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CONTEXT: Few studies utilize randomized clinical trials (RCT) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels. OBJECTIVE: Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions. DESIGN: Cluster Randomized Controlled Trial (XXX). SETTING: Sports medicine clinic and field settings. PARTICIPANTS: The RCT enrolled 251 concussed athletes (median age=20 years; female n=48) across 28 sites from New Zealand professional rugby (n=31), Canadian professional football (n=52), United States (U.S.)/Canadian colleges (n=128) and U.S. high schools (n=40). INTERVENTIONS: Two medically supervised interventions: 1) Enhanced Graded Exertion (EGE): international return to sport strategy and sport specific activities only (EGE-only n=119) and 2) Multidimensional Rehabilitation (MDR) followed by EGE: early symptom-directed exercises once symptoms were stable, followed by EGE after symptoms resolved (MDR+EGE n=132). MAIN OUTCOME MEASURES: Primary outcomes were intrasession total symptom severity score exacerbation and significant intersession (increase 10+ severity points) sustained total symptom severity exacerbation, each measured with a Postconcussion Symptom Scale (132 total severity points on scale). Reported AEs were also described. Activity-based rehabilitation sessions (n=1437) were the primary analysis unit. Frequencies, proportions, medians, and Interquartile Ranges (IQRs) were calculated for outcomes by treatment group. RESULTS: The 251 post-injury participants completed 1437 (MDR+EGE=819, EGE-only=618) activity-based intervention sessions. A total of 110 and 105 participants contributed data (those missing had no documented session data) to at least 1 activity-based session in the MDR+EGE and EGE-only arms respectively. Intrasession symptom exacerbations were equivilantly low in MDR+EGE and EGE-only arms (MDR+EGE: 16.7%, 95% CI:14.1%,19.1%; EGE-only: 15.7%, 95% CI: 12.8%,18.6%). In total, 9/819 MDR+EGE sessions (0.9%) and 1/618 EGE-only sessions (0.2%) resulted in a pre- to post-session symptom exacerbation beyond a 10+ severity point increase; 8/9 resolved to <10 points by the next session. Two study-related AEs (1 in each arm) were reported. CONCLUSIONS: Participants in MDR+EGE and EGE-only activities reported equivalently low rates of symptom exacerbation.
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BACKGROUND AND OBJECTIVES: Expanding outpatient surgery to the increasing number of procedures and patient populations warrants continuous evaluation of postoperative outcomes to ensure the best care and safety. We describe adverse postoperative outcomes and transfer rates related to anesthesia in a large sample of patients who underwent same-day cancer surgery at a freestanding ambulatory surgery center. METHODS: Between January 2017 and June 2021, 3361 cancer surgeries, including breast and plastic, head and neck, gynecology, and urology, were performed. The surgeries were indicated for diagnosis, staging, and/or treatment. We report the incidence of transfers and adverse postoperative outcomes related to anesthesia. RESULTS: Breast and plastic surgeries were the most common (1771, 53%), followed by urology (1052, 31%), gynecology (410, 12%), and head and neck surgeries (128, 4%). Based on patients' first procedure, comorbidity levels were highest for urology (75% American Society of Anesthesiologists physical status score 3, 1.7% score 4) and lowest for breast surgeries (31% score 3, 0.2% score 4). Most gynecology surgeries used general anesthesia (97.6%), whereas breast surgeries used the least (38%). A total of seven patients (0.2%; 95% CI: 0.08%-0.4%) were immediately transferred to an outside hospital; four due to anesthesia-related reasons. Only 7 (0.2%) patients needed additional postoperative care related to anesthesia-related adverse events, specifically cardiac events (4), difficult intubations (2), desaturation (1), and agitation, nausea, and headache (1). CONCLUSIONS: The incidence of anesthesia-related adverse postoperative outcomes is low in cancer patients undergoing outpatient surgeries at our freestanding ambulatory surgery center. This suggests that carefully selected cancer patients, including patients with metastatic cancer, can undergo anesthesia for same-day surgery, making cancer care accessible locally and reducing stress associated with travel for treatment. More research investigating complication rates related to surgery and to cancer disease trajectory are needed to establish a complete evaluation of safety for outpatient cancer surgery.
