Outcomes associated with total neoadjuvant therapy with non-operative intent for rectal adenocarcinoma.

Purpose/objectives: To evaluate rates of clinical complete response (cCR), surgery-free survival, permanent ostomy-free survival, and factors associated with these outcomes in patients treated with total neoadjuvant therapy (TNT) with intent for non-operative management of rectal adenocarcinoma. Methods: A retrospective review was conducted of patients treated with TNT for stage II-IV rectal adenocarcinoma (n=45) at our institution between 2013 - 2022 with curative intent. All patients received radiation with concurrent capecitabine and additional chemotherapy, either prior to or following chemoradiation (CRT), with intent for non-operative management. Response rates were determined based on post-treatment MRI and endoscopy. Kaplan-Meier method was utilized to estimate the 1- and 2-year surgery- and permanent ostomy-free survivals. Cox regression was used to evaluate associations between surgery- and permanent ostomy-free survivals and various factors of interest, including patient and tumor characteristics and clinical response. Chi-squared analysis compared rates of cCR and surgery by sequence of TNT modality and cell count ratios. Results: Of the 45 patients treated with TNT, most patients had low-lying rectal tumors with a median distance of 4.1 cm from the anal verge (range, 0.0 - 12.0). Overall, 64.4% (n=29) achieved cCR after TNT. 13 patients (28.9%) underwent surgical resection following TNT, 12 of whom had incomplete response and one who elected to undergo surgery after reaching cCR. At median follow up of 32.0 months (range, 7.1 - 86.1), 22.2% (n=10) of patients had a permanent colostomy, with only 2 of these completed for tumor regrowth after cCR. At one and two years, respectively, surgery-free survival was 77.3% and 66.2%, and permanent ostomy-free survival was 90.9% and 78.2%. Rates of cCR were higher in patients who received CRT first compared to those who received chemotherapy first (72.2% vs. 33.3%, p=0.029) and rates of surgery were also lower in patients who received CRT first compared to those who received chemotherapy first (19.4% vs. 66.7%, p=0.005). On Cox regression model, cCR on 6 month post-CRT endoscopy was associated with surgery-free survival (p=0.006) and permanent ostomy-free survival (p=0.033). Clinical response at earlier follow up points did not predict surgery- nor permanent ostomy-free survival. Conclusion: These results support evidence that TNT may be a non-surgical option for select patients with rectal adenocarcinoma who desire organ preservation. In this investigation at a single institution, the treatment response on 6-month post-CRT endoscopy was the best predictor of surgery- and permanent ostomy-free survival, which are outcomes that are important to patient quality of life. CRT followed by consolidation chemotherapy was associated with higher rates of cCR and lower rates of surgery compared to those treated with induction chemotherapy.

Have outcomes following colectomy in the United States improved over time?

BACKGROUND: There has been tremendous effort to improve quality following colorectal surgery, including the proliferation of minimally invasive techniques, enhanced recovery protocols, and surgical site infection prevention bundles. While these programs have demonstrated improved postoperative outcomes at the institutional level, it is unclear whether similar benefits are present on a national scale. METHODS: American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Targeted Colectomy data from 2012 to 2020 were used to identify patients undergoing minimally invasive surgery (MIS) or open partial colectomy (CPT 44140, 44204) or low anterior resection (CPT 44145, 44207). Chronological cohorts as well as annual trends in 30-day postoperative outcomes including surgical site infection, venous thromboembolism, and length of stay were assessed using both univariable and multivariable regression analyses. RESULTS: 261,301 patients, 135,876 (52 â€‹%) female, with a median age of 62 (IQR 53-72) were included. Across all years, MIS partial colectomy was the most common procedure (37 â€‹%), followed by MIS low anterior resection (27 â€‹%), open partial colectomy (24 â€‹%), and open low anterior resection (12 â€‹%). MIS increased from 59 â€‹% in 2012-2014 to 66 â€‹% in 2018-2020 (p â€‹< â€‹0.001). During this same period, postoperative length of stay decreased from a median of 5 days (IQR 4-7) in 2012-2014 to 4 days (IQR 3-6) in 2018-2020 (p â€‹< â€‹0.001). Superficial surgical site infections decreased from 5.5 â€‹% in 2012-2014 to 2.9 â€‹% in 2018-2020 (p â€‹< â€‹0.001). Deep surgical site infections similarly decreased from 1.1 â€‹% to 0.4 â€‹% between these periods (p â€‹< â€‹0.001). Pulmonary embolism also decreased from 0.6 â€‹% to 0.5 â€‹% between periods (p â€‹= â€‹0.02). 30-day mortality was unchanged at 1.7 â€‹% between 2012-2014 and 2018-2020 (p â€‹= â€‹0.40). After adjustment for ACS NSQIP estimated probability of morbidity and mortality, undergoing a colectomy in 2020 compared to 2012 was associated with a 14 â€‹% decrease in postoperative length of stay (p â€‹< â€‹0.001). CONCLUSIONS: Between 2012 and 2020, significant improvements in postoperative outcomes after colectomy were observed in the United States. These results support the positive impact that the widespread adoption of quality improvement initiatives is having on colorectal patient care nationally.

Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy: A Secondary Analysis of the OPRA Randomized Clinical Trial.

Importance: Assessing clinical tumor response following completion of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer is paramount to select patients for watch-and-wait treatment. Objective: To assess organ preservation (OP) and oncologic outcomes according to clinical tumor response grade. Design, Setting, and Participants: This was secondary analysis of the Organ Preservation in Patients with Rectal Adenocarcinoma trial, a phase 2, nonblinded, multicenter, randomized clinical trial. Randomization occurred between April 2014 and March 2020. Eligible participants included patients with stage II or III rectal adenocarcinoma. Data analysis occurred from March 2022 to July 2023. Intervention: Patients were randomized to induction chemotherapy followed by chemoradiation or chemoradiation followed by consolidation chemotherapy. Tumor response was assessed 8 (±4) weeks after TNT by digital rectal examination and endoscopy and categorized by clinical tumor response grade. A 3-tier grading schema that stratifies clinical tumor response into clinical complete response (CCR), near complete response (NCR), and incomplete clinical response (ICR) was devised to maximize patient eligibility for OP. Main Outcomes and Measures: OP and survival rates by clinical tumor response grade were analyzed using the Kaplan-Meier method and log-rank test. Results: There were 304 eligible patients, including 125 patients with a CCR (median [IQR] age, 60.6 [50.4-68.0] years; 76 male [60.8%]), 114 with an NCR (median [IQR] age, 57.6 [49.1-67.9] years; 80 male [70.2%]), and 65 with an ICR (median [IQR] age, 55.5 [47.7-64.2] years; 41 male [63.1%]) based on endoscopic imaging. Age, sex, tumor distance from the anal verge, pathological tumor classification, and clinical nodal classification were similar among the clinical tumor response grades. Median (IQR) follow-up for patients with OP was 4.09 (2.99-4.93) years. The 3-year probability of OP was 77% (95% CI, 70%-85%) for patients with a CCR and 40% (95% CI, 32%-51%) for patients with an NCR (P < .001). Clinical tumor response grade was associated with disease-free survival, local recurrence-free survival, distant metastasis-free survival, and overall survival. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, most patients with a CCR after TNT achieved OP, with few developing tumor regrowth. Although the probability of tumor regrowth was higher for patients with an NCR compared with patients with a CCR, a significant proportion of patients achieved OP. These findings suggest the 3-tier grading schema can be used to estimate recurrence and survival outcomes in patients with locally advanced rectal cancer who receive TNT. Trial Registration: ClinicalTrials.gov Identifier: NCT02008656.

Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.To assess long-term risk of local tumor regrowth, we report updated organ preservation rate and oncologic outcomes of the OPRA trial (ClinicalTrials.gov identifier: NCT02008656). Patients with stage II/III rectal cancer were randomly assigned to receive induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Patients who achieved a complete or near-complete response after finishing treatment were offered watch-and-wait (WW). Total mesorectal excision (TME) was recommended for those who achieved an incomplete response. The primary end point was disease-free survival (DFS). The secondary end point was TME-free survival. In total, 324 patients were randomly assigned (INCT-CRT, n = 158; CRT-CNCT, n = 166). Median follow-up was 5.1 years. The 5-year DFS rates were 71% (95% CI, 64 to 79) and 69% (95% CI, 62 to 77) for INCT-CRT and CRT-CNCT, respectively (P = .68). TME-free survival was 39% (95% CI, 32 to 48) in the INCT-CRT group and 54% (95% CI, 46 to 62) in the CRT-CNCT group (P = .012). Of 81 patients with regrowth, 94% occurred within 2 years and 99% occurred within 3 years. DFS was similar for patients who underwent TME after restaging (64% [95% CI, 53 to 78]) and patients in WW who underwent TME after regrowth (64% [95% CI, 53 to 78]; P = .94). Updated analysis continues to show long-term organ preservation in half of the patients with rectal cancer treated with total neoadjuvant therapy. In patients who enter WW, most cases of tumor regrowth occur in the first 2 years.

