A novel "video-game" simulator for training fetoscopic laser coagulation of anastomoses in twin-to-twin transfusion syndrome.

 : We have developed a high-fidelity interactive "video-game" simulator in order to teach fetoscopic laser ablation of placental anastomoses for twin-twin transfusion syndrome This simulator may be used by teachers in order to provide metrics-based simulator education to multiple trainees, in both hands-on and distanced learning settings WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?: The use of simulation improves training of the fetoscopic laser techniques utilized in the treatment of twin-twin transfusion syndrome A number of mannequins have been developed to aid this education WHAT DOES THIS STUDY ADD?: Two new simulators are described for twin-twin transfusion syndrome training-silicone and digital The digital simulator is a novel digital video game virtual format This new format has enhanced interactivity and has the potential to enable distance learning.

Validation of a high-fidelity training model for fetoscopic spina bifida surgery.

Open fetal surgery for spina bifida (SB) is safe and effective yet invasive. The growing interest in fetoscopic SB repair (fSB-repair) prompts the need for appropriate training. We aimed to develop and validate a high-fidelity training model for fSB-repair. fSB-repair was simulated in the abdominal cavity and on the stomach of adult rabbits. Laparoscopic fetal surgeons served either as novices (n = 2) or experts (n = 3) based on their experience. Technical performance was evaluated using competency Cumulative Sum (CUSUM) analysis and the group splitting method. Main outcome measure for CUSUM competency was a composite binary outcome for surgical success, i.e. watertight repair, operation time ≤ 180 min and Objective-Structured-Assessment-of-Technical-Skills (OSATS) score ≥ 18/25. Construct validity was first confirmed since competency levels of novices and experts during their six first cases using both methods were significantly different. Criterion validity was also established as 33 consecutive procedures were needed for novices to reach competency using learning curve CUSUM, which is a number comparable to that of clinical fSB-repair. Finally, we surveyed expert fetal surgeons worldwide to assess face and content validity. Respondents (26/49; 53%) confirmed it with ≥ 71% of scores for overall realism ≥ 4/7 and usefulness ≥ 3/5. We propose to use our high-fidelity model to determine and shorten the learning curve of laparoscopic fetal surgeons and retain operative skills.

How we measure and determine competence: lessons from fetal myelomeningocele repair.

Linked Comment: Ultrasound Obstet Gynecol 2020; 55:730-739.

Open fetal surgery for myelomeningocele - is there the learning curve at reduction mother and fetal morbidity?

OBJECTIVES: We aimed to show how increased experience of a surgery team in fMMC repair influences maternal and fetal/neonatal outcomes. MATERIAL AND METHODS: We compare perinatal results of fMMC repair in our Fetal Surgery Center (FSC) in cohort groups for the early period (2005-2011 year; previous - PFSC, n = 46) and current period (2012-2015 year; current - CFSC, n = 74) to results of the randomized Management of Myelomeningocele Study (MOMS, 78 patients). RESULTS: The maternal morbidity due to fMMC repair was low and there was no difference comparing CFSC to PFSC and MOMS. The frequency of iatrogenic preterm labor (iPTL) ≤ 30 weeks of gestation decreased from 34.1% in PFSC to 23.9% in CFSC. Iatrogenic preterm premature rupture of membranes (iPPROM) was a common complication after fMMC repair in all cohorts. The total reduction rate of hindbrain hernation (HH) was similar in CFSC - 90.3% and PFSC - 82.1%. CONCLUSIONS: The increasing experience of our surgery team in fMMC repair majorly decreased the risk of iPTL.

Comparison of Mannequin Training Satisfaction with a Conventional Box Trainer and a Low-Fidelity Fetoscopic Surgical Simulator for Selective Fetoscopic Laser Photocoagulation.