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Procedimientos Quirúrgicos Ambulatorios , Neoplasias , Complicaciones Posoperatorias , Humanos , Femenino , Estudios Retrospectivos , Masculino , Procedimientos Quirúrgicos Ambulatorios/estadística & datos numéricos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Anciano , Neoplasias/cirugía , Neoplasias/epidemiología , Transferencia de Pacientes/estadística & datos numéricos , Adulto , Anestesia/efectos adversos , Estudios de Seguimiento , PronósticoRESUMEN
BACKGROUND: Ovarian cancer with extensive metastatic disease involving pelvic structures often requires rectosigmoid resection for complete gross resection; however, it is associated with increased surgical morbidity. There are limited data, and none in ovarian cancer, on near-infrared assessment of perfusion in rectosigmoid resections with anastomosis. PRIMARY OBJECTIVE: To compare the rate of pelvic complications (pelvic abscesses, anastomotic leaks, and infections) within 30 days of surgery with and without near-infrared assessment of perfusion at time of rectosigmoid resection and re-anastomosis in patients undergoing cytoreductive surgery for ovarian cancer. STUDY HYPOTHESIS: We hypothesize the use of near-infrared technology (intravenous indocyanine green and endoscopic near-infrared fluorescence imaging), compared with standard intra-operative assessment, to evaluate anastomotic perfusion at time of rectosigmoid resection and re-anastomosis will result in lower rates of post-operative pelvic complications. TRIAL DESIGN: This is a planned multicenter randomized controlled trial. Patients who undergo rectosigmoid resection as part of their ovarian cytoreductive surgery will be randomized 1:1 to standard assessment of anastomosis with the surgeon's usual technique (control arm) or assessment with near-infrared angiography using indocyanine green and endoscopic fluorescence imaging (experimental arm). Randomization will occur after rectosigmoid resection has been completed and the surgeon declares their plan to create a diverting ostomy. Randomization will be stratified by plan for diverting ostomy. MAJOR INCLUSION/EXCLUSION CRITERIA: Main inclusion criteria include patients with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for cytoreductive surgery with suspected need for low-anterior rectosigmoid resection. PRIMARY ENDPOINT: Rate of 30-day post-operative pelvic complications. SAMPLE SIZE: 310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively. TRIAL REGISTRATION: NCT04878094.
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Anastomosis Quirúrgica , Neoplasias Ováricas , Femenino , Humanos , Anastomosis Quirúrgica/métodos , Anastomosis Quirúrgica/efectos adversos , Angiografía/métodos , Colon Sigmoide/cirugía , Colon Sigmoide/diagnóstico por imagen , Procedimientos Quirúrgicos de Citorreducción/métodos , Verde de Indocianina/administración & dosificación , Neoplasias Ováricas/cirugía , Neoplasias Ováricas/diagnóstico por imagen , Neoplasias Ováricas/patología , Complicaciones Posoperatorias , Ensayos Clínicos Controlados Aleatorios como Asunto , Recto/cirugía , Recto/diagnóstico por imagen , Espectroscopía Infrarroja Corta/métodosRESUMEN
OBJECTIVE: To evaluate the theoretical impact of regionalizing cytoreductive surgery for ovarian cancer (OC) to high-volume facilities on patient travel. METHODS: We retrospectively identified patients with OC who underwent cytoreduction between 1/1/2004-12/31/2018 from the New York State Cancer Registry and Statewide Planning and Research Cooperative System. Hospitals were stratified by low-volume (<21 cytoreductive surgical procedures for OC annually) and high-volume centers (≥21 procedures annually). A simulation was performed; outcomes of interest were driving distance and time between the centroid of the patient's residence zip code and the treating facility zip code. RESULTS: Overall, 60,493 patients met inclusion criteria. Between 2004 and 2018, 210 facilities were performing cytoreductive surgery for OC in New York; 159 facilities (75.7%) met low-volume and 51 (24.3%) met high-volume criteria. Overall, 10,514 patients (17.4%) were treated at low-volume and 49,979 (82.6%) at high-volume facilities. In 2004, 78.2% of patients were treated at high-volume facilities, which increased to 84.6% in 2018 (P < .0001). Median travel distance and time for patients treated at high-volume centers was 12.2 miles (IQR, 5.6-25.5) and 23.0 min (IQR, 15.2-37.0), and 8.2 miles (IQR, 3.7-15.9) and 16.8 min (IQR, 12.4-26.0) for patients treated at low-volume centers. If cytoreductive surgery was centralized to high-volume centers, median distance and time traveled for patients originally treated at low-volume centers would be 11.2 miles (IQR, 3.8-32.3; P < .001) and 20.2 min (IQR, 13.6-43.0; P < .001). CONCLUSIONS: Centralizing cytoreductive surgery for OC to high-volume centers in New York would increase patient travel burden by negligible amounts of distance and time for most patients.
