Circulating Tumor DNA to Predict Radiographic and Pathologic Response to Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer.

Despite advances in treatment and response assessment in locally advanced rectal cancer (LARC), it is unclear which patients should undergo nonoperative management (NOM). We performed a single-center, retrospective study to evaluate post-total neoadjuvant therapy (TNT) circulating tumor DNA (ctDNA) in predicting treatment response. We found that post-TNT ctDNA had a sensitivity of 23% and specificity of 100% for predicting residual disease upon resection, with a positive predictive value (PPV) of 100% and a negative predictive value (NPV) of 47%. For predicting poor tumor regression on MRI, ctDNA had a sensitivity of 16% and specificity of 96%, with a PPV of 75% and NPV of 60%. A commercially available ctDNA assay was insufficient to predict residual disease after TNT and should not be used alone to select patients for NOM in LARC.

Implementation of a Multispecialty Geriatric Surgery Pathway Reduces Inpatient Cost for Frail Patients.

OBJECTIVE: The objective of this study was to evaluate the effect of geriatric surgical pathway (GSP) implementation on inpatient cost of care. BACKGROUND: Achieving high-value care for older patients is the goal of the American College of Surgeons Geriatric Verification Program (ACS-GSV). We have previously shown that implementation of our geriatric surgery pathway, which aligns with the ACS-GSV standards, resulted in a reduction in loss of independence and complications. METHODS: Patients ≥65 years who underwent an inpatient elective surgical procedure included in the American College of Surgeons National Quality Improvement Program (ACS NSQIP) registry from July 2016 through December 2017 were compared with those patients from February 2018 to December 2019 who were cared for on our GSP. An amalgamation of Clinformatics DataMart, the electronic health record, and the ACS NSQIP registry produced the analytical dataset. We compared mean total and direct costs of care for the entire cohort as well as through propensity matching of frail surgical patients to account for differences in clinical characteristics. RESULTS: The total mean cost of health care services during hospitalization was significantly lower in the cohort on our GSP ($23,361±$1110) as compared with the precohort ($25,452±$1723), P <0.001. On propensity-matched analysis, cost savings was more evident in our frail geriatric surgery patients. CONCLUSIONS: This study shows that high-value care can be achieved with the implementation of a GSP that aligns with the ACS-GSV program.

Early Outcomes Following Implementation of a Multispecialty Geriatric Surgery Pathway.

OBJECTIVE: To examine geriatric-specific outcomes following implementation of a multispecialty geriatric surgical pathway (GSP). BACKGROUND: In 2018, we implemented a GSP in accordance with the proposed 32 standards of American College of Surgeons' Geriatric Surgery Verification Program. METHODS: This observational study combined data from the electronic health record system (EHR) and ACS-National Surgery Quality Improvement Program (NSQIP) to identify patients ≥65 years undergoing inpatient procedures from 2016 to 2020. GSP patients (2018-2020) were identified by preoperative high-risk screening. Frailty was measured with the modified frailty index. Surgical procedures were ranked according to the operative stress score (1-5). Loss of independence (LOI), length of stay, major complications (CD II-IV), and 30-day all-cause unplanned readmissions were measured in the pre/postpatient populations and by propensity score matching of patients by operative procedure and frailty. RESULTS: A total of 533 (300 pre-GSP, 233 GSP) patients similar by demographics (age and race) and clinical profile (frailty) were included. On multivariable analysis, GSP patients showed decreased risk for LOI [odds ratio (OR) 0.26 (0.23, 0.29) P <0.001] and major complications [OR: 0.63 (0.50, 0.78) P <0.001]. Propensity matching demonstrated similar findings. Examining frail patients alone, GSP showed decreased risk for LOI [OR: 0.30 (0.25, 0.37) P <0.001], major complications [OR: 0.31 (0.24, 0.40) P <0.001], and was independently associated with a reduction in length of stay [incidence rate ratios: 0.97 (0.96, 0.98), P <0.001]. CONCLUSIONS: In our diverse patient population, implementation of a GSP led to improved geriatric-specific surgical outcomes. Future studies to examine pathway compliance would promote the identification of further interventions.

Domains of Frailty Predict Loss of Independence in Older Adults After Noncardiac Surgery.

IMPORTANCE: Preoperative frailty has been consistently associated with death, severe complications, and loss of independence (LOI) after surgery. LOI is an important patient-centered outcome, but it is unclear which domains of frailty are most strongly associated with LOI. Such information would be important to target individual geriatric domains for optimization. OBJECTIVE: To assess whether impairment in individual domains of the Edmonton Frail Scale (EFS) can predict LOI in older adults after noncardiac surgery. DESIGN: Retrospective Cohort Study. SETTING: One Academic Hospital. PARTICIPANTS: Patients aged 65 or older who were living independently and evaluated with the EFS during a preoperative visit to the Center for Preoperative Optimization at the Johns Hopkins Hospital between June 2018 and January 2020. MAIN OUTCOME: LOI defined as discharge to increased level of care outside of the home with new mobility deficit or functional dependence. New mobility deficit and functional dependence were extracted from chart review of the standardized occupational therapy and physical therapy assessment performed before discharge. RESULTS: A total of 3497 patients were analyzed. Age (mean±SD) was 73.4±6.2 years, and 1579 (45.2%) were female. The median total EFS score was 3 (range 0-16), and 725/3497 (27%) were considered frail (EFS≥6). The frequencies of impairment in each EFS domain were functional performance (33.5% moderately impaired, 11% severely impaired), history of hospital readmission (42%), poor self-described health status (37%), and abnormal cognition (17.1% moderately impaired, 13.8% severely impaired). Overall, 235/3497 (6.7%) patients experienced LOI. Total EFS score was associated with LOI (odds ratio: 1.37, 95% CI, 1.30-1.45, P <0.001) in a model adjusted for age, sex, body mass index, American Society of Anesthesiologists rating, congestive heart failure, valvular heart disease, hypertension diagnosis, chronic lung disease, diabetes, renal failure, liver disease, weight loss, anemia, and depression. Using a nested log likelihood approach, the domains of functional performance, functional dependence, social support, health status, and urinary incontinence improved the base multivariable model. In cross-validation, total EFS improved the prediction of LOI with the final model achieving an area under the curve of 0.840. Functional performance was the single domain that most improved outcome prediction, but together with functional dependence, social support, and urinary incontinence, the model resulted in an area under the curve of 0.838. CONCLUSION AND RELEVANCE: Among domains measured by the EFS before a wide range of noncardiac surgeries in older adults, functional performance, functional dependence, social support, and urinary incontinence were independently associated with and improved the prediction of LOI. Clinical initiatives to mitigate LOI may consider screening with the EFS and targeting abnormalities within these domains.

