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OBJECTIVE: To provide a composite endpoint in pancreatic surgery. SUMMARY BACKGROUND DATA: Single endpoints in prospective and randomized studies have become impractical due to their low frequency and the marginal benefit of new interventions. METHODS: Data from prospective studies were used to develop (n=1273) and validate (n=544) a composite endpoint based on postoperative pancreatic fistula, post-pancreatectomy hemorrhage as well as reoperation and reinterventions. All patients had pancreatectomies of different extents. The association of the developed PAncreatic surgery Composite Endpoint (PACE) with prolonged length of hospital stay (LOS) >75th percentile and mortality was assessed. A single-institution database was used for external validation (n = 2666). Sample size calculations were made for single outcomes and the composite endpoint. RESULTS: In the internal validation cohort, the PACE demonstrated an AUC of 78.0%, a sensitivity of 90.4% and a specificity of 67.6% in predicting a prolonged LOS. In the external cohort, the AUC was 76.9%, the sensitivity 73.8% and the specificity 80.1%. The 90-day mortality rate was significantly different for patients with a positive versus a negative PACE both in the development and internal validation cohort (5.1% vs 0.9%; P< 0.001), as well as in the external validation cohort (8.5% vs 1.2%, P< 0.001). The PACE enabled sample size reductions of up to 80.5% compared to single outcomes. CONCLUSION: The PACE performed well in predicting prolonged hospital stays and can be used as a standardized and clinically relevant endpoint for future prospective trials enabling lower sample sizes and therefore improved feasibility compared to single outcome parameters.
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BACKGROUND: With an increase in robot-assisted surgery across all specialties, adequate training and credentialing strategies need to be identified to ensure patients safety. The meta-analysis assesses the transferability of technical surgical skills between laparoscopic surgery, open surgery, and robot-assisted surgery. DESIGN: A systematic search was conducted in Medline, Cochrane Central Register of Controlled Trials, and Web of Science. Outcomes were categorized into time, process, product, and composite outcome measures and pooled separately using Hedges'g (standardized mean difference [SMD]). Subgroup analyses were performed to assess the effect of study design, virtual reality platforms and task difficulty. RESULTS: Out of 14,120 screened studies, 30 were included in the qualitative synthesis and 26 in the quantitative synthesis. Technical surgical skill transfer was demonstrated from laparoscopic to robot-assisted surgery (composite: SMD 0.40, 95%-confidence interval [CI] [0.19; 0.62], time: SMD 0.62, CI [0.33; 0.91]) and vice versa (composite: SMD 0.66, CI [0.33; 0.99], time [basic skills]: SMD 0.36, CI [0.01; 0.72]). No skill transfer was seen from open to robot-assisted surgery with limited available data. CONCLUSION: Technical surgical skills can be transferred from laparoscopic to robot-assisted surgery and vice versa. Robot-assisted and laparoscopic surgical skills training and credentialing should not be regarded separately, but a reasonable combination could shorten overall training times and increase efficiency. Previous experience in open surgery should not be considered as an imperative prerequisite for training in robot-assisted surgery. Recommendations for studies assessing skill transfer are proposed to increase comparability and significance of future studies. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42018104507.
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Competencia Clínica , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Laparoscopía/educación , Procedimientos Quirúrgicos Robotizados/educación , HumanosRESUMEN
BACKGROUND: Anastomotic suturing is the Achilles heel of pancreatic surgery. Especially in laparoscopic and robotically assisted surgery, the pancreatic anastomosis should first be trained outside the operating room. Realistic training models are therefore needed. METHODS: Models of the pancreas, small bowel, stomach, bile duct, and a realistic training torso were developed for training of anastomoses in pancreatic surgery. Pancreas models with soft and hard textures, small and large ducts were incrementally developed and evaluated. Experienced pancreatic surgeons (n = 44) evaluated haptic realism, rigidity, fragility of tissues, and realism of suturing and knot tying. RESULTS: In the iterative development process the pancreas models showed high haptic realism and highest realism in suturing (4.6 ± 0.7 and 4.9 ± 0.5 on 1-5 Likert scale, soft pancreas). The small bowel model showed highest haptic realism (4.8 ± 0.4) and optimal wall thickness (0.1 ± 0.4 on -2 to +2 Likert scale) and suturing behavior (0.1 ± 0.4). The bile duct models showed optimal wall thickness (0.3 ± 0.8 and 0.4 ± 0.8 on -2 to +2 Likert scale) and optimal tissue fragility (0 ± 0.9 and 0.3 ± 0.7). CONCLUSION: The biotissue training models showed high haptic realism and realistic suturing behavior. They are suitable for realistic training of anastomoses in pancreatic surgery which may improve patient outcomes.
