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.

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.

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.

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.

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.

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.

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.

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.

Wearable Technology in the Perioperative Period: Predicting Risk of Postoperative Complications in Patients Undergoing Elective Colorectal Surgery.

BACKGROUND: The implementation of protocolized care pathways has resulted in major improvements in surgical outcomes. Additional gains will require focused efforts to alter preexisting risk. Prehabilitation programs provide a promising avenue for risk reduction. OBJECTIVE: This study used wearable technology to monitor activity levels before colorectal surgery to evaluate the impact of preoperative activity on postoperative outcomes. DESIGN: This was a prospective nonrandomized observational study. SETTINGS: The study was conducted at a large academic medical center. PATIENTS: Patients undergoing elective colorectal surgery from January 2018 to February 1, 2019, were included. MAIN OUTCOME MEASURES: Patients were trained in the usage of wearable activity-tracking devices and instructed to wear the device for 30 days before surgery. Patients were stratified as active (≥5000 steps per day) and inactive (<5000 steps per day) based on preoperative step counts. Univariate analyses compared postoperative outcomes. Multivariable regression models analyzed the impact of preoperative activity on postoperative complications, adjusting for each patient's baseline risk as calculated using the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator. Models were rerun without the addition of activity and the predictive ability of the models compared. RESULTS: Ninety-nine patients were included, with 40 (40.4%) classified as active. Active patients experienced fewer overall complications (11/40 (27.5%) vs 33/59 (55.9%); p = 0.005) and serious complications (2/40 (5%) vs 12/59 (20.3%); p = 0.032). Increased preoperative activity was associated with a decreased risk of any postoperative complication (OR = 0.386; p = 0.0440) on multivariable analysis. The predictive ability of the models for complications and serious complications was improved with the addition of physical activity. LIMITATIONS: The study was limited by its small sample size and single institution. CONCLUSIONS: There is significant room for improvement in baseline preoperative activity levels of patients undergoing colorectal surgery, and poor activity is associated with increased postoperative complications. These data will serve as the basis for an interventional trial investigating whether wearable devices help improve surgical outcomes through a monitored preoperative exercise program. See Video Abstract at http://links.lww.com/DCR/B145. TECNOLOGÍA PORTÁTIL EN EL PERÍODO PERIOPERATORIO: PREDICCIÓN DEL RIESGO DE COMPLICACIONES POSTOPERATORIAS EN PACIENTES SOMETIDOS A CIRUGÍA COLORRECTAL ELECTIVA: La implementación de vías de atención protocolizadas ha dado lugar a importantes mejoras en los resultados quirúrgicos. Para obtener más beneficios será necesario realizar esfuerzos concentrados para modificar el riesgo preexistente. Los programas de rehabilitación proporcionan una vía prometedora para la reducción del riesgo.Este estudio utilizó tecnología portátil para monitorear los niveles de actividad antes de la cirugía colorrectal para evaluar el impacto de la actividad preoperatoria en los resultados postoperatorios.Estudio observacional prospectivo no aleatorizado.Gran centro médico académico.Pacientes sometidos a cirugía colorrectal electiva desde enero de 2018 hasta el 1 de febrero de 2019.Los pacientes fueron entrenados en el uso de dispositivos portátiles para el seguimiento de la actividad y se les indicó usar el dispositivo durante 30 días antes de la cirugía. Los pacientes fueron estratificados como activos (> 5000 pasos / día) e inactivos (<5000 pasos / día) en base a los recuentos de pasos preoperatorios. Los análisis univariados compararon los resultados postoperatorios. Los modelos de regresión multivariable analizaron el impacto de la actividad preoperatoria en las complicaciones postoperatorias, ajustando el riesgo de referencia de cada paciente según lo calculado utilizando la Calculadora de riesgo quirúrgico del Programa Nacional de Mejora de la Calidad Quirúrgica del Colegio Americano de Cirujanos. Los modelos se volvieron a ejecutar sin agregar actividad, y se comparó la capacidad de predicción de los modelos.Noventa y nueve pacientes fueron incluidos con 40 (40.4%) clasificados como activos. Los pacientes activos experimentaron menos complicaciones generales [11/40 (27,5%) frente a 33/59 (55,9%); p = 0,005] y complicaciones graves [2/40 (5%) frente a 12/59 (20,3%); p = 0,032]. El aumento de la actividad preoperatoria se asoció con una disminución del riesgo de cualquier complicación postoperatoria (OR 0.386, p = 0.0440) en el análisis multivariable. La capacidad predictiva de los modelos para complicaciones y complicaciones graves mejoró con la adición de actividad física.Tamaño de muestra pequeño, una sola institución.Existe un margen significativo para mejorar los niveles basales de actividad preoperatoria de los pacientes de cirugía colorrectal, y la escasa actividad se asocia con mayores complicaciones postoperatorias. Estos datos servirán de base para un ensayo intervencionista que investigue si los dispositivos portátiles ayudan a mejorar los resultados quirúrgicos a través de un programa de ejercicio preoperatorio monitoreado. Consulte Video Resumen en http://links.lww.com/DCR/B145.