BACKGROUND: A low-fidelity fetoscopic surgical simulator (FSS) for training of selective fetoscopic laser photocoagulation (SFLP) was developed. OBJECTIVE: To evaluate and compare training satisfaction with an FSS and with a conventional box trainer (BT). METHODS: The BT consisted of a cleaned human placenta attached to the inside of a plastic storage box with a watertight lock cover and an ultrasound-transparent rubber skin. The FSS consisted of the replica of a monochorionic twin placenta attached to the inside of a spherically shaped, ultrasound-transparent phantom. Tap water was used as an ultrasound conduction agent. Evaluation of the mannequin trainings was conducted on 8 junior maternal-fetal medicine (MFM) attending physicians and 22 MFM fellows. Training satisfaction was scored from 0 to 10 on 8 different domains. RESULTS: The mean satisfaction score (±SD) with the FSS was higher than with the BT in all domains (p < 0.05). The fellows' training satisfaction with the BT was greater than that of the attending physicians in 4 domains: tactile feedback, demonstration of chorionic vessels, feedback on performance, and overall value as learning aid (p < 0.05). CONCLUSIONS: As evaluated by a small group of trainees, our FSS is superior to the BT in mannequin training of SFLP. However, the BT may be more useful for trainees with limited clinical experience.

Learning curves of open and endoscopic fetal spina bifida closure: systematic review and meta-analysis.

