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OBJECTIVE: To evaluate the effect on patient outcomes when introducing a novice robotic surgeon, trained in accordance with a structured learning curriculum, to an experienced robotic surgery team treating cervical cancer patients. METHODS: Patients with early-stage cervical cancer who were treated with primary robot-assisted surgery between 2007 and 2019 were retrospectively included. In addition to the 165 patients included in a former analysis, we included a further 61 consecutively treated patients and divided all 226 patients over three groups: early learning phase of 61 procedures without structured training (group 1), experienced phase of 104 procedures (group 2), and the 61 procedures during introduction of a novice with structured training (group 3). Risk-adjusted cumulative sum (RA-CUSUM) analysis was performed to assess the learning curve effect. Patient outcomes between the groups were compared. RESULTS: Based on RA-CUSUM analysis, no learning curve effect was observed for group 3. Regarding surgical outcomes, mean operation time in group 3 was significantly shorter than group 1 (p < 0.001) and similar to group 2 (p = 0.96). Proportions of intraoperative and postoperative adverse events in group 3 were not significantly different from the experienced group (group 2). Regarding oncological outcomes, the 5-year disease-free survival, disease-specific survival, and overall survival in group 3 were not significantly different from the experienced group. CONCLUSIONS: Introducing a novice robotic surgeon, who was trained in accordance with a structured learning curriculum, resulted in similar patient outcomes as by experienced surgeons suggesting novices can progress through a learning phase without compromising outcomes of cervical cancer patients.

Asunto(s)

Laparoscopía , Procedimientos Quirúrgicos Robotizados , Cirujanos , Neoplasias del Cuello Uterino , Femenino , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Estudios Retrospectivos , Neoplasias del Cuello Uterino/cirugía , Neoplasias del Cuello Uterino/etiología , Estudios de Cohortes , Curva de Aprendizaje , Curriculum , Laparoscopía/métodos

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OBJECTIVE: Gestational trophoblastic diseases (GTD) comprise a group of rare diseases originating from the trophoblast affecting women of childbearing age. Providing optimal information to patients with a rare disease is challenging because of the small number of patients and limited clinical expertise of many healthcare professionals. Both knowledge and lack of knowledge in patients may influence illness perception. We investigated whether a web-based interactive intervention influences illness perception and knowledge in women with GTD. DESIGN: This was a multicenter randomized control trial conducted at general and academic hospitals in the Netherlands, including newly diagnosed GTD patients between 2017 and 2019. METHODS: Sixty-nine patients were randomized between direct access or postponed access to an online tool on GTD and received online questionnaires about illness perception, knowledge, and anxiety. The main outcome measures were illness perception (primary outcome measure) and knowledge (secondary outcome measure). RESULTS: Patients using the online tool were satisfied with the information from the tool (92%). Although they had a higher level of knowledge compared to the control group (p = 0.006), illness perception did not change. Also, no differences in levels of anxiety, depression, or distress were observed between the groups. LIMITATIONS: Participants had access to other information sources and many searched other websites. It is unknown what kind of websites were visited and when. It is unknown if the increased knowledge levels and low levels of distress will sustain over time as no long term follow-up took place. Healthcare professionals were not interviewed on how they experienced the consultation before and after using the tool by the patients. CONCLUSIONS: The online tool did not change illness perception but was shown to be valuable for newly diagnosed GTD patients to gain knowledge. The improvement in knowledge after digital education indicates that this tool can be used as an effective method of supporting GTD patients' informational needs without causing extra distress. TWEETABLE ABSTRACT: A web-based tool for trophoblastic disease does not change illness perception of patients but is valuable to gain knowledge.

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Enfermedad Trofoblástica Gestacional , Intervención basada en la Internet , Embarazo , Humanos , Femenino , Enfermedad Trofoblástica Gestacional/terapia , Enfermedad Trofoblástica Gestacional/complicaciones , Ansiedad/etiología , Evaluación de Resultado en la Atención de Salud , Encuestas y Cuestionarios