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Procedimientos Quirúrgicos del Sistema Digestivo , Laparoscopía , Humanos , Técnicas de Sutura , Laparoscopía/educación , Anastomosis Quirúrgica , Páncreas/cirugía , Competencia ClínicaRESUMEN
INTRODUCTION: The aim of this study was to develop a reliable objective structured assessment of technical skills (OSATS) score for linear-stapled, hand-sewn closure of enterotomy intestinal anastomoses (A-OSATS). MATERIALS AND METHODS: The Delphi methodology was used to create a traditional and weighted A-OSATS score highlighting the more important steps for patient outcomes according to an international expert consensus. Minimally invasive novices, intermediates, and experts were asked to perform a minimally invasive linear-stapled intestinal anastomosis with hand-sewn closure of the enterotomy in a live animal model either laparoscopically or robot-assisted. Video recordings were scored by two blinded raters assessing intrarater and interrater reliability and discriminative abilities between novices (n = 8), intermediates (n = 24), and experts (n = 8). RESULTS: The Delphi process included 18 international experts and was successfully completed after 4 rounds. A total of 4 relevant main steps as well as 15 substeps were identified and a definition of each substep was provided. A maximum of 75 points could be reached in the unweighted A-OSATS score and 170 points in the weighted A-OSATS score respectively. A total of 41 anastomoses were evaluated. Excellent intrarater (r = 0.807-0.988, p < 0.001) and interrater (intraclass correlation coefficient = 0.923-0.924, p < 0.001) reliability was demonstrated. Both versions of the A-OSATS correlated well with the general OSATS and discriminated between novices, intermediates, and experts defined by their OSATS global rating scale. CONCLUSION: With the weighted and unweighted A-OSATS score, we propose a new reliable standard to assess the creation of minimally invasive linear-stapled, hand-sewn anastomoses based on an international expert consensus. Validity evidence in live animal models is provided in this study. Future research should focus on assessing whether the weighted A-OSATS exceeds the predictive capabilities of patient outcomes of the unweighted A-OSATS and provide further validity evidence on using the score on different anastomotic techniques in humans.
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Competencia Clínica , Procedimientos Quirúrgicos del Sistema Digestivo , Anastomosis Quirúrgica/métodos , Animales , Humanos , Reproducibilidad de los Resultados , Grabación en VideoRESUMEN
OBJECTIVE: To provide an overview of ML models and data streams utilized for automated surgical phase recognition. BACKGROUND: Phase recognition identifies different steps and phases of an operation. ML is an evolving technology that allows analysis and interpretation of huge data sets. Automation of phase recognition based on data inputs is essential for optimization of workflow, surgical training, intraoperative assistance, patient safety, and efficiency. METHODS: A systematic review was performed according to the Cochrane recommendations and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Web of Science, IEEExplore, GoogleScholar, and CiteSeerX were searched. Literature describing phase recognition based on ML models and the capture of intraoperative signals during general surgery procedures was included. RESULTS: A total of 2254 titles/abstracts were screened, and 35 full-texts were included. Most commonly used ML models were Hidden Markov Models and Artificial Neural Networks with a trend towards higher complexity over time. Most frequently used data types were feature learning from surgical videos and manual annotation of instrument use. Laparoscopic cholecystectomy was used most commonly, often achieving accuracy rates over 90%, though there was no consistent standardization of defined phases. CONCLUSIONS: ML for surgical phase recognition can be performed with high accuracy, depending on the model, data type, and complexity of surgery. Different intraoperative data inputs such as video and instrument type can successfully be used. Most ML models still require significant amounts of manual expert annotations for training. The ML models may drive surgical workflow towards standardization, efficiency, and objectiveness to improve patient outcome in the future. REGISTRATION PROSPERO: CRD42018108907.
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Algoritmos , Colecistectomía Laparoscópica/métodos , Aprendizaje Automático , Cirugía Asistida por Computador/métodos , Humanos , Flujo de TrabajoRESUMEN
BACKGROUND: Laparoscopic suturing and knot tying is essential for advanced laparoscopic procedures and requires training outside of the operating room. However, personal instruction by experienced surgeons is limitedly available. To address this, the concept of combining e-learning with practical training has become of interest. This study aims to investigate the influence of the first-person perspective in instructional videos, as well as the feasibility of a completely self-directed training curriculum for laparoscopic suturing and knot tying. MATERIALS AND METHODS: Ninety-one laparoscopically naïve medical students were randomised into two groups training with e-learning videos in either the first-person perspective (combining endoscopic view and view of hands/instruments/forearm motion) or the endoscopic view only. Both groups trained laparoscopic suturing and knot tying in teams of two until reaching predefined proficiency levels. Blinded, trained raters regularly assessed the participants' performance by using validated checklists. After training, participants filled out questionnaires regarding training experience and personal characteristics. RESULTS: Average training time to reach proficiency did not differ between groups [first-person perspective (min): 112 ± 44; endoscopic view only (min): 109 ± 47; p = 0.746]. However, participants from both groups perceived the first-person perspective as useful for learning new laparoscopic skills. Both groups showed similar baseline performances and improved significantly after training [Objective Structured Assessment of Technical Skills (OSATS) (max. 37 points): first-person perspective: 30.3 ± 2.3; endoscopic view only: 30.8 ± 2.3]. All participants managed to reach proficiency, needing 8-43 attempts without differences between groups. Visuospatial abilities (mental rotation) seemed to enhance the learning curve. CONCLUSION: Modifying instructional videos to the first-person perspective did not translate into a better performance in this setting but was welcomed by participants. Completely self-directed training with the use of e-learning can be a feasible training approach to achieve technical proficiency in laparoscopic suturing and knot tying in a training setting.
