una transfusión de sangre perioperatoria con la sobrevida libre de enfermedad y la sobrevida general en pacientes llevados a resección curativa de cáncer de recto en estadio clínico I-III. Nuestra hipótesis es que la transfusión de sangre se asocia con una peor sobrevida global y libre de enfermedad en esta cohorte de pacientes.DISEÑO:Es un estudio de cohorte retrospectivo que utilizó un puntaje de propensión por análisis de concordancia.AMBITO:El estudio se realizó en seis centros médicos académicos de tercer nivel en los Estados Unidos que contribuían al Consorcio de Cáncer de Recto de los Estados Unidos.PACIENTES:Se incluyeron pacientes que fueron llevados a resección curativa por cáncer de recto entre 2010 y 2018.PRINCIPALES VARIABLES EVALUADAS:El objeitvo principal fue la sobrevida libre de enfermedad. Los objetivos secundarios fueron la sobrevida global, el tiempo de estancia en la unidad de cuidados intensivos, el tiempo de la estancia hospitalaria, la infección del sitio quirúrgico y el reingreso.RESULTADOS:De los 924 pacientes elegibles para el emparejamiento, se emparejaron 312 pacientes, incluidos 100 pacientes que recibieron una transfusión y 212 que no. En el puntaje de propensión por análisis de concordancia, recibir una transfusión de sangre perioperatoria no se asoció con una peor sobrevida libre de enfermedad a 5 años (TRANSFUSIÓN 78%; NO TRANSFUSIÓN 83%; p = 0,32), pero se asoció con una peor sobrevida global a 5 años (TRANSFUSION 65% vs NO TRANSFUSION 86%; p <0,001) y aumento de la estancia hospitalaria (TRANSFUSIÓN 9,9 días; NO TRANSFUSION 7,6 días; p = 0,001).LIMITACIONES:A pesar de la concordancia de propensión, pueden existir desviaciones. El emparejamiento de propensión puede limitar el poder para detectar una diferencia en la sobrevida libre de enfermedad.CONCLUSIONES:Recibir una transfusión de sangre perioperatoria no se asocia con una peor sobrevida libre de enfermedad, pero sí con una peor sobrevida global. Es importante que los médicos y los pacientes comprendan estos hallazgos al considerar las transfusiones de sangre perioperatorias. Consulte Video Resumen en http://links.lww.com/DCR/B531. (Traducción-Dr Lisbeth Alarcon-Bernes).

A US Rectal Cancer Consortium Study of Inferior Mesenteric Artery Versus Superior Rectal Artery Ligation: How High Do We Need to Go?