OBJECTIVE: The Management of Myelomeningocele Study (MOMS) trial demonstrated the safety and efficacy of open fetal surgery for spina bifida aperta (SBA). Recently developed alternative techniques may reduce maternal risks without compromising the fetal neuroprotective effects. The aim of this systematic review was to assess the learning curve (LC) of different fetal SBA closure techniques. METHODS: MEDLINE, Web of Science, EMBASE, Scopus and Cochrane databases and the gray literature were searched to identify relevant articles on fetal surgery for SBA, without language restriction, published between January 1980 and October 2018. Identified studies were reviewed systematically and those reporting all consecutive procedures and with postnatal follow-up ≥ 12 months were selected. Studies were included only if they reported outcome variables necessary to measure the LC, as defined by fetal safety and efficacy. Two authors independently retrieved data, assessed the quality of the studies and categorized observations into blocks of 30 patients. For meta-analysis, data were pooled using a random-effects model when heterogeneous. To measure the LC, we used two complementary methods. In the group-splitting method, competency was defined when the procedure provided results comparable to those in the MOMS trial for 12 outcome variables representing the immediate surgical outcome, short-term neonatal neuroprotection and long-term neuroprotection at ≥ 12 months of age. Then, when raw patient data were available, we performed cumulative sum analysis based on a composite binary outcome defining successful surgery. The composite outcome combined four clinically relevant variables for safety (absence of extreme preterm delivery < 30 weeks, absence of fetal death ≤ 7 days after surgery) and efficacy (reversal of hindbrain herniation and absence of any neonatal treatment of dehiscence or cerebrospinal fluid leakage at the closure site). RESULTS: Of 6024 search results, 17 (0.3%) studies were included, all of which had low, moderate or unclear risk of bias. Fetal SBA closure was performed using standard hysterotomy (11 studies), mini-hysterotomy (one study) or fetoscopy by either exteriorized-uterus single-layer closure (one study), percutaneous single-layer closure (three studies) or percutaneous two-layer closure (one study). Only outcomes for standard hysterotomy could be meta-analyzed. Overall, outcomes improved significantly with experience. Competency was reached after 35 consecutive cases for standard hysterotomy and was predicted to be achieved after ≥ 57 cases for mini-hysterotomy and ≥ 56 for percutaneous two-layer fetoscopy. For percutaneous and exteriorized-uterus single-layer fetoscopy, competency was not reached in the 81 and 28 cases available for analysis, respectively, and LC prediction analysis could not be performed. CONCLUSIONS: The number of cases operated is correlated with the outcome of fetal SBA closure, and the number of operated cases required to reach competency ranges from 35 for standard hysterotomy to ≥ 56-57 for minimally invasive modifications. Our observations provide important information for institutions looking to establish a new fetal center, develop a new fetal surgery technique or train their team, and inform referring clinicians, potential patients and third parties. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Curvas de aprendizaje del cierre de la espina bífida fetal mediante cirugía abierta y endoscópica: revisión sistemática y metaanálisis OBJETIVO: El ensayo del Estudio sobre la Gestión del Mielomeningocele (MOMS, por sus siglas en inglés) demostró la seguridad y eficacia de la cirugía fetal abierta para la espina bífida aperta (EBA). Las técnicas alternativas recientemente desarrolladas pueden reducir los riesgos de la madre sin comprometer los efectos neuroprotectores del feto. El objetivo de esta revisión sistemática fue evaluar la curva de aprendizaje (CA) de diferentes técnicas de cierre de la EBA fetal. MÉTODOS: Se realizaron búsquedas en las bases de datos de MEDLINE, Web of Science, EMBASE, Scopus y Cochrane, así como en la literatura gris, para identificar artículos relevantes sobre cirugía fetal para la EBA, sin restricción de idioma, publicados entre enero de 1980 y octubre de 2018. Se examinaron sistemáticamente los estudios identificados y se seleccionaron los que informaban de todos los procedimientos consecutivos y con seguimiento postnatal ≥12 meses. Los estudios se incluyeron sólo si informaban sobre las variables de resultado necesarias para medir la CA, definidas por la seguridad y la eficacia para el feto. Dos autores recuperaron los datos de forma independiente, evaluaron la calidad de los estudios y clasificaron las observaciones en bloques de 30 pacientes. Para el metaanálisis, los datos se agruparon mediante un modelo de efectos aleatorios cuando fueron heterogéneos. Para medir la CA, se usaron dos métodos complementarios. En el método de división de grupos, la competencia se definió cuando el procedimiento proporcionó resultados comparables a los del ensayo MOMS para 12 variables de resultados que representaban el resultado quirúrgico inmediato, la neuroprotección neonatal a corto plazo y la neuroprotección a largo plazo a ≥12 meses de edad. Luego, cuando se dispuso de los datos brutos de los pacientes, se realizó un análisis de suma acumulada basado en un resultado binario compuesto que definió el éxito de la cirugía. El resultado compuesto combinó cuatro variables clínicamente relevantes en cuanto a la seguridad (ausencia de parto pretérmino extremo <30 semanas; ausencia de muerte fetal a ≤7 días después de la cirugía) y eficacia (reducción de la hernia del rombencéfalo y ausencia de cualquier tratamiento neonatal de dehiscencia o derrame de líquido cefalorraquídeo en el lugar del cierre). RESULTADOS: De los 6024 resultados de la búsqueda, se incluyeron 17 (0,3%) estudios, todos ellos con un riesgo de sesgo bajo, moderado o incierto. El cierre de la EBA fetal se realizó mediante histerotomía estándar (11 estudios), mini histerotomía (un estudio) o fetoscopia, ya fuera mediante el cierre exteriorizado del útero de una sola capa (un estudio), el cierre percutáneo de una sola capa (tres estudios) o el cierre percutáneo de dos capas (un estudio). Sólo se pudieron metaanalizar los resultados de la histerotomía estándar. En general, los resultados mejoraron significativamente con la experiencia. Se alcanzó la competencia después de 35 casos consecutivos para la histerotomía estándar y se predijo que se alcanzaría después de ≥57 casos para la mini histerotomía y ≥56 para la fetoscopia percutánea de dos capas. En el caso de las fetoscopias percutánea y exteriorizada del útero de una sola capa, no se alcanzó la competencia en los 81 y 28 casos disponibles para el análisis, respectivamente, y no se pudo realizar el análisis de predicción de la CA. CONCLUSIONES: El número de casos operados está correlacionado con el resultado del cierre de la EBA fetal, y el número de casos operados necesarios para alcanzar la competencia estuvo entre 35 para la histerotomía estándar y ≥56-57 para las operaciones con mínima agresividad. Las observaciones realizadas proporcionan información importante para las instituciones que buscan establecer un nuevo centro fetal, desarrollar una nueva técnica de cirugía fetal o entrenar a su equipo, e informar a los médicos que remiten a especialistas a los posibles pacientes y a terceros. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Low-Fidelity Simulator for the Standardized Training of Fetoscopic Meningomyelocele Repair.