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BACKGROUND: There is a growing need for genetic testing of women with epithelial ovarian cancer. Mainstream genetic testing provides an alternative care pathway in which non-genetic healthcare professionals offer pre-test counseling themselves. We aimed to explore the impact of mainstream genetic testing on patients' experiences, turnaround times and adherence of non-genetic healthcare professionals to the mainstream genetic testing protocol. METHODS: Patients receiving pre-test counseling at the gynecology departments between April 2018 and April 2020 were eligible to participate in our intervention group. Patients receiving pre-test counseling at the genetics department between January 2017 and April 2020 were eligible to participate in our control group. We evaluated patients' experiences with questionnaires, consisting of questions regarding knowledge, satisfaction and psychosocial outcomes. Patients in the intervention group were sent two questionnaires: one after pre-test counseling and one after receiving their DNA test result. Patients in our control group were sent one questionnaire after receiving their test result. In addition, we collected data regarding turnaround times and adherence of non-genetic healthcare professionals to the mainstream genetic testing protocol. RESULTS: Participation was 79% in our intervention group (105 out of 133 patients) and 60% in our control group (91 out of 152 patients). Knowledge regarding genetics, decisional conflict, depression, anxiety, and distress were comparable in the two groups. In the intervention group, the risk of breast cancer in patients carrying a pathogenic germline variant was discussed less often (49% versus 74% in control group, p ≤ 0.05), and the mean score of regret about the decision to have genetic testing was higher than in the control group (mean 12.9 in the intervention group versus 9.7 in the control group, p ≤ 0.05), although below the clinically relevant threshold of 25. A consent form for the DNA test and a checklist to assess family history were present for ≥ 95% of patients in the intervention group. CONCLUSION: Mainstream genetic testing is an acceptable approach to meet the increase in genetic testing among women with epithelial ovarian cancer.

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The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin to interval cytoreductive surgery improves recurrence-free (RFS) and overall survival (OS) in patients with stage III ovarian cancer. Homologous recombination deficient (HRD) ovarian tumors are usually more platinum sensitive. Since hyperthermia impairs BRCA1/2 protein function, we hypothesized that HRD tumors respond best to treatment with HIPEC. We analyzed the effect of HIPEC in patients in the OVHIPEC trial, stratified by HRD status and BRCAm status. Clinical data and tissue samples were collected from patients included in the randomized, phase III OVHIPEC-1 trial. DNA copy number variation (CNV) profiles, HRD-related pathogenic mutations and BRCA1 promotor hypermethylation were determined. CNV-profiles were categorized as HRD or non-HRD, based on a previously validated algorithm-based BRCA1-like classifier. Hazard ratios (HR) and corresponding 99% confidence intervals (CI) for the effect of RFS and OS of HIPEC in the BRCAm, the HRD/BRCAwt and the non-HRD group were estimated using Cox proportional hazard models. Tumor DNA was available from 200/245 (82%) patients. Seventeen (9%) tumors carried a pathogenic mutation in BRCA1 and 14 (7%) in BRCA2. Ninety-one (46%) tumors classified as BRCA1-like. The effect of HIPEC on RFS and OS was absent in BRCAm tumors (HR 1.25; 99%CI 0.48-3.29), and most present in HRD/BRCAwt (HR 0.44; 99%CI 0.21-0.91), and non-HRD/BRCAwt tumors (HR 0.82; 99%CI 0.48-1.42), interaction P value: 0.024. Patients with HRD tumors without pathogenic BRCA1/2 mutation appear to benefit most from treatment with HIPEC, while benefit in patients with BRCA1/2 pathogenic mutations and patients without HRD seems less evident.

Asunto(s)

Quimioterapia Intraperitoneal Hipertérmica , Neoplasias Ováricas , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Variaciones en el Número de Copia de ADN , Femenino , Genómica , Recombinación Homóloga , Humanos , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/terapia

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OBJECTIVE: Decrease in skeletal muscle index (SMI) during neoadjuvant chemotherapy (NACT) has been associated with worse outcome in patients with advanced ovarian cancer. To validate these findings, we tested if a decrease in SMI was a prognostic factor for a homogenous cohort of patients who received NACT in the randomized phase 3 OVHIPEC-trial. METHODS: CT-scans were performed at baseline and after two cycles of neoadjuvant chemotherapy in stage III ovarian cancer patients. The SMI (skeletal muscle area in cm2 divided by body surface area in m2) was calculated using SliceOMatic software. The difference in SMI between both CT-scans (ΔSMI) was calculated. Cox-regression analyses were performed to analyze the independent effect of a difference in SMI (ΔSMI) on outcome. Log-rank tests were performed to plot recurrence-free (RFS) and overall survival (OS). The mean number of adverse events per patient were compared between groups using t-tests. RESULTS: Paired CT-scans were available for 212 out of 245 patients (87%). Thirty-four of 74 patients (58%) in the group with a decrease in ΔSMI and 73 of 138 of the patients (53%) in the group with stable/increase in ΔSMI had died. Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups. Patients with a decrease in SMI experienced more pre-operative adverse events, and more grade 3-4 adverse events. CONCLUSION: Decreased SMI during neoadjuvant chemotherapy was not associated with worse outcome in patients with stage III ovarian cancer included in the OVHIPEC-trial. However, a strong association between decreasing SMI and adverse events was found.

