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PURPOSE: Postoperative venous thromboembolism (VTE) can potentially be associated with significant morbidity, mortality, and healthcare costs. The aim of this study was to determine the utilization of Caprini guideline indicated VTE in elective gynecologic surgery patients and its impact on postoperative VTE and bleeding complications. METHODS: This was a retrospective cohort study of elective gynecologic surgical procedures performed between January 1, 2016, and May 31, 2021. Two study cohorts were generated: (1) those who received and (2) those who did not receive VTE prophylaxis based on Caprini score risk stratification. Outcome measures were then compared between the study cohorts and included the development of a VTE up to 90-days postoperatively. Secondary outcome measures included postoperative bleeding events. RESULTS: A total of 5471 patients met inclusion criteria and the incidence of VTE up to 90 days postoperatively was 1.04%. Overall, 29.6% of gynecologic surgery patients received Caprini score-based guideline VTE prophylaxis. 39.2% of patients that met high-risk VTE criteria (Caprini > 5) received appropriate Caprini score-based prophylaxis. In multivariate regression analysis, the American Society of Anesthesiologists (ASA) score (OR 2.37, CI 1.27-4.45, p < 0.0001) and Caprini score (OR 1.13, CI 1.03-1.24, p = 0.008) predicted postoperatively VTE occurrence. Increasing Charlson comorbidity score (OR 1.39, CI 1.31-1.47, P < 0.001) ASA score (OR 1.36, CI 1.19-1.55, P < 0.001) and Caprini score (OR 1.10, CI 1.08-1.13, P < 0.001) were associated with increased odds of receiving appropriate inpatient VTE prophylaxis. CONCLUSION: While the overall incidence of VTE was low in this cohort, enhanced adherence to risk-based practice guidelines may provide more patient benefit than harm to postoperative gynecologic patients.
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Tromboembolia Venosa , Humanos , Femenino , Medición de Riesgo/métodos , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Seguridad del Paciente , Hemorragia , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Factores de RiesgoRESUMEN
STUDY OBJECTIVE: To gather validity evidence for and determine acceptability of Surgical Science-Simbionix Hysterectomy Modules for the DaVinci Xi console simulation system (software; 3D Systems by Simbionix [now Surgical Science-Simbionix], Littleton, CO, and hardware; Intuitive Surgical, Inc., Sunnyvale, CA) and evaluate performance benchmarks between novice and experienced or expert surgeons. DESIGN: Prospective education study (Messick validity framework). SETTING: Multicenter, academic medical institutions. PARTICIPANTS: Residents, fellows, and faculty in obstetrics and gynecology were invited to participate at 3 institutions. Participants were categorized by experience level: fewer than 10 hysterectomies (novice), 10 to 50 hysterectomies (experienced), and more than 50 hysterectomies (expert). A total of 10 novice, 10 experienced, and 14 expert surgeons were included. INTERVENTIONS: Participants completed 4 simulator modules (ureter identification, bladder flap development, colpotomy, complete hysterectomy) and a qualitative survey. Simulator recordings were reviewed in duplicate by educators in minimally invasive gynecologic surgery using the Modified Global Evaluative Assessment of Robotic Skills (GEARS) rating scale. MEASUREMENTS AND MAIN RESULTS: Most participants felt that the simulator realistically simulated robotic hysterectomy (64.7%) and that feedback provided by the simulator was as or more helpful than feedback from previous simulators (88.2%) but less helpful than feedback provided in the operating room (73.5%). Participants felt that this simulator would be helpful for teaching junior residents. Simulator-generated metrics correlated with GEARS performance for the bladder flap and ureter identification modules in multiple domains including total movements and total time for completion. GEARS performance for the bladder flap module correlated with experience level (novice vs experienced/expert) in the domains of interest and total score but did not consistently correlate for the other procedural modules. Performance benchmarks were evaluated for the bladder flap module for each GEARS domain and total score. CONCLUSION: The modules were well received by participants of all experience levels. Individual simulation modules appear to better discriminate between novice and experienced/expert users than overall simulator performance. Based on these data and participant feedback, the use of individual modules in early residency education may be helpful for providing feedback and may ultimately serve as 1 component of determining readiness to perform robotic hysterectomy.
