Minimal-access surgery has revolutionised diagnosis and management in many surgical specialties, including gynaecology. It is well known that the surgical skill set required to carry out endoscopic surgery is essentially different from open surgery, creating a longer learning curve. Fewer opportunities exist for trainees as a result of reduced working hours and also the use of less invasive procedures, such as endometrial ablation procedures, Mirena ® intrauterine system, and methotrexate in treating ectopic pregnancies. Significant work has been undertaken to introduce simulation to enhance laparoscopic training and to test the construct validity and face validity of different simulators. In this chapter, we summarise the evidence on simulation training in minimal-access gynaecology, and provide practical recommendations to develop an evidence-based simulation-training curriculum.
Introduction
Endoscopic minimal-access surgery has revolutionised diagnosis and management in many surgical specialties, including gynaecology. Diagnostic laparoscopy was first carried out routinely in the 1960s and 1970s; this was followed by the first laparoscopic salpingectomy and salpingostomy for treatment of ectopic pregnancy in 1973 and 1978, respectively.
Similarly, diagnostic and operative hysteroscopy have also become part of mainstream gynaecological practice.
The laparoscopic approach has been associated with shorter operating times, less intraoperative blood loss, less analgesic requirements, quicker recovery, and shorter hospital stay. It has also been regarded as the preferable surgical treatment of ectopic pregnancies compared with an open approach. Minimal-access surgery is now the preferred method to manage a wide spectrum of benign gynaecological conditions, including ovarian cystectomy, oophorectomy, hysterectomy, prolapse correction surgery, and the treatment of endometriosis.
It is well known that the surgical skill set to carry out endoscopic surgery is essentially different from open surgery, creating a longer learning curve. Significant hand-eye co-ordination and optimal psychomotor skills are essential requirements to be a skilled laparoscopist. Lack of three-dimensional visualisation, loss of tactile feedback, and counterintuitive movement of instruments caused by the fulcrum effect, however, create major obstacles for trainees to master the art.
Moreover, the opportunities for trainees to master these techniques in the traditional apprenticeship model have diminished. This is partly because of reduced working hours resulting from the European Working Time Directives (EWTR). Most trainees feel that EWTR complaint rotas have had a negative effect on their training, and core surgical skills training in gynaecology have suffered as a result ( Fig. 1 ).
At the same time, use of conservative management for many gynaecological problems has increased (e.g. methotrexate for ectopic pregnancy, the Mirena ® intrauterine system, and ablation techniques for heavy menstrual bleeding), which has resulted in fewer surgical interventions and thus training opportunities.
According to a UK national survey of trainees in obstetrics and gynaecology, most of the trainees carry out between zero and three major gynaecological procedures in a month.
Laparoscopic skills have been identified as one of the top areas of deficiency in a UK national survey of gynaecology trainees in 2010; 46% of all trainees from specialty trainee year 1 to 7 said that they had not done any laparoscopic procedures to manage ectopic pregnancies and were not being trained to carry out such procedures ( Fig. 2 ). This has been fully appreciated by the Royal College of Obstetricians and Gynaecologists (RCOG) and the British Society for Gynaecological Endoscopy (BSGE). The RCOG strategic plan has advocated the need for evidence-based recommendations on simulation training to ensure the highest quality of care.
From all the evidence, simulation training is the ideal way to address both these issues of reduced training opportunities and the special psychomotor skills needed to carry out endoscopic surgery safely and competently.
History of simulation
Simulation is defined as ‘an educational technique that allows interactive, and at times, immersive activity by recreating all or part of a clinical experience without exposing patients to the associated risks’. Data on laparoscopic and hysteroscopic simulators have been published since 1994.
Simulation training has been, and continues to be, the subject of extensive research in an attempt to provide evidence of its application in surgical training, its validation, and its use in optimisation of surgical skills.
Benefits of simulation in laparoscopic training
Simulation provides a risk-free environment and allows trainees in a well-controlled environment to learn and carry out parts of a procedure or the whole procedure. The original apprenticeship model of letting trainees experience and learn all the surgical skills in the operating room is no longer appropriate, as all patients deserve best standards of care and the risk to the patients should be minimised; ‘Patients are not commodities to be used as conveniences of training.’ Research into minimising medical errors and risk-reduction strategies has emphasised the role of simulation to ensure safer surgery and delivery of care. This has significant implications for laparoscopic surgery, where the learning curve for the surgeon is longer, and complication rates are higher.