Asunto(s)

Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Terapia Neoadyuvante/efectos adversos , Recurrencia Local de Neoplasia/epidemiología , Neoplasias Ováricas/terapia , Sarcopenia/epidemiología , Anciano , Índice de Masa Corporal , Ensayos Clínicos Fase III como Asunto , Procedimientos Quirúrgicos de Citorreducción , Supervivencia sin Enfermedad , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Femenino , Humanos , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Músculo Esquelético/diagnóstico por imagen , Recurrencia Local de Neoplasia/prevención & control , Estadificación de Neoplasias , Neoplasias Ováricas/complicaciones , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/mortalidad , Periodo Preoperatorio , Pronóstico , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Medición de Riesgo/estadística & datos numéricos , Factores de Riesgo , Sarcopenia/diagnóstico , Sarcopenia/etiología , Tomografía Computarizada por Rayos X

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INTRODUCTION: Hyperthermic intraperitoneal chemotherapy (HIPEC) improved investigator-assessed recurrence-free survival and overall survival in patients with stage III ovarian cancer in the phase III OVHIPEC-1 trial. We analyzed whether an open-label design affected the results of the trial by central blinded assessment of recurrence-free survival, and tested whether HIPEC specifically targets the peritoneal surface by analyzing the site of disease recurrence. METHODS: OVHIPEC-1 was an open-label, multicenter, phase III trial that randomized 245 patients after three cycles of neoadjuvant chemotherapy to interval cytoreduction with or without HIPEC using cisplatin (100 mg/m2). Patients received three additional cycles of chemotherapy after surgery. Computed tomography (CT) scans and serum cancer antigen 125 (CA125) measurements were performed during chemotherapy, and during follow-up. Two expert radiologists reviewed all available CT scans. They were blinded for treatment allocation and clinical outcome. Central revision included Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurements and peritoneal cancer index scorings at baseline, during treatment, and during follow-up. Time to centrally-revised recurrence was compared between study arms using Cox proportional hazard models. Subdistribution models compared time to peritoneal recurrence between arms, accounting for competing risks. RESULTS: CT scans for central revision were available for 231 patients (94%) during neoadjuvant treatment and 212 patients (87%) during follow-up. Centrally-assessed median recurrence-free survival was 9.9 months in the surgery group and 13.2 months in the surgery+HIPEC group (HR for disease recurrence or death 0.72, 95% CI 0.55 to 0.94; p=0.015). The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index. Cumulative incidence of peritoneal recurrence was lower after surgery+HIPEC, but there was no difference in extraperitoneal recurrences. CONCLUSION: Centrally-assessed recurrence-free survival analysis confirms the benefit of adding HIPEC to interval cytoreductive surgery in patients with stage III ovarian cancer, with fewer peritoneal recurrences. These results rule out radiological bias caused by the open-label nature of the study.

Asunto(s)

Quimioterapia Intraperitoneal Hipertérmica/métodos , Neoplasias Ováricas/diagnóstico por imagen , Neoplasias Ováricas/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Carboplatino/administración & dosificación , Ensayos Clínicos Fase III como Asunto , Procedimientos Quirúrgicos de Citorreducción , Supervivencia sin Enfermedad , Femenino , Humanos , Estudios Multicéntricos como Asunto , Terapia Neoadyuvante , Estadificación de Neoplasias , Neoplasias Ováricas/patología , Paclitaxel/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Tomografía Computarizada por Rayos X

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Background. To determine face and construct validity for the new Bimanual Fundamentals curriculum for the Simendo® Virtual Reality Laparoscopy Simulator and prove its efficiency as a training and objective assessment tool for surgical resident's advanced psychomotor skills. Methods. 49 participants were recruited: 17 medical students (novices), 15 residents (intermediates), and 17 medical specialists (experts) in the field of gynecology, general surgery, and urology in 3 tertiary medical centers in the Netherlands. All participants performed the 5 exercises of the curriculum for 3 consecutive times on the simulator. Intermediates and experts filled in a questionnaire afterward, regarding the reality of the simulator and training goals of each exercise. Statistical analysis of performance was performed between novices, intermediates, and experts. Parameters such as task time, collisions/displacements, and path length right and left were compared between groups. Additionally, a total performance score was calculated for each participant. Results. Face validity scores regarding realism and training goals were overall positive (median scores of 4 on a 5-point Likert scale). Participants felt that the curriculum was a useful addition to the previous curricula and the used simulator would fit in their residency programs. Construct validity results showed significant differences on the great majority of measured parameters between groups. The simulator is able to differentiate between performers with different levels of laparoscopic experience. Conclusions. Face and construct validity for the new Bimanual Fundamental curriculum for the Simendo virtual reality simulator could be established. The curriculum is suitable to use in resident's training programs to improve and maintain advanced psychomotor skills.