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Procedimientos Quirúrgicos Robotizados , Robótica , Competencia Clínica , Simulación por Computador , Femenino , Humanos , Histerectomía , Estudios Prospectivos , Procedimientos Quirúrgicos Robotizados/educaciónRESUMEN
STUDY OBJECTIVE: The "illusion of validity" is a cognitive bias in which the ability to interpret and predict surgical performance accurately is overestimated. To address this bias, we assessed participants comparing fundamentals of laparoscopic surgery (FLS) and non-FLS tasks with cadaveric vaginal cuff suturing to determine the most representative simulation task for laparoscopic vaginal cuff suturing. DESIGN: Validity (Messick framework) study comparing FLS and non-FLS tasks with cadaveric vaginal cuff suturing. SETTING: Simulation center cadaver laboratory. PARTICIPANTS: Obstetrics and gynecology residents (n = 21), minimally invasive gynecologic surgery fellows (n = 3), gynecologic surgical subspecialists (n = 4), general obstetrician/gynecologists (n = 10). INTERVENTIONS: Tasks included a simulated vaginal cuff (ipsilateral port placement), needle passage through a metal eyelet loop (contralateral and ipsilateral), and intracorporeal knot tying (contralateral and ipsilateral). Simulation task times were compared with the placement of the first cadaveric vaginal cuff suture time, as well as the in-person and blinded Global Operative Assessment of Laparoscopic Skills (GOALS) score ("relations to other variables" validity evidence). Statistical analyses included Spearman's test of correlation (continuous and ordinal variables) or Wilcoxon rank sum test (categoric variables). MEASUREMENTS AND MAIN RESULTS: There was a stronger association with cadaver cuff suturing time for simulated vaginal cuff suturing time (r = 0.73, p <.001) compared with FLS intracorporeal contralateral suturing time (r = 0.54, p <.001). Additional measures associated with cadaveric performance included subspecialty training (median: 82 vs 185 seconds, p = .002), number of total laparoscopic hysterectomies (r = -0.53, p <.001), number of laparoscopic cuff closures (r = -0.61, p <.001), number of simulated laparoscopic suturing experiences (r = -0.51, p <.001), and eyelet contralateral time (r = 0.52, p <.001). Strong agreement between the in-person and blinded GOALS (intraclass correlation coefficient = 0.80) supports response process evidence. Correlations of cadaver cuff time with in-person (Spearman's r = -0.84, p <.001) and blinded GOALS (r = -0.76, p <.001) supports relations to other variables evidence CONCLUSION: The weaker correlation between FLS suturing and cadaver cuff suturing compared with a simulated vaginal cuff model may lead to an "illusion of validity" for assessment in gynecology. Since gynecology specific validity evidence has not been well established for FLS, we recommend prioritizing the use of a simulated vaginal cuff suturing assessment in addition to FLS.