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Procedimientos Quirúrgicos de Citorreducción , Neoplasias Ováricas , Humanos , Femenino , New York , Estudios Retrospectivos , Accesibilidad a los Servicios de Salud , Hospitales de Alto Volumen , Viaje , Neoplasias Ováricas/cirugíaRESUMEN
PURPOSE: Patients undergoing oncologic surgery at major referral centers frequently experience postdischarge care fragmentation, which has been associated with poor outcomes. This report describes and evaluates the outcomes of an intervention at Memorial Sloan Kettering Cancer Center (MSKCC) to decentralize postdischarge postoperative acute care within our health care system. METHODS: In 2018, MSKCC completed the addition of six regional acute care clinics called symptom care clinics (SCCs) to existing regional outpatient clinics. Acute care was previously only available within our system at a single centralized urgent care center (UCC). All patients undergoing surgery in our system between January 1, 2019, and June 30, 2021, were followed for 90 days. The exposure was the site of initial acute care presentation-UCC or SCC-and outcomes included utilization, access, financial toxicity, and mortality. Mortality was adjusted using hierarchical modeling at the level of the region. RESULTS: A total of 6,992 postsurgical patients experienced 10,525 acute care visits in our system within 90 days of surgery. Twenty-nine percent of these patients presented to the SCC first. These patients were older but had fewer comorbidities and shorter index length of stay compared with UCC patients. Utilization of SCCs increased substantially while UCC utilization decreased during a period of stable case volume. SCCs were closer to patients' homes, and wait times were shorter. Rates of financial toxicity were similar between groups. Of this high-risk cohort accessing acute care postoperatively, 90-day mortality was similar for UCC and SCC patients (P = .731). CONCLUSION: This model of decentralized acute care after oncologic surgery was increasingly used over time with comparable patient safety. Health systems should emphasize patient-centered care by supporting safe strategies for regionalized care even when treatments are delivered at centralized referral centers.
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Cuidados Posoperatorios , Humanos , Masculino , Femenino , Persona de Mediana Edad , Neoplasias/cirugía , Anciano , Atención a la SaludRESUMEN
OBJECTIVE: To evaluate the feasibility and outcomes of performing procedural interventions, defined as surgical resection, tumor ablation, or targeted radiation therapy, for oligoprogressive disease among patients with gynecologic malignancies who are treated with immune checkpoint blockade. METHODS: Patients with gynecologic cancers treated with immune checkpoint blockade between January 2013 and October 2021 who underwent procedural interventions including surgical resection, interventional radiology ablation, or radiation therapy for oligoprogressive disease were identified. Procedures performed before immune checkpoint therapy initiation or ≥6 months after therapy completion were excluded. Long immunotherapy duration prior to intervention was defined as ≥6 months. Progression-free survival and overall survival were calculated from procedure date until disease progression or death, respectively. RESULTS: During the study period, 886 patients met inclusion criteria and received immune checkpoint blockade therapy. Of these, 34 patients underwent procedural interventions for oligoprogressive disease; 7 underwent surgical resection, 3 underwent interventional radiology ablation, and 24 underwent radiation therapy interventions. Primary disease sites included uterus (71%), ovary (24%), and cervix (6%). Sites of oligoprogression included abdomen/pelvis (26%), bone (21%), lung (18%), distant lymph node (18%), brain (9%), liver (6%), and vagina (3%). Most tumors (76%) did not exhibit microsatellite instability or mismatch repair deficiency. Approximately half (53%) of the patients had long immune checkpoint therapy duration prior to intervention. Median progression-free survival following the procedure was 5.3 months (95% CI, 3.1-9.9), and median overall survival was 21.7 months (95% CI, 14.9-not estimable). Long versus short immune checkpoint therapy duration prior to procedure and length of immune checkpoint therapy had no effect on progression-free or overall survival. CONCLUSIONS: Procedural interventions for patients with oligoprogression on immune checkpoint blockade therapy are feasible and demonstrate favorable outcomes. With expanding use of immune checkpoint therapy, it is important to investigate combined modalities to maximize therapeutic benefit for patients with gynecologic cancers.