How I Do It: Suicidal Ideation During Surgical Training: Is an Innovative Surgical Trainee Check Ins Program a Part of the Solution?

OBJECTIVE: Mental health distress and suicidal ideation are leading contributors to the silent epidemic of physician suicide leading to approximately 300 to 400 physician deaths per year. The Second Trial has illuminated the alarming fact that several of our residents have experienced suicidal thoughts within the last year. Unfortunately, our institution is not an outlier. Suicidal ideation and under- or untreated mental health disorders are increasingly prevalent in the surgical trainee population. Given the major concern for our residents' well-being, our department consulted a licensed mental health professional familiar with resident training and the GME to develop a program to provide access to a mental health professional that is free of cost for trainees, safe and confidential. DESIGN: Implementation of a 30 minute opt-out resident check-in program with a licensed mental health professional and a post-session survey that provided retrospective survey data for analysis. SETTING: This program was implemented at the University of Virginia Health System in Charlottesville, VA. PARTICIPANTS: General surgery categorical and preliminary residents participated in this program. RESULTS: Thirty residents participated in the program and an overwhelming majority would like to continue this program at regular intervals. Sessions were 25 minutes on average and 27.7% of participants requested additional sessions. CONCLUSIONS: Implementation of this program for our surgical trainees was favorably perceived with request for continuation of the program and provided access to a safe space with a familiar provider.

Associations of Race, Ethnicity, and Social Determinants of Health With Colorectal Cancer Screening.