Preoperative bleeding requiring transfusion: An under-reported indication for hemorrhoidectomy.

BACKGROUND: Though hemorrhoids commonly cause minor gastrointestinal bleeding, major hemorrhage requiring blood transfusion is believed to be rare. We sought to identify the prevalence and risk factors for preoperative transfusion in surgical hemorrhoidectomy patients. METHODS: Patients undergoing surgical hemorrhoidectomy at a single institution (2012-2017) were evaluated for preoperative bleeding requiring transfusion. Bivariate analysis compared patients requiring transfusion to those who did not, and multivariable analysis evaluated for independent risk factors for transfusion. RESULTS: Out of 520 patients, 7.3% experienced hemorrhoidal bleeding requiring transfusion, and 80.6% reported bleeding. On multivariable analysis, the use of either an anticoagulant or non-aspirin antiplatelet agent was associated with transfusion (OR 3.08, p = 0.03). Patients requiring transfusion had extensive preoperative workups, including colonoscopy (94.7%), flexible sigmoidoscopy (7.89%), upper endoscopy (50%) and capsule endoscopy (26.3%). CONCLUSIONS: Bleeding requiring transfusion is an under-reported complication of hemorrhoids. Increased recognition could lead to expeditious surgical treatment and less costly diagnostic workup.

Compliance with the Accreditation Council for Graduate Medical Education duty hours in a general surgery residency program: Challenges and solutions in a teaching hospital.

BACKGROUND: The inception of work hour restrictions for resident physicians in 2003 created controversial changes within surgery training programs. On a recent Accreditation Council for Graduate Medical Education survey at our institution, we noted a discrepancy between low recorded violations of the duty hour restrictions and the surgery resident's perception of poor duty hour compliance. We sought to identify factors that lead to duty hour violations and to encourage accurate reporting among surgery trainees. METHODS: The A3/Lean methodology, an industry-derived, systematic, problem-solving approach, was used to investigate barriers to accurate reporting of duty hours by residents within the Department of Surgery at our academic institution. In partnership with our office of Graduate Medical Education, we encouraged a 6-month period where residents were asked to record duty hour accurately and to provide honest, descriptive explanations of violations without punitive effects on residents or the program. We performed a 6-month before-and-after analysis of duty hours violations after the A3/Lean implementation. Quantitative analysis was used to elucidate trends in violations by post graduate year and rotation. Qualitative evaluation by key thematic areas revealed resident attitudes and opinions about duty hour violations. RESULTS: Residents reported concern for personal and programmatic, punitive measures, desire to retain control of their education, and frustration with the administrative burden after violations as deterrents to honest duty hour reporting. The intervention was successful in changing logging behavior with 10 total violations prior to A3 meeting and 179 violations afterward (P = .003). This change was driven largely from an increase in short break violations (4 vs 134, P = .021). Analysis of violations revealed trends by post-graduate year, rotation, and weekend cross-coverage. Key findings including less than anticipated violations of the 80-hour work week despite high rates of short break violations. The ability to participate in procedures voluntarily and a sense of professional responsibility emerged as the prevailing themes among surgery residents describing violations. CONCLUSION: Systematic evaluation of duty hour reporting within a surgery training program can identify structural and cultural barriers to accurate reporting of duty hours. Accurate reporting can identify program-specific trends in duty hour violations that can be addressed though programmatic intervention.

An Unintended Consequence of a New Opioid Legislation.