BACKGROUND: The optimal level of pedicle ligation during proctectomy for rectal cancer, either at the origin of the inferior mesenteric artery or the superior rectal artery, is still debated. OBJECTIVE: The objective was to determine whether superior rectal artery ligation portends equivalent technical or oncologic outcomes. DESIGN: This was a retrospective analysis of a rectal cancer database (2007-2017). SETTINGS: The study was conducted at 6 tertiary referral centers in the United States (Emory University, University of Michigan, University of Pittsburgh Medical Center, The Ohio State University Wexner Medical Center, Vanderbilt University Medical Center, and Washington University School of Medicine in St. Louis). PATIENTS: Patients with primary, nonmetastatic rectal cancer who underwent low anterior resection or abdominoperineal resection were included. MAIN OUTCOME MEASURES: Anastomotic leak, lymph node harvest, locoregional recurrence-free survival, recurrence-free survival, and overall survival were measured. RESULTS: Of 877 patients, 86% (n = 755) received an inferior mesenteric artery ligation, whereas 14% (n = 122) received a superior rectal artery ligation. A total of 12%, 33%, 24%, and 31% were pathologic stage 0, I, II, and III. Median follow-up was 31 months. Superior rectal artery ligation was associated with a similar anastomotic leak rate compared with inferior mesenteric artery ligation (9% vs 8%; p = 1.0). The median number of lymph nodes removed was identical (15 vs 15; p = 0.38). On multivariable analysis accounting for relevant clinicopathologic factors, superior rectal artery ligation was not associated with increased anastomotic leak rate, worse lymph node harvest, or worse locoregional recurrence-free survival, recurrence-free survival, or overall survival (all p values >0.1). LIMITATIONS: This was a retrospective design. CONCLUSIONS: Compared with inferior mesenteric artery ligation, superior rectal artery ligation is not associated with either worse technical or oncologic outcomes. Given the potential risks of inadequate blood flow to the proximal limb of the anastomosis and autonomic nerve injury, we advocate for increased use of superior rectal artery ligation. See Video Abstract at http://links.lww.com/DCR/B646. ESTUDIO DEL CONSORCIO DE CNCER DE RECTO DE ESTADOS UNIDOS DE LIGADURA BAJA DE LA ARTERIA MESENTRICA INFERIOR CONTRA LIGADURA ALTA DE LA ARTERIA MESENTRICA INFERIOR QU TAN ALTO DEBEMOS EXTENDERNOS: ANTECEDENTES:el nivel óptimo de la ligadura del pedículo en la proctectomía para el cáncer de recto, ya sea en el origen de la arteria mesentérica inferior o en la arteria rectal superior aún no esta definido.OBJETIVO:El objetivo era determinar si la ligadura de la arteria rectal superior pronostica resultados técnicos u oncológicos similares.DISEÑO:Análisis retrospectivo de una base de datos de cáncer de recto (2007-2017).ESCENARIO:el estudio se realizó en seis centros de referencia de tercer nivel en los Estados Unidos (Universidad de Emory, Universidad de Michigan, Centro médico de la Universidad de Pittsburgh, Centro médico Wexner de la Universidad Estatal de Ohio, Centro médico de la Universidad de Vanderbilt y Escuela de Medicina de la Universidad de Washington en St. Louis).PACIENTES:Se incluyeron pacientes con cáncer de recto primario no metastásico que se sometieron a resección anterior baja o resección abdominoperineal.PRINCIPALES VARIABLES ANALIZADAS:Se midió la fuga anastomótica, los ganglios linfáticos recuperados, la sobrevida sin recidiva locorregional, la sobrevida sin recidiva y la sobrevida global.RESULTADOS:De 877 pacientes, en el 86% (n = 755) se realizó una ligadura de la arteria mesentérica inferior, y en el 14% (n = 122) se realizó una ligadura de la arteria rectal superior. El 12%, 33%, 24% y 31% estaban en estadio patológico 0, I, II y III respectivamente. La mediana de seguimiento fue de 31 meses. La ligadura de la arteria rectal superior se asoció con una tasa de fuga anastomótica similar a la ligadura de la arteria mesentérica inferior (9 vs 8%, p = 1,0). La mediana del número de ganglios linfáticos extirpados fue idéntica (15 contra 15, p = 0,38). En el análisis multivariado que tiene en cuenta los factores clínico-patológicos relevantes, la ligadura de la arteria rectal superior no se asoció con una mayor tasa de fuga anastomótica, una peor cosecha de ganglios linfáticos o una peor sobrevida libre de recurrencia locorregional, sobrevida libre de recurrencia o sobrevida global (todos p> 0,1).LIMITACIONES:Diseño retrospectivo.CONCLUSIONES:En comparación con la ligadura de la arteria mesentérica inferior, la ligadura de la arteria rectal superior no se asocia a peores resultados técnicos ni oncológicos. Debido a los riesgos potenciales de un flujo sanguíneo inadecuado del muñon proximal de la anastomosis y la lesión de los nervios autonómicos, proponemos una mayor realización de la ligadura de la arteria rectal superior. Consulte Video Resumen en http://links.lww.com/DCR/B646.

Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial.

