Application of failure mode and effect analysis in laparoscopic colon surgery training.

AIM: To evaluate if application of failure mode and effect analysis (FMEA) to laparoscopy training can help surgeons acquire laparoscopy skills. METHODS: After preparing a FMEA matrix of laparoscopic sigmoidectomy, we have introduced it during three laparoscopy courses. Forty-eight surgeons, divided into 24 teams of two surgeons, have participated in three courses. During each course, every team has performed three laparoscopic sigmoidectomies in three experimental animals (1 OR session every day). Risk priority number (RPN) has been calculated for every surgery, and the results have been discussed at the end of each training day with all participants. RESULTS: We have observed a decline in the median RPN from 1339 during the first OR session through 62 during second OR session to reach 0 in the third OR session. Only two teams out of 24 were not able to reach a RPN of less than 300 during third OR session. When the type of failures were analysed, we have observed a shift from procedure-type failures to technical failures that depended on each participant technical abilities. CONCLUSION: Application of FMEA principles to laparoscopy training can help acquire non-technical skills necessary for safe laparoscopic surgery.

Comparison of single access devices during cut and suturing tasks on simulator.

BACKGROUND: Published comparisons of the different available laparoendoscopic single-site surgery (LESS) devices focused on its economic cost and technical aspects. With this study, we aimed to objectively compare the use of three different LESS access devices in controlled experimental tasks. MATERIALS AND METHODS: Twenty subjects participated in simulator trials. A cut and an intracorporeal suturing task were carried out. Three single access devices (SILS: SILS(TM) Port, GPN. GelPOINT Advanced Access Platform, and XCN: XCONE) were used according to a randomized nine-session schedule. Completion time was registered and performance objectively assessed with task-specific rating scales. Two blinded expert raters worked over video recordings of the hands-on sessions. RESULTS: Participants showed improvement with all devices on total cut completion times and significantly for SILS (P = 0.017). The GPN decreased its adapted Global Rating Scale score (P = 0.002) from the first (W1) to the last week (W9). On the suture task, XCN constituted the device with longer completion times compared with SILS (P < 0.001) and to GPN (P < 0.001). There was significant improvement in times from W1 to W9 with XCN (P < 0.001), SILS (P = 0.003), and GPN (P < 0.001). On average summative score, we observed significant improvement in performance with all devices from W1 to W9 (SILS: P = 0.003; GPN: P = 0.001; and XCN: P < 0.001). CONCLUSIONS: Although we advise surgeons to focus on the specific procedures and patient characteristics to select the most adequate access device to maintain procedural safety standards, single-use devices appear to confer an easier adaptation to LESS surgery.

Early postoperative complications of transvaginal access in minimally invasive sigmoid colon procedures.

OBJECTIVES: The aim of the study was to evaluate early (the first 30 days) postoperative complications after transvaginal resection of the sigmoid colon. MATERIAL AND METHODS: A total of 23 laparoscopy-assisted transvaginal resections of the sigmoid colon and 1 NOTES transvaginal sigmoid resection were performed in the course of 3 years. Postoperative complications were recorded in a prospective manner. RESULTS: In the group of 24 patients operated on using the transvaginal approach, 6 (25%) complications were recorded, including 3 urinary tract infections, 2 vaginal bleedings, and 1 abdominal trocar site hernia. CONCLUSION: Early postoperative complication rate after transvaginal resection of the sigmoid colon is relatively low and the clinical complications are not severe.

Ureteral obstruction swine model through laparoscopy and single port for training on laparoscopic pyeloplasty.