BACKGROUND: Racial and ethnic disparities in receipt of recommended colorectal cancer screening exist; however, the impact of social determinants of health on such disparities has not been recently studied in a national cohort. OBJECTIVE: This study aimed to determine whether social determinants of health attenuate racial disparities in receipt of colorectal cancer screening. DESIGN: This was a cross-sectional telephone survey of self-reported race and ethnicity and up-to-date colorectal cancer screening. Associations between race/ethnicity and colorectal cancer screening were tested before and after adjustment for demographics, behavioral factors, and social determinants of health. SETTING: This was a nationally representative telephone survey of US residents in 2018. PATIENTS: The patients included were US residents aged 50 to 75 years. MAIN OUTCOME MEASURES: The primary outcome was up-to-date colorectal cancer screening status, according to 2008 US Preventive Services Task Force recommendations. RESULTS: This study included 226,106 respondents aged 50 to 75 years. Before adjustment, all minority racial and ethnic groups demonstrated a significantly lower odds of screening than those of non-Hispanic white respondents. After adjustment for demographics, behavioral factors, and social determinants of health, compared to non-Hispanic white respondents, odds of screening were found to be increased among non-Hispanic black respondents (OR, 1.10; p = 0.02); lower but attenuated among Hispanic respondents (OR, 0.73; p < 0.001), non-Hispanic American Indian/Alaskan Native respondents (OR, 0.85; p = 0.048), and non-Hispanic respondents of other races (OR, 0.82; p = 0.01); and lower but not attenuated among non-Hispanic Asian respondents (OR, 0.68; p < 0.001). LIMITATIONS: Recall bias, participant bias, and residual confounding. CONCLUSIONS: Adjustment for social determinants of health reduced racial and ethnic disparities in colorectal cancer screening among all minority racial and ethnic groups except non-Hispanic Asian individuals; however, other unmeasured confounders likely exist. See Video Abstract at http://links.lww.com/DCR/B977 . ASOCIACIN DE RAZA, ETNICIDAD Y DETERMINANTES SOCIALES DE LA SALUD CON LA DETECCIN DEL CNCER COLORRECTAL: ANTECEDENTES: Existen disparidades raciales y étnicas en la recepción de las pruebas recomendadas de detección de cáncer colorrectal; sin embargo, el impacto de los determinantes sociales de la salud en dichas disparidades no se ha estudiado recientemente en una cohorte nacional.OBJETIVO: El objetivo de este estudio fue determinar si los determinantes sociales de la salud atenúan las disparidades raciales en la recepción de pruebas de detección del cáncer colorrectal.DISEÑO: Encuesta telefónica transversal de raza y etnia autoinformada y detección actualizada de cáncer colorrectal. Las asociaciones entre la raza/etnicidad y la detección del cáncer colorrectal se probaron antes y después del ajuste por demografía, factores conductuales y determinantes sociales de la salud.ESCENARIO: Esta fue una encuesta telefónica representativa a nivel nacional de los residentes de EE. UU. en 2018.PACIENTES: Los pacientes eran residentes de EE. UU. de 50 a 75 años.PRINCIPALES MEDIDAS DE RESULTADO: Estado actualizado de detección de cáncer colorrectal, según las recomendaciones del Grupo de Trabajo de Servicios Preventivos de EE. UU. de 2008.RESULTADOS: Este estudio incluyó a 226.106 encuestados de 50 a 75 años. Antes del ajuste, todos los grupos étnicos y raciales minoritarios demostraron probabilidades significativamente más bajas de detección en comparación con los encuestados blancos no hispanos. Después del ajuste por demografía, factores conductuales y determinantes sociales de la salud, en comparación con los encuestados blancos no hispanos, las probabilidades de detección aumentaron entre los encuestados negros no hispanos (OR 1,10, p = 0,02); más bajo pero atenuado entre los encuestados hispanos (OR 0,73, p < 0,001), los encuestados indios americanos/nativos de Alaska no hispanos (OR 0,85, p = 0,048) y los encuestados no hispanos de otras razas (OR 0,82, p = 0,01); y menor pero no atenuado entre los encuestados asiáticos no hispanos (OR 0,68, p < 0,001).LIMITACIONES: Sesgo de recuerdo y sesgo de participante, así como confusión residual.CONCLUSIONES: El ajuste para los determinantes sociales de la salud redujo las disparidades raciales y étnicas en la detección del cáncer colorrectal entre todos los grupos étnicos y raciales minoritarios, excepto las personas asiáticas no hispanas; sin embargo, es probable que existan otros factores de confusión no medidos. Consulte Video Resumen en http://links.lww.com/DCR/B977 . (Traducción-Dr. Felipe Bellolio ).

Impact of a High-Resolution Anoscopy Clinic on Management of Anal Dysplasia in Women Living With HIV.

BACKGROUND: The rate of anal squamous cell cancer (aSCC) is increasing among women living with HIV. Treatment of precursor high grade squamous intraepithelial lesions (HSIL) may reduce the risk of progression to aSCC. The objective of this study was to examine effects of a dedicated high-resolution anoscopy (HRA) clinic on management of HSIL in women with HIV. METHODS: Women living with HIV who underwent anal dysplasia screening at a single institution between 2006 and 2020 were reviewed. Those who underwent screening before (Group A) and after (Group B) the implementation of an HRA program in 2017 were compared. The primary outcome of interest was the successful detection and treatment of HSIL. RESULTS: A total of 201 women living with HIV underwent anal dysplasia screening between 2006 and 2020. Seventy-seven patients were found to have abnormal anal cytology requiring further treatment: 43 (55.8%) in Group A and 34 (44.2%) patients in Group B. Of the patients with abnormal anal cytology, 76.7% of patients in Group A received further biopsy and treatment, whereas 79.4% of Group B patients underwent subsequent biopsy and treatment. In propensity score weighting logistic regression analysis, the Group B was 4.6 times as likely to diagnosis HSIL on biopsy compared to Group A (OR = 4.60, 95% CI: 1.15 to 18.38, P = .03). CONCLUSIONS: Anal dysplasia is common among women living with HIV. The establishment of a HRA program was associated with increased identification and treatment of HSIL among women living with HIV, which may prevent the progression to aSCC.

Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.

PURPOSE: Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited. METHODS: In this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival. RESULTS: Median follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates. CONCLUSION: Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy.

Residents as Leaders: Using a Delphi Process to Conduct an Institutional Preoperative Patient Optimization Quality Improvement Initiative.