PURPOSE: Short-course radiation therapy (SCRT) and nonoperative management are emerging paradigms for rectal cancer treatment. This clinical trial is the first to evaluate SCRT followed by chemotherapy as a nonoperative treatment modality. METHODS: Patients with nonmetastatic rectal adenocarcinoma were treated on the single-arm, Nonoperative Radiation Management of Adenocarcinoma of the Lower Rectum study of SCRT followed by chemotherapy. Patients received 25 Gy in 5 fractions to the pelvis followed by FOLFOX ×8 or CAPOX ×5 cycles. Patients with clinical complete response (cCR) underwent nonoperative surveillance. The primary end point was cCR at 1 year. Secondary end points included safety profile and anorectal function. RESULTS: From June 2016 to March 2019, 19 patients were treated (21% stage I, 32% stage II, and 47% stage III disease). At a median follow-up of 27.7 months for living patients, the 1-year cCR rate was 68%. Eighteen of 19 patients are alive without evidence of disease. Patients with cCR versus without had improved 2-year disease-free survival (93% vs 67%; P = .006), distant metastasis-free survival (100% vs 67%; P = .03), and overall survival (100% vs 67%; P = .03). Involved versus uninvolved circumferential resection margin on magnetic resonance imaging was associated with less initial cCR (40% vs 93%; P = .04). Anorectal function by Functional Assessment of Cancer Therapy-Colorectal cancer score at 1 year was not different than baseline. There were no severe late effects. CONCLUSIONS: Treatment with SCRT and chemotherapy resulted in high cCR rate, intact anorectal function, and no severe late effects. NCT02641691.

Delaying definitive resection in early stage (I/II) colon cancer appears safe up to 6 weeks.

BACKGROUND: The objective of this study was to determine if there is an impact of surgical delay on 5-year overall survival (OS) from early stage colon cancer, and if so, to define how long surgery can safely be postponed. METHODS: Using the NCDB, we compared early (14-30 days) and delayed surgery (31-90 days) in patients with Stage I/II colon cancer. Outcomes included OS at five years and odds of death. RESULTS: Delayed resection conferred a decreased 5-year OS of 73.0% (95% CI, 72.6-73.4), compared to early resection 78.3% (95% CI, 77.9-78.8). When time to surgery was divided into one-week intervals, there was no difference in the odds of death with delay up to 35-41 days (6 weeks), but odds of death increased by 9% per week thereafter. CONCLUSIONS: These data support that definitive resection for early stage colon cancer may be safely delayed up to 6 weeks.

Preoperative Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function and Perioperative Complication in Major Abdominal Colorectal Operations.

BACKGROUND: Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) is a validated tool for capturing a patient's perception of their physical capacity. The goal of this study was to determine whether preoperative PF correlates with a risk of postoperative complications. STUDY DESIGN: Patients from a single-institution American College of Surgeons NSQIP database undergoing elective colorectal abdominal operations from January 2018 to June 2019 with a preoperative PROMIS-PF T-score were eligible for this retrospective study. Patients were divided into moderate to severe (score <40) and minimal to mild (score ≥40) physical disability cohorts. Primary outcomes were any complication and any Clavien-Dindo grade III or higher complication. Multivariate logistic regression was performed. RESULTS: In total, 249 patients were included: 78 (31%) with self-scored moderate to severe disability and 171 (69%) with minimal to mild disability. Patients who scored as moderate to severe disability had a higher frequency of comorbidities and an open operative approach compared with patients with minimal to mild disability. These patients then had higher rates of any complication (37.2% vs 19.9%; p = 0.0036) and Clavien-Dindo grade III or higher complications (14.1% vs 7.6%; p = 0.017). After adjusting for patient factors, surgical procedure, and approach, patients scoring as moderate to severe disability were 2.00 times more likely (95% CI, 1.05 to 3.84; p = 0.036) to have any complication and 2.76 times more likely (95% CI, 1.07 to 7.14; p = 0.036) to have a Clavien-Dindo grade III or higher complication. CONCLUSIONS: Moderate to severe PF disability score is associated with increased risk of postoperative complications among patients undergoing colorectal operations. PROMIS-PF T-score can be a useful tool to identify patients who would benefit from targeted preoperative interventions, such as patient education, nutritional optimization, and prehabilitation.

First, Do No Harm: Rethinking Routine Diversion in Sphincter-Preserving Rectal Cancer Resection.