Advantages of virtual reality in laparoscopic training have been confirmed by several studies, including a Cochrane systematic review by Gurusamy et al. reviewing 23 trials, including 612 participants, and also a recent systematic review. It has been shown that, in trainees without surgical experience, virtual-reality simulation training improves technical accuracy while decreasing errors and the time taken to complete a task. Moreover, virtual-reality simulation has proved to be superior in reducing operating time and errors compared with standard training and provides higher composite operative performance scores compared with video training.
Studies measuring different simulators and different performance indicators, however, are quite heterogeneous. A recent systematic review showed that operation time in human studies was reduced by 17% to 50% in intervention groups undergoing virtual-reality simulator training. In animal models, operating time was reduced between 21% and 53%. The magnitude depended on type of simulator and training principles. Simulators offering training for complete surgical procedures displayed evidence of a higher effect on the operation time.
A randomised-controlled trial by Larsen et al. showed that simulator-trained trainees scored significantly higher in surgical skills while carrying out a laparoscopic salpingectomy for ectopic pregnancy in theatre compared with a control group; the training helped them to reduce the operating time by 50%. Therefore, it is possible that the integration of simulation training into the curriculum can bypass the early learning curve with its inherently higher risk of complications for trainees and newly qualified surgeons.
Moreover, simulation training helps trainees to develop skills in a less stressful, controlled environment, with no time constraints, minimal distraction, and can be a self-directed opportunity tailored to each individual’s needs. This can complement and enhance operating-theatre experience by bringing the trainees to a higher level of performance and helping them optimise their actual theatre experience. Moreover, by mastering the relevant surgical skills on a simulator, surgeons will have more confidence in dealing with a difficult case and be more prepared to manage complications at their next level of expertise.
Apart from risk reduction and provision of a more desirable environment for new learners, trainees can benefit from a variety of feedback mechanisms provided during their simulation training. Simply, a senior colleague or trainer can provide them with ongoing feedback as they progress with a procedure, and be advised about errors, poor surgical technique, and operating time on a simple box trainer. More sophisticated versions (e.g. virtual-reality simulators) benefit from structured software, which provides every trainee with detailed feedback in different areas, including total operating time, total instrument path lengths, economy of movements, degree of unwanted thermal spread while using energy sources, amount of blood loss, and a total score based on all these items. These are all recorded and kept on the computer memory. The log of experience can be used to compare trainee progress, for assessment and ranking purposes.
Types of surgical simulators
Various laparoscopic simulators are available on the market. The first simulators used were the box trainers; this was a box with varying designs with a camera, a light source and a monitor. Compared with virtual reality, they have the advantage of being inexpensive and easily accessible. Different tasks can be designed to be carried out with instruments through the trocars at the top of the box. Although this is a simple simulator, and has little resemblance to live anatomy, most trainees can access or even own one and practise to improve their hand-eye co-ordination and psychomotor skills.
Construct and face validity of box trainers has been investigated by Schreuder et al. In this cross-sectional study, participants were divided into three groups according to their laparoscopic experience: novices, intermediate and experts. Each group’s performance on box trainers was assessed and scored. A significant association was found between the level of experience and the score obtained on simulator assessments (i.e. the experts performed better than the intermediates and novices). This concept is known as construct validity.
Virtual-reality simulators are more sophisticated and consist of software on a computer attached to hand pieces. These simulators provide environments with different degrees of realism, and candidates carry out tasks similar to those undertaken during surgery. The software registers all movements and actions undertaken. It can then provide detailed objective feedback to the trainee on economy of movements, safe technique, surgical errors, blood loss, lateral thermal spread while using energy sources, and also time taken to complete a procedure.
The earliest virtual-reality simulators used the handling of objects in a non-anatomical environment. In the newer versions, anatomical objects, such as ovary, fallopian tubes, and uterus, have been introduced to mimic the real surgical field and hence increase realism or the so-called face validity.