This study aims firstly to assess the most adequate surgical approach for the creation of an ureteropelvic juntion obstruction (UPJO) animal model, and secondly to validate this model for laparoscopic pyeloplasty training among urologists. Thirty six Large White pigs (28.29±5.48 Kg) were used. The left ureteropelvic junction was occluded by means of an endoclip. According to the surgical approach for model creation, pigs were randomized into: laparoscopic conventional surgery (LAP) or single port surgery (LSP). Each group was further divided into transperitoneal (+T) or retroperitoneal (+R) approach. Time needed for access, surgical field preparation, wound closure, and total surgical times were registered. Social behavior, tenderness to the touch and wound inflammation were evaluated in the early postoperative period. After ten days, all animals underwent an Anderson-Hynes pyeloplasty carried out by 9 urologists, who subsequently assessed the model by means of a subjective validation questionnaire. Total operative time was significantly greater in LSP+R (p=0.001). Tenderness to the touch was significantly increased in both retroperitoneal approaches, (p=0.0001). Surgeons rated the UPJO porcine model for training on laparoscopic pyeloplasty with high or very high scores, all above 4 on a 1-5 point Likert scale. Our UPJO animal model is useful for laparoscopic pyeloplasty training. The model created by retroperitoneal single port approach presented the best score in the subjective evaluation, whereas, as a whole, transabdominal laparoscopic approach was preferred.

[Training and research in urologic laparoscopic surgery. Design of training programs and experimental models of renal tumor]. / Formación e investigación en cirugía laparoscópica urológica. Diseño de programas formativos y modelos experimentales de tumor renal.

We present our experience with surgical training programs development for basic and advanced laparoscopic urological surgery. Both training programs consist of 21 and 28 hours respectively. Basic surgical programs start with general knowledge of ergonomics and instrumentation, there after, attendants acquire basic skills on physical simulator. Posteriorly, techniques on animal model are undertaken, always assisted by an expert. Advanced activities start with surgical tasks on physical simulator. Posteriorly, reconstructive urological surgical techniques are undertaken on animal model, focused on partial nephrectomy, and always assisted by an expert tutor. We present our results on exophytic renal tumour model creation based chromatic Alginate.

Totally transvaginal resection of the descending colon in an experimental model.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES), although in its embryonic phase, is currently experiencing important developments. The technique has been successfully applied for cholecystectomies and appendectomies. However, several doubts exist as to the technical limitations and feasibility of NOTES in other clinical settings. METHODS: The authors have performed totally transvaginal colon resections in a sheep model. Although completion of the surgery was possible through the transvaginal route, the addition of a transumbilical laparoscope was used as an added safety measure. RESULTS: Totally transvaginal resection of the sigmoid colon was performed for two sheep with no intra- or postoperative complications. CONCLUSION: Totally transvaginal resection of the colon (pure NOTES) is feasible in a sheep model.

[Ergonomics in laparoscopic surgery and its importance in surgical training]. / Ergonomía en cirugía laparoscópica y su importancia en la formación quirúrgica.

Despite the many advantages that laparoscopic surgery has for patients, it involves a series of risks for the surgeon. These are related to the reduced freedom of movement and forced postures which lead to greater muscle fatigue than with conventional surgery. In laparoscopic surgery there are few references on the introduction of training programs in ergonomics, despite the numerous advantages demonstrated in other disciplines. The application of ergonomic criteria in the surgical field could have great benefits, both for surgeons and patients. In this work we attempt to review the existing literature and our experience to provide the surgeon with some ergonomic guidelines for body stance and positioning of equipment. We also present a training model based on ergonomics which we have introduced into the training activities carried out in our Centre.

[Validity studies in laparoscopic simulation. Methodology and design considerations.] / Validación en simulación laparoscópica. Consideraciones metodológicas y de diseño.

OBJECTIVES: To describe a roadmap of the most representative milestones and considerations in the validation of surgical simulators, especially those of laparoscopic surgery. And additionally, help determine when in this process a simulator can be considered as validated. METHODS: A non-systematic review was carried out searching terms like simulation, validation, training, assessment, skills and learning curve, as well as providing the experience accumulated by our center. RESULTS: An ideal classical validation process should consist of the following steps: fidelity, verification/calibration/ reliability, subjective and objective strategies. Baseline tests of fidelity and verification/calibration/ technological reliability are not always detailed in the simulation literature. A simulator can be considered validated if, at least, satisfactorily completed any of the two main objective strategies, that is, constructive and/or criterion validity. CONCLUSIONS: The methodologies to validate simulators as useful and reliable for the improvement of psychomotor/ technical skills are widely analyzed, although there is a variety of approaches depending on the scientific reference consulted, not being implemented equally in all works. This apparent arbitrariness should be considered in advance because it can lead the researcher to misunderstandings, especially when the simulator will be regarded as valid.