Initial Clinical Outcomes Using Umbilical Cord-Derived Tissue Grafts to Repair Anovaginal Fistula.

BACKGROUND: Perianal fistula is a debilitating disease and challenging condition to treat. Recently, the use of stem cells has been shown to improve healing of fistulas. OBJECTIVE: The aim was to examine the use of an umbilical cord-derived stem cell graft in a pilot study as a novel scaffold/stem inlay implanted into fistula repairs for anovaginal fistula to examine healing rates. DESIGN: This was a pilot study. SETTINGS: This study took place in a colorectal surgery practice. PATIENTS: Patients with anovaginal fistula consented to participate. Cryopreserved umbilical cord tissue graft with viable cells was incorporated as an inlay using a previously reported technique by the authors. Demographic data including history of previous repairs and IBD were included. All patients were followed for a minimum of 6 weeks. MAIN OUTCOME MEASURES: The primary measures were safety and efficacy of novel stem cell graft in the treatment of anovaginal fistula. RESULTS: From September 2017 to September 2019, 15 patients underwent anovaginal fistula repair. Three of these patients underwent a second repair, for a total of 18 repairs. No patient was intentionally diverted, but 3 patients presented for repair with a preexisting stoma. The majority of repairs were previous repair failures (12; 67%), and 7 repairs were performed on 5 patients with IBD. Median follow-up was 30 (6-104) weeks. The safety profile for cryopreserved umbilical cord tissue graft was excellent as no adverse events occurred. Overall complete healing rate was 39%, and 12 (67%) repairs resulted in improvement of symptoms. LIMITATIONS: This was a small pilot study. CONCLUSIONS: This is the largest series using cryopreserved umbilical cord graft for anovaginal fistula repair. The use of umbilical cord was safe and effective at closing defects. Randomized studies are necessary to determine added benefits over current standard of care. See Video Abstract at http://links.lww.com/DCR/B896 . RESULTADOS CLNICOS INICIALES DEL USO DE INJERTOS DE TEJIDO DERIVADO DE PLACENTA PARA REPARACIN DE FSTULAS ANOVAGINALES: ANTECEDENTES:La fístula perianal es una enfermedad debilitante y una afección difícil de tratar. Recientemente, se ha demostrado que el uso de células madre mejora la curación de las fístulas.OBJETIVO:Deseamos examinar el uso de un injerto de células madre derivadas de cordón umbilical en un estudio piloto como una nueva matriz/injerto de células madre implantado en reparaciones de fístula para fístula anovaginal para examinar las tasas de curación.DISEÑO:Este fue un estudio piloto.ESCENARIO:Este estudio se llevó a cabo en una clínica de cirugía colorrectal.PACIENTES:Se obtuvo consentimiento informado de pacientes con fístula anovaginal. El injerto de tejido de cordón umbilical criopreservado con células viables se incorporó como incrustación utilizando una técnica previamente informada por los autores. Se incluyeron datos demográficos que incluían antecedentes de reparaciones previas y enfermedad inflamatoria intestinal. Todos los pacientes fueron seguidos durante un mínimo de 6 semanas.PRINCIPALES MEDIDAS DE RESULTADO:Las principales medidas fueron la seguridad y la eficacia del nuevo injerto de células madre en el tratamiento de la fístula anovaginal.RESULTADOS:Desde 9/2017-9/2019, 15 pacientes fueron sometidas a reparación de fístula anovaginal. Tres de estos pacientes fueron sometidos a una segunda reparación, para un total de 18 reparaciones. Ningún paciente fue derivado intencionalmente mientras que 3 pacientes se presentaron para reparación con un estoma preexistente. La mayoría de las reparaciones fueron fallas de reparaciones previas (12, 67%) y se realizaron siete reparaciones en 5 pacientes con enfermedad inflamatoria intestinal (EII). La mediana de seguimiento fue de 30 semanas (6-104). El perfil de seguridad del injerto de tejido de cordón umbilical criopreservado fue excelente ya que no se produjeron efectos adversos. La tasa general de curación completa fue del 39% y 12 (67%) reparaciones dieron como resultado una mejoría de los síntomas.LIMITACIONES:Este fue un pequeño estudio piloto.CONCLUSIÓNES:Ésta es la serie más grande de utilización de injerto de cordón umbilical criopreservado para la reparación de una fístula anovaginal. La utilización del cordón umbilical resultó segura y eficaz para cerrar defectos. Se necesitan estudios aleatorizados para determinar los beneficios adicionales sobre el estándar de atención actual. Consulte Video Resumen en http://links.lww.com/DCR/B896 . (Traducción-Dr. Jorge Silva Velazco ).