Latest virtual-reality simulators use more sophisticated computer software programmes with a higher levels of realism to optimise the training experience: Simbionix ® (Symbionix-Baker, Cleveland OH, USA), LapsymGyn ® (Surgical science Sweden, Goteborg, Sweden) and Simsurgery ® (Simsurgery, Oslo, Norway) are examples of fourth-generation virtual-reality simulators with teaching videos on common surgical procedures.
Can virtual-reality simulators distinguish between novices and expert surgeons?
Before using a simulator for training, it should be shown to be valid and reliable. ‘Validity measures whether a simulator is actually teaching or evaluating what it is intended to teach or evaluate.’ Validity is measured on three different levels: (1) face validity (measures the degree or realism of the simulator); (2) construct validity (assesses whether a simulation method can identify and differentiate between applicants with different levels of experience); (3) content validity (measures the appropriateness of the simulator as a teaching modality).
A number of researchers have investigated construct validity of virtual-reality simulators to see if they could differentiate between novices and experts. This has significant implications, first, to reassure that the skills taught on surgical simulators are the appropriate skills needed for the actual surgery and, second, to ensure that using simulators in assessment and evaluation of trainees is justified.
Performance of three groups of medical students, surgical trainees and members of a laparoscopic faculty were assessed using the LapSim ® simulator. Level of experience was reflected on some of the performance parameters. Several other studies have reached the same conclusions. These important findings indicate that not all aspects of performance on simulators can differentiate novices from experts, and therefore this needs to be exposed to further testing and validation before being used in evaluation of trainees.
Similarly Langelotz et al. assessed surgeons with different levels of laparoscopic skills in five exercises for navigation, co-ordination, grasping, cutting, and clipping. Results showed that experienced surgeons were quicker in completing tasks, had better economy of movements, and smaller angular pathway. Duffy et al. added error scores and laparoscopic suturing to the previously mentioned indices as reliable indicators of experience.
A prospective cohort by Aggarwal et al. assessed three groups of laparoscopists (novice, intermediate and experienced) on an ectopic pregnancy module. Results showed that learning curves for the experienced group plateaued at the second session, although more sessions were needed for the intermediate (seven) and novice group (nine) to achieve the same standard. This has important implications about laparoscopic training. Gynaecologists with little laparoscopic experience would benefit from short-phase training on a virtual-reality simulator. First, such training can help them to bypass the early learning curve, which is associated with a higher risk of complications. Second, although learning curves for the intermediate and novice groups were longer and steeper, they managed to achieve the same level of skills towards the end of the training period. Obviously, this needs to be translated into surgical skills in operating theatres. Therefore, these skills need to be objectively assessed in real procedures.
Transfer of virtual-reality simulation training to operating theatre
Effects of virtual-reality training have been assessed in some studies assessing actual performance during live surgery. This is important, as the end point of any training method is to improve the outcome (i.e. surgical skills).
Youngblood et al. compared performance of medical students trained on LapSim ® with those trained with a traditional box trainer and a control group. Results showed that the LapSim ® group performed better while operating on porcine models in surgical time, accuracy and performance global score. Hyltander et al. have also shown better results in an animal laboratory after training students on a virtual-reality simulator.
Studies on the effect of simulator training to improve actual surgical skills during live surgery is limited and sometimes of poor quality.
Use of a virtual-reality environment as a warm-up session before surgery has been shown to improve overall performance in laparoscopic cholecystectomy in a study by Calatayud et al.
In another study by Ahlberg et al., surgical trainees performed better in their first 10 laparoscopic cholecystectomies after virtual-reality simulation training; the control group made three times as many errors and had 58% longer surgical time. Although this study only included 13 trainees, they were randomised to training and control groups, and reviews were conducted independently in a blinded fashion.
The high-quality study by Larsen et al. in assessing virtual-reality simulation on actual surgical skills in the operating theatre is probably the best evidence we have of the effectiveness of virtual-reality simulation training in gynaecology. Trainee gynaecologists were randomised, and the intervention group received a proficiency-based training programme using the LapSim ® virtual-reality simulator for a right salpingectomy scenario. The training sessions were repeated until the expert criterion level was reached in two consecutive and independent simulations. Trainees were assessed in theatre performing a right-sided salpingectomy on cases with similar complexity; trainees were not allowed to operate on obese women, women who had undergone previous abdominal surgery, or those with significant co morbidities. The simulator-trained group reached a median total score of 33 compared with 23 in the control group, and completed the procedure in half the surgical time (12 min v 24 min).