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Instrucción por Computador , Laparoscopía/educación , Autoaprendizaje como Asunto , Estudiantes de Medicina , Técnicas de Sutura/educación , Competencia Clínica , Femenino , Humanos , Curva de Aprendizaje , Masculino , Estudios Prospectivos , Adulto JovenRESUMEN
INTRODUCTION: The most common way of assessing surgical performance is by expert raters to view a surgical task and rate a trainee's performance. However, there is huge potential for automated skill assessment and workflow analysis using modern technology. The aim of the present study was to evaluate machine learning (ML) algorithms using the data of a Myo armband as a sensor device for skills level assessment and phase detection in laparoscopic training. MATERIALS AND METHODS: Participants of three experience levels in laparoscopy performed a suturing and knot tying task on silicon models. Experts rated performance using Objective Structured Assessment of Surgical Skills (OSATS). Participants wore Myo armbands (Thalmic Labs™, Ontario, Canada) to record acceleration, angular velocity, orientation, and Euler orientation. ML algorithms (decision forest, neural networks, boosted decision tree) were compared for skill level assessment and phase detection. RESULTS: 28 participants (8 beginner, 10 intermediate, 10 expert) were included, and 99 knots were available for analysis. A neural network regression model had the lowest mean absolute error in predicting OSATS score (3.7 ± 0.6 points, r2 = 0.03 ± 0.81; OSATS min.-max.: 4-37 points). An ensemble of binary-class neural networks yielded the highest accuracy in predicting skill level (beginners: 82.2% correctly identified, intermediate: 3.0%, experts: 79.5%) whereas standard statistical analysis failed to discriminate between skill levels. Phase detection on raw data showed the best results with a multi-class decision jungle (average 16% correctly identified), but improved to 43% average accuracy with two-class boosted decision trees after Dynamic time warping (DTW) application. CONCLUSION: Modern machine learning algorithms aid in interpreting complex surgical motion data, even when standard analysis fails. Dynamic time warping offers the potential to process and compare surgical motion data in order to allow automated surgical workflow detection. However, further research is needed to interpret and standardize available data and improve sensor accuracy.
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Algoritmos , Laparoscopía/educación , Aprendizaje Automático , Técnicas de Sutura/educación , Flujo de Trabajo , Competencia Clínica , Árboles de Decisión , Humanos , Modelos Anatómicos , Redes Neurales de la Computación , Ontario , SilicioRESUMEN
INTRODUCTION: Virtual reality (VR-)trainers are well integrated in laparoscopic surgical training. However, objective feedback is often provided in the form of single parameters, e.g., time or number of movements, making comparisons and evaluation of trainees' overall performance difficult. Therefore, a new standard for reporting outcome data is highly needed. The aim of this study was to create a weighted, expert-based composite score, to offer simple and direct evaluation of laparoscopic performance on common VR-trainers. MATERIALS AND METHODS: An integrated analytic hierarchy process-Delphi survey was conducted with 14 international experts to achieve a consensus on the importance of different skill categories and parameters in evaluation of laparoscopic performance. A scoring algorithm was established to allow comparability between tasks and VR-trainers. A weighted composite score was calculated for basic skills tasks and peg transfer on the LapMentor™ II and III and validated for both VR-trainers. RESULTS: Five major skill categories (time, efficiency, safety, dexterity, and outcome) were identified and weighted in two Delphi rounds. Safety, with a weight of 67%, was determined the most important category, followed by efficiency with 17%. The LapMentor™-specific score was validated using 15 (14) novices and 9 experts; the score was able to differentiate between both groups for basic skills tasks and peg transfer (LapMentor™ II: Exp: 86.5 ± 12.7, Nov. 52.8 ± 18.3; p < 0.001; LapMentor™ III: Exp: 80.8 ± 7.1, Nov: 50.6 ± 16.9; p < 0.001). CONCLUSION: An effective and simple performance measurement was established to propose a new standard in analyzing and reporting VR outcome data-the Heidelberg virtual reality (VR) score. The scoring algorithm and the consensus results on the importance of different skill aspects in laparoscopic surgery are universally applicable and can be transferred to any simulator or task. By incorporating specific expert baseline data for the respective task, comparability between tasks, studies, and simulators can be achieved.