BACKGROUND: Fetoscopic meningomyelocele repair in a gas-filled uterus is a new technique performed in very few centers. There are few opportunities as well as ethical prohibitions on the initial development and subsequent refinement of innovative fetal surgery techniques in humans, and using an animal model is both very expensive and logistically difficult. METHOD: We developed a low-fidelity endoscopic fetal surgery simulation using a plastic doll and pieces of chicken breast to simulate a fetal meningomyelocele, and a polyurethane ball to simulate a gas-filled uterus, along with a standard endoscopy system and instruments. EXPERIENCE: A unique two-port technique with significant differences from the standard laparoscopic surgery procedure was developed and refined through an iterative phase into a standardized methodology, and the simulator was then used to train three other teams to perform standardized fetoscopic meningomyelocele repair. CONCLUSION: A low-fidelity fetoscopic surgery simulator is a useful tool for developing new fetoscopic operations and for training multidisciplinary fetal surgery teams without the need for extensive use of an animal model. This simulator may be used to further explore the human uterus as a new surgical space for additional fetal surgeries.

Fetoscopic laser coagulation in 1020 pregnancies with twin-twin transfusion syndrome demonstrates improvement in double-twin survival rate.

OBJECTIVE: To investigate the growing experience and learning curve of fetoscopic laser coagulation of the placental vascular anastomoses in severe mid-trimester twin-twin transfusion syndrome (TTTS) and its influence on perinatal outcome in a single-center setting. METHODS: Between January 1995 and March 2013 we performed laser therapy in 1020 consecutive pregnancies with TTTS between 15.1 and 27.4 weeks' gestation. We compared perinatal outcome in blocks of five sequential groups of 200 cases, taking into account several covariates in order to adjust for case mix and to demonstrate learning curves and success rates. RESULTS: The percentage of pregnancies with survival of both fetuses increased from 50.0% (n = 100) in the first 200 cases to 69.5% (n = 153) in the last 220 cases (P = 0.018 for trend) and the overall survival rate for both fetuses in the complete series of 1019 cases with known outcome was 63.3% (n = 645). The survival rate of at least one fetus increased from 80.5% (161/200) in the first group to 91.8% (202/220) in the last group (P = 0.072 for trend) and the overall survival rate of at least one fetus in the complete series was 86.7% (883/1019). In the total population, the mean gestational age at delivery of pregnancies with at least one liveborn neonate was 33.7 ± 3.2 weeks, with a mean interval of 12.9 ± 4.0 weeks between intervention and delivery. Among the first two groups, 124 pregnancies had anterior placentae and were treated with a 0° fetoscope. These cases had the poorest overall outcome, with a double-twin survival rate of 44.4% (55/124), which increased to 65.1% (207/318; P = 0.001) after the introduction of a 30° fetoscope for cases with anterior placenta. The success rate for double-twin survival reached a plateau of 69% at 600 procedures, a rate equalled by a new operator who was trained hands-on and performed 174 of the last 400 procedures. CONCLUSIONS: We report the largest single-center experience of laser coagulation in TTTS. We observed a continuous increase in double-twin survival rate owing to the growing experience based on the learning curve and refinements in fetoscopic instruments and techniques. These data provide strong arguments for the centralization of minimally invasive intrauterine surgery in specialized high-volume centers. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Rapid initiation of fetal therapy services with a system of learner-centred training under proctorship: the National University Hospital (Singapore) experience.