BACKGROUND: Although diverting stomas have reduced anastomotic leak rates after sphincter-preserving proctectomy in some series, the effectiveness of routine diversion among a broad population of rectal cancer patients remains controversial. We hypothesized that routine temporary diversion is not associated with decreased rates of leak or reintervention in cancer patients at large undergoing sphincter-sparing procedures. STUDY DESIGN: The Florida State Inpatient Database (AHRQ, Healthcare Cost and Utilization Project) was queried for patients undergoing sphincter-preserving proctectomy for cancer (2005 to 2014). Matched cohorts defined by diversion status were created using propensity scores based on patient and hospital characteristics. Incidence of anastomotic leak, nonelective reintervention, and readmission were compared, and cumulative 90-day inpatient costs were calculated. RESULTS: Of 8,620 eligible sphincter-sparing proctectomy patients, 1,992 matched pairs were analyzed. Leak rates did not significantly vary between groups (4.5% vs 4.3%; p = 0.76), but diversion was associated with significantly higher odds of nonelective reintervention (2.37; 95% CI 1.90 to 2.96) and readmission (1.55; 95% CI 1.33 to 1.81) compared with undiverted patients. Median costs were higher among those diverted (US$21,325 vs US$15,050; p < 0.01). CONCLUSIONS: No association between diversion and anastomotic leak was found. However, temporary diversion was associated with increased incidence of nonelective reinterventions, readmissions, and higher costs. We therefore challenge the paradigm of routine diversion in rectal cancer operations. Additional study is needed to identify which patients would benefit most from diversion.

Thoracic Epidural Analgesia: Does It Enhance Recovery?

BACKGROUND: Thoracic epidural analgesia has been shown to be an effective method of pain control. The utility of epidural analgesia as part of an enhanced recovery after surgery protocol is debatable. OBJECTIVE: This study aimed to determine if the use of thoracic epidural analgesia in an enhanced recovery after surgery protocol decreases hospital length of stay or inpatient opioid consumption after elective colorectal resection. DESIGN: This is a single-institution retrospective cohort study. SETTINGS: The study was performed at a high-volume, tertiary care center in the Midwest. An institutional database was used to identify patients. PATIENTS: All patients undergoing elective transabdominal colon or rectal resection by board-certified colon and rectal surgeons from 2013 to 2017 were included. MAIN OUTCOME MEASURES: The main outcome was length of stay. The secondary outcome was oral morphine milligram equivalents consumed during the first 48 hours. RESULTS: There were 1006 patients (n = 815 epidural, 191 no epidural) included. All patients received multimodal analgesia with opioid-sparing agents. Univariate analysis demonstrated no difference in length of stay between those who received thoracic epidural analgesia and those who did not (median, 4 vs 5 days; p = 0.16), which was substantiated by multivariable linear regression. Subgroup analysis showed that the addition of epidural analgesia resulted in no difference in length of stay regardless of an open (n = 362; p = 0.66) or minimally invasive (n = 644; p = 0.46) approach. Opioid consumption data were available after 2015 (n = 497 patients). Univariate analysis demonstrated no difference in morphine milligram equivalents consumed in the first 48 hours between patients who received epidural analgesia and those who did not (median, 135 vs 110 oral morphine milligram equivalents; p = 0.35). This was also confirmed by multivariable linear regression. LIMITATIONS: The retrospective observational design was a limitation of this study. CONCLUSION: The use of thoracic epidural analgesia within an enhanced recovery after surgery protocol was not found to be associated with a reduction in length of stay or morphine milligram equivalents consumed within the first 48 hours. We cannot recommend routine use of thoracic epidural analgesia within enhanced recovery after surgery protocols. See Video Abstract at http://links.lww.com/DCR/A765.

Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse.

PURPOSE: Pelvic floor abnormalities often affect multiple organs. The incidence of concomitant uterine/vaginal prolapse with rectal prolapse is at least 38%. For these patients, addition of sacrocolpopexy to rectopexy may be appropriate. Our aim was to determine if addition of sacrocolpopexy to rectopexy increases the procedural morbidity over rectopexy alone. METHODS: We utilized the ACS-NSQIP database to examine female patients who underwent rectopexy from 2005 to 2014. We compared patients who had a combined procedure (sacrocolpopexy and rectopexy) to those who had rectopexy alone. Thirty-day morbidity was compared and a multivariable model constructed to determine predictors of complications. RESULTS: Three thousand six hundred patients underwent rectopexy; 3394 had rectopexy alone while 206 underwent a combined procedure with the addition of sacrocolpopexy. Use of the combined procedure increased significantly from 2.6 to 7.7%. Overall morbidity did not differ between groups (14.8% rectopexy alone vs. 13.6% combined procedure, p = 0.65). Significant predictors of morbidity included addition of resection to a rectopexy procedure, elevated BMI, smoking, wound class, and ASA class. After controlling for these and other patient factors, the addition of sacrocolpopexy to rectopexy did not increase overall morbidity (OR 1.00, p = 0.98). CONCLUSIONS: There is no difference in operative morbidity when adding sacrocolpopexy to a rectopexy procedure. Despite a modest increase in utilization of combined procedures over time, the overall rate remains low. These findings support the practice of multidisciplinary evaluation of patients presenting with rectal prolapse, with the goal of offering concurrent surgical correction for all compartments affected by pelvic organ prolapse disorders.