OBJETIVOS: Describir una hoja de ruta de los hitos y consideraciones más representativos en la validación de simuladores quirúrgicos, especialmente los de cirugía laparoscópica. Y adicionalmente contribuir a determinar en qué momento de este proceso puede considerarse un simulador como validado.MÉTODOS: Se realizó una revisión no sistemática con los términos simulación, validación, formación, entrenamiento, evaluación, habilidades y curva de aprendizaje, además de aportar la experiencia acumulada por nuestro centro. RESULTADOS: Un proceso ideal clásico de validación debería constar de los siguientes pasos: Fidelidad, Verificación/ Calibración/Fiabilidad, estrategias subjetivas y objetivas. Las pruebas de inicio tanto de Fidelidad como de Verificación/Calibración/Fiabilidad tecnológica no siempre están descritas de manera explícita en los trabajos de validación de simuladores. Un simulador puede considerarse validado si al menos ha completado satisfactoriamente una validación de cualquiera de los dos grandes bloques de tipo objetivo, es decir, constructiva y/o de criterio. CONCLUSIONES: Los métodos que permiten validar simuladores como útiles y fiables para la mejora de habilidades de tipo psicomotor/técnico están ampliamente documentados aunque existe cierta variedad de enfoques en función de la referencia científica que se consulte, no aplicándose por igual en todos los trabajos. Esta aparente arbitrariedad debería ser conocida de antemano porque puede llevar al investigador a ciertos equívocos, especialmente a la hora de afirmar cuándo el simulador se considera plenamente validado.

[Evaluation of competencies in urology. Esscolap® basic, as aproximation to urologists skills improvement.] / Evaluación de competencias en Urología. Esscolap® basic, como aproximación a la mejora de las capacidades de los urólogos.

Urology needs models of competencies assessment, although there is a wide range of tools not yet integrated into the official training programs. CONTEXT: At present, there is no universal framework for measuring surgeons' level of competence. Urology training programs should provide and consider knowledge, pyschomotor/cognitive skills, and simulator, cadaver or animal models-based training. Validity is a complex concept that refers to the capacity of the evaluation tool, so it is necessary to demonstrate several types of validation to assure the capacity of a method, reinforced with different reliability tests and calculation of internal consistency between evaluators. OBJECTIVE: Based on a structured dossier of surgical skills, classified by groups, the ESSCOLAP® Basic system was proposed with 5 simulator tasks to evaluate basic laparoscopic skills. Once validated in the JUMISC (Spain), the tool was proposed to extend its scope and implementation in other locations. RESULTS: Our system has not yet demonstrated a full validity in the real clinical setting because a predictive validity needs to be demonstrated on the basis of clinical data. It also suffers from a certain range of subjectivity, thus implying clear and defined criteria for any situation. Factors like the number of evaluators and tasks to assess will influence the reliability tests that measure the degree of agreement between evaluators, so that a higher number of evaluated cases would imply a greater reliability of our system. Finally, we assume that the incorporation of this type of tools implies an added cost, charged to the public and private responsible institutions, which will only be considered cost-effective when it is demonstrated its real and positive traceability in health outcomes. CONCLUSIONS: ESSCOLAP® Basic, of quick and simple implementation capacity, has been validated and calibrated for the evaluation of basic technical skills in laparoscopy.

[Training in basic and advanced laparoscopy: Evaluation of a 30-year experience in a training program in Spain.] / Formación en cirugía laparoscópica urológica básica y avanzada: evaluación de 30 años de experiencia de un programa de formación en España.