A Novel Patient-like Swine Model of Perianal Crohn's Disease.

BACKGROUND: Perianal Crohn's disease is associated with poor outcomes and high medical costs. It is notoriously difficult to treat despite therapeutic advancements for luminal disease. A large animal model that mimics human perianal disease is needed to test innovative therapies. OBJECTIVE: This study aimed to create a swine model that replicates the inflammatory component and therapeutic challenges found in patients with perianal Crohn's disease. DESIGN: This was an animal preclinical study. SETTINGS: The experiments were performed at the animal laboratory at the Johns Hopkins University. PATIENTS: Four sus scrufus female pigs were included in the study. INTERVENTIONS: Four female pigs underwent creation of 3 surgical perianal fistulas each, 1 rectovaginal and 2 perianal. Size 24 French setons were placed to maintain patency of the fistula tracts for 4 weeks. After removal of the setons, trinitrobenzene sulfonic acid was administered into the fistula tract to create and maintain local inflammation mimicking perianal Crohn's disease. MAIN OUTCOMES MEASURES: An MRI was obtained to assess the fistulas and the pigs were euthanized to review histopathology. RESULTS: Three inflammatory chronic fistula tracts were successfully created in each pig as confirmed by MRI and examination under anesthesia. This is the first report of maintaining patent fistulas in swine 2 weeks after removal of setons. For the first time, we reported that 2 pigs developed branching fistulas and small abscesses reminiscent of human perianal Crohn's disease. The corresponding histopathologic examination found significant chronic active inflammation on standard hematoxylin and eosin staining. LIMITATIONS: The fistulas were surgically induced and did not occur naturally. CONCLUSIONS: A chronic perianal fistula model in pigs that strongly resembles human perianal Crohn's disease was successfully created. This model can be used to test novel therapeutics and techniques to pave the path for human trials. See Video Abstract at http://links.lww.com/DCR/B969 . UN NUEVO MODELO PORCINO SIMILAR A UN PACIENTE DE LA ENFERMEDAD DE CROHN PERIANAL ANTECEDENTES: La enfermedad de Crohn perianal se asocia con malos resultados y altos costos médicos. Es notoriamente difícil de tratar a pesar de los avances terapéuticos para la enfermedad luminal. Se precisa de un modelo animal grande que imite la enfermedad perianal humana para probar terapias innovadoras.OBJETIVO:Nuestro objetivo de este estudio fue crear un modelo porcino que replique el componente inflamatorio y los desafíos terapéuticos que se encuentran en los pacientes con enfermedad de Crohn perianal.DISEÑO:Este fue un estudio preclínico en animales.AJUSTES:Los experimentos se realizaron en el laboratorio de animales de la Universidad Johns Hopkins.PACIENTES:Se incluyeron en el estudio cuatro cerdas sus scrofa.INTERVENCIONES:Cuatro cerdas fueron sometidas a la creación de 3 fístulas perianales quirúrgicas cada una: 1 recto vaginal y 2 perianales. Se colocaron sedales de 24 French para mantener la permeabilidad de los trayectos fistulosos durante 4 semanas. Tras el retiro de los sedales, se administró ácido trinitrobenceno sulfónico en el trayecto de la fístula para crear y mantener la inflamación local simulando la enfermedad de Crohn perianal.PRINCIPALES MEDIDAS DE RESULTADOS:Se obtuvo una resonancia magnética para evaluar las fístulas y los cerdos fueron sacrificados para revisar la histopatología.RESULTADOS:Se crearon de manera exitosa tres trayectos fistulosos inflamatorios crónicos en cada cerdo, confirmados por imágenes de resonancia magnética y examen bajo anestesia. Este es el primer informe de preservación de fístulas permeables en cerdos 2 semanas tras el retiro de los setones. Por primera vez, informamos que dos cerdos desarrollaron fístulas ramificadas y pequeños abscesos que recuerdan a la enfermedad de Crohn perianal humana. El examen histopatológico correspondiente encontró una significativa inflamación crónica activa en la tinción estándar de hematoxilina y eosina.LIMITACIONES:Las fístulas se indujeron quirúrgicamente y no se produjeron de forma natural.CONCLUSIONES:Se logro recrear con éxito un modelo de fístula perianal crónica en cerdos que se asemeja mucho a la enfermedad de Crohn perianal humana. Este modelo se puede utilizar para probar nuevas terapias y técnicas para allanar el camino para los ensayos en humanos. Consulte Video Resumen en http://links.lww.com/DCR/B969 . (Traducción-Dr Osvaldo Gauto).

National trends and feasibility of a robotic surgical approach in the management of patients with inflammatory bowel disease.