Benchmarking rectal cancer care: institutional compliance with a longitudinal checklist.

BACKGROUND: In 2012, the American Society of Colon and Rectal Surgeons published the Rectal Cancer Surgery Checklist, a consensus document listing 25 essential elements of care for all patients undergoing radical surgery for rectal cancer. The authors herein examine checklist adherence in a mature, multisurgeon specialty academic practice. MATERIALS AND METHODS: A retrospective medical record review of patients undergoing elective radical resection for rectal adenocarcinoma over a 23-mo period was conducted. Checklists were completed post hoc for each patient, and these results were tabulated to determine levels of compliance. Subgroup analyses by compliance and experience levels of the treating surgeon were performed. RESULTS: A total of 161 patients underwent resection, demonstrating a median completion rate of 84% per patient. Poor compliance was noted consistently in documenting baseline sexual function (0%), multidisciplinary discussion of treatment plans (16.8%), pelvic nerve identification (8.7%) and leak testing (52.9%), and radial margin status reporting (57.5%). Junior surgeons achieved higher rates of compliance and were more likely to restage after neoadjuvant therapy (67.9% versus 29.4%, P < 0.001), discuss patients at tumor board (31.3% versus 13.2%, P = 0.014), and document leak testing (86.7% versus 47.2%, P = 0.005) compared with senior surgeons. CONCLUSIONS: Checklist compliance within a high-volume, specialty academic practice remains varied. Only surgeon experience level was significantly associated with high checklist compliance. Junior surgeons achieved greater compliance with certain items, particularly those that reinforce decision-making. Further efforts to standardize rectal cancer care should focus on checklist implementation, targeted surgeon outreach, and assessment of checklist compliance correlation to clinical outcomes.

Combination of Oral Antibiotics and Mechanical Bowel Preparation Reduces Surgical Site Infection in Colorectal Surgery.

BACKGROUND: Surgical site infections (SSI) are a common complication after colorectal surgery. An infection prevention bundle (IPB) was implemented to improve outcomes. STUDY DESIGN: A standardized IPB that included the administration of oral antibiotics with a mechanical bowel preparation, preoperative shower with chlorhexidine, hair removal and skin preparation in holding, antibiotic wound irrigation, and a "clean-closure" protocol was implemented in January 2013. Data from the American College of Surgeons NSQIP were analyzed at a single academic institution to compare pre-IPB and post-IPB SSI rates. In January 2014, a prospective database was implemented to determine compliance with individual IPB elements and their effect on outcomes. RESULTS: For the 24 months pre-IPB, the overall SSI rate was 19.7%. During the 30 months after IPB implementation, the SSI rate decreased to 8.2% (p < 0.0001). A subset of 307 patients was identified in both NSQIP and our prospective compliance databases. Elements of IPB associated with decreased SSI rates included preoperative shower with chlorhexidine (4.6% vs 16.2%; p = 0.005), oral antibiotics (3.4% vs 15.4%; p < 0.001), and mechanical bowel preparation (4.4% vs 14.3%; p = 0.008). Patients who received a full bowel preparation of both oral antibiotics and a mechanical bowel preparation had a 2.7% SSI rate compared with 15.8% for all others (p < 0.001). On multivariate analysis, full bowel preparation was independently associated with significantly fewer SSI (adjusted odds ratio 0.2; 95% CI 0.1 to 0.9; p = 0.006). CONCLUSIONS: Implementation of an IPB was successful in decreasing SSI rates in colorectal surgery patients. The combination of oral antibiotics with a mechanical bowel preparation was the strongest predictor of decreased SSI.