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Competencia Clínica , Simulación por Computador , Educación de Postgrado en Medicina/métodos , Laparoscopía/educación , Realidad Virtual , Humanos , Masculino , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: Mental training of laparoscopic procedures with E-learning has been shown to translate to the operating room. The present study aims to explore whether the use of checklists during E-learning improves transfer of skills to the simulated OR on a Virtual Reality (VR) trainer for Roux-en-Y gastric bypass (RYGB). METHODS: Laparoscopy naive medical students (n = 80) were randomized in two groups. After an E-learning introduction to RYGB, checklist group rated RYGB videos using the validated Bariatric Objective Structured Assessment of Technical Skills (BOSATS) checklist while group without checklist only observed the videos. Participants then performed RYGB on a VR-trainer twice and were evaluated by a blinded expert rater using BOSATS. A multiple choice (MC) knowledge test on RYGB was performed. Suturing on a cadaveric porcine small bowel was evaluated using objective structured assessment of technical skill (OSATS). RESULTS: Checklist group was better in the knowledge test (A 8.3 ± 1.1 vs. B 7.1 ± 1.3; p ≤ 0.001) and there was a trend towards better VR RYGB performance (BOSATS) on the first try (85.9 ± 10.2 vs. 81.1 ± 11.5; p = 0.058), but not on the second try (92.0 ± 9.7 vs. 89.3 ± 10.5; p = 0.251). Suturing as measured by OSATS was not different (29.5 ± 3.0 vs. 29.0 ± 3.5; p = 0.472). CONCLUSION: This study presents evidence that the use of a BOSATS checklist during E-learning helps trainees to improve their knowledge acquisition with E-learning. The transfer from mental training to the simulated OR environment seems to be partially enhanced by use of the BOSATS checklist. However, more research is required to investigate potential benefits.
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Lista de Verificación , Competencia Clínica , Derivación Gástrica/educación , Entrenamiento Simulado/métodos , Realidad Virtual , Femenino , Alemania , Humanos , Masculino , Estudios Prospectivos , Estudiantes de Medicina , Adulto JovenRESUMEN
BACKGROUND: There is limited evidence on the transferability of conventional laparoscopic and open surgical skills to robotic-assisted surgery. The primary aim of this study was to evaluate the transferability of expertise in conventional laparoscopy and open surgery to robotic-assisted surgery using the da Vinci Skills Simulator (dVSS). Secondary aims included evaluating the influence of individual participants' characteristics. METHODS: Participants performed four tasks on the dVSS: Peg Board 1 (PB), Pick and Place (PP), Thread the Rings (TR), and Suture Sponge 1 (SS). Participants were classified into three groups (Novice, Intermediate, Experts) according to experience in laparoscopic and open surgery. All tasks were performed twice except for SS. Performance was assessed using the built-in scoring system. RESULTS: 37 medical students and 25 surgeons participated. Experts did not perform significantly better than less experienced participants on the dVSS. Specifically, with regard to laparoscopic experience, total simulator scores were: Novices 68.2 ± 28.8; Intermediates 65.1 ± 31.2; Experts 65.1 ± 30.0; p = 0.611. Regarding open surgical experience, scores were: Novices 68.6 ± 28.7; Intermediates 68.2 ± 30.8; Experts 63.2 ± 30.3; p = 0.305. Although there were some significant differences among groups for single parameters in specific tasks, there was no constant superiority of one group. Laparoscopic and open surgical Novices improved significantly in overall score and time for all three tasks (p < 0.05). Laparoscopic intermediates improved only in PP time (4.64 ± 3.42; p = 0.006), open Intermediates in PB score (11.98 ± 13.01; p = 0.025), and open Experts in PP score (6.69 ± 11.48; p = 0.048). Laparoscopic experts showed no improvement. Participants with gaming experience had better overall scores than non-gamers when comparing all second attempts (Gamer 83.62 ± 7.57; Non-Gamer 76.31 ± 12.78; p = 0.008) as well as first and second attempts together (Gamer 72.08 ± 8.86; Non-Gamer 65.45 ± 11.68; p = 0.039). Musical and sports experience showed no correlation with robotic performance. CONCLUSIONS: Robotic-assisted surgery requires skills distinct from conventional laparoscopy or open surgery. Basic robotic skills training prior to patient contact should be required.