BACKGROUND: Research on the utilization of robotic surgical approaches in the management of inflammatory bowel disease (IBD) is limited. The aims of this study were to identify temporal trends in robotic utilization and compare the safety of a robotic to laparoscopic operative approach in patients with IBD. METHODS: Patients who underwent minimally invasive surgery (MIS) for IBD were identified using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2013-2021). Temporal trends of robotic utilization were assessed from 2013 to 2021. Primary (30-day overall and serious morbidity) and secondary (unplanned conversion to open) outcomes were assessed between 2019 and 2021, when robotic utilization was highest. Multivariable logistic regression was performed. RESULTS: The use of a robotic approach for colectomies and proctectomies increased significantly between 2013 and 2021 (p < 0.001), regardless of disease type. A total of 6016 patients underwent MIS for IBD between 2019 and 2021. 2234 (37%) patients had surgery for UC [robotic 430 (19.3%), lap 1804 (80%)] and 3782 (63%) had surgery for CD [robotic 500 (13.2%), lap 3282 (86.8%)]. For patients with UC, there was no difference in rates of overall morbidity (22.6% vs. 20.7%, p = 0.39), serious morbidity (11.4% vs. 12.3%, p = 0.60) or conversion to open (1.5% vs. 2.1%, p = 0.38) between the laparoscopic and robotic approaches, respectively. There was no difference in overall morbidity between the two groups in patients with CD (lap 14.0% vs robotic 16.4%, p = 0.15), however the robotic group exhibited higher rates of serious morbidity (7.3% vs. 11.2%, p < 0.01), shorter LOS (3 vs. 4 days, p < 0.001) and lower rates of conversion to an open procedure (3.8% vs. 1.6%, p = 0.02). Adjusted analysis showed similar results. CONCLUSION: The use of the robotic platform in the surgical management of IBD is increasing and is not associated with an increase in 30-day overall morbidity compared to a laparoscopic approach.

Validation of the self-reported domains of the Edmonton Frail Scale in patients 65 years of age and older.

INTRODUCTION: In the era of virtual care, self-reported tools are beneficial for preoperative assessments and facilitating postoperative planning. We have previously reported the use of the Edmonton Frailty Scale (EFS) as a valid preoperative assessment tool. OBJECTIVE: We wished to validate the self-reported domains of the EFS (srEFS) by examining its association with loss of independence (LOI) and mortality. METHODS: This is a post-hoc analysis of a single-institution observational study of patients 65 years of age or older undergoing multi-specialty surgical procedures and assessed with the EFS in the preoperative setting. Exploratory data analysis was used to determine the threshold for identifying frailty using the srEFS. Procedures were classified using the Operative Stress Score (OSS) scored 1 to 5 (lowest to highest). Hierarchical Condition Category (HCC) was utilized to risk-adjust. LOI was described as requiring more support at discharge and mortality was defined as death occurring up to 30 days following surgery. Receiver operating characteristic (ROC) curves were used to determine the ability of the srEFS to predict the outcomes of interest in relation to the EFS. RESULTS: Five hundred thirty-five patients were included. Exploratory analysis confirmed best positive predictive value for srEFS was greater or equal to 5. Overall, 113 (21 percent) patients were considered high risk for frailty (HRF) and 179 (33 percent) patients had an OSS greater or equal to 5. LOI occurred in 7 percent (38 patients) and the mortality rate was 4 percent (21 patients). ROC analysis showed that the srEFS performed similar to the standard EFS with no difference in discriminatory thresholds for predicting LOI and mortality. Examination of the domains of the EFS not included in the srEFS demonstrated a lack of association between cognitive decline and the outcomes of interest. However, functional status assessed with either the Get up and Go (EFS only) or self-reported ADLs was independently associated with increased risk for LOI. CONCLUSION: This study shows that self-reported EFS may be an optional preoperative tool that can be used in the virtual setting to identify patients at HRF. Early identification of patients at risk for LOI and mortality provides an opportunity to implement targeted strategies to improve patient care.

Edmonton frailty scale score predicts postoperative delirium: a retrospective cohort analysis.

BACKGROUND: Frailty has been associated with postoperative delirium (POD). Studies suggest that the Fried phenotype has a stronger association with POD than the Edmonton Frailty Scale (EFS) criteria. Although phenotypic frailty is recognized as a good predictor of delirium, the EFS has higher ratings for feasibility in the surgical setting. Thus, our aim was to determine the association between EFS-assessed vulnerability and POD in an elective surgical population of older adults. A secondary aim was to determine which domains assessed by the EFS were closely associated with POD. METHODS: After IRB approval was received, electronic medical records of surgical patients at our institution were downloaded from 12/1/2018 to 3/1/2020. Inclusion criteria included age ≥ 65 years, preoperative EFS assessment within 6 months of surgery, elective surgery not scheduled for intensive care unit (ICU) stay but followed by at least 1 day postoperative stay, and at least two in-hospital evaluations with the 4 A's test (arousal, attention, abbreviated mental test-4, acute change [4AT]) on the surgical ward. Vulnerability was determined by EFS score ≥ 6. Patients were stratified into two groups according to highest postoperative 4AT score: 0-3 (no POD) and ≥ 4 (POD). Odds of POD associated with EFS score ≥ 6 were evaluated by using logistic regression adjusted for potential confounders. RESULTS: The dataset included 324 patients. Vulnerability was associated with higher incidence of POD (p = 0.0007, Fisher's exact). EFS ≥6 was consistently associated with POD in all bivariate models. Vulnerability predicted POD in multivariable modeling (OR = 3.5, 95% CI 1.1 to 11.5). Multivariable analysis of EFS domains revealed an overall trend in which higher scores per domain had a higher odds for POD. The strongest association occurred with presence of incontinence (OR = 3.8, 95% CI 1.2 to 11.0). CONCLUSIONS: EFS criteria for vulnerability predict POD in older, non-ICU patients undergoing elective surgery.

Frailty and postoperative urinary tract infection.