The mean time spent on the simulator by the intervention group was 7 h and 15 min. The rating scale in this study had been previously validated, and this is a strong point of the study. In the previous study by Larsen et al., intermediate experienced trainees (20–50 procedures) scored a median of 33 points compared with 39 for experts and 24 for novices. Therefore, an average of 7 h and 15 min can be equal to the experience gained by performing 20–50 laparoscopic procedures.
All the studies assessing simulation methods on clinical outcomes, however, have limitations. It is difficult to comment on the effects of simulation training on the end point outcomes (i.e. patient outcomes), as many complex processes are involved. Secondly, every care is taken to ensure that patients’ care is never compromised when trainees operate, and they are therefore closely supervised, rather than undertaking the procedure independently.
Recommendations for development of a simulation curriculum
Any simulation-training programme needs to be structured around what has been referred to as the 5 ‘W’s.
Who
Generally, less experienced staff will gain more than senior staff members.
What
Content needs to be appropriate for the experience and expectations of the trainee. Simulation training succeeds best when it is accompanied by a structured theoretical course, and trainees are mentored by a more senior colleague to provide direction and feedback.
Where
Off-site has the advantage of avoiding distractions, but may prove difficult to access. On-site, close to the clinical environment, encourages frequent use by trainees, which will help them to acquire skills more quickly, and then to retain those skills once mastered.
When
Ideally, there should be protected time, with regular mentored feedback sessions. The inclusion of simulation training as a mandatory part of the curriculum ensures that this will occur. It also ensures that trainees actually engage with the simulation training. In surveys, most trainees profess a fervent wish to have access to simulation training in endoscopic surgery, but experience shows that many do not actually use the simulation facilities unless they are made to. Frequent, shorter sessions (e.g. 1 h per week) are more beneficial than infrequent courses lasting for 1–2 days. Distributed practice sessions improve acquisition and transfer of a learned skill, and help the skill to consolidate between training sessions.
Why
The psychomotor skills required to perform endoscopic surgery can be acquired by simulation training. This has obvious benefits for patient safety. For the trainee, it shortens the time needed to acquire these skills, which also benefits the overall health economy.
It is important to incorporate appropriate feedback into skills training. Extrinsic feedback (i.e. feedback by an expert) accelerates technical skill acquisition. Feedback should be provided by an expert and at the completion of the task. This is better than feedback provided while performing tasks. It has been shown that trainees who receive summary feedback outperform trainees who receive concurrent feedback at a 1 month retention test.
Any successful training curriculum should be proficiency based rather than time based, aiming to achieve a bench mark level set by experts’ performance. Moreover, gaining knowledge and understanding of the correct sequence of steps in an operative procedure, team working, communication skills, and dealing with unpredicted situations, has emphasised cognitive training as an important part of the curriculum.
The assessment of motor tasks at varying levels of difficulty have been shown to enhance learning, and this should be considered when designing the curriculum.
The key to a successful, well-established, and widely accepted curriculum is to involve all stakeholders, including the regulatory bodies (i.e. the RCOG and the BSGE, trainers, trainees, clinical units and deaneries). The need for good-quality research to obtain evidence-based information to optimise this curriculum and its detailed structure is needed. Studies suggest that shorter inter-training intervals are associated with shorter training time, but not necessarily better performance. Simulation training can also be a useful adjunct to help surgeons to retain their skills and also for assessments. Units should be able and willing to provide trainees with simulators, but this has cost implications and needs liaison with trusts, deaneries and business planning. Every hour of theatres cost 1200 pounds, and investment in training can save money by saving theatre time, and is therefore money well spent! Simulation training should become mandatory, and trainees also need encouragement to grasp every opportunity to develop these skills using simple box trainers and, wherever possible, virtual-reality simulators.
Most studies have looked into the improvement of manual dexterity and visuo-spatial capabilities by simulation training. As mentioned previously, however, measuring these effects on patient outcomes is ideal, but difficult in reality, as many other complex processes are involved.
Finally, simulation is definitely not a replacement for clinical experience, but a tool to enhance and optimise surgical experience, resulting in improved outcomes for our patients.
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