BACKGROUND: Many residency programs struggle to meet the ACGME requirement for resident participation in quality improvement initiatives. STUDY DESIGN: As part of an institutional quality improvement effort, trainees from the Departments of Surgery and Anesthesiology at a single academic medical center were teamed with institutional content experts in 7 key risk factor areas within preoperative patient optimization. A systematic review of each subject matter area was performed using the MEDLINE database. Institutional recommendations for the screening and management of each risk factor were developed and approved using modified Delphi consensus methodology. Upon project completion, an electronic survey was administered to all individuals who participated in the process to assess the perceived value of participation. RESULTS: Fifty-one perioperative stakeholders participated in recommendation development: 26 trainees and 25 content experts. Residents led 6 out of 7 groups specific to a subject area within preoperative optimization. A total of 4,649 abstracts were identified, of which 456 full-text articles were selected for inclusion in recommendation development. Seventeen out of 26 (65.4%) trainees completed the survey. The vast majority of trainees reported increased understanding of their preoperative optimization subject area (15/17 [88.2%]) as well as the Delphi consensus method (14/17 [82.4%]) after participation in the project. Fourteen out of 17 (82.4%) trainees stated that they would participate in a similar quality improvement initiative again. CONCLUSIONS: We demonstrate a novel way to involve trainees in an institutional quality initiative that served to educate trainees in quality improvement, the systematic review process, Delphi methodology, and preoperative optimization. This study provides a framework that other residency programs can use to engage residents in institutional quality improvement efforts.

Incidence and Characterization of Rectal Complications From Fecal Management Systems.

BACKGROUND: Fecal management systems have become ubiquitous in hospitalized patients with fecal incontinence or severe diarrhea, especially in the setting of perianal wounds. Although fecal management system use has been shown to be safe and effective in initial series, case reports of rectal ulceration and severe bleeding have been reported, with a relative paucity of clinical safety data in the literature. OBJECTIVE: The purpose of this study was to determine the rate of rectal complications attributable to fecal management systems, as well as to characterize possible risk factors and appropriate management strategies for such complications. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at a large academic medical center. PATIENTS: All medical and surgical patients who underwent fecal management system placement from December 2014 to March 2017 were included. MAIN OUTCOME MEASURES: We measured any rectal complication associated with fecal management system use, defined as any rectal injury identified after fecal management system use confirmed by lower endoscopy. RESULTS: A total of 629 patients were captured, with a median duration of fecal management system use of 4 days. Overall, 8 patients (1.3%) experienced a rectal injury associated with fecal management system use. All of the patients who experienced a rectal complication had severe underlying comorbidities, including 2 patients on dialysis, 1 patient with cirrhosis, and 3 patients with a recent history of emergent cardiac surgery. In 3 patients the bleeding resolved spontaneously, whereas the remaining 5 patients required intervention: transanal suture ligation (n = 2), endoscopic clip placement (n = 1), rectal packing (n = 1), and proctectomy in 1 patient with a history of pelvic radiotherapy. LIMITATIONS: The study was limited by its retrospective design and single institution. CONCLUSIONS: This is the largest study to date evaluating rectal complications from fecal management system use. Although rectal injury rates are low, they can lead to serious morbidity. Advanced age, severe comorbidities, pelvic radiotherapy, and anticoagulation status or coagulopathy are important factors to consider before fecal management system placement. See Video Abstract at http://links.lww.com/DCR/B698. INCIDENCIA Y CARACTERIZACIN DE LAS COMPLICACIONES RECTALES DE LOS SISTEMAS DE MANEJO FECAL: ANTECEDENTES:Los sistemas de manejo fecal se han vuelto omnipresentes en pacientes hospitalizados con incontinencia fecal o diarrea severa, especialmente en el contexto de heridas perianales. Aunque se ha demostrado que el uso del sistema de tratamiento fecal es seguro y eficaz en la serie inicial, se han notificado casos de ulceración rectal y hemorragia grave, con una relativa escasez de datos de seguridad clínica en la literatura.OBJETIVO:Determinar la tasa de complicaciones rectales atribuibles a los sistemas de manejo fecal. Caracterizar los posibles factores de riesgo y las estrategias de manejo adecuadas para tales complicaciones.DISEÑO:Estudio de cohorte retrospectivo.ENTORNO CLINICO:Centro médico académico de mayor volumen.PACIENTES:Todos los pacientes médicos y quirúrgicos que se sometieron a la colocación del sistema de manejo fecal desde diciembre de 2014 hasta marzo de 2017.PRINCIPALES MEDIDAS DE VALORACION:Cualquier complicación rectal asociada con el uso del sistema de manejo fecal, definida como cualquier lesión rectal identificada después del uso del sistema de manejo fecal confirmada por endoscopia baja.RESULTADOS:Se identificaron un total de 629 pacientes, con una duración media del uso del sistema de manejo fecal de 4,0 días. En general, 8 (1,3%) pacientes desarrollaron una lesión rectal asociada con el uso del sistema de manejo fecal. Todos los pacientes que mostraron una complicación rectal tenían comorbilidades subyacentes graves, incluidos dos pacientes en diálisis, un paciente con cirrosis y tres pacientes con antecedentes recientes de cirugía cardíaca emergente. En tres pacientes el sangrado se resolvió espontáneamente, mientras que los cinco pacientes restantes requirieron intervención: ligadura de sutura transanal (2), colocación de clip endoscópico (1), taponamiento rectal (1) y proctectomía en un paciente con antecedentes de radioterapia pélvica.LIMITACIONES:Diseño retrospectivo, institución única.CONCLUSIONES:Este es el estudio más grande hasta la fecha que evalúa las complicaciones rectales del uso del sistema de manejo fecal. Si bien las tasas de lesión rectal son bajas, pueden provocar una morbilidad grave. La edad avanzada, las comorbilidades graves, la radioterapia pélvica y el estado de anticoagulación o coagulopatía son factores importantes a considerar antes de la colocación del sistema de manejo fecal. Consulte Video Resumen en http://links.lww.com/DCR/B698.