BACKGROUND: Among older adults, postoperative urinary tract infection is associated with significant harms including increased risk of hospital readmission and perioperative mortality. While risk of urinary tract infection is known to increase with age, the independent association between frailty and postoperative urinary tract infection is unknown. In this study we used 2014-2018 data from the U.S. National Surgical Quality Improvement Program (NSQIP) to investigate whether frailty is an independent risk factor for postoperative urinary tract infection, controlling for age and other relevant confounders. METHODS: Frailty was assessed using the modified Frailty Index. Postoperative urinary tract infection was defined as any symptomatic urinary tract infection (of the kidneys, ureters, bladder, or urethra) developing within 30 days of the operative procedure. To examine associations between frailty and other specific factors and postoperative urinary tract infection, chi squared tests, students t-tests, and logistic regression modelling were used. RESULTS: Urinary tract infection was identified after 22,356 of 1,724,042 procedures (1.3%). In a multivariable model controlling for age and other patient and surgical characteristics, the relative odds for urinary tract infection increased significantly with increasing frailty score. For example, compared to a frailty score of 0, the relative odds for urinary tract infection for a frailty score of 3 was 1.50 (95% confidence interval 1.41, 1.60). The relative odds associated with the maximum frailty score (5) was 2.50 (95% confidence interval 1.73, 3.61). CONCLUSIONS: Frailty is associated with postoperative urinary tract infection, independent of age. Further research should focus on the underlying mechanisms and strategies to mitigate this risk among frail adults.

The combined effects of physical frailty and cognitive impairment on emergency department- versus direct-admission hospitalizations.

BACKGROUND: We aimed to study whether physical frailty and cognitive impairment (CI) increase the risk of recurrent hospitalizations in older adults, independent of comorbidity, and disability. METHODS: Two thousand five hundred forty-nine community-dwelling participants from the National Health and Aging Trends Study (NHATS) with 3 + years of continuous Medicare coverage from linked claims data were included. We used the marginal means/rates recurrent events model to investigate the association of baseline CI (mild CI or dementia) and physical frailty, separately and synergistically, with the number of all-source vs. Emergency Department (ED)-admission vs. direct admission hospitalizations over 2 years. RESULTS: 17.8% of participants had at least one ED-admission hospitalization; 12.7% had at least one direct admission hospitalization. Frailty and CI, modeled separately, were both significantly associated with risk of recurrent all-source (Rate Ratio (RR) = 1.24 for frailty, 1.21 for CI; p < .05) and ED-admission (RR = 1.49 for frailty, 1.41 for CI; p < .05) hospitalizations but not direct admission, adjusting for socio-demographics, obesity, comorbidity and disability. When CI and frailty were examined together, 64.3% had neither (Unimpaired); 28.1% CI only; 3.5% Frailty only; 4.1% CI + Frailty. Compared to those Unimpaired, CI alone and CI + Frailty were predictive of all-source (RR = 1.20, 1.48, p < .05) and ED-admission (RR = 1.36, 2.14, p < .05) hospitalizations, but not direct admission, in our adjusted model. CONCLUSIONS: Older adults with both CI and frailty experienced the highest risk for recurrent ED-admission hospitalizations. Timely recognition of older adults with CI and frailty is needed, paying special attention to managing cognitive impairment to mitigate preventable causes of ED admissions and potentiate alternatives to hospitalization.

Frailer Patients Undergoing Robotic Colectomies for Colon Cancer Experience Increased Complication Rates Compared With Open or Laparoscopic Approaches.