BACKGROUND: The Controlled Substance Act was enacted in efforts to reduce the abuse and misuse of opioid pain relievers. However, the effects of this regulation on the prescribing patterns of providers has yet to be realized. OBJECTIVE: We sought to identify the changes in opioid-prescribing patterns of an elective colorectal surgical practice as a result of this legislative change. DESIGN: This is a retrospective study of patients undergoing elective colorectal surgery. Patients were intentionally grouped into group A (January 1, 2012 to October 5, 2014) and group B (October 6, 2014 to December 31, 2016) to capture the period surrounding the new legislation. SETTINGS: We evaluated patients undergoing elective colorectal surgery at a single academic center over a 5-year period. PATIENTS: There were 443 patients undergoing elective colorectal surgery between 2012 and 2016. MAIN OUTCOME MEASURES: The primary outcome was total milligram morphine equivalent of pain medication prescribed at discharge. Secondary outcomes included total number of pills prescribed, total milligram morphine equivalent of pain medication at subsequent prescriptions, and numeric postoperative pain scores. RESULTS: Patients in group B were found to have a greater mean total milligram morphine equivalent prescribed at discharge (719 (SD 593) vs 660 (SD 548), p = 0.03), mean total quantity of pills prescribed at discharge (98 (SD 106) vs 87 (SD 63), p = 0.05), and mean total quantity of pills prescribed as subsequent prescriptions (77 (SD 117) vs 68 (SD 83), p = 0.05) compared with group A. On multivariable analysis, group B was a significant predictor of greater total milligram morphine equivalents prescribed at discharge compared with group A (p = 0.01). LIMITATIONS: This study is limited by analysis from a single institution. CONCLUSIONS: Efforts to minimize opioid prescriptions after surgery through legislation could result in unintended consequences. Recognition of this result is important to effectively reduce opioid prescriptions after surgery. See Video Abstract at http://links.lww.com/DCR/B96. UNA CONSECUENCIA NO DESEADA DE UNA NUEVA LEGISLACIÓN DE OPIOIDES: La Ley de Sustancias Controladas se promulgó con el fin de reducir el abuso y el uso indebido de analgésicos opioides. Sin embargo, los efectos de esta regulación en los patrones de prescripción de los proveedores aún no se han realizado.Se intento identificar los cambios en los patrones de prescripción de opioides de una práctica quirúrgica colorrectal electiva como resultado de este cambio legislativo.Este es un estudio retrospectivo de pacientes sometidos a cirugía colorrectal electiva. Los pacientes fueron agrupados intencionalmente en el Grupo A (1 de enero de 2012 al 5 de octubre de 2014) y el Grupo B (6 de octubre de 2014 al 31 de diciembre de 2016) para capturar el período que rodea la nueva legislación.Se evaluaron a los pacientes sometidos a cirugía colorrectal electiva en un solo centro académico durante un período de 5 años.Hubo 443 pacientes que se sometieron a cirugía colorrectal electiva entre 2012-2016.La medida de resultado primaria fue el equivalente de miligramos de morfina total de los analgésicos prescritos al momento del alta. Las medidas de resultado secundarias incluyeron el número total de píldoras prescritas, el equivalente total de miligramos de morfina de la medicación para el dolor en las prescripciones posteriores y las puntuaciones numéricas de dolor postoperatorio.Se encontró que los pacientes en el Grupo B tenían un equivalente de miligramos de morfina total total mayor prescrito al alta (719 [DE 593] v. 660 [DE 548], p = 0.03), cantidad total promedio de píldoras prescritas al alta (98 [SD 106] v. 87 [SD 63], p = 0.05), y la cantidad total promedio de píldoras recetadas como recetas posteriores (77 [SD 117] v. 68 [SD 83], p = 0.05) en comparación con el Grupo A. En análisis multivariable, el Grupo B fue un predictor significativo de mayores equivalentes de morfina en miligramos totales prescritos al alta en comparación con el grupo A (p = 0.01).Este estudio está limitado por el análisis de una sola instituciónLos esfuerzos para minimizar las recetas de opioides después de la cirugía a través de la legislación podrían tener consecuencias no deseadas. El reconocimiento de este resultado es importante para reducir eficazmente las recetas de opioides después de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/B96.

Implementation of an Enhanced Recovery Protocol Is Associated With On-Time Initiation of Adjuvant Chemotherapy in Colorectal Cancer.