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Neoplasias Encefálicas , Neoplasias de los Genitales Femeninos , Humanos , Femenino , Neoplasias de los Genitales Femeninos/radioterapia , Inhibidores de Puntos de Control Inmunológico , Terapia Combinada , Supervivencia sin Progresión , Estudios RetrospectivosRESUMEN
OBJECTIVE: We sought to investigate the safety and feasibility of therapeutic anticoagulation for newly diagnosed venous thromboembolism among women who undergo neoadjuvant chemotherapy for the treatment of advanced ovarian cancer. METHODS: A retrospective study using data extrapolated from a prospectively maintained institutional database was used to identify all patients with ovarian cancer who underwent neoadjuvant chemotherapy from April 2015 through September 2018 at our institution. All patients who received therapeutic anticoagulation for newly diagnosed venous thromboembolism at initial diagnosis or during neoadjuvant chemotherapy were included. RESULTS: Of 290 patients who underwent neoadjuvant chemotherapy for advanced ovarian cancer during the study period, 67 (23%) had newly diagnosed venous thromboembolism at the time of initial diagnosis or developed venous thromboembolism during neoadjuvant chemotherapy. Of these 67 patients, 64 (96%) received therapeutic anticoagulation. A total of 13 (20%) of 64 patients who underwent therapeutic anticoagulation experienced a bleeding episode while on anticoagulation; 4 (31%) of the 13 events were of major severity. Three patients developed major internal bleeding in the peritoneal cavity, and one patient suffered from a major vaginal bleeding episode. All four patients were hospitalized (range, 5-11 days) and received ≥2 units of red blood cells for anemia. None of these patients died from fatal bleeding or had to delay starting chemotherapy. Of note, all four patients received low-molecular-weight heparin via subcutaneous injection. Overall, 13 (20%) of 64 patients required an anticoagulant dose reduction, mostly due to weight loss or new bleeding episodes. CONCLUSION: Therapeutic anticoagulation in this setting appeared safe, with a low risk of major bleeding complications. Furthermore, anticoagulation did not result in delay of chemotherapy or cytoreductive surgery.
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OBJECTIVE: To describe patient-reported postoperative symptoms and to evaluate the use of digital symptom tracking and alerts to detect postoperative complications. METHODS: We retrospectively reviewed patients who underwent a minimally invasive hysterectomy and enrolled in our Recovery Tracker program from 4/5/17-12/31/21. The Recovery Tracker is an at-home virtual tool used to track patient-reported postoperative symptoms for 10 days. Predefined thresholds for "red" and "yellow" alerts are based on symptom severity and timing. Data on patient demographics, surgery, and postoperative course were collected to evaluate the association of alerts with complications and compare outcomes of patients who did/did not enroll in the program. RESULTS: Of 2362 eligible patients, 1694 (71.7%) enrolled in the Recovery Tracker program. Pain was the most severe symptom, followed by fatigue. Eighty-seven patients experienced 102 complications (5.1% complication rate) and 32 experienced 39 grade ≥ 2 complications (1.9% severe complication rate). Excluding complications that occurred prior to Recovery Tracker use, 1673 patients experienced 28 grade ≥ 2 complications. Of 345 patients (20.6%) who triggered a red alert, 13 (3.8%) had a grade ≥ 2 complication. Of 1328 patients (79.4%) with no red alerts, 15 (1.13%) had a grade ≥ 2 complication. Relative risk of a grade ≥ 2 complication if a red alert was triggered was 3.25 (95% CI: 1.6-6.9, P = .002). Rate of severe complications was significantly higher among patients who did not use the tool (3.3% vs 1.9%; P = .04). CONCLUSIONS: The Recovery Tracker tool may assist in early identification of postoperative symptoms after minimally invasive hysterectomy.