BACKGROUND: Minimally invasive surgical techniques are routinely promoted as alternatives to open surgery because of improved outcomes. However, the impact of robotic surgery on certain subsets of the population, such as frail patients, is poorly understood. OBJECTIVE: The purpose of our study was to examine the association between frailty and minimally invasive surgical approaches with colon cancer surgery. DESIGN: This is a retrospective study of prospectively collected outcomes data. Thirty-day surgical outcomes were compared by frailty and surgical approach using doubly robust multivariable logistic regression with propensity score weighting, and testing for interaction effects between frailty and surgical approach. SETTING: Patients undergoing an open, laparoscopic, or robotic colectomy for primary colon cancer, 2012 to 2016, were identified from the American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS: Patients undergoing a colectomy with an operative indication for primary colon cancer were selected. MAIN OUTCOME MEASURES: The primary outcomes measured were 30-day postoperative complications. RESULTS: After propensity score weighting of patients undergoing colectomy, 33.8% (n = 27,649) underwent an open approach versus 34.3% (n = 28,058) underwent laparoscopic surgery versus 31.9% (n = 26,096) underwent robotic surgery. Robotic (OR, 0.53; 95% CI, 0.42-0.69, p < 0.001) and laparoscopic (OR, 0.58; 95% CI, 0.52-0.66, p < 0.001) surgeries were independently associated with decreased rates of major complications. Frailer patients had increased complication rates (OR, 1.56; 95% CI, 1.07-2.25, p = 0.018). When considering the interaction effects between surgical approach and frailty, frailer patients undergoing robotic surgery were more likely to develop a major complication (combined adjusted OR, 3.15; 95% CI, 1.34-7.45, p = 0.009) compared with patients undergoing open surgery. LIMITATIONS: Use of the modified Frailty Index as an associative proxy for frailty was a limitation of this study. CONCLUSIONS: Although minimally invasive surgical approaches have decreased postoperative complications, this effect may be reversed in frail patients. These findings challenge the belief that robotic surgery provides a favorable alternative to open surgery in frail patients. See Video Abstract at http://links.lww.com/DCR/B163. LOS PACIENTES MÁS FRÁGILES SOMETIDOS A COLECTOMÍA ROBÓTICA POR CÁNCER DE COLON EXPERIMENTAN MAYORES TASAS DE COMPLICACIONES EN COMPARACIÓN CON ABORDAJES LAPAROSCÓPICO O ABIERTO: Las técnicas quirúrgicas mínimamente invasivas estan frecuentement promovidas como alternativas a la cirugía abierta debido a sus mejores resultados. Sin embargo, el impacto de la cirugía robótica en ciertos subgrupos de población, como el caso de los pacientes endebles, es poco conocido.El propósito de nuestro estudio fue examinar la asociación entre la fragilidad de los pacientes y el aborgaje quirúrgico mínimamente invasivo para la cirugía de cáncer de colon.Estudio retrospectivo de datos de resultados recolectados prospectivamente. Los resultados quirúrgicos a 30 días se compararon entre fragilidad y abordaje quirúrgico utilizando la regresión logística multivariable doblemente robusta con ponderación de puntaje de propensión y pruebas de efectos de interacción entre fragilidad y abordaje quirúrgico.Los pacientes identificados en la base de datos del Programa Nacional de Mejora de la Calidad Quirúrgica del Colegio Estadounidense de Cirujanos, que fueron sometidos a una colectomía abierta, laparoscópica o robótica por cáncer de colon primario, de 2012 a 2016.Todos aquellos pacientes seleccionados con indicación quirúrgica de cáncer primario de colon que fueron sometidos a una colectomía.Las complicaciones postoperatorias a 30 días.Luego de ponderar el puntaje de propensión de los pacientes colectomizados, el 33.8% (n = 27,649) fué sometido a laparotomía versus el 34.3% (n = 28,058) operados por laparoscopía versus el 31.9% (n = 26,096) operados con tecnica robótica. Las cirugías robóticas (OR 0.53, IC 95% 0.42-0.69, p < 0.001) y laparoscópicas (OR 0.58, IC 95% 0.52-0.66, p < 0.001) se asociaron de forma independiente con una disminución de las tasas de complicaciones mayores. Los pacientes más delicados tenían mayores tasas de complicaciones (OR 1.56, IC 95% 1.07-2.25, p = 0.018). Al considerar los efectos de interacción entre el abordaje quirúrgico y la fragilidad, los pacientes más débiles sometidos a cirugía robótica tenían más probabilidades de desarrollar una complicación mayor (OR ajustado combinado 3.15, IC 95% 1.34-7.45, p = 0.009) en comparación con los pacientes sometidos a cirugía abierta.El uso del índice de fragilidad modificado como apoderado asociativo de la fragilidad.Si bien los abordajes quirúrgicos mínimamente invasivos han disminuido las complicaciones postoperatorias, este efecto puede revertirse en pacientes lábiles. Estos hallazgos desafían la creencia de que la cirugía robótica proporciona una alternativa favorable a la cirugía abierta en pacientes frágiles. Consulte Video Resumen en http://links.lww.com/DCR/B163. (Traducción-Dr. Xavier Delgadillo).

Minimally Invasive Proctectomy for Rectal Cancer: A National Perspective on Short-term Outcomes and Morbidity.

BACKGROUND: Prior randomized trials showed comparable short-term outcomes between open and minimally invasive proctectomy (MIP) for rectal cancer. We hypothesize that short-term outcomes for MIP have improved as surgeons have become more experienced with this technique. METHODS: Rectal cancer patients who underwent elective abdominoperineal resection (APR) or low anterior resection (LAR) were included from the American College of Surgeons National Surgical Quality Improvement Program database (2016-2018). Patients were stratified based on intent-to-treat protocol: open (O-APR/LAR), laparoscopic (L-APR/LAR), robotic (R-APR/LAR), and hybrid (H-APR/LAR). Multivariable logistic regression analysis was used to assess the impact of operative approach on 30-day morbidity. RESULTS: A total of 4471 procedures were performed (43.41% APR and 36.59% LAR); O-APR 42.72%, L-APR 20.99%, R-APR 16.79%, and H-APR 19.51%; O-LAR 31.48%, L-LAR 26.34%, R-LAR 17.48%, and H-LAR 24.69%. Robotic APR and LAR were associated with shortest length of stay and significantly lower conversion rate. After adjusting for other factors, lap, robotic and hybrid APR and LAR were associated with decreased risk of overall morbidity when compared to open approach. R-APR and H-APR were associated with decreased risk of serious morbidity. No difference in the risk of serious morbidity was observed between the four LAR groups. CONCLUSION: Appropriate selection of patients for MIP can result in better short-term outcomes, and consideration for MIP surgery should be made.

High Compliance to an Enhanced Recovery Pathway for Patients ≥65 Years Undergoing Major Small and Large Intestinal Surgery Is Associated With Improved Postoperative Outcomes.

OBJECTIVE: This study was performed to evaluate compliance to an Enhanced Recovery Pathway (ERP) among patients ≥65 years and determine the effect of compliance on postoperative outcomes. SUMMARY BACKGROUND DATA: ERPs improve postoperative outcomes in patients undergoing major surgery. Given the inherent decline of the older surgical patient, the benefit of an ERP in this population has been questioned. METHODS: Patients undergoing major small and large intestinal surgery prior to and following ERP implementation at the Johns Hopkins Medical Institutions were entered into the ACS-NSQIP database. Outcomes included ERP compliance rates, complications, length of stay (LOS), and 30-day readmission rates were determined for older patients. RESULTS: Nine hundred seventy-four patients (693 < 65 yrs and 281 ≥ 65 yrs) were included. Of those ≥ 65 years, 142 (51%) were entered prior to and 139 (49%) were entered following ERP implementation. More ERP than pre-ERP patients underwent laparoscopic procedures (45.3% vs. 32.4%, P = 0.02), had disseminated malignancies (9.4% vs. 2.8%, P = 0.03), and smoked (14.4% vs. 4.9%, P = 0.01). Overall compliance was 74.5%, and 47% of older ERP patients achieved high compliance (≥75% compliance with ERP variables). High compliance was associated with a 30% decrease LOS (IRR: 0.7 P = 0.001) and 60% decrease in major (CD ≥ II) complications (OR: 0.4 P = 0.05). CONCLUSION: LOS and complication rates following implementation of an ERP were significantly improved in highly compliant elderly patients. Interventions to further improve outcomes should target decreasing variability by increasing individual compliance with an effective clinical pathway.