Factors Associated with Receipt of Oral Antibiotic Agents and Mechanical Bowel Preparation before Elective Colectomy.

Background: Pre-operative administration of combined oral antibiotic agents and mechanical bowel preparation has been demonstrated to improve post-operative outcomes after elective colectomy, however, many patients do not receive combined preparation. Patient and procedural determinants of combined preparation receipt remain understudied. Patients and Methods: All patients undergoing elective colectomy within the 2018 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Participant Use File and Targeted Colectomy datasets were included. Univariable and multivariable logistic regression analyses were performed to identify factors associated with receipt of combined preparation. Results: A total of 21,889 patients were included, of whom 13,848 (63.2%) received combined preparation pre-operatively. Patients who received combined preparation tended to be younger, male, of white race, and of non-Hispanic ethnicity (all p < 0.05). After multivariable adjustment, male gender, body mass index (BMI) 30-39 kg/m2, independent functional status, and laparoscopic and robotic surgical approaches were associated with receipt of combined preparation (all p < 0.05), whereas Asian race, hypertension, disseminated cancer, and inflammatory bowel disease were associated with omission of combined preparation (all p < 0.05). Conclusions: Patients with risk factors for infectious complications-including a poor functional status, comorbid conditions, and undergoing an open procedure-are less likely to receive combined preparation before elective colectomy. Similarly, female and Asian patients are less likely to receive combined preparation, emphasizing the need for equitable administration of combined preparation.

Wearable technology and the association of perioperative activity level with 30-day readmission among patients undergoing major colorectal surgery.

BACKGROUND: The proliferation of wearable technology presents a novel opportunity for perioperative activity monitoring; however, the association between perioperative activity level and readmission remains underexplored. This study sought to determine whether physical activity data captured by wearable technology before and after colorectal surgery can be used to predict 30-day readmission. METHODS: In this prospective observational cohort study of adults undergoing elective major colorectal surgery (January 2018 to February 2019) at a single institution, participants wore an activity monitor 30 days before and after surgery. The primary outcome was return to baseline percentage, defined as step count on the day before discharge as a percentage of mean preoperative daily step count, among readmitted and non-readmitted patients. RESULTS: 94 patients had sufficient data available for analysis, of which 16 patients (17.0%) were readmitted within 30 days following discharge. Readmitted patients achieved a lower return to baseline percentage compared to patients who were not readmitted (median 15.1% vs. 31.8%; P = 0.004). On multivariable analysis adjusting for readmission risk and hospital length of stay, an absolute increase of 10% in return to baseline percentage was associated with a 40% decreased risk of 30-day readmission (odds ratio 0.60; P = 0.02). Analysis of the receiver operating characteristic curve identified 28.9% as an optimal return to baseline percent threshold for predicting readmission. CONCLUSIONS: Achieving a higher percentage of an individual's preoperative baseline activity level on the day prior to discharge after major colorectal surgery is associated with decreased risk of 30-day hospital readmission.