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Histerectomía , Laparoscopía , Femenino , Humanos , Estudios Retrospectivos , Histerectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Medición de Resultados Informados por el Paciente , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Laparoscopía/efectos adversosRESUMEN
PURPOSE: Using next generation sequencing (NGS), The Cancer Genome Atlas (TCGA) found that endometrial carcinomas (ECs) fall under one of four molecular subtypes, and a POLE mutation status, mismatch repair (MMR) and p53 immunohistochemistry (IHC)-based surrogate has been developed. We sought to retrospectively classify and characterize a large series of unselected ECs that were prospectively subjected to clinical sequencing by utilizing clinical molecular and IHC data. EXPERIMENTAL DESIGN: All patients with EC with clinical tumor-normal MSK-IMPACT NGS from 2014 to 2020 (n = 2115) were classified by integrating molecular data (i.e., POLE mutation, TP53 mutation, MSIsensor score) and MMR and p53 IHC results. Survival analysis was performed for primary EC patients with upfront surgery at our institution. RESULTS: Utilizing our integrated approach, significantly more ECs were molecularly classified (1834/2115, 87%) as compared to the surrogate (1387/2115, 66%, p < 0.001), with an almost perfect agreement for classifiable cases (Kappa 0.962, 95% CI 0.949-0.975). Discrepancies were primarily due to TP53 mutations in p53-IHC-normal ECs. Of the 1834 ECs, most were of copy number (CN)-high molecular subtype (40%), followed by CN-low (32%), MSI-high (23%) and POLE (5%). Histologic and genomic variability was present amongst all molecular subtypes. Molecular classification was prognostic in early- and advanced-stage disease, including early-stage endometrioid EC. CONCLUSIONS: The integration of clinical NGS and IHC data allows for an algorithmic approach to molecularly classifying newly diagnosed EC, while overcoming issues of IHC-based genetic alteration detection. Such integrated approach will be important moving forward given the prognostic and potentially predictive information afforded by this classification.
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Neoplasias Endometriales , Proteína p53 Supresora de Tumor , Femenino , Humanos , Proteína p53 Supresora de Tumor/genética , Inmunohistoquímica , Estudios Retrospectivos , Neoplasias Endometriales/genética , Neoplasias Endometriales/patología , Pronóstico , MutaciónRESUMEN
INTRODUCTION: Delirium is a major public health issue for surgical patients and their families because it is associated with increased mortality, cognitive and functional decline, prolonged hospital admission and increased healthcare expenditures. Based on preliminary data, this trial tests the hypothesis that intravenous caffeine, given postoperatively, will reduce the incidence of delirium in older adults after major non-cardiac surgery. METHODS AND ANALYSIS: The CAffeine, Postoperative Delirium And CHange In Outcomes after Surgery-2 (CAPACHINOS-2) Trial is a single-centre, placebo-controlled, randomised clinical trial that will be conducted at Michigan Medicine. The trial will be quadruple-blinded, with clinicians, researchers, participants and analysts all masked to the intervention. The goal is to enrol 250 patients with a 1:1:1: allocation ratio: dextrose 5% in water placebo, caffeine 1.5 mg/kg and caffeine 3 mg/kg as a caffeine citrate infusion. The study drug will be administered intravenously during surgical closure and on the first two postoperative mornings. The primary outcome will be delirium, assessed via long-form Confusion Assessment Method. Secondary outcomes will include delirium severity, delirium duration, patient-reported outcomes and opioid consumption patterns. A substudy analysis will also be conducted with high-density electroencephalography (72-channel system) to identify neural abnormalities associated with delirium and Mild Cognitive Impairment at preoperative baseline. ETHICS AND DISSEMINATION: This study was approved by the University of Michigan Medical School Institutional Review Board (HUM00218290). An independent data and safety monitoring board has also been empanelled and has approved the clinical trial protocol and related documents. Trial methodology and results will be disseminated via clinical and scientific journals along with social and news media. TRIAL REGISTRATION NUMBER: NCT05574400.
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Disfunción Cognitiva , Delirio , Delirio del Despertar , Humanos , Anciano , Delirio/etiología , Delirio/prevención & control , Delirio/epidemiología , Cafeína/uso terapéutico , Disfunción Cognitiva/complicaciones , Michigan/epidemiología , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: Few data are available to guide postadenotonsillectomy (AT) pediatric intensive care (PICU) admission. The aim of this study of children with a preoperative polysomnogram (PSG) was to assess whether preoperative information may predict severe respiratory events (SRE) after AT. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary center. METHODS: Children aged 6 months to 17 years who underwent AT with preoperative polysomnography (2012-2018) were identified by billing codes. Data were extracted from medical records. SRE were defined as any 1 or more of desaturations <80% requiring intervention; newly initiated positive airway pressure; postoperative intubation; pneumonia/pneumonitis; respiratory code, cardiac arrest, or death. We hypothesized that SRE would be associated with age <24 months, major medical comorbidity, obesity (>95th percentile), apnea-hypopnea index (AHI) ≥ 30, and O2 nadir <70% on PSG. Analysis was performed with multivariable logistic regression. RESULTS: Of 1774 subjects, 28 (1.7%) experienced SRE. Compared to those without, children with SRE were on average younger (3 vs 5 years, p < .01) with a greater probability of medical comorbidities (59% vs 18%, p < .001). After adjustment for sex, black race, obesity, and age <24 months, children with major medical comorbidity were more likely than other children to have SRE (odds ratio [OR]: 14.2; 95% confidence interval [CI]: [5.7, 35.2]), as were children with AHI ≥ 30 (OR: 7.7 [3.0, 19.9]), or O2 nadir <70% (OR 6.1 [2.1, 17.9]). Age, obesity, sex, and black race did not independently predict SRE. CONCLUSION: PICU admission may be most prudent for children with complex medical co-morbidities, high AHI (>30), and/or low O2 nadir (<70%).