Asunto(s)

Laparoscopía , Realidad Virtual , Competencia Clínica , Simulación por Computador , Curriculum , Humanos , Interfaz Usuario-Computador

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BACKGROUND: Determination of the learning curve of new techniques is essential to improve safety and efficiency. Limited information is available regarding learning curves in robot-assisted laparoscopic pelvic floor surgery. OBJECTIVE: The purpose of this study was to assess the learning curve in robot-assisted laparoscopic pelvic floor surgery. STUDY DESIGN: We conducted a prospective cohort study. Consecutive patients who underwent robot-assisted laparoscopic sacrocolpopexy or sacrocolporectopexy were included (n=372). Patients were treated in a teaching hospital with a tertiary referral function for gynecologic/multicompartment prolapse. Procedures were performed by 2 experienced conventional laparoscopic surgeons (surgeons A and B). Baseline demographics were scored per groups of 25 consecutive patients. The primary outcome was the determination of proficiency, which was based on intraoperative complications. Cumulative sum control chart analysis allowed us to detect small shifts in a surgeon's performance. Proficiency was obtained when the first acceptable boundary line of cumulative sum control chart analysis was crossed. Secondary outcomes that were examined were shortening and/or stabilization of surgery time (measured with the use of cumulative sum control chart analysis and the moving average method). RESULTS: Surgeon A performed 242 surgeries; surgeon B performed 137 surgeries (n=7 surgeries were performed by both surgeons). Intraoperative complications occurred in 1.9% of the procedures. The learning curve never fell below the unacceptable failure limits and stabilized after 23 of 41 cases. Proficiency was obtained after 78 cases for both surgeons. Surgery time decreased after 24-29 cases in robot-assisted sacrocolpopexy (no distinct pattern for robot-assisted sacrocolporectopexy). Limitations were the inclusion of 2 interventions and concomitant procedures, which limited homogeneity. Furthermore, analyses treated all complications in cumulative sum as equal weight, although there are differences in the clinical relevance of complications. CONCLUSION: After 78 cases, proficiency was obtained. After 24-29 cases, surgery time stabilized for robot-assisted sacrocolpopexy. In this age of rapidly changing surgical techniques, it can be difficult to determine the learning curve of each procedure. Cumulative sum control chart analysis can assist with this determination and prove to be a valuable tool. Training programs could be individualized to improve both surgical performance and patient benefits.

Asunto(s)

Laparoscopía/educación , Curva de Aprendizaje , Diafragma Pélvico/cirugía , Procedimientos Quirúrgicos Robotizados/educación , Estudios de Cohortes , Femenino , Humanos , Complicaciones Intraoperatorias , Persona de Mediana Edad , Tempo Operativo , Prolapso de Órgano Pélvico/cirugía , Recto/cirugía

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PURPOSE: In the randomized open-label phase III OVHIPEC trial, the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improved recurrence-free and overall survival in patients with stage III ovarian cancer. We studied the cost effectiveness of the addition of HIPEC to interval CRS in patients with ovarian cancer. PATIENTS AND METHODS: We constructed a Markov health-state transition model to measure costs and clinical outcomes. Transition probabilities were derived from the OVHIPEC trial by fitting survival distributions. Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY), was calculated from a Dutch societal perspective, with a time horizon of 10 years. Univariable and probabilistic sensitivity analyses were conducted to evaluate the decision uncertainty. RESULTS: Total health care costs were €70,046 (95% credibility interval [CrI], €64,016 to €76,661) for interval CRS compared with €85,791 (95% CrI, €78,766 to €93,935) for interval CRS plus HIPEC. The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group. The ICER amounted to €28,299/QALY. In univariable sensitivity analysis, the utility of recurrence-free survival and the number of days in the hospital affected the calculated ICER most. CONCLUSION: On the basis of the trial data, treatment with interval CRS and HIPEC in patients with stage III ovarian cancer was accompanied by a substantial gain in QALYs. The ICER is below the willingness-to-pay threshold in the Netherlands, indicating interval CRS and HIPEC is cost effective for this patient population. These results lend additional support for reimbursing the costs of treating these patients with interval CRS and HIPEC in countries with comparable health care systems.