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Ilusiones , Laparoscopía , Competencia Clínica , Femenino , Humanos , Técnicas de Sutura , SuturasRESUMEN
STUDY OBJECTIVE: Determine the prevalence of burnout and frustration among participants currently completing a fellowship in minimally invasive gynecologic surgery (FMIGS). DESIGN: Cross-sectional survey. SETTING: An anonymous survey was distributed to fellows in November 2018. PARTICIPANTS: Current FMIGS fellows. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: A total of 57 of 83 (67.7%) FMIGS participants in American Association of Gynecologic Laparoscopists-accredited programs completed a survey regarding fellowship characteristics and experiences. Overall, 40 participants (70.2%) indicated that they were satisfied with their fellowship program experience. There were 33 participants (57.9%) who reported burnout, and 38 participants (66.7%) had experienced anxiety, depression, or extreme fatigue during the last month. Of those who reported burnout, 26 (76.5%) reported that they did not receive support from their fellowship program. Participants who experienced burnout were more likely to be in their second year (pâ¯=â¯.003), spent less time per week doing scholarly activities (pâ¯=â¯.048), and were less satisfied with their fellowship experience (p <.001). Participants who experienced anxiety, depression, or extreme fatigue had more cofellows in their program (pâ¯=â¯.031), worked on average more hours per week (pâ¯=â¯.020), and were more often required to practice obstetrics in their fellowship (pâ¯=â¯.022). CONCLUSION: Burnout symptoms are common among physicians across multiple specialties. Our findings suggest that this issue is prevalent among FMIGS participants. In addition, there is a lack of access to emotional and psychologic support programs for fellows experiencing burnout. We hope that this study will prompt attention to this important topic by both individual programs and American Association of Gynecologic Laparoscopists as a society to increase awareness and access to resources and promote wellness for fellows.
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Agotamiento Profesional/epidemiología , Frustación , Procedimientos Quirúrgicos Ginecológicos/estadística & datos numéricos , Internado y Residencia/estadística & datos numéricos , Procedimientos Quirúrgicos Mínimamente Invasivos/estadística & datos numéricos , Cirujanos/estadística & datos numéricos , Adulto , Agotamiento Profesional/etiología , Estudios Transversales , Becas/estadística & datos numéricos , Femenino , Procedimientos Quirúrgicos Ginecológicos/psicología , Humanos , Satisfacción en el Trabajo , Masculino , Obstetricia/estadística & datos numéricos , Médicos/psicología , Médicos/estadística & datos numéricos , Factores de Riesgo , Factores Socioeconómicos , Cirujanos/psicología , Encuestas y Cuestionarios , Estados Unidos/epidemiologíaRESUMEN
STUDY OBJECTIVE: To demonstrate the process for establishing or refuting validity for the Limbs and Things hysterectomy model. DESIGN: Prospective study using Kane's framework for establishing validity (Canadian Task Force classification: II-2). SETTING: Total laparoscopic hysterectomy (TLH) assessments completed in the operating room (OR) and simulation at 3 academic medical centers. PARTICIPANTS: Obstetrics and gynecology residents (n = 26 postgraduate years 3-4), a gynecologic oncology fellow (postgraduate year 5), and a gynecology oncology attending. INTERVENTIONS: Participants were rated with the myTIPreport feedback application by nonblinded faculty in the OR after TLH. In-person, simulation-based assessments were provided by 2 faculty members blinded to experience level using myTIPreport and Global Operative Assessment of Laparoscopic Skills (GOALS). Videos of simulated TLHs were rated by 2 minimally invasive gynecology fellows. MEASUREMENTS AND MAIN RESULTS: OR scores for TLH steps were significantly higher than simulation assessments (p < .001) with "competent" marked more frequently in the OR. Number of robotic + conventional TLHs performed as primary surgeon was not significantly correlated with OR myTIPreport rating (Spearman r = .30, p = .14) but was significantly correlated with myTIPreport and GOALS in-person simulation ratings (Spearman r = .39-.58, p = .001-.04). Agreement between in-person simulation rater 1 and 2 myTIPreport assessments was 71.4% (weighted κ, .68; 95% confidence interval, .45-.90), and intraclass correlation for the GOALS overall assessment was .71 (95% confidence interval, .46-.85), indicating substantial agreement. Blinded video reviews showed similar agreement (73.1%) between raters but less correlation with experience (Spearman r = .32-.42, p = .11-.03) than in-person reviews. Using area under the receiver operating characteristic curve, mean score for the individual components of GOALS that best differentiated myTIPreport noncompetent and competent levels of performance was 4.3. Feedback acceptability and model realism were rated highly. CONCLUSION: The scoring and generalization validity inferences for Limbs and Things and myTIPreport are supported when global assessments of performance are evaluated but not for individual components of the assessment instruments.