INTRODUCTION: Management of complicated monochorionic twins and certain intrauterine structural anomalies is a pressing challenge in communities that still lack advanced fetal therapy. We describe our efforts to rapidly initiate selective feticide using radiofrequency ablation (RFA) and selective fetoscopic laser photocoagulation (SFLP) for twin-to-twin transfusion syndrome (TTTS), and present the latter as a potential model for aspiring fetal therapy units. METHODS: Five pregnancies with fetal complications were identified for RFA. Three pregnancies with Stage II TTTS were selected for SFLP. While RFA techniques utilising ultrasonography skills were quickly mastered, SFLP required stepwise technical learning with an overseas-based proctor, who provided real-time hands-off supervision. RESULTS: All co-twins were live-born following selective feticide; one singleton pregnancy was lost. Fetoscopy techniques were learned in a stepwise manner and procedures were performed by a novice team of surgeons under proctorship. Dichorionisation was completed in only one patient. Five of six twins were live-born near term. One pregnancy developed twin anaemia-polycythaemia sequence, while another was complicated by co-twin demise. DISCUSSION: Proctor-supervised directed learning facilitated the rapid provision of basic fetal therapy services by our unit. While traditional apprenticeship is important for building individual expertise, this system is complementary and may benefit other small units committed to providing these services.

Training Significantly Improves Fetoscopy Performance: A Pilot Randomized Controlled Trial.

Background Implementation of complex fetoscopic procedures that included intracorporeal suturing has been limited due to technical difficulties that might be surmounted with adequate training. Evaluating the impact of laparoscopic or fetoscopic training on fetoscopic performance was the aim of this study. Methods To evaluate fetoscopic performance after either laparoscopic or fetoscopic training, subjects were asked to perform four surgeon's square knots fetoscopically prior and post 2 hours of hands-on training. All subjects were medical students and novice in laparoscopic and fetoscopic interventions. Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality, and fetoscopic performance were assessed. Results Forty-six subjects were included in the study; after simple randomization, 24 were trained fetoscopically and 22 laparoscopically. Both groups had comparable baseline characteristics and improved after training significantly regarding all aspects assessed in this study. Subjects who trained fetoscopically were superior in terms of suturing and knot-tying performance. Conclusion Training significantly improves fetoscopic performance and may indeed be the keystone for future complex fetoscopic interventions. It seems advisable to train rather fetoscopically than laparoscopically resulting in higher suture and knot-tying quality.

Operator competence in fetoscopic laser surgery for twin-twin transfusion syndrome: validation of a procedure-specific evaluation tool.

OBJECTIVES: Fetoscopic laser surgery for twin-twin transfusion syndrome is a procedure for which no objective tools exist to assess technical skills. To ensure that future fetal surgeons reach competence prior to performing the procedure unsupervised, we developed a performance assessment tool. The aim of this study was to validate this assessment tool for reliability and construct validity. METHODS: We made use of a procedure-specific evaluation instrument containing all essential steps of the fetoscopic laser procedure, which was previously created using Delphi methodology. Eleven experts and 13 novices from three fetal medicine centers performed the procedure on the same simulator. Two independent observers assessed each surgery using the instrument (maximum score: 52). Interobserver reliability was assessed using Spearman correlation. We compared the performance of novices and experts to assess construct validity. RESULTS: The interobserver reliability was high (Rs = 0.974, P < 0.001). Checklist scores for experts and novices were significantly different; the median score for novices was 28/52 (54%), whereas that for experts was 47.5/52 (91%) (P < 0.001). The procedure time and fetoscopy time were significantly shorter (P < 0.001) for experts. Residual anastomoses were found in 1/11 (9%) procedures performed by experts and in 9/13 (69%) procedures performed by novices (P = 0.005). Multivariable analysis showed that the checklist score, independent of age and gender, predicted competence. CONCLUSIONS: The procedure-specific assessment tool for fetoscopic laser surgery shows good interobserver reliability and discriminates experts from novices. This instrument may therefore be a useful tool in the training curriculum for fetal surgeons. Further intervention studies with reassessment before and after training may increase the construct validity of the tool. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Simulator training in fetoscopic laser surgery for twin-twin transfusion syndrome: a pilot randomized controlled trial.