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Competencia Clínica/normas , Internado y Residencia , Laparoscopía/educación , Procedimientos Quirúrgicos Robotizados/educación , Entrenamiento Simulado , Cirujanos/educación , Femenino , Humanos , Laparoscopía/métodos , Estudios Prospectivos , Procedimientos Quirúrgicos Robotizados/normas , Análisis y Desempeño de TareasRESUMEN
BACKGROUND: Touch Surgery™ (TS) is a serious gaming application for cognitive task simulation and rehearsal of key steps in surgical procedures. The aim was to establish face, content, and construct validity of TS for laparoscopic cholecystectomy (LC). Furthermore, learning curves with TS and a virtual reality (VR) trainer were compared in a randomized trial. METHODS: The performance of medical students and general surgeons was compared for all three modules of LC in TS to establish construct validity. Questionnaires assessed face and content validity. For analysis of learning curves, students were randomized to train on VR or TS first, and then switched to the other training modality. Performance data were recorded. RESULTS: 54 Surgeons and 51 medical students completed the validation study. Surgeons outperformed students with TS: patient preparation (students = 45.0 ± 19.1%; surgeons = 57.3 ± 15.2%; p < 0.001), access and laparoscopy (students = 70.2 ± 10.9%; surgeons = 75.9 ± 9.7%; p = 0.008) and LC (students = 69.8 ± 12.4%; surgeons = 77.7 ± 9.6%; p < 0.001). Both groups agreed that TS was a highly useful and realistic application. 46 students were randomized for learning curve analysis. It took them 2-4 attempts to reach a 100% score with TS. Training with TS first did not improve students' performance on the VR trainer; however, students who trained with VR first scored significantly higher in module 3 of TS. CONCLUSION: TS is an accepted serious gaming application for learning cognitive aspects of LC with established construct, face, and content validity. There appeared to be a synergy between TS and the VR trainer. Therefore, the two training modalities should accompany one another in a multimodal training approach to laparoscopy.
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Colecistectomía Laparoscópica/educación , Educación Médica/métodos , Aplicaciones Móviles/estadística & datos numéricos , Cirujanos/educación , Realidad Virtual , Adulto , Competencia Clínica/estadística & datos numéricos , Cognición/fisiología , Simulación por Computador , Femenino , Humanos , Curva de Aprendizaje , Masculino , Proyectos Piloto , Reproducibilidad de los Resultados , Estudiantes de Medicina/estadística & datos numéricos , Encuestas y Cuestionarios , Juegos de VideoRESUMEN
INTRODUCTION: Training and assessment outside of the operating room is crucial for minimally invasive surgery due to steep learning curves. Thus, we have developed and validated the sensor- and expert model-based laparoscopic training system, the iSurgeon. MATERIALS: Participants of different experience levels (novice, intermediate, expert) performed four standardized laparoscopic knots. Instruments and surgeons' joint motions were tracked with an NDI Polaris camera and Microsoft Kinect v1. With frame-by-frame image analysis, the key steps of suturing and knot tying were identified and registered with motion data. Construct validity, concurrent validity, and test-retest reliability were analyzed. The Objective Structured Assessment of Technical Skills (OSATS) was used as the gold standard for concurrent validity. RESULTS: The system showed construct validity by discrimination between experience levels by parameters such as time (novice = 442.9 ± 238.5 s; intermediate = 190.1 ± 50.3 s; expert = 115.1 ± 29.1 s; p < 0.001), total path length (novice = 18,817 ± 10318 mm; intermediate = 9995 ± 3286 mm; expert = 7265 ± 2232 mm; p < 0.001), average speed (novice = 42.9 ± 8.3 mm/s; intermediate = 52.7 ± 11.2 mm/s; expert = 63.6 ± 12.9 mm/s; p < 0.001), angular path (novice = 20,573 ± 12,611°; intermediate = 8652 ± 2692°; expert = 5654 ± 1746°; p < 0.001), number of movements (novice = 2197 ± 1405; intermediate = 987 ± 367; expert = 743 ± 238; p < 0.001), number of movements per second (novice = 5.0 ± 1.4; intermediate = 5.2 ± 1.5; expert = 6.6 ± 1.6; p = 0.025), and joint angle range (for different axes and joints all p < 0.001). Concurrent validity of OSATS and iSurgeon parameters was established. Test-retest reliability was given for 7 out of 8 parameters. The key steps "wrapping the thread around the instrument" and "needle positioning" were most difficult to learn. CONCLUSION: Validity and reliability of the self-developed sensor-and expert model-based laparoscopic training system "iSurgeon" were established. Using multiple parameters proved more reliable than single metric parameters. Wrapping of the needle around the thread and needle positioning were identified as difficult key steps for laparoscopic suturing and knot tying. The iSurgeon could generate automated real-time feedback based on expert models which may result in shorter learning curves for laparoscopic tasks. Our next steps will be the implementation and evaluation of full procedural training in an experimental model.