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Competencia Clínica , Histerectomía/educación , Internado y Residencia , Modelos Anatómicos , Femenino , Ginecología/educación , Humanos , Laparoscopía/educación , Obstetricia/educación , Estudios Prospectivos , Reproducibilidad de los ResultadosRESUMEN
This study describes the use of the Internet for health information research by patients attending a gynecologic oncology practice and examines the association between its use and anxiety. A self-administered survey assessed patients' demographic information and Internet use. The Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI) were administered concurrently. Of 212 patients who consented to the study, 98 (46%) had an appointment because of a cancer diagnosis. Of 199 respondents, 91 (46%) reported searching the Internet for information about their condition. Internet searching was unassociated with race/ethnicity and positively associated with education level, annual household income, and married/partnered civil status. Only 16% of the patients reported that a health-care provider recommended use of the Internet for research. Comparing patients who used the Internet for research with those who did not, the STAI state and trait anxiety scores were similar. The HADS anxiety subscale score was higher for those who used the Internet versus those who did not, which suggests heightened anxiety. Internet use for research is common in gynecologic oncology patients, and its use is associated with increased anxiety. Physicians can use this medium to educate patients about their disease, build trust, and alleviate fear.
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Ansiedad/diagnóstico , Información de Salud al Consumidor/estadística & datos numéricos , Neoplasias de los Genitales Femeninos/terapia , Conducta en la Búsqueda de Información , Internet/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Neoplasias de los Genitales Femeninos/psicología , Humanos , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Adulto JovenRESUMEN
OBJECTIVES: We report the results of a phase 2 clinical trial of the combination of everolimus and letrozole in patients with relapsed estrogen receptor-positive high-grade ovarian cancer. The trial's primary endpoint was the proportion of patients alive and progression-free after 12weeks of therapy with the combination of everolimus and letrozole. A 12-week PFS of 45% or greater was considered a positive result. The feasibility of generating patient-derived xenograft (PDX) models from biopsy specimens was also evaluated. METHODS: Eligibility criteria included relapsed estrogen receptor-positive ovarian, fallopian tube or primary peritoneal carcinomas with measurable disease, not previously treated with everolimus or AIs. Both platinum-resistant and sensitive tumors were included. Xenografts were created from image-guided tumor biopsies at baseline. Patients received oral everolimus 10mg daily and letrozole 2.5mg daily. RESULTS: Twenty patients were enrolled, 19 were evaluable. Nine out of 19 were alive, progression-free, and still on treatment at the 12week evaluation time-point (12-week PFS of 47%) with a median PFS of 3.9months (95% CI: 2.8-11.0). The median overall survival was 13.0months. Twelve patients (63%) experienced at least one grade 3 or worse adverse events. PDX tumor engraftment was feasible in the majority of patients (9 out of 17, 52.9%). CONCLUSIONS: The combination of everolimus and letrozole is associated with a promising 47% 12-week PFS rate in patients with ER-positive relapsed high-grade ovarian cancer with acceptable toxicity. PDX tumor models can be generated from biopsies of ovarian tumors.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/metabolismo , Receptores de Estrógenos/biosíntesis , Administración Oral , Anciano , Animales , Inhibidores de la Aromatasa/administración & dosificación , Supervivencia sin Enfermedad , Everolimus/administración & dosificación , Femenino , Humanos , Letrozol , Ratones , Ratones SCID , Persona de Mediana Edad , Clasificación del Tumor , Nitrilos/administración & dosificación , Neoplasias Ováricas/patología , Triazoles/administración & dosificación , Ensayos Antitumor por Modelo de XenoinjertoRESUMEN
A 46-year-old female presents with a pelvic mass and is diagnosed as having a high-grade endometrial stromal sarcoma. During surgery, she is noted to have areas of intussusception of the small bowel secondary to large hamartomatous polyps. The patient had a previous history of small bowel obstruction secondary to what had been thought to be hyperplastic polyps but represented hamartomatous polyps on further review. Additional examination revealed the presence of subtle hyperpigmented macules on the fingers leading to a diagnosis of Peutz-Jeghers Syndrome (PJS). The diagnosis was confirmed by the presence of a germ-line STK11 mutation. Immunohistochemistry analysis of the tumor showed decreased expression of STK-11 as compared to one of the patient's hamartomatous polyps. Next generation sequencing of the tumor specimen failed to demonstrate a "second hit" somatic mutation in STK-11. This case represents the first case of endometrial stromal sarcoma associated with PJS and illustrates the importance of increased awareness of this condition among oncologists. PJS is associated with dysregulation of the mTOR pathway; treatment with an mTOR inhibitor was not effective in this case.