Asunto(s)

Procedimientos Quirúrgicos de Citorreducción/economía , Neoplasias Ováricas/economía , Neoplasias Ováricas/cirugía , Análisis Costo-Beneficio , Procedimientos Quirúrgicos de Citorreducción/métodos , Femenino , Humanos , Estadificación de Neoplasias , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/patología , Análisis de Supervivencia

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OBJECTIVES: To provide a systematic overview of the literature assessing the value of haptic and force feedback in current simulators teaching laparoscopic surgical skills. DATA SOURCES: The databases of Pubmed, Cochrane, Embase, Web of Science, and Google Scholar were searched to retrieve relevant studies published until January 31st, 2017. The search included laparoscopic surgery, simulation, and haptic or force feedback and all relevant synonyms. METHODS: Duplicates were removed, and titles and abstracts screened. The remaining articles were subsequently screened full text and included in this review if they followed the inclusion criteria. A total of 2 types of feedback have been analyzed and will be discussed separately: haptic- and force feedback. RESULTS: A total of 4023 articles were found, of which 87 could be used in this review. A descriptive analysis of the data is provided. Results of the added value of haptic interface devices in virtual reality are variable. Haptic feedback is most important for more complex tasks. The interface devices do not require the highest level of fidelity. Haptic feedback leads to a shorter learning curve with a steadier upward trend. Concerning force feedback, force parameters are measured through force sensing systems in the instrument and/or the environment. These parameters, especially in combination with motion parameters, provide box trainers with an objective evaluation of laparoscopic skills. Feedback of force-use both real time and postpractice has been shown to improve training. CONCLUSIONS: Haptic feedback is added to virtual reality simulators to increase the fidelity and thereby improve training effect. Variable results have been found from adding haptic feedback. It is most important for more complex tasks, but results in only minor improvements for novice surgeons. Force parameters and force feedback in box trainers have been shown to improve training results.

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Retroalimentación Fisiológica , Laparoscopía/educación , Entrenamiento Simulado , Tacto

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STUDY OBJECTIVE: To assess the improvement of cognitive surgical knowledge of laparoscopic hysterectomy in postgraduate year (PGY) 1 and 2 gynecology residents who used an interactive computer-based Laparoscopic Hysterectomy Trainer (Red Llama, Inc., Seattle, WA). DESIGN: A multicenter, randomized, controlled study (Canadian Task Force classification I). SETTING: Five departments of obstetrics and gynecology: Keck School of Medicine of the University of Southern California, Los Angeles, CA; University of California, Los Angeles, Los Angeles, CA; University of Washington, Seattle, WA; University of British Columbia, Vancouver, British Columbia, Canada; and University of Toronto, Toronto, Ontario, Canada. PARTICIPANTS: Gynecology residents, fellows, faculty, and minimally invasive surgeons. INTERVENTIONS: The use of an interactive computer-based Laparoscopic Hysterectomy Trainer. MEASUREMENTS AND MAIN RESULTS: In phase 1 of this 3-phase multicenter study, 2 hysterectomy knowledge assessment tests (A and B) were developed using a modified Delphi technique. Phase 2 administered these 2 online tests to PGY 3 and 4 gynecology residents, gynecology surgical fellows, faculty, and minimally invasive surgeons (n = 60). In phase 3, PGY 1 and 2 gynecology residents (n = 128) were recruited, and 101 chose to participate, were pretested (test A), and then randomized to the control or intervention group. Both groups continued site-specific training while the intervention group additionally used the Laparoscopic Hysterectomy Trainer. Participant residents were subsequently posttested (test B). Phase 2 results showed no differences between cognitive tests A and B when assessed for equivalence, internal consistency, and reliability. Construct validity was shown for both tests (p < .001). In phase 3, the pretest mean score for the control group was 242 (standard deviation [SD] = 56.5), and for the intervention group it was 217 (SD = 57.6) (nonsignificant difference, p = .089). The t test comparing the posttest control group (mean = 297, SD = 53.6) and the posttest intervention group (mean = 343, SD = 50.9) yielded a significant difference (p < .001, 95% confidence interval, 48.4-108.8). Posttest scores for the intervention group were significantly better than for the control group (p < .001). CONCLUSION: Using the Laparoscopic Hysterectomy Trainer significantly increased knowledge of the hysterectomy procedure in PGY 1 and 2 gynecology residents.

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Competencia Clínica , Histerectomía/educación , Internado y Residencia , Entrenamiento Simulado , California , Femenino , Humanos , Masculino , Modelos Anatómicos