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Laparoscopía/educación , Entrenamiento Simulado , Competencia Clínica , Retroalimentación , Humanos , Reproducibilidad de los Resultados , Técnicas de Sutura/educaciónRESUMEN
INTRODUCTION: Minimally invasive surgery skill laboratories are indispensable in training, especially for complex procedural skills such as intracorporal suturing and knot tying (ICKT). However, maintaining a laboratory is expensive, and specially trained teachers are in short supply. During the COVID-19 pandemic, in-person instruction has reduced to almost zero, while model learning via video instruction (VID) has become an integral part of medical education. The aim of this study was to compare the learning effectiveness and efficiency of ICKT by laparoscopically inexperienced medical students through video versus direct expert instruction. MATERIALS AND METHODS: A secondary analysis of two randomized controlled trials was performed. We drew data from students who were trained in ICKT with expert instruction (EXP, n = 30) and from students who were trained via VID, n = 30). A laparoscopic box trainer including laparoscope was used for ICKT. Objective Structured Assessment of Technical Skills (OSATS), knot quality, and total ICKT time were the parameters for the assessment in this study. Proficiency criteria were also defined for these parameters. RESULTS: Students in the EXP group performed significantly better in OSATS-procedure-specific checklist (PSC) and knot quality compared with students in the VID group, with no difference in task time. Of the students who reached the proficiency criteria for OSATS-PSC and knot quality, those in the EXP group required fewer attempts to do so than those in the VID group. Students in both groups improved significantly in all parameters over the first hour of evaluation. CONCLUSION: For the laparoscopically inexperienced, training in ICKT through expert instruction presents an advantage compared with video-based self-study in the form of faster understanding of the procedure and the associated consistent implementation of good knot quality. Both teaching methods significantly improved participants' ICKT skills.
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COVID-19 , Laparoscopía , Estudiantes de Medicina , Humanos , Pandemias , Técnicas de Sutura/educación , Laparoscopía/educación , Competencia ClínicaRESUMEN
BACKGROUND: Lymph node involvement is the most important prognostic factor for recurrence and survival in vulvar cancer. Sentinel node (SN) procedure can be offered in well-selected patients with early vulvar cancer. This study aimed to assess current management practices with respect to the sentinel node procedure in women with early vulvar cancer in Germany. METHODS: A Web-based survey was conducted. Questionnaires were e-mailed to 612 gynecology departments. Data were summarized as frequencies and analyzed using the chi-square test. RESULTS: A total of 222 hospitals (36.27%) responded to the invitation to participate. Among the responders, 9.5% did not offer the SN procedure. However, 79.5% evaluated SNs by ultrastaging. In vulvar cancer of the midline with unilateral localized positive SN, 49.1% and 48.6% of respondents, respectively, would perform ipsilateral or bilateral inguinal lymph node dissection. Repeat SN procedure was performed by 16.2% of respondents. For isolated tumor cells (ITCs) or micrometastases, 28.1% and 60.5% of respondents, respectively, would perform inguinal lymph node dissection, whereas 19.3% and 23.8%, respectively, would opt for radiation without further surgical intervention. Notably, 50.9% of respondents would not initiate any further therapy and 15.1% would opt for expectant management. CONCLUSIONS: The majority of German hospitals implement the SN procedure. However, only 79.5% of respondents performed ultrastaging and only 28.1% were aware that ITC may affect survival in vulvar cancer. There is a need to ensure that the management of vulvar cancer follows the latest recommendations and clinical evidence. Deviations from state-of-the-art management should only be after a detailed discussion with the concerned patient.
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PURPOSE: To systematically review the current body of evidence on the efficacy and safety of immunotherapy for cervical cancer (CC). MATERIAL AND METHODS: Medline, the Cochrane Central Register of Controlled Trials and Web of Science were searched for prospective trials assessing immunotherapy in CC patients in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Full-text articles in English and German reporting outcomes of survival, response rates or safety were eligible. RESULTS: Of 4655 screened studies, 51 were included (immune checkpoint inhibitors (ICI) n=20; therapeutic vaccines n = 25; adoptive cell transfer therapy n=9). Of these, one qualified as a phase III randomized controlled trial and demonstrated increased overall survival following treatment with pembrolizumab, chemotherapy and bevacizumab. A minority of studies included a control group (n = 7) or more than 50 patients (n = 15). Overall, response rates were low to moderate. No response to ICIs was seen in PD-L1 negative patients. However, few remarkable results were achieved in heavily pretreated patients. There were no safety concerns in any of the included studies. CONCLUSION: Strong evidence on the efficacy of strategies to treat recurrent or metastatic cervical cancer is currently limited to pembrolizumab in combination with chemotherapy and bevacizumab, which substantiates an urgent need for large confirmatory trials on alternative immunotherapies. Overall, there is sound evidence on the safety of immunotherapy in CC.