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Tonsilectomía , Niño , Humanos , Adenoidectomía , Estudios Retrospectivos , Complicaciones Posoperatorias , Obesidad , Cuidados CríticosRESUMEN
OBJECTIVE: Gynecologic cancers, especially ovarian cancer, are associated with a high incidence of venous thromboembolism (VTE). Recent data have shown the risk of VTE development is not only limited to the postoperative period; there also appears to be an increased risk during neoadjuvant chemotherapy (NACT) administration, prompting the need for better risk stratification in this setting. We sought to assess the risk of VTE development in patients with ovarian cancer undergoing NACT. METHODS: We performed a PubMed literature review using the following medical terms: advanced ovarian cancer, advanced peritoneal cancer, advanced fallopian tube cancer, thrombosis, thromboembolic events, and neoadjuvant chemotherapy. Eligible studies included patients with advanced ovarian, fallopian tube, or peritoneal cancer who underwent NACT and had VTE. VTE was defined as either a deep venous thrombosis or a pulmonary embolism. RESULTS: Seven relevant studies were identified; all 7 were published between 2017 and 2021. Across these studies, we identified 1427 patients who underwent NACT and either had VTE at presentation or developed VTE during their treatment course. Of these patients, 1171 underwent NACT and were at risk for VTE development and were included in our pooled analysis. Of these patients, 144 (12.3%) developed VTE. CONCLUSIONS: VTE prophylaxis may be considered in patients with ovarian cancer undergoing NACT.
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Neoplasias de los Genitales Femeninos , Neoplasias Ováricas , Neoplasias Peritoneales , Tromboembolia Venosa , Humanos , Femenino , Tromboembolia Venosa/etiología , Terapia Neoadyuvante/efectos adversos , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias de los Genitales Femeninos/cirugía , Carcinoma Epitelial de Ovario/complicaciones , Incidencia , Neoplasias Peritoneales/cirugía , Factores de RiesgoRESUMEN
OBJECTIVE: To determine the relationship between bowel preparation and surgical-site infection (SSI) incidence following colorectal resection during gynecologic oncology surgery. METHODS: This post-hoc analysis used data from a randomized controlled trial of patients enrolled from 03/01/2016-08/20/2019 with presumed gynecologic malignancy investigating negative-pressure wound therapy among those requiring laparotomy. Patients were treated preoperatively without bowel preparation, oral antibiotic bowel preparation (OABP), or OABP plus mechanical bowel preparation (MBP) per surgeon preference. Univariate and multivariable analyses with stepwise model selection for SSI were performed for confirmed gynecologic malignancies requiring colorectal resection. RESULTS: Of 161 cases, 15 (9%) had no preparation, 39 (24%) OABP only, and 107 (66%) OABP+MBP. The overall SSI rate was 19% (n = 31)-53% (n = 8/15) in the no preparation, 21% (n = 8/39) in the OABP alone, and 14% (n = 15/107) in the OABP+MBP groups (P = 0.003). The difference between OABP and OABP+MBP was non-significant (P = 0.44). The median length of stay was 9 (range, 6-12), 6 (range, 5-8), and 7 days (range, 6-10), respectively (P = 0.045). The overall complication rate (34%; n = 54) did not significantly vary by preparation type (P = 0.23). On univariate logistic regression analysis, OABP (OR, 0.23; 95% CI: 0.06-0.80) and OABP+MBP (OR, 0.14; 95% CI: 0.04-0.45) were associated with decreased SSI risk compared to no preparation (P = 0.004). On multivariate analysis, both methods of preparation retained a significant impact on SSI rates (P = 0.004). CONCLUSION: Bowel preparation is associated with reduced SSI incidence and is beneficial for patients undergoing gynecologic oncology surgery with anticipated colorectal resection. Further investigation is needed to determine whether OABP alone is sufficient.