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BACKGROUND: Treatment of newly diagnosed advanced-stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy. We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. METHODS: In a multicenter, open-label, phase 3 trial, we randomly assigned 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter). Randomization was performed at the time of surgery in cases in which surgery that would result in no visible disease (complete cytoreduction) or surgery after which one or more residual tumors measuring 10 mm or less in diameter remain (optimal cytoreduction) was deemed to be feasible. Three additional cycles of carboplatin and paclitaxel were administered postoperatively. The primary end point was recurrence-free survival. Overall survival and the side-effect profile were key secondary end points. RESULTS: In the intention-to-treat analysis, events of disease recurrence or death occurred in 110 of the 123 patients (89%) who underwent cytoreductive surgery without HIPEC (surgery group) and in 99 of the 122 patients (81%) who underwent cytoreductive surgery with HIPEC (surgery-plus-HIPEC group) (hazard ratio for disease recurrence or death, 0.66; 95% confidence interval [CI], 0.50 to 0.87; P=0.003). The median recurrence-free survival was 10.7 months in the surgery group and 14.2 months in the surgery-plus-HIPEC group. At a median follow-up of 4.7 years, 76 patients (62%) in the surgery group and 61 patients (50%) in the surgery-plus-HIPEC group had died (hazard ratio, 0.67; 95% CI, 0.48 to 0.94; P=0.02). The median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery-plus-HIPEC group. The percentage of patients who had adverse events of grade 3 or 4 was similar in the two groups (25% in the surgery group and 27% in the surgery-plus-HIPEC group, P=0.76). CONCLUSIONS: Among patients with stage III epithelial ovarian cancer, the addition of HIPEC to interval cytoreductive surgery resulted in longer recurrence-free survival and overall survival than surgery alone and did not result in higher rates of side effects. (Funded by the Dutch Cancer Society; ClinicalTrials.gov number, NCT00426257 ; EudraCT number, 2006-003466-34 .).

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Cisplatino/administración & dosificación , Procedimientos Quirúrgicos de Citorreducción , Hipertermia Inducida , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carboplatino/administración & dosificación , Carcinoma Epitelial de Ovario , Terapia Combinada , Femenino , Humanos , Análisis de Intención de Tratar , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Glandulares y Epiteliales/mortalidad , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/cirugía , Paclitaxel/administración & dosificación , Análisis de Supervivencia

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BACKGROUND: Robotic camera holders for endoscopic surgery have been available for 20 years but market penetration is low. The current camera holders are controlled by voice, joystick, eyeball tracking, or head movements, and this type of steering has proven to be successful but excessive disturbance of surgical workflow has blocked widespread introduction. The Autolap™ system (MST, Israel) uses a radically different steering concept based on image analysis. This may improve acceptance by smooth, interactive, and fast steering. These two studies were conducted to prove safe and efficient performance of the core technology. METHODS: A total of 66 various laparoscopic procedures were performed with the AutoLap™ by nine experienced surgeons, in two multi-center studies; 41 cholecystectomies, 13 fundoplications including hiatal hernia repair, 4 endometriosis surgeries, 2 inguinal hernia repairs, and 6 (bilateral) salpingo-oophorectomies. The use of the AutoLap™ system was evaluated in terms of safety, image stability, setup and procedural time, accuracy of imaged-based movements, and user satisfaction. RESULTS: Surgical procedures were completed with the AutoLap™ system in 64 cases (97%). The mean overall setup time of the AutoLap™ system was 4 min (04:08 ± 0.10). Procedure times were not prolonged due to the use of the system when compared to literature average. The reported user satisfaction was 3.85 and 3.96 on a scale of 1 to 5 in two studies. More than 90% of the image-based movements were accurate. No system-related adverse events were recorded while using the system. CONCLUSION: Safe and efficient use of the core technology of the AutoLap™ system was demonstrated with high image stability and good surgeon satisfaction. The results support further clinical studies that will focus on usability, improved ergonomics and additional image-based features.

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Laparoscopía/instrumentación , Procedimientos Quirúrgicos Robotizados , Cirugía Asistida por Computador/instrumentación , Adulto , Anciano , Actitud del Personal de Salud , Femenino , Humanos , Persona de Mediana Edad , Tempo Operativo , Adulto Joven

RESUMEN

OBJECTIVE: To evaluate the cost-effectiveness of a diagnostic laparoscopy prior to primary cytoreductive surgery to prevent futile primary cytoreductive surgery (i.e. leaving >1cm residual disease) in patients suspected of advanced stage ovarian cancer. METHODS: An economic analysis was conducted alongside a randomized controlled trial in which patients suspected of advanced stage ovarian cancer who qualified for primary cytoreductive surgery were randomized to either laparoscopy or primary cytoreductive surgery. Direct medical costs from a health care perspective over a 6-month time horizon were analyzed. Health outcomes were expressed in quality-adjusted life-years (QALYs) and utility was based on patient's response to the EQ-5D questionnaires. We primarily focused on direct medical costs based on Dutch standard prices. RESULTS: We studied 201 patients, of whom 102 were randomized to laparoscopy and 99 to primary cytoreductive surgery. No significant difference in QALYs (utility=0.01; 95% CI 0.006 to 0.02) was observed. Laparoscopy reduced the number of futile laparotomies from 39% to 10%, while its costs were € 1400 per intervention, making the overall costs of both strategies comparable (difference € -80 per patient (95% CI -470 to 300)). Findings were consistent across various sensitivity analyses. CONCLUSION: In patients with suspected advanced stage ovarian cancer, a diagnostic laparoscopy reduced the number of futile laparotomies, without increasing total direct medical health care costs, or adversely affecting complications or quality of life.