BACKGROUND: Delayed initiation of adjuvant chemotherapy negatively impacts long-term survival in patients with colorectal cancer. Colorectal enhanced recovery protocols result in decreased complications and length of stay; however, the impact of enhanced recovery on the timing of adjuvant chemotherapy remains unknown. OBJECTIVE: This study aimed to identify factors associated with on-time delivery of adjuvant chemotherapy after colorectal cancer surgery, hypothesizing that implementation of an enhanced recovery protocol would result in more patients receiving on-time chemotherapy. DESIGN: This was a retrospective cohort study comparing the rate of on-time adjuvant chemotherapy delivery after colorectal cancer resection before and after implementation of an enhanced recovery protocol. SETTINGS: The study was conducted at a large academic medical center. PATIENTS: All of the patients who underwent nonemergent colorectal cancer resections for curative intent from January 2010 to June 2017, excluding patients who had no indication for adjuvant chemotherapy, had received preoperative systemic chemotherapy, or did not have medical oncology records available were included. MAIN OUTCOME MEASURES: Patients before and enhanced recovery were compared, with the rate of on-time adjuvant chemotherapy delivery as the primary outcome. Adjuvant chemotherapy delivery was considered on time if initiated ≤8 weeks postoperatively, and treatment was considered delayed or omitted if initiated >8 weeks postoperatively (delayed) or never received (omitted). Multivariable logistic regression identified predictors of on-time chemotherapy delivery. RESULTS: A total of 363 patients met inclusion criteria, with 189 patients (52.1%) undergoing surgery after enhanced recovery implementation. Groups differed in laparoscopic approach and median procedure duration, both of which were higher after enhanced recovery. Significantly more patients received on-time chemotherapy after enhanced recovery implementation (p = 0.007). Enhanced recovery was an independent predictor of on-time adjuvant chemotherapy (p = 0.014). LIMITATIONS: The study was limited by its retrospective and nonrandomized before-and-after design. CONCLUSIONS: Enhanced recovery was associated with receiving on-time adjuvant chemotherapy. As prompt initiation of adjuvant chemotherapy improves survival in colorectal cancer, future investigation of long-term oncologic outcomes is necessary to evaluate the potential impact of enhanced recovery on survival. See Video Abstract at http://links.lww.com/DCR/B21. LA IMPLEMENTACIÓN DE UN PROTOCOLO DE RECUPERACIÓN ACELERADA SE ASOCIA CON EL INICIO A TIEMPO DE QUIMIOTERAPIA ADYUVANTE EN CÁNCER COLORRECTAL:: El inicio tardío de la quimioterapia adyuvante afecta negativamente la supervivencia a largo plazo en pacientes con cáncer colorrectal. Los protocolos de recuperación acelerada colorrectales dan lugar a una disminución de las complicaciones y la duración de estancia hospitalaria; sin embargo, el impacto de la recuperación acelerada en el momento de inicio de quimioterapia adyuvante sigue siendo desconocido.Este estudio tuvo como objetivo identificar los factores asociados con la administración a tiempo de la quimioterapia adyuvante después de la cirugía de cáncer colorrectal, con la hipótesis de que la implementación de un protocolo de recuperación acelerada daría lugar a que más pacientes reciban quimioterapia a tiempo.Estudio de cohorte retrospectivo que compara la tasa de administración de quimioterapia adyuvante a tiempo después de la resección del cáncer colorrectal antes y después de la implementación de un protocolo de recuperación acelerada.Centro médico académico grande.Todos los pacientes que se sometieron a resecciones de cáncer colorrectal no emergentes con intención curativa desde enero de 2010 hasta junio de 2017, excluyendo a los pacientes que no tenían indicación de quimioterapia adyuvante, que recibieron quimioterapia sistémica preoperatoria o no tenían registros médicos de oncología disponibles.Los pacientes se compararon antes y después de la implementación de la recuperación acelerada, con la tasa de administración de quimioterapia adyuvante a tiempo como el resultado primario. La administración de quimioterapia adyuvante se consideró a tiempo si se inició ≤8 semanas después de la operación, y el tratamiento se consideró retrasado / omitido si se inició> 8 semanas después de la operación (retrasado) o nunca fue recibido (omitido). La regresión logística multivariable identificó predictores de administración de quimioterapia a tiempo.363 pacientes cumplieron con los criterios de inclusión, con 189 (52.1%) pacientes sometidos a cirugía después de la implementación de recuperación acelerada. Los grupos difirieron en el abordaje laparoscópico y la duración media del procedimiento; ambos factores fueron mayores después de la recuperación acelerada. Significativamente más pacientes recibieron quimioterapia a tiempo después de la implementación de recuperación acelerada (p = 0.007). La recuperación acelerada fue un factor predictivo independiente de quimioterapia adyuvante a tiempo (p = 0.014).Diseño retrospectivo, tipo ¨antes y después¨ no aleatorizado.La recuperación acelerada se asoció con la recepción de quimioterapia adyuvante a tiempo. Debido a que el inicio rápido de la quimioterapia adyuvante mejora la supervivencia en el cáncer colorrectal, en el futuro será necesario investigar los resultados oncológicos a largo plazo para evaluar el impacto potencial de la recuperación acelerada en la supervivencia. Vea el Resumen en Video en http://links.lww.com/DCR/B21.