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Objective: To determine the effectiveness of communication training and its impact on burnout among healthcare providers (physicians, physician assistants, nurse practitioners), in the setting of the COVID-19 pandemic. Methods: To evaluate the effectiveness of communication training on burnout during the COVID-19 pandemic, healthcare providers participating in a Communication in Healthcare (CIH) module between October 31, 2019, through February 20, 2020, were identified using a scanned sign-in sheet. A 3-question online survey regarding the utilization of communication skills during the COVID-19 pandemic was sent via email. An ordinal scale was used to rate the effectiveness of the training on subsequent burnout and work satisfaction during the pandemic. Results: Of the 98 surveys distributed via email, a total of 33 participants completed the survey. Seventy-three percent of respondents agreed that communication training helped prevent burnout, and 39% strongly agreed that the modules improved work satisfaction. Conclusion: Our study found communication training was effective in reducing burnout in healthcare providers, in the setting of the COVID-19 pandemic. The participants felt the communication tools learned from the training modules were useful in improving work satisfaction and communication with patients during the pandemic.
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Significant toxicities from multiple cycles of chemotherapy often cause delays or early termination of treatment, leading to poor outcomes in ovarian cancer patients. Complementary modalities that potentiate the efficacy of traditional agents with fewer cycles and less toxicity are needed. Photodynamic therapy is a mechanistically-distinct modality that synergizes with chemo and biologic agents. A combination regimen with a clinically relevant chemotherapy cocktail (cisplatin + paclitaxel) and anti-EGFR targeted photoimmunotherapy (PIT) is evaluated in a murine model for ovarian carcinomatosis. Mice received either 1 or 2 chemotherapy cycles followed by PIT with a chlorine6-Erbitux photoimmunoconjugate and 25 J/cm2 light. PIT + 1 cycle of chemotherapy significantly reduced tumor burden, comparable to multiple chemotherapy cycles. Relative to 1 cycle of chemotherapy, the addition of PIT did not cause significant mouse weight loss, whereas 2 cycles of chemotherapy led to a significant reduction in weight. Irradiance-dependence on PIT efficacy was a function of the conjugation chemistry, providing an additional variable for optimization of PIT outcome.
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The advantages of dual console use in robotic surgical education have not been described. The aims of this study are to compare fellow console time, surgical steps performed, and surgical takeovers between attending and fellow surgeons using dual versus single console robotic systems. Participants included minimally invasive gynecologic surgery (MIGS) fellows (N = 3) and subspecialty trained gynecologic surgeons (N = 5). Prospective data were obtained on 126 patients (N = 77 single console, N = 49 dual console) undergoing robotic hysterectomy. Variables included demographics, surgical characteristics (fellow, month of fellowship, attending surgeon, concomitant oophorectomy, additional surgical procedures, estimated blood loss, specimen weight), and outcomes (console time, docking time, console time/docking time ratio, total case time, number of surgical steps performed by the fellow, number of surgical takeovers, complications). After controlling for potential confounders, fellows spent a mean of 25.8 min longer (P < 0.001) at the console in dual console operations compared to single. Dual console surgeries had a greater number of steps performed by the fellow (OR[> 5 steps]: 3.37, P = 0.009), a higher console time/docking time ratio (P < 0.001), and more surgical takeovers between fellow and attending (OR [> 1 takeover]: 3.53, P < 0.001). There were no significant differences between the two groups regarding docking time (P = 0.15), case time (P = 0.79), or complications (P = 0.30). Our findings suggest dual console robotic training provide fellows the opportunity for more "hands-on" experience with longer console time, higher number of surgical steps performed, and added interaction with the attending surgeon when compared with single console training. These surgical metrics provide objectivity in competency-based robotic training without increasing the complications or surgical time.