Asunto(s)

Procedimientos Quirúrgicos de Citorreducción/economía , Costos de la Atención en Salud , Laparoscopía/economía , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/cirugía , Quimioterapia Adyuvante/economía , Análisis Costo-Beneficio , Técnicas de Diagnóstico Quirúrgico/economía , Femenino , Humanos , Inutilidad Médica , Persona de Mediana Edad , Terapia Neoadyuvante/economía , Estadificación de Neoplasias , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/patología , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida

RESUMEN

BACKGROUND: Medical students often do not feel prepared to manage emergency situations after graduation. They experience a lack of practical skills and show significant deficits in cognitive performance to assess and stabilize trauma patients. Most reports in the literature about simulation-based education pertain to postgraduate training. Simulation-based trauma education (SBTE) in undergraduate medical education could improve confidence and performance of recently graduated doctors in trauma resuscitation. We reviewed the literature in search of SBTE effectiveness for medical students. METHODS: A PubMed, Embase and CINAHL literature search was performed to identify all studies that reported on the effectiveness of SBTE for medical students, on student perception on SBTE or on the effectiveness of different simulation modalities. RESULTS: Eight studies were included. Three out of four studies reporting on the effectiveness of SBTE demonstrated an increase in performance of students after SBTE. SBTE is generally highly appreciated by medical students. Only one study directly compared two modalities of SBTE and reported favorable results for the mechanical model rather than the standardized live patient model. CONCLUSION: SBTE appears to be an effective method to prepare medical students for trauma resuscitation. Furthermore, students enjoy SBTE and they perceive SBTE as a very useful learning method.

Asunto(s)

Educación de Pregrado en Medicina/métodos , Maniquíes , Simulación de Paciente , Resucitación/educación , Estudiantes de Medicina , Competencia Clínica , Humanos , Aprendizaje

RESUMEN

INTRODUCTION: The following research questions were answered: (1) What are the training pathways followed by the current robot professionals? (2) Are there any differences between the surgical specialties in robot training and robot use? (3) What is their opinion about multidisciplinary basic skills training? METHODS: An online questionnaire was sent to 91 robot professionals in The Netherlands. The questionnaire contained 21 multiple-choice questions focusing on demographics, received robot training, and their opinion on basic skills training in robotic surgery. RESULTS: The response rate was 62 % (n = 56): 13 general surgeons, 16 gynecologists, and 27 urologists. The urologists performed significantly more robotic procedures than surgeons and gynecologists. The kind of training of all professionals varied from a training program by Intuitive Surgical, master-apprenticeship with or without duo console, fellowship, and self-designed training programs. The training did neither differ significantly among the different specialties nor the year of starting robotic surgery. Majority of respondents favor an obliged training program including an examination for the basics of robot skills training. CONCLUSION: Training of the current robot professionals is mostly dependent on local circumstances and the manufacturer of the robot system. Training is independent of the year of start with robotic surgery and speciality. To guarantee the quality of future training of residents and fellows in robot-assisted surgery, clear training goals should be formulated and implemented. Since this study shows that current training of different specialities does not differ, training in robotic surgery could be started by a multidisciplinary basic skills training and assessment.

Asunto(s)

Procedimientos Quirúrgicos Robotizados/educación , Adulto , Competencia Clínica , Femenino , Humanos , Laparoscopía/educación , Masculino , Persona de Mediana Edad , Países Bajos , Especialidades Quirúrgicas , Encuestas y Cuestionarios

Asunto(s)

Hernia Ventral/diagnóstico , Hernia Incisional/diagnóstico , Ultrasonografía , Anciano , Cistadenocarcinoma Seroso/patología , Neoplasias Endometriales/patología , Femenino , Hernia Ventral/etiología , Humanos , Hernia Incisional/etiología , Laparoscopía/efectos adversos , Laparoscopía/instrumentación , Estadificación de Neoplasias/efectos adversos , Estadificación de Neoplasias/métodos , Pruebas en el Punto de Atención , Procedimientos Quirúrgicos Robotizados/efectos adversos , Ultrasonografía/métodos , Estudios de Validación como Asunto