Preoperative REM sleep is associated with complication development after colorectal surgery.

BACKGROUND: While total sleep duration and rapid eye movement (REM) sleep duration have been associated with long-term mortality in non-surgical cohorts, the impact of preoperative sleep on postoperative outcomes has not been well studied. METHODS: In this secondary analysis of a prospective observational cohort study, patients who recorded at least 1 sleep episode using a consumer wearable device in the 7 days before elective colorectal surgery were included. 30-day postoperative outcomes among those who did and did not receive at least 6 h of total sleep, as well as those who did and did not receive at least 1 h of rapid eye movement (REM) sleep, were compared. RESULTS: 34 out of 95 (35.8%) patients averaged at least 6 h of sleep per night, while 44 out of 82 (53.7%) averaged 1 h or more of REM sleep. Patients who slept less than 6 h had similar postoperative outcomes compared to those who slept 6 h or more. Patients who averaged less than 1 h of REM sleep, compared to those who achieved 1 h or more of REM sleep, had significantly higher rates of complication development (29.0% vs. 9.1%, P = 0.02), and return to the OR (10.5% vs. 0%, P = 0.04). After adjustment for confounding factors, increased REM sleep duration remained significantly associated with decreased complication development (increase in REM sleep from 50 to 60 min: OR 0.72, P = 0.009; REM sleep ≥ 1 h: OR 0.22, P = 0.03). CONCLUSION: In this cohort of patients undergoing elective colorectal surgery, those who developed a complication within 30 days were less likely to average at least 1 h of REM sleep in the week before surgery than those who did not develop a complication. Preoperative REM sleep duration may represent a risk factor for surgical complications; however additional research is necessary to confirm this relationship.

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer.

Checkpoint-blockade therapy (CBT) is approved for select colorectal cancer (CRC) patents, but additional immunotherapeutic options are needed. We hypothesized that vaccination with carcinoembryonic antigen (CEA) and Her2/neu (Her2) peptides would be immunogenic and well tolerated by participants with advanced CRC. A pilot clinical trial (NCT00091286) was conducted in HLA-A2+ or -A3+ Stage IIIC-IV CRC patients. Participants were vaccinated weekly with CEA and Her2 peptides plus tetanus peptide and GM-CSF emulsified in Montanide ISA-51 adjuvant for 3 weeks. Adverse events (AEs) were recorded per NIH Common Terminology Criteria for Adverse Events version 3. Immunogenicity was evaluated by interferon-gamma ELISpot assay of in vitro sensitized peripheral blood mononuclear cells and lymphocytes from the sentinel immunized node. Eleven participants were enrolled and treated; one was retrospectively found to be ineligible due to HLA type. All 11 participants were included in AEs and survival analyses, and the 10 eligible participants were evaluated for immunogenicity. All participants reported AEs: 82% were Grade 1-2, most commonly fatigue or injection site reactions. Two participants (18%) experienced treatment-related dose-limiting Grade 3 AEs; both were self-limiting. Immune responses to Her2 or CEA peptides were detected in 70% of participants. Median overall survival (OS) was 16 months; among those enrolled with no evidence of disease (n = 3), median OS was not reached after 10 years of follow-up. These data demonstrate that vaccination with CEA or Her2 peptides is well tolerated and immunogenic. Further study is warranted to assess potential clinical benefits of vaccination in advanced CRC either alone or in combination with CBT.

A history of Clostridioides difficile infection portends infection recurrence and worse outcomes after stoma reversal.