Treatment Strategies and Survival Trends for Anorectal Melanoma: Is it Time for a Change?

BACKGROUND: Immunotherapy advances for the treatment of cutaneous melanoma question its efficacy in treating anorectal mucosal melanoma (ARMM). We aimed to identify the prevalence, current management, and overall survival (OS) for ARMM. METHODS: Review of patients with ARMM from 2004 to 2015 National Cancer Database. Factors associated with immunotherapy were identified using multivariable logistic regression. The primary outcome was 2- and 5-year OS. Subgroup analysis by treatment type was performed. RESULTS: A total of 1331 patients were identified with a significant increase in prevalence (2004: 6.99%, 2015: 10.53%). ARMM patients were older, white, on Medicare, and from the South. The most common treatment was surgery (48.77%), followed by surgery + radiation (11.75%), surgery + immunotherapy (8.68%), and surgery + chemotherapy (8.68%). 16.93% of patients received immunotherapy, with utilization increasing (7.24%: 2004, 21.27%: 2015, p < 0.001). Patients who received immunotherapy had a significantly better 2-year OS (42.47% vs. 49.21%, p < 0.001), and other therapies did not reveal a significant difference. Adjusted analysis showed no difference in 2- and 5-year OS based on therapy type. CONCLUSION: The prevalence of ARMM has increased. The use of immunotherapy has increased substantially. Some survival benefit with the administration of immunotherapy may exist that has yet to be revealed. A more aggressive treatment paradigm is warranted.

Readmission Adversely Affects Survival in Surgical Rectal Cancer Patients.

BACKGROUND: Readmission has received attention as a potential healthcare quality metric. No studies have investigated the relationship between readmission and survival in patients undergoing rectal cancer surgery. The aims of this study were to identify factors associated with 30-day readmission after rectal cancer surgery and to determine the impact of readmission on overall survival (OS). METHODS: Patients who underwent surgical treatment for rectal/rectosigmoid adenocarcinoma stages I-IV were identified using the National Cancer Database (2004-2014). Multivariable logistic regression was used to identify factors for readmission. 2:1 nearest neighbor caliper matching without replacement was used to ensure similarity of patients being compared. Survival analyses were performed using Kaplan-Meier method along with log-rank test and Cox proportional hazards model. RESULTS: Of 110,167 patients, 7045 (6.39%) were readmitted. Factors associated with readmission included higher Charlson comorbidity score, non-private or no insurance, procedure type, hospitals in the Northeast, South, and Midwest regions, and prolonged length of stay. Within the matched cohort (13,756 non-readmitted and 6878 readmitted), readmitted patients had worse 5- and 10-year OS regardless of cancer stage (p < 0.001) and procedure type. Five- and 10-year OS were 58.98% and 41.01% for readmitted patients, 64.96% and 43.50% for non-readmitted patients. Readmitted patients had shorter OS by 13.14 months and increased risk of mortality (HR 1.20, 95% CI 1.15-1.25, p < 0.001). CONCLUSIONS: Thirty-day readmission after rectal cancer surgery is associated with decreased OS. Efforts to reduce readmissions should be considered to advance cancer care and enhance the potential for improved patient survival.

The Impact of Anesthesia-Influenced Process Measure Compliance on Length of Stay: Results From an Enhanced Recovery After Surgery for Colorectal Surgery Cohort.

BACKGROUND: Process measure compliance has been associated with improved outcomes in enhanced recovery after surgery (ERAS) programs. Herein, we sought to assess the impact of compliance with measures directly influenced by anesthesiology in an ERAS for colorectal surgery cohort. METHODS: From January 2013 to April 2015, data from 1140 consecutive patients were collected for all patients before (pre-ERAS) and after (ERAS) implementation of an ERAS program. Compliance with 9 specific process measures directly influenced by the anesthesiologist or acute pain service was analyzed to determine the impact on hospital length of stay (LOS). RESULTS: Process measure compliance was associated with a stepwise reduction in LOS. Patients who received >4 process measures (high compliance) had a significantly shorter LOS (incident rate ratio [IRR], 0.77; 95% CI, 0.70-0.85); P < .001) compared to low compliance (0-2 process measures) counterparts. Multivariable regression suggests that utilization of multimodal nausea and vomiting prophylaxis (IRR, 0.78; 95% CI, 0.68-0.89; P < .001), scheduled postoperative nonsteroidal pain medication use (IRR, 0.76; 95% CI, 0.67-0.85; P < .001), and strict adherence to a postoperative opioid administration (IRR, 0.58; 95% CI, 0.51-0.67; P < .001) protocol for breakthrough pain were independently associated with reduced LOS. CONCLUSIONS: Our findings suggest that increased compliance with process measures directly influenced by the anesthesiologists and in concert with a formal anesthesia protocol is associated with reduced LOS. Engaging anesthesiology colleagues throughout the surgical encounter increases the overall value of perioperative care.

Predicting the Risk of Readmission From Dehydration After Ileostomy Formation: The Dehydration Readmission After Ileostomy Prediction Score.