OBJECTIVE: To evaluate the effect of a newly developed training curriculum on the performance of fetoscopic laser surgery for twin-twin transfusion syndrome (TTTS) using an advanced high-fidelity simulator model. METHODS: Ten novices were randomized to receive verbal instructions and either skills training using the simulator (study group; n = 5) or no training (control group; n = 5). Both groups were evaluated with a pre-training and post-training test on the simulator. Performance was assessed by two independent observers and comprised a 52-item checklist for surgical performance (SP) score, measurement of procedure time and number of anastomoses missed. Eleven experts set the benchmark level of performance. Face validity and educational value of the simulator were assessed using a questionnaire. RESULTS: Both groups showed an improvement in SP score at the post-training test compared with the pre-training test. The simulator-trained group significantly outperformed the control group, with a median SP score of 28 (54%) in the pre-test and 46 (88%) in the post-test vs 25 (48%) and 36 (69%), respectively (P = 0.008). Procedure time decreased by 11 min (from 44 to 33 min) in the study group vs 1 min (from 39 to 38 min) in the control group (P = 0.69). There was no significant difference in the number of missed anastomoses at the post-training test between the two groups (1 vs 0). Subsequent feedback provided by the participants indicated that training on the simulator was perceived as a useful educational activity. CONCLUSIONS: Proficiency-based simulator training improves performance, indicated by SP score, for fetoscopic laser therapy. Despite the small sample size of this study, practice on a simulator is recommended before trainees carry out laser therapy for TTTS in pregnant women.

Identification of essential steps in laser procedure for twin-twin transfusion syndrome using the Delphi methodology: SILICONE study.

OBJECTIVE: To determine, by expert consensus, the essential substeps of fetoscopic laser surgery (FLS) for twin-twin transfusion syndrome (TTTS) that could be used to create an authority-based curriculum for training in this procedure among fetal medicine specialists. METHODS: A Delphi survey was conducted among an international panel of experts (n = 98) in FLS. Experts rated the substeps of FLS on a five-point Likert-type scale to indicate whether they considered them to be essential, and were able to comment on each substep, using a dedicated online platform accessed by the invited tertiary care facilities that specialize in fetal therapy. Responses were returned to the panel until consensus was reached (Cronbach's α ≥ 0.80). All substeps that were rated ≥ 4 by 80% of the experts were included in the evaluation instrument. RESULTS: After the first iteration of the Delphi procedure, a response rate of 74% (73/98) was reached, and in the second and third iterations response rates of 90% (66/73) and 81% (59/73) were reached, respectively. Among a total of 81 substeps rated in the first round, 21 substeps had to be re-rated in the second round. Finally, from the initial list of substeps, 55 were agreed by experts to be essential. In the third round, the 18 categorized substeps were ranked in order of importance, with 'coagulation of all anastomoses that cross the equator' and 'determination of fetoscope insertion site' as the most important. CONCLUSIONS: A total of 55 substeps of FLS for TTTS were defined by a panel of experts to be essential in the procedure. This list is the first authority-based evidence to be used in the development of a final training model for future fetal surgeons.

Fetal surgery: an overview.

In utero fetal surgery interventions are currently considered in selected cases of congenital diaphragmatic hernia, cystic pulmonary abnormalities, amniotic band sequence, selected congenital heart abnormalities, myelomeningocele, sacrococcygeal teratoma, obstructive uropathy, and complications of twin pregnancy. Randomized controlled trials have demonstrated an advantage for open fetal surgery of myelomeningocele and for fetoscopic selective laser coagulation of placental vessels in twin-to-twin transfusion syndrome. The evidence for other fetal surgery interventions, such as tracheal occlusion in congenital diaphragmatic hernia, excision of lung lesions, fetal balloon cardiac valvuloplasty, and vesicoamniotic shunting for obstructive uropathy, is more limited. Conditions amenable to intrauterine surgical treatment are rare; the mother may consider termination of pregnancy as an option for many of them; treatment can be lifesaving but in itself carries risks to both the infant (preterm premature rupture of the membranes, preterm delivery) and the mother. This makes conducting prospective or randomized trials difficult and explains the relative lack of good-quality evidence in this field. Moreover, there is scanty information on long-term outcomes. It is recommended that fetal surgery procedures be performed in centers with extensive facilities and expertise. The aims of this review were to describe the main fetal surgery procedures and their evidence-based results and to provide generalist obstetricians with an overview of current indications for fetal surgery.