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(1) Background: Endometriosis is a frequent chronic pain condition in women of fertile age. Pain management with analgesics is frequently used by women with endometriosis. During the COVID-19 pandemic, access to health services was temporarily restricted in various countries for persons without serious conditions, resulting in increased physical and mental health issues. The present study was conducted in order to assess the risk factors predicting increased analgesic intake by women with endometriosis during the COVID-19 pandemic. (2) Methods: The increased intake of over-the-counter (OTC) and prescription-only (PO) analgesics was assessed with an anonymous online questionnaire, along with demographic, pandemic-specific, disease-specific, and mental health characteristics. Anxiety and depression were assessed with the Generalized Anxiety Disorder Scale (GAD-2) and the Patient Health Questionnaire for Depression (PHQ-2), respectively. Pain-induced disability was assessed with the pain-induced disability index (PDI). (3) Results: A high educational level (OR 2.719; 95% CI 1.137-6.501; p = 0.025) and being at higher risk for depressive disorders, as measured by PHQ-2 ≥ 3 (OR 2.398; 95% CI 1.055-5.450; p = 0.037), were independent risk factors for an increased intake of OTC analgesics. Current global pain-induced disability (OR 1.030; 95% CI 1.007-1.054; p = 0.010) was identified as a risk factor for an increased intake of PO pain medication. The degree of reduction in social support and in social networks were independent predictors of an increased intake of PO analgesics in a univariate logistic regression analysis, but lost significance when adjusted for additional possible influencing factors. (4) Conclusions: In this population, an increased intake of OTC analgesics was related to a higher educational level and having a depressive disorder, while a higher pain-induced disability was an independent risk factor for an increased intake of PO analgesics. Pandemic-specific factors did not significantly and independently influence an increased intake of analgesics in women with endometriosis during the first wave of the COVID-19 pandemic in Germany. Healthcare providers should be aware of the possible factors related to increased analgesic use in women with endometriosis in order to identify persons at risk for the misuse of pain medication and to prevent potential adverse effects.
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Background: Endometriosis is a multifaceted chronic pain disorder that can have an impact on both physical and mental health. Women suffering from chronic pain may be more susceptible to various health disorders, especially during adversity, such as the COVID-19 pandemic. Previous research has identified resilience as a mediator between internal or external stressors and well-being. Methods: An online survey was conducted during the first wave of the COVID-19 pandemic in Germany through patient support groups of women with endometriosis. The Brief Resilience Score (BRS) was employed to evaluate resilience, while the PHQ-4 questionnaire was used to assess self-reported mental health. Univariate and multivariate logistic regression analyses were applied to determine resilience's independent risk and protective parameters. Results: High educational level was found to be an independent supportive moderator of high resilience in women with a resilience score greater than the study population's median (BRS > 2.66; OR 2.715; 95% CI 1.472−5.007; p = 0.001) but not in women in the highest resilience score quartile (BRS > 3.33). A decrease in perceived social support was detected to be the most powerful independent risk factor for low resilience: OR 0.541, 95% CI 0.307−0.952, p = 0.033 for predicting BRS > 2.66, and OR 0.397, 95% CI 0.189−0.832, p = 0.014 for predicting scores > 3.33 on the BRS scale. A high burden of mental health symptoms, as measured by the PHQ-4 scale, was negatively associated with resilience. Conclusions: Satisfying social support and good mental health were shown to be key resources for resilience. The results of this study may assist in the identification of women at risk for low resilience and the development of resilience-building strategies in patients with endometriosis.
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(1) Background: The main aim of this research was to examine the factors leading to pain-induced disability by assessing the impact of demographic, endometriosis-specific, pandemic-specific, and mental health factors. (2) Methods: Women with endometriosis who attended online support groups were invited to respond to an online survey during the first wave of the COVID-19 pandemic in Germany. The Pain Disability Index (PDI) was employed to assess disability-related daily functioning. Independent predictors of pain-induced disability were determined using univariate and multivariate logistic regression analyses. (3) Results: The mean PDI score of the study population was 31.61 (SD = 15.82), which was significantly higher (p < 0.001) than that reported in a previously published normative study of the German population. In the present study, a high level of pain-induced disability, as defined by scores equal to or higher than the median of the study population, older age (OR 1.063, 95% CI 1.010−1.120, p = 0.020), dysmenorrhea (OR 1.015, 95% CI 1.005−1.026, p = 0.005), dysuria (OR 1.014; 95% CI 1.001−1.027, p = 0.029), lower back pain (OR 1.018, 95% CI 1.007−1.029, p = 0.001), and impaired mental health (OR 1.271, 95% CI 1.134−1.425, p < 0.001) were found to be independent risk factors. Pandemic-specific factors did not significantly influence the pain-induced disability of the participants in this study. (4) Conclusions: The level of pain-induced disability was significantly higher among the women with endometriosis than among women in the normative German validation study. Our findings identified risk factors for experiencing a high level of pain-induced disability, such as demographic and specific pain characteristics. Pandemic-specific factors did not significantly and independently influence the pain-induced disability during the first wave of the COVID-19 pandemic in Germany. Impaired mental health negatively influenced functioning during daily activities. Thus, women with endometriosis should be managed by a multidisciplinary team of healthcare professionals to prevent negative effects of pain-induced disability on their quality of life.