BACKGROUND: All-cause readmission rates in patients undergoing ileostomy formation are as high as 20% to 30%. Dehydration is a leading cause. No predictive model for dehydration readmission has been described. OBJECTIVE: The purpose of this study was to develop and validate the Dehydration Readmission After Ileostomy Prediction scoring system to predict the risk of readmission for dehydration after ileostomy formation. DESIGN: Patients who underwent ileostomy formation were identified using the American College of Surgeons National Surgical Quality Improvement Program data set (2012-2015). Predictors for dehydration were identified using multivariable logistic regression analysis and translated into a point scoring system based on corresponding ß-coefficients using 2012-2014 data (derivation). Model discrimination was assessed with receiver operating characteristic curves using 2015 data (validation). SETTINGS: This study used the American College of Surgeons National Surgical Quality Improvement Program. PATIENTS: A total of 8064 (derivation) and 3467 patients (validation) were included from the American College of Surgeons National Surgical Quality Improvement Program. MAIN OUTCOME MEASURES: Dehydration readmission within 30 days of operation was measured. RESULTS: A total of 8064 patients were in the derivation sample, with 2.9% (20.1% overall) readmitted for dehydration. Twenty-five variables were queried, and 7 predictors were identified with points assigned: ASA class III (4 points), female sex (5 points), IPAA (4 points), age ≥65 years (5 points), shortened length of stay (5 points), ASA class I to II with IBD (7 points), and hypertension (9 points). A 39-point, 5-tier risk category scoring system was developed. The model performed well in derivation (area under curve = 0.71) and validation samples (area under curve = 0.74) and passed the Hosmer-Lemeshow goodness-of-fit test. LIMITATIONS: Limitations of this study pertained to those of the American College of Surgeons National Surgical Quality Improvement Program, including a lack of generalizability, lack of ileostomy-specific variables, and inability to capture multiple readmission International Classification of Diseases, 9/10 edition, codes. CONCLUSIONS: The Dehydration Readmission After Ileostomy Prediction score is a validated scoring system that identifies patients at risk for dehydration readmission after ileostomy formation. It is a specific approach to optimize patient factors, implement interventions, and prevent readmissions. See Video Abstract at http://links.lww.com/DCR/A746.

Routine Pouchoscopy Prior to Ileostomy Takedown May Not Be Necessary in Patients with Chronic Ulcerative Colitis.

BACKGROUND: Creation of a J pouch is the gold standard surgical intervention in the treatment of chronic ulcerative colitis (UC). Pouchoscopy prior to ileostomy takedown is commonly performed. We describe the frequency, indication, and findings on pouchoscopy, and determine if pouchoscopy affects rates of complications after takedown. METHODS: All UC or indeterminate inflammatory bowel disease patients with a J pouch were retrospectively evaluated from January 1994 to December 2014. Cases were defined as having routine (asymptomatic) pouchoscopy after pouch creation but before ileostomy takedown. Controls were defined as having no pouchoscopy or pouchoscopy on the same day as that of takedown. RESULTS: The study included 178 patients (81.5% cases, 18.5% controls). Fifty two percent of pouchoscopies were reported as normal. Common abnormal endoscopy findings included stricture (35%), pouchitis (7%), and cuffitis (0.7%). Length of stay during takedown hospitalization was shorter for cases than controls (3 vs. 5 days; p = 0.001), but neither short- nor long-term complications were statistically different between cases and controls. Abnormalities on pouchoscopy were not predictive for short-term complications (p = 0.73) or long-term complications (p = 0.55). Routine pouchoscopy did not delay takedown surgery in any of the included patients. CONCLUSIONS: Routine pouchoscopy may not be necessary prior to ileostomy takedown; its greatest utility is in patients with suspected pouch complications.

Development of a train-to-proficiency curriculum for the technical skills component of the fundamentals of endoscopic surgery exam.

BACKGROUND: The demonstration of competency in endoscopy is required prior to obtaining American Board of Surgery Certification. To demonstrate competency, the resident must pass a national high-stakes cognitive test and a technical skills exam on a virtual reality simulator. The purpose of this preliminary study was to design a proficiency-based endoscopy simulation curriculum to meet this competency requirement. METHODS: This is a mixed methods prospective cohort study at a single academic medical institution. Prior to taking the national exam, surgery residents were required to participate in a skills lab and demonstrate proficiency on 10 simulation tasks. Proficiency was based on time and percent of objects targeted/mucosa seen. Simulation practice time, number of task repetitions to proficiency, and prior endoscopic experience were recorded. Resident's self-reported confidence scores in endoscopic skills prior to and following simulation lab training were obtained. RESULTS: From January 1, 2016 through August 1, 2017, 20 surgical residents (8 PGY2, 8 PGY3, 4 PGY4) completed both a faculty-supervised endoscopy skills lab and independent learning with train-to-proficiency simulation tasks. Median overall simulator time per resident was 306 min (IQR: 247-405 min). Median overall time to proficiency in all tasks was 235 min (IQR: 208-283 min). The median time to proficiency decreased with increasing PGY status (r = 0.4, P = 0.05). There was no correlation between prior real-time endoscopic experience and time to proficiency. Reported confidence in endoscopic skills increased significantly from mean of 5.75 prior to 7.30 following the faculty-supervised endoscopy skills lab (P = 0.0002). All 20 residents passed the national exam. CONCLUSIONS: In this preliminary study, a train-to-proficiency curriculum in endoscopy improved surgical resident's confidence in their endoscopic skills and 100% of residents passed the FES technical skills test on their first attempt. Our findings also indicate that uniform proficiency was not achieved by real-time experience alone.