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Ginecología , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Femenino , Procedimientos Quirúrgicos Robotizados/métodos , Estudios Prospectivos , Robótica/educación , BecasRESUMEN
Aberrancies in the tumor microvasculature limit the systemic delivery of anticancer agents, which impedes tumor response. Using human intravital microscopy (HIVM), we hypothesized that HIVM would be feasible in patients with peritoneal carcinomatosis (PC). During cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for PC, HIVM was performed in both tumor and non-tumor areas. The primary outcome was HIVM feasibility to measure vessel characteristics. We secondarily evaluated associations between HIVM vessel characteristics and oncologic outcomes (RECIST response to neoadjuvant therapy and disease-specific survival). Thirty patients with PC were enrolled. Nineteen patients (63.3%) received neoadjuvant therapy. HIVM was feasible in all patients. Compared to non-tumor (control) areas, PC areas had a lower density of functional vessels, higher proportion of non-functional vessels, smaller lumenal diameters, and lower blood flow velocity. Qualitative differences in these vessel characteristics were observed among patients who had partial response, stable disease, or progressive disease after receiving neoadjuvant therapy. However, no statistically significant relationships were found between HIVM vessel characteristics and oncologic outcomes. These novel findings comprise the first-in-human, real-time evidence of the microscopic differences between normal and tumor-associated vessels and form the basis for our larger, ongoing clinical trial appropriately powered to determine the clinical utility of HIVM (NCT03823144).
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Microscopía Intravital , Terapia Neoadyuvante , Neoplasias Peritoneales , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias Peritoneales/irrigación sanguínea , Neoplasias Peritoneales/diagnóstico por imagen , Neoplasias Peritoneales/terapia , Proyectos PilotoRESUMEN
BACKGROUND: Office hysteroscopy (OH) is becoming increasingly popular. Our objective was to determine the use patterns, reported pain scores, and success rates of OH with the 2.9 mm Storz TrophyScope® and handheld portable Cooper surgical Endosee® device in a clinic without previous office hysteroscopy experience. METHODS: A prospective cohort study of a hysteroscopy quality improvement database was conducted in a tertiary care center gynecology clinic. Patients undergoing OH with either the Storz TrophyScope® or Cooper Surgical Endosee® device were included. RESULTS: Of the 171 office hysteroscopies, 77 utilized the TrophyScope®, with 8 (10%) being inadequate, while 94 utilized Endosee®, with 13 (14%) being inadequate (P=0.50). Of the 13 inadequate Endosee® hysteroscopies, 4 (31%) were due to visualization, 4 (31%) to patient intolerance, 3 (23%) to cervical stenosis, and 2 (15%) to a combination of these factors. Of the 8 inadequate TrophyScope® hysteroscopies, 7 (87%) were due to patient intolerance and 1 (13%) to cervical stenosis. Of the 150 adequate office procedures performed, 52 cases underwent subsequent procedures in the operating room (OR). Of these, 26 (84%) of 31 Endosee® cases and 18 (86%) of 21 TrophyScope® cases were in agreement with OR procedure findings. A subgroup analysis comparing mean pain levels did not significantly differ between the two hysteroscopes. CONCLUSIONS: There was no difference in accuracy with OR pathologic diagnoses, adequacy of procedure, and reported pain scores when comparing the TrophyScope® and Endosee® in this prospective cohort. Larger studies are needed to confirm the sensitivity, and specificity for these newer, disposable office hysteroscopic devices.