The lack of globally established standards for learning urological laparoscopy has not prevented laparoscopic techniques from evolution and continuous development. Laparoscopy coexists with robotic surgery today, and in the last decade there have been many techniques that have undergone a boom with the use of a laparoscopic approach (total and partial nephrectomy, pyeloplasty, colposacropexy, etc.).We intend to evaluate the progressive incorporation of different surgical techniques in the laparoscopic learning program and, on the other hand, to analyze the evolution of training programs in urological laparoscopy to bring this type of techniques within the hospital surgical activity. We describe our 30-years experience in different training programs in urological laparoscopy that have been sponsored by the Spanish Association of Urology (AEU), and have undergone several validity studies to assess their capacity in order to evaluate effectively basic and advanced laparoscopic skills. We will also highlight the current and future trend towards training models based on surgical competences where individualized training, accreditation and specialization of tutors is crucial, and where the increase in the use of training and evaluation methods based on the simulation are increasingly common.

Porcine Model In The Laparoscopic Liver Surgery Training.

The aim of the study was to evaluate the possibility to use live anesthetized pigs as a model for laparoscopic liver resection. During two days laparoscopy course two trainees were operating on two live animals performing exposure of the liver, Pringle manoeuver, division of liver ligaments, dissecting of the structures inside the hepatoduodenal ligament, dissection of the hepatic veins and left lateral liver sectionectomy. Exposure of the liver and Pringle manoeuver were performed correctly within 50 and 35 minutes. Left lateral sectionectomy has been performed correctly within 2 hours. The full dissection of the hepatoduodenal ligament and exposure of the hepatic veins were judged as insufficient by experienced laparoscopic tutors. There was one injury to the suprahepatic vena cava that was managed laparoscopically. The porcine model can be used as an advanced training for laparoscopic liver surgery.

Transvaginal sigmoid cancer resection: first case with 12 months of follow-up--technique description.

OBJECTIVE: Several minimally invasive techniques using natural orifices as an entrance site to the peritoneal cavity have been described recently. Pure natural orifice translumenal endoscopic surgery (NOTES) techniques have been mainly implemented to perform cholecystectomies and appendectomies, while more complex operations like colon resections have been described in a hybrid setting and with the use of the transumbilical approach. Here we describe the technique of transvaginal sigmoid colon resection for cancer with standard laparoscopy equipment. MATERIALS AND METHODS: After developing the transvaginal technique of sigmoid colon resection in an experimental sheep model, we have performed this operation in a human patient for cancer. Twelve months of follow-up is reported. RESULTS: A totally transvaginal R0 resection of the sigmoid colon for adenocarcinoma has been successfully performed in a female patient with laparoscopy equipment. The specimen included 13 lymph nodes, all of which were free of metastasis. Twelve months after surgery the patient is alive with no evidence of disease. CONCLUSION: A pure transvaginal NOTES approach to sigmoid colon cancer is feasible in human patients.

[Training design and improvement of technical skills in the transvaginal cholecystectomy (NOTES)]. / Diseño del entrenamiento y la adquisición de habilidades técnicas en la colecistectomía transvaginal (NOTES).

INTRODUCTION: The current surgical scenario of the surgery through natural orifices or <> requires acquiring new technical skills by the surgeon. We introduce the initial experience of the Minimally Invasive Surgery Centre Jesús Usón (MISCJU) in the design and setting-up of a surgical training programme using the the natural orifices approach for the acquisition of surgical skills and abilities, based on the preliminary trials in simulators and a pig model. MATERIAL AND METHODS: After initial training, using a laparoscopic pelvic-trainer, 7 female pigs, with weights between 35-40 kg, were operated on. The transvaginal approach was completed using a one-channel gastroscope in all the animals. After accessing the abdomen, the abdominal cavity was explored, and the surgery was concluded with the endoscopic cholecystectomy. RESULTS: Endoscopic cholecystectomy was successfully completed in 6 cases. In one of the animals, the procedure was stopped because of technical problems regarding the endoscope leaning to one end. The average surgical time was 107.14 min (range, 80-150 min). The transvaginal approach enabled the abdominal to be explored and the dissection, ligature and section of the cystic duct and the cystic artery. After cholecystectomy, the gallbladder was extracted through the vagina. After the procedure necropsy did not reveal intra-abdominal lesions or intraoperative complications. CONCLUSIONS: The pure transvaginal cholecystectomy is a feasible and reproducible procedure in the animal model. A systematized training model, which includes physiopathology knowledge as well as technical knowledge, in order to translate these procedures to the clinical practice in a safe way, is needed.