BACKGROUND: Clostridioides difficile infection is reported to occur after 2.2% of colorectal operations and is associated with longer length of hospital stay, greater overall healthcare cost, and significant morbidity and mortality. The incidence of Clostridioides difficile infection is greatest after elective stoma reversal. The purpose of this study was to evaluate the effect of prior Clostridioides difficile infection on patients undergoing stoma reversal. We hypothesized that patients with a history of Clostridioides difficile infection who underwent stoma reversal will be at an increased risk of postoperative Clostridioides difficile infection compared with patients without a history of Clostridioides difficile infection. METHODS: This was an observational cohort study of patients undergoing elective stoma reversal surgery by colorectal surgeons at a single academic institution during a 10-year period. A prospectively maintained institutional database was queried to identify 454 patients who underwent stoma reversal surgery between January 1, 2007 and December 31, 2017. The primary outcomes were Clostridioides difficile infection after stoma reversal and time to Clostridioides difficile infection after bowel refunctionalization. Secondary outcomes included postoperative complications, length of hospital stay, discharge destination, and 30-day readmission rate. Univariate and multivariable logistic regression analyses were conducted to identify factors associated with Clostridioides difficile infection after stoma reversal. RESULTS: A total of 445 patients were identified who underwent elective stoma reversal, 42 of whom had a history of Clostridioides difficile infection before the stoma reversal. There were no significant differences in patient age, number of days diverted, or use of perioperative antibiotics between patients with and without a history of Clostridioides difficile infection. The incidence of postreversal Clostridioides difficile infection was 23.4% in patients with a history of Clostridioides difficile infection compared with 9.6% in patients with no Clostridioides difficile infection history (P = .004); however, time to Clostridioides difficile infection after reversal did not differ. History of Clostridioides difficile infection was also associated with greater risk of postoperative complications (26.2% vs 9.4%, P < .01), increased length of stay (3 vs 5 days postoperatively, P < .01), increased likelihood of discharge to a skilled-care facility (11.9% vs 6.2%, P < .01), and readmission (13.7 vs 31.0%, P < .01) within 30 days. In a multivariable logistic regression model, history of Clostridioides difficile infection, increased length of hospital stay, and discharge to a skilled facility were associated with increased risk of Clostridioides difficile infection after reversal, while proton pump inhibitors use was associated with decreased risk of Clostridioides difficile infection. CONCLUSION: Patients with a prior history of Clostridioides difficile infection who underwent stoma reversal exhibited higher rates of postoperative Clostridioides difficile infection and were at greater risk of postoperative complications, discharge to a skilled facility, and 30-day readmission. Furthermore, research into interventions aimed at improving outcomes in this unique, high-risk population is needed.

Preoperative opioid use is associated with increased risk of postoperative complications within a colorectal-enhanced recovery protocol.

BACKGROUND: As the opioid epidemic escalates, preoperative opioid use has become increasingly common. Recent studies associated preoperative opioid use with postoperative morbidity. However, limited study of its impact on patients within enhanced recovery protocols (ERP) exists. We assessed the impact of preoperative opioid use on postoperative complications among colorectal surgery patients within an ERP, hypothesizing that opioid-exposed patients would be at increased risk of complications. METHODS: Elective colorectal cases from August 2013 to June 2017 were reviewed in a retrospective cohort study comparing preoperative opioid-exposed patients to opioid-naïve patients. Postoperative complications were defined as a composite of complications captured by the American College of Surgeons National Surgical Quality Improvement Program. Logistic regression identified risk factors for postoperative complications. RESULTS: 707 patients were identified, including 232 (32.8%) opioid-exposed patients. Opioid-exposed patients were younger (57.9 vs 61.9 years; p < 0.01) and more likely to smoke (27.6 vs 17.1%; p < 0.01). Laparoscopic procedures were less common among opioid-exposed patients (44.8 vs 58.1%; p < 0.01). Median morphine equivalents received were higher in opioid-exposed patients (65.0 vs 20.1 mg; p < 0.01), but compliance to ERP elements was otherwise equivalent. Postoperative complications were higher among opioid-exposed patients (28.5 vs 15.0%; p < 0.01), as was median length of stay (4.0 vs 3.0 days; p < 0.01). Logistic regression identified multiple patient- and procedure-related factors independently associated with postoperative complications, including preoperative opioid use (p = 0.001). CONCLUSION: Preoperative opioid use is associated with increased risk of postoperative complications in elective colorectal surgery patients within an ERP. These results highlight the negative impact of opioid use, suggesting an opportunity to further reduce the risk of surgical complications through ERP expansion to include preoperative mitigation strategies for opioid-exposed patients.