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COVID-19 , Endometriosis , COVID-19/epidemiología , Dismenorrea/epidemiología , Endometriosis/complicaciones , Endometriosis/epidemiología , Endometriosis/psicología , Femenino , Humanos , Pandemias , Calidad de VidaRESUMEN
Background: Intermittent fasting (IF) is defined as an eating pattern without calorie restrictions, alternating between periods of fasting and eating. In the past decades IF has not only become a popular weight-reducing diet but is thought to improve Quality of Life (QoL) and fatigue. However, very little evidence exists for the general population. Thus, we aimed to assess the impact of a 16-h fasting period per day over a three-month study period on QoL and especially fatigue in healthy people. Methods: We conducted a prospective cohort study including healthy subjects. All participants fasted 16 h for at least five days a week while maintaining their normal lifestyle. In the study, we analysed blood samples as well as QoL through standardized questionnaires (WHO-5 questionnaire, Short Form Health 36). Furthermore, we measured the degree of fatigue with the Fatigue Assessment Scale (FAS) and Fatigue Severity Scale (FSS) as well as compliance, activity records, and weight alterations. All endpoints were evaluated at baseline, after two weeks, four weeks, and three months of IF. Results: A total of 30 participants fasted for the entire study period. The results of the WHO-5 questionnaire (15.6 ± 4.6 vs. 18 ± 3.6, p < 0.0019) demonstrated a significant increase in QoL. For long-term QoL six out of eight domains measured by the Short Form Health 36 (SF-36) significantly improved (e.g., physical health: 92.3 ± 11.6 vs. 96.5 ± 6.3, p = 0.015; mental health: 75.5 ± 12.0 vs. 81.7 ± 9.0; p < 0.001 and body pain: 74.1 ± 31.8 vs. 89.5 ± 14.9; p = 0.008) after three months. Fatigue significantly decreased from 10.3 ± 3.2 to 8.4 ± 2.5; p = 0.002 for mental fatigue and from 12.6 ± 3.8 to 10.7 ± 3.3; p = 0.002 measured by the FAS. The mean FSS-Score at baseline was 3.5 ± 1.2 compared to 2.9 ± 1.1 (scale 1−7) after three months (p < 0.001). Notably, the proliferation marker IGF-1 was significantly reduced. No clinically significant changes in laboratory parameters were observed that would have endangered a participant's safety. Conclusions: IF according to the 16:8 regime over a fasting period of three months significantly improved several aspects of the QoL and decreased fatigue in healthy people, while maintaining a good safety profile. The practicability of this diet was also demonstrated for shift workers and people with a high percentage of active labour. Apart from the improvement in QoL and fatigue, the significant reduction in IGF-1, which can act as an accelerator of tumour development and progression, might be an indicator of the potential benefits of IF for patients with cancer.
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Ayuno , Calidad de Vida , Dieta Reductora , Femenino , Humanos , Factor I del Crecimiento Similar a la Insulina/análisis , Embarazo , Estudios ProspectivosRESUMEN
Undifferentiated carcinoma metastatic to the bowel is uncommon in surgical pathology practice and might be confused with primary gastrointestinal carcinoma, melanoma, lymphoma, and others. We present 14 cases of uni- (n = 9) or multifocal (n = 5) undifferentiated large cell/rhabdoid carcinoma presenting in the bowel of patients with concurrent (n = 9) or recent (diagnosed 1 to 25 months earlier; median, 4) non-small cell lung cancer (NSCLC). Patients were 6 females and 8 males, aged 52 to 85 years. Primary NSCLC was verified histologically in 10 cases and by imaging in 4. The undifferentiated histology was present in the lung biopsy in 4/10 patients (as sole pattern in 3 and combined with adenocarcinoma in 1) and was limited to the intestinal metastases in the remainder. PDL1 was strongly expressed in 7/9 cases (CPS: 41 to 100). Loss of at least one SWI/SNF subunit was detected in 7/13 cases (54%). SMARCA2 loss (n = 6) was most frequent and was combined with SMARCA4 loss in one case. PBRM1 loss was observed in one tumor. Successful molecular testing of 11 cases revealed BRAF mutations in 4 (3 were non-V600E variants), KRAS mutations in 3, and wildtype in 4. None had EGFR mutations. Analysis of 4 paired samples revealed concordant KRAS (2) and BRAF (1) mutations or wildtype (1). Our study indicates that undifferentiated carcinoma within the intestines of patients with concurrent/recent NSCLC represents dedifferentiated metastasis from the NSCLC. Recognition of this unusual presentation is cardinal to avoid misdiagnosis with inappropriate therapeutic and prognostic implications.