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Neoplasias Colorrectales , Neoplasias de los Genitales Femeninos , Humanos , Femenino , Neoplasias de los Genitales Femeninos/tratamiento farmacológico , Profilaxis Antibiótica , Cuidados Preoperatorios/métodos , Catárticos/uso terapéutico , Estudios Retrospectivos , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Antibacterianos , Procedimientos Quirúrgicos Electivos/métodos , Administración Oral , Neoplasias Colorrectales/tratamiento farmacológicoRESUMEN
PURPOSE: We sought to determine whether sequencing analysis of circulating cell-free DNA (cfDNA) in patients with prospectively accrued endometrial cancer captures the mutational repertoire of the primary lesion and allows for disease monitoring. EXPERIMENTAL DESIGN: Peripheral blood was prospectively collected from 44 newly diagnosed patients with endometrial cancer over a 24-month period (i.e., baseline, postsurgery, every 6 months after). DNA from the primary endometrial cancers was subjected to targeted next-generation sequencing (NGS) of 468 cancer-related genes, and cfDNA to a high-depth NGS assay of 129 genes with molecular barcoding. Sequencing data were analyzed using validated bioinformatics methods. RESULTS: cfDNA levels correlated with surgical stage in endometrial cancers, with higher levels of cfDNA being present in advanced-stage disease. Mutations in cfDNA at baseline were detected preoperatively in 8 of 36 (22%) patients with sequencing data, all of whom were diagnosed with advanced-stage disease, high tumor volume, and/or aggressive histologic type. Of the 38 somatic mutations identified in the primary tumors also present in the cfDNA assay, 35 (92%) and 38 (100%) were detected at baseline and follow-up, respectively. In 6 patients with recurrent disease, changes in circulating tumor DNA (ctDNA) fraction/variant allele fractions in cfDNA during follow-up closely mirrored disease progression and therapy response, with a lead time over clinically detected recurrence in two cases. The presence of ctDNA at baseline (P < 0.001) or postsurgery (P = 0.014) was significantly associated with reduced progression-free survival. CONCLUSIONS: cfDNA sequencing analysis in patients with endometrial cancer at diagnosis has prognostic value, and serial postsurgery cfDNA analysis enables disease and treatment response monitoring. See related commentary by Grant et al., p. 305.
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Ácidos Nucleicos Libres de Células , ADN Tumoral Circulante , Neoplasias Endometriales , Femenino , Humanos , Ácidos Nucleicos Libres de Células/genética , ADN Tumoral Circulante/genética , Neoplasias Endometriales/diagnóstico , Neoplasias Endometriales/genética , Pronóstico , Mutación , Secuenciación de Nucleótidos de Alto Rendimiento/métodos , Biomarcadores de Tumor/genéticaRESUMEN
OBJECTIVES: To compare outcomes of patients with premalignant endometrial pathology undergoing hysterectomy with or without sentinel lymph node (SLN) removal. Outcomes of interest included surgical adverse events (AEs), cancer status on final pathology, postoperative treatment, and The Cancer Genome Atlas (TCGA) molecular risk profiles. METHODS: We retrospectively identified patients with premalignant pathology on preoperative endometrial biopsy who underwent hysterectomy with or without SLN mapping/excision at our institution from 01/01/2017-12/31/2021. Clinical, pathologic, surgical, and TCGA profiling data were abstracted. Appropriate statistical tests were used. RESULTS: Of 221 patients identified, 161 (73%) underwent hysterectomy with SLN excision and 60 (27%) underwent hysterectomy without SLN excision. Median age and body mass index were similar between groups. Median operative time was 130 min for those who underwent SLN mapping/excision versus 136 min for those who did not (p = 0.6). Thirty-day postoperative AE rates were 9% (n = 15/161) and 13% (n = 8/60), respectively (p = 0.9). Ninety-eight (44%) of 221 patients had grade 1-2 endometrioid endometrial cancer on final pathology (4 [4%] were stage IB or higher). Ten (10%) of 98 patients, all within the SLN group, received adjuvant treatment. Among all patients, of 33 (15%) with TCGA molecular classification data, 27 (82%) had copy number-low, 3 (9%) microsatellite instability-high, 2 (6%) POLE-ultramutated, and 1 (3%) copy number-high disease. CONCLUSIONS: SLN assessment appears safe, detects a small number of occult nodal metastases for those upstaged, and provides additional staging information that can guide adjuvant treatment. SLN mapping should be discussed in preoperative counseling and offered using a shared decision-making approach.