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Histeroscopios , Histeroscopía , Procedimientos Quirúrgicos Ambulatorios , Femenino , Humanos , Dolor , Embarazo , Estudios ProspectivosRESUMEN
BACKGROUND: The aim of this study was to determine if uterine dimensions on preoperative imaging are associated with route of contained morcellation during laparoscopic hysterectomy. METHODS: This is a prospective cohort study of patients undergoing laparoscopic hysterectomy and requiring morcellation for specimen extraction from March 2017 through August 2019. A contained extraction system was inserted and manual morcellation was performed vaginally, abdominally, or via a combination of both methods in cases of failed vaginal extraction. RESULTS: A total of 47 patients were treated. Median age was 47 (range 38-70). Morcellation was performed vaginally for 29 patients (61.7%), abdominally for 13 patients (27.7%), and via combined approach for 5 patients (10.6%). The combined group had the highest frequency of patients who were black (vaginal: 24%, abdominal: 31%, combined: 100%; P=0.005), the longest median total operating time (vaginal: 167 minutes, abdominal: 183 minutes, combined: 268 minutes; P=0.006) and the longest median time of uterine morcellation (vaginal: 14 minutes, abdominal: 37 minutes, combined: 85 minutes; P<0.001). There was strong evidence of a positive correlation with time of uterine morcellation for both largest uterine diameter (Spearman's r: 0.62, P<0.001) and uterine volume (Spearman's r: 0.70, P<0.001). These associations remained consistent after multivariable linear regression models that were adjusted for route of morcellation, hysterectomy type, and BMI (both P<0.001). CONCLUSIONS: Larger uterine dimensions are associated with increased total operating and morcellation times. Uterine size and volume on preoperative imaging were not associated with route of morcellation, but there was a trend towards failed vaginal extraction when uterine dimensions exceeded 16 centimeters.
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Laparoscopía , Morcelación , Femenino , Humanos , Histerectomía , Persona de Mediana Edad , Morcelación/efectos adversos , Estudios Prospectivos , Útero/cirugíaRESUMEN
OBJECTIVE: We describe a phase II clinical trial of the combination of ribociclib and letrozole for treatment of relapsed oestrogen receptor (ER)-positive ovarian cancer (OC) and endometrial cancer (EC). The primary endpoint was the proportion of patients alive, progression-free survival (PFS), and still on treatment at 12 weeks (PFS12), with 45% or greater considered positive. METHODS: Patients with measurable, relapsed ER-positive OC or EC (platinum-sensitive or resistant) were eligible and treated with 400 mg of oral ribociclib and 2.5 mg of oral letrozole daily. Patient-derived xenografts (PDXs) were created from imaging-guided tumour biopsies. RESULTS: Forty patients (20 OC and 20 EC) were enrolled. A PFS12 of 55% was observed in the EC cohort and 50% in the OC cohort. A PFS greater or equal to 24 weeks (PFS24) was seen in 20% (4/20) of the OC cohort and 35% (7/20) of the EC cohort. The greatest benefit was seen in low-grade serous OC (LGSOC) (3/3, 100% PFS24) and grades 1 and 2 EC (5/11, 45% PFS24). All three LGSOC patients obtained at least a partial response lasting for over 2 years, with two of the three patients still on treatment. PDX tumour engraftment was feasible in 45% of patients. Positive survival effects of the combination of ribociclib and letrozole were observed in two of three EC PDX models. CONCLUSION: Ribociclib and letrozole have promising clinical activity in relapsed ER-positive OC and EC, particularly in LGSOC and relapsed ER-positive grade 1 and 2 EC. Generation of PDX models is feasible with positive survival effects observed in EC models. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT02657928).