RESUMEN

OBJECTIVE: Serious games are new in the field of laparoscopic surgical training. We evaluate the residents׳ opinion of a new laparoscopic simulator for the Nintendo Wii-U platform. DESIGN: Prospective questionnaire study. Participants received a standardized introduction and completed level 3 and 4 of the game "Underground." They filled out a questionnaire concerning demographics and their opinion on realism, usefulness, suitability, haptic feedback, and home training-use of the game. SETTING: Two tertiary teaching hospitals. PARTICIPANTS: Obstetrics and gynaecology residents postgraduate year 1 to 6 (n = 59) from several European countries. RESULTS: Subjects (n = 59) were divided into 2 groups based on laparoscopic experience: Group A (n = 38) and Group B (n = 21). The realism of different aspects of the game received mean scores around 3 on a 5-point Likert scale. The hand-eye coordination was regarded most useful for training with a mean of 3.92 (standard deviation 0.93) and the game was considered most suitable for residents in the first part of their postgraduate training with a mean of 3.73 (standard deviation 0.97). Both groups differed especially concerning their opinion of the usefulness of the game as a training tool. CONCLUSIONS: Most residents liked the new serious game for the Nintendo Wii-U. The usefulness and suitability as a laparoscopic training tool were rated at an acceptable to high level. However, the game does require improvements such as inclusion of a good scoring system before it can be integrated in resident training curricula.

Asunto(s)

Competencia Clínica , Simulación por Computador , Internado y Residencia/métodos , Laparoscopía/educación , Entrenamiento Simulado , Encuestas y Cuestionarios , Educación de Postgrado en Medicina/métodos , Femenino , Procedimientos Quirúrgicos Ginecológicos/educación , Humanos , Masculino , Estudios Prospectivos , Interfaz Usuario-Computador , Juegos de Video

RESUMEN

Purpose To investigate whether initial diagnostic laparoscopy can prevent futile primary cytoreductive surgery (PCS) by identifying patients with advanced-stage ovarian cancer in whom > 1 cm of residual disease will be left after PCS. Patients and Methods This multicenter, randomized controlled trial was undertaken within eight gynecologic cancer centers in the Netherlands. Patients with suspected advanced-stage ovarian cancer who qualified for PCS were eligible. Participating patients were randomly assigned to either laparoscopy or PCS. Laparoscopy was used to guide selection of primary treatment: either primary surgery or neoadjuvant chemotherapy followed by interval surgery. The primary outcome was futile laparotomy, defined as a PCS with residual disease of > 1 cm. Primary analyses were performed according to the intention-to-treat principle. Results Between May 2011 and February 2015, 201 participants were included, of whom 102 were assigned to diagnostic laparoscopy and 99 to primary surgery. In the laparoscopy group, 63 (62%) of 102 patients underwent PCS versus 93 (94%) of 99 patients in the primary surgery group. Futile laparotomy occurred in 10 (10%) of 102 patients in the laparoscopy group versus 39 (39%) of 99 patients in the primary surgery group (relative risk, 0.25; 95% CI, 0.13 to 0.47; P < .001). In the laparoscopy group, three (3%) of 102 patients underwent both primary and interval surgery compared with 28 (28%) of 99 patients in the primary surgery group ( P < .001). Conclusion Diagnostic laparoscopy reduced the number of futile laparotomies in patients with suspected advanced-stage ovarian cancer. In women with a plan for PCS, these data suggest that performance of diagnostic laparoscopy first is reasonable and that if cytoreduction to < 1 cm of residual disease seems feasible, to proceed with PCS.

Asunto(s)

Neoplasias Glandulares y Epiteliales/diagnóstico , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/cirugía , Anciano , Carcinoma Epitelial de Ovario , Supervivencia sin Enfermedad , Femenino , Humanos , Laparoscopía/métodos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasia Residual , Neoplasias Glandulares y Epiteliales/patología , Neoplasias Ováricas/patología , Valor Predictivo de las Pruebas , Resultado del Tratamiento

RESUMEN

Benign metastasising leiomyoma (BML) is a rare benign disease associated with uterine leiomyoma and history of uterine surgery. It most frequently occurs in premenopausal woman, with a pulmonary localisation, and consisting of multiple nodules. We present an uncommon case of a 69-year-old woman with a single BML of an inguinal lymph node. CT scans of thorax and abdomen excluded other metastasis localisation. The patient was cured with surgical excision of the mass. Lymph node involvement has been reported incidentally in BML literature. Lymphangitic spread can be considered a possible mechanism of BML metastasis.

Asunto(s)

Leiomioma/patología , Ganglios Linfáticos/patología , Neoplasias Uterinas/patología , Anciano , Femenino , Humanos , Conducto Inguinal , Metástasis Linfática