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Carcinoma Endometrioide , Hiperplasia Endometrial , Neoplasias Endometriales , Ganglio Linfático Centinela , Femenino , Humanos , Biopsia del Ganglio Linfático Centinela , Ganglio Linfático Centinela/cirugía , Ganglio Linfático Centinela/patología , Neoplasias Endometriales/genética , Neoplasias Endometriales/cirugía , Neoplasias Endometriales/diagnóstico , Estudios Retrospectivos , Hiperplasia Endometrial/cirugía , Hiperplasia Endometrial/patología , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Escisión del Ganglio Linfático , Carcinoma Endometrioide/patología , Estadificación de NeoplasiasRESUMEN
Background: Transfusion rates in cardiac surgery are high. Aim: To determine if intraoperative autologous blood removal without volume replacement is associated with fewer homologous blood transfusions without increasing acute kidney injury. Setting and Design: Retrospective, comparative study. Materials and Methods: Adult patients undergoing cardiac surgery, excluding those who underwent ventricular assist device surgery, heart transplants, or cardiac surgery without cardiopulmonary bypass were excluded, who had 1-3 units of intraoperative autologous blood removal were compared to patients without blood removal for determination of volume replacement, vasopressor support, acute kidney injury, and transfusions. Results: Autologous blood removal was associated with fewer patients receiving homologous transfusions: intraoperative red cell transfusions fell from 75% (Control) to 48% (1 unit removed), 40% (2 units), and 30% (3 units), P < 0.001. Total intraoperative and postoperative homologous RBC units transfused were lower in the blood removal groups: median (interquartile range) 3 (1, 6) in Control patients and 0 (0, 2), 0 (0, 2) and 0 (0, 1) in the 1, 2, and 3 units removed groups, P < 0.001. Similarly, plasma, platelet, and cryoprecipitate transfusions decreased. After adjustment for confounders, increased amounts of autologous blood removal were associated with increased intravenous fluids, only when 2 units were removed, and trivially increased vasopressor use. However, it was not associated with acidosis or acute kidney injury. Conclusions: Intraoperative autologous blood removal without volume replacement of 1-3 units for later autologous transfusion is associated with decreased homologous transfusions without acidosis or acute kidney injury.
Asunto(s)
Lesión Renal Aguda , Procedimientos Quirúrgicos Cardíacos , Cirugía Torácica , Lesión Renal Aguda/terapia , Adulto , Transfusión Sanguínea , Transfusión de Sangre Autóloga , Humanos , Estudios RetrospectivosRESUMEN
OBJECTIVES: Gastric-type endocervical adenocarcinoma (GEA) is a rare form of cervical cancer not associated with human papilloma virus (HPV) infection. We summarize our experience with GEA at a large cancer center. METHODS: Clinical and demographic information on all patients diagnosed with GEA between June 1, 2002 and July 1, 2019 was obtained retrospectively from clinical charts. Kaplan-Meier survival analysis was performed to describe progression-free survival (PFS) and overall survival (OS). Tumors from a subset of patients underwent next generation sequencing (NGS) analysis. RESULTS: A total of 70 women with GEA were identified, including 43 who received initial treatment at our institution: of these 4 (9%) underwent surgery alone, 15 (35%) underwent surgery followed by adjuvant therapy, 10 (23%) were treated with definitive concurrent chemoradiation (CCRT), 7 (16%) with chemotherapy alone, and 3 (7%) with neoadjuvant CCRT and hysterectomy with or without chemotherapy. One-third (n = 14) of patients experienced disease progression, of whom 86% (n = 12) had prior CCRT. The median PFS and OS for patients with stage I GEA were 107 months (95% CI 14.8-199.2 months) and 111 months (95% CI 17-205.1 months) respectively, compared to 17 months (95% CI 5.6-28.4 months) and 33 months (95% CI 28.2-37.8 months) for patients with stages II-IV, respectively. On NGS, 4 patients (14%) had ERBB2 alterations, including 2 patients who received trastuzumab. CONCLUSIONS: GEA is an aggressive form of cervical cancer with poor PFS and OS when diagnosed at stage II or later. Further investigation is needed to identify the optimal management approach for this rare subtype.