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Neoplasias Endometriales , Receptores de Estrógenos , Aminopiridinas , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Supervivencia sin Enfermedad , Neoplasias Endometriales/tratamiento farmacológico , Femenino , Humanos , Letrozol/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Purinas , Receptores de Estrógenos/uso terapéuticoRESUMEN
OPINION STATEMENT: Nearly 500,000 new cases of cervical cancer and 274,000 cervical cancer deaths are occurring worldwide each year. Approximately 80% of the 500,000 new cases occur in developing countries and this percentage is expected to increase to 90% by 2020. In developing countries, cervical cancer tends to affect relatively young poor women and is the single largest cause of years of life lost to cancer, since screening and treatment programs, and health care, in general, are relatively inaccessible to these women. Each 5-year delay in vaccinating women against HPV may lead to the deaths of 1.5 to 2 million women from cervical cancer in developing countries. The high efficacy of the two available cervical cancer vaccines and their proven ability to reduce the incidence of cervical cancer precursor lesions offer hope that the vaccine will have enormous worldwide impact and may dramatically reduce the cervical cancer burden. The current vaccines protecting against HPV-16 and HPV-18 may prevent up to 70% of new cervical cancers. Vaccine cross-reactivity for HPV-31, -33, -45, and -52 suggest that an even higher percentage of cervical cancers might be prevented with its use. Currently, the prohibitive cost of the vaccine precludes its widespread implementation. Cooperation between governments, international health organizations, and the vaccine industry is needed to overcome this significant barrier so that women are no longer denied a potentially life-saving advance. Worldwide HPV vaccination and cervical cancer screening should be made an international priority.
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Salud Global , Vacunas contra Papillomavirus , Adolescente , Adulto , Alphapapillomavirus/inmunología , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , Niño , Ensayos Clínicos como Asunto/estadística & datos numéricos , Costos y Análisis de Costo , Reacciones Cruzadas , Países en Desarrollo/economía , Método Doble Ciego , Femenino , Prioridades en Salud , Accesibilidad a los Servicios de Salud , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18 , Humanos , Cooperación Internacional , Estudios Multicéntricos como Asunto , Infecciones por Papillomavirus/epidemiología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/economía , Vacunas contra Papillomavirus/inmunología , Vacunas contra Papillomavirus/provisión & distribución , Lesiones Precancerosas/epidemiología , Lesiones Precancerosas/prevención & control , Lesiones Precancerosas/virología , Prevalencia , Neoplasias del Cuello Uterino/epidemiología , Neoplasias del Cuello Uterino/prevención & control , Cervicitis Uterina/epidemiología , Cervicitis Uterina/prevención & control , Cervicitis Uterina/virología , Vacunación/economía , Vacunación/estadística & datos numéricos , Adulto JovenRESUMEN
â¢Superior mesenteric vein thrombosis (SMVT) is rare but seen in patients with hypercoagulable states.â¢Prevention of mortality in patients with SMVT requires immediate diagnosis and complex management.â¢A hierarchical approach to treatment progresses to more aggressive treatment as needed.â¢Supportive care, medication, and endovascular and/or surgical interventions are available management options.â¢In patients with underlying conditions, long-term treatment such as anticoagulation must also be initiated.
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BACKGROUND: This study aimed to report the computer-enhanced robotic surgery experience of the authors' gynecologic oncology division. METHODS: From January 2001 to August 2006, 41 patients underwent laparoscopic surgery by our gynecologic oncology service using a computer-enhanced surgical robot. This report describes a retrospective review of these patients. RESULTS: The patients ranged in age from 27 to 77 years (mean, 44.2 years), in weight from 44 to 131 kg (mean, 72.1 kg), in operative time from 1 h and 50 min to 9 h (mean, 5 h and 2 min), and in estimated blood loss from 50 to 1,500 ml (mean, 253 ml). Of the 20 patients with gynecologic malignancies, 14 had cervical cancer. A total of 21 patients had benign indications for surgery. Complications included shoulder palsy, robot failure, colotomy, bradycardia, and intraabdominal bleeding requiring minilaparotomy and ligation of a bleeding pedicle. CONCLUSION: This case series is one of the first to report the use of a computer-enhanced surgical robot in gynecologic oncology. This approach proved to be feasible and well tolerated in this series of patients and deserves further study for clarification of its indications, benefits, and safety.