Learning curve for fetoscopic laser surgery using cumulative sum analysis.

OBJECTIVE: To identify a learning curve and monitor operator performance for fetoscopic laser surgery for twin-to-twin transfusion syndrome using cumulative sum analysis. DESIGN: Retrospective cohort study. SETTING: National tertiary referral center for invasive fetal therapy. POPULATION: A total of 340 consecutive monochorionic pregnancies with twin-to-twin transfusion syndrome treated with fetoscopic laser coagulation between August 2000 and December 2010. METHODS: A learning curve was generated using learning curve cumulative sum analysis and cumulative sum methodology to assess changes in double survival across the case sequence. Laser surgery was initially performed by two operators, joined by a third and fourth operator after 1 and 2 years, respectively. MAIN OUTCOME MEASURES: Individual operator performance, double perinatal survival at 4 weeks. RESULTS: Overall survival of both twins occurred in 59% (201/340), median gestational age at birth was 32.0 weeks. Cumulative sum graphs showed that level of competence for double survival for the operators was reached after 26, 25, 26, and 35 procedures, respectively. Two operators kept their competence level and continued to improve after completing the initial learning process; two others went out of control at one point in time, according to the cumulative sum boundaries. A difference in learning effect was associated with number of procedures performed annually and previous experience with other ultrasound-guided invasive procedures. CONCLUSIONS: This study shows that all operators reached a level of competence after at least 25 fetoscopic laser procedures and confirms the value of using the cumulative sum method both for learning curve assessment and for ongoing quality control.

Does website-based information add any value in counseling mothers expecting a baby with severe congenital diaphragmatic hernia?

OBJECTIVE: We aimed to measure whether website-provided information about congenital diaphragmatic hernia (CDH) and fetal therapy for severe cases provides added value compared with clinical counseling of parents. METHODS: This is a single center study in 102 couples who earlier opted for fetoscopic endoluminal tracheal occlusion (FETO) because of isolated severe CDH. They were asked to fill out an anonymized web-based survey of 12 questions. Then, they were offered access to information on the web pages of the randomized Tracheal Occlusion to Accelerate Lung Growth (TOTAL) trial. One week later, their appreciation was measured again by a second questionnaire. RESULTS: Eighty-two (80%) parents completed the first questionnaire, and 48 (47%) completed the entire survey. Several items became more clear to the parents after reading the website, such as the length of hospital stay (23.2% prior to web information, 60.4% after; P = 0.004), maternal risk, or the requirement of fetal anesthesia for FETO (43.9% resp. 79.2%; P = <0.001). CONCLUSION: Complementing prenatal counseling on CDH and FETO by standardized information via website is perceived by parents as of added value. Maternal risks and the need for fetal medication need more clarification during the verbal counseling prior to prenatal interventions.

Use of the Learning Curve-Cumulative Summation test for quantitative and individualized assessment of competency of a surgical procedure in obstetrics and gynecology: fetoscopic laser ablation as a model.

OBJECTIVE: We sought to determine the learning curve (LC) for fetoscopic laser photocoagulation (FLP) as a model for the evaluation of training in surgical procedures. STUDY DESIGN: A retrospective review of consecutive case series of FLP from 2 centers with 3 operators (operator I [O-I], observer trained; operator II [O-II], hands-on trained; and operator III [O-III], clinical fellow) was performed and the LC-cumulative summation (CUSUM) test was plotted. RESULTS: The acceptable and unacceptable success rates for at least 1 fetus survival after FLP were set at 82% and 70%, respectively, from a systematic review. A total of 171 consecutive cases were performed by the 3 operators (O-I, 91; O-II, 49; and O-III, 31). From LC-CUSUM test O-I needed 60 procedures, O-II needed 20 procedures, and O-III needed 20 procedures to reach an acceptable performance rate for at least 1 survivor. CONCLUSION: The LC-CUSUM test can be used to accurately assess the LC in a surgical procedure in obstetrics and gynecology. Hands-on trained operators exhibit a shorter LC.