Laparoscopy Today

Nicholson Center Grand Opening - New Center Prepared to Train 20,000 Clinicians a Year in the Latest Robotic and MIS Techniques

With an all new 54,000 square foot training facility the Florida Hospital Nicholson Center for Surgical Advancement is designed to host major medical training and educational events. It is expected that the center will be used to train about 20,000 clinicians per year in the latest robotic and mininally invasive surgical techniques. The center is designed for face to face events as well as distance learning in remote locations. Visit www.nicholsoncenter.com to learn more about the center and to take the tour of the new facililty.

REPORT FROM THE SPECIAL SLS WORKSHOP: Recent Findings About How Our Brains Learn: Implications for How we Teach

by Ann Conti Morcos, MA, ELS

The brain can’t handle nonsense, but it can handle meaning.
--Hilliard Jason, MD, PhD

A special workshop was held at the 19th SLS Annual Meeting and Endo Expo in New York City for faculty, moderators, residents, and fellows. Hilliard Jason, MD, PhD, and his wife Jane Westberg, PhD, education experts, discussed “Recent findings about how our brains learn. Implications for how we teach.” 

Being a Great Surgical Teacher

"Being effective teachers, like being effective clinicians, depends in part on what we do, and in part on who we are. In both domains we deal with people, and in both domains everything begins with an accurate and complete diagnosis. (Yes, great teaching also begins with being a diagnostician.)

Good brain research is confirming that we are all unique in the ways we perceive the world and in the ways we learn. We are even more diverse as learners than we are in the ways we manifest our medical needs." -- excerpted from Being/Becoming a Great Surgical Teacher by Hilliard Jason, MD, EdD 

Even if you missed the learning session or teaching workshop presented by Hilliard Jason, MD, EdD, at the SLS 19th Annual Meeting and Endo Expo 2010, you can still get the distilled notes.  Review 8 questions you should ask yourself as a teacher, and get the opportunity to go further into the topic through the suggested reading list.

FROM THE 19TH SLS ANNUAL MEETING: Award Winning Resident Paper

 Vadim P. Koshenkov, MD, (left) received the Michael S. Kavic (left) Award for Best Resident Paper for his abstract submission to the SLS 19th Annual Meeting and Endo Expo 2010

Laparoscopic Approach After Laparoscopic Inguinal Hernia Recurrence

Khaled El Zarrok Elgazwi, MD, PhD, Prof. Ivo. Baca, MD, PhD, Akrem Elshakhy, MD,  Arash Khani, MD
Klinikum Bremen ost. Bremen, Germany 

Background: Recurrent inguinal hernias have occurred after endoscopic inguinal hernia repair, although far less frequently than after conventional repair (in the literature between 0.1% to 1.5%). The aim of this study was to evaluate whether these recurrences can be repaired by using the laparoscopic approach with acceptable complication and recurrence rates.

FEATURED ARTICLE: THE ROLE OF SIMULATION TRAINING AND SKILL EVALUATION IN MAINTENANCE OF CERTIFICATION

HARRITH M. HASSON, MD, JOHN E. MORRISON, MD

ABSTRACT 
The American Board of Surgery revamped the Maintenance of Certification program in 2005, changing the recertification process. The 6 basic physician competencies are reflected in the 4 components of maintenance of certification: professional standing, life-long learning and self-assessment, cognitive expertise, and evaluation of surgical performance outcomes. Proficiency will be defined on the basis of objective assessment

JOURNAL WATCH: SURG ENDOSC

A Lifelike Patient Simulator for Teaching Robotic Colorectal Surgery: How to Acquire Skills for Robotic Rectal Dissection. Marecik SJ et al. 2008;22:1876-1881 • The authors report on the creation and use of a cost-effective, portable, and reusable model for training in robotic rectal dissection. Various components were included or added to the device depending on the procedure being simulted, but the basis of the tool is a plastic model of the human pelvic skeleton mounted onto a sturdy laminate-covered base using an adjustable bracket to alter the pelvic angle. The authors concluded that the trainer provided an accurate simulation of true robotic rectal dissection.

JOURNAL WATCH: J Minimally Invasive Gynecol

The Efficacy of Viewing an Educational Video as a Method for the Acquisition of Basic Laparoscopic Suturing Skills. Akl MN et al. 2008;15(4):410–413 • The twelve participants in this prospective observational study were evaluated performing 5 tasks after watching a 6 minute basic principles video: needle intro through trocar, needle loading and positioning, running continous suture, intra- and extracorporeal knot tying. The authors concluded that an educational video appears to be an effective method.

Virtual Reality and Computer-Enhanced Training Devices Equally Improve Laparoscopic Surgical Skill in Novices

PICK FROM JSLS, JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS

PRATHIMA KANUMURI, MD, SABHA GANAI, MD, EYAD M. WOHAIBI, MD, RONALD W. BUSH, BS, DANIEL R. GROW, MD, NEAL E. SEYMOUR, MD

INTRODUCTION

The advent of simulation training of minimally invasive surgical skills has created significant opportunities for ongoing development of innovative training methods. Several recent investigations have shown that the use of computer-driven simulation training devices results in transfer of skills into the operating room environment [1-4], and mandatory application of simulation methods has been forwarded as a means of improving surgical results and patient safety [5]. A growing number of laparoscopic simulation training platforms and generally limited institutional resources have created difficulties for educators faced with the prospect of introducing these training methods into their programs [6]. Ideally, the decision to procure a specific device ought to be based on the anticipated effectiveness in the specific application for which it will be used.

A wide variety of laparoscopic simulators is now available, and they can be broadly classified into videoscopic and computer-driven laparoscopic simulation platforms, which are further divided into virtual reality (VR) and computer-enhanced videoscopic (CE) trainers. These trainers primarily differ in their user interface and ability to provide reliable performance measurements. Videoscopic trainers allow manipulation of actual physical objects and require manual data collection. In contrast, VR trainers utilize a virtual environment and provide computer automated performance metrics. CE trainers attempt to bridge the gap between videoscopic and VR systems, their user interface is similar to the former, but they provide computer-generated performance metrics like VR trainers do [7]. Despite these fundamental differences, their intended purpose is the same: To provide assessment and training in specific skills based on sophisticated performance measurement capabilities that would not be available without the use of desktop computing. Effective performance measurement is the basis for establishment of performance objectives and for proficiency-based training, which is emerging as the educational model of choice in skills training [8].

In the present study, we examined training effectiveness of examples of the 2 classifications of computer-driven laparoscopic skills trainers using proficiency-based training models with the specific aims of (1) demonstrating that novice surgical trainees can acquire complex laparoscopic skills using fundamentally different simulation systems and (2) to demonstrate that the use of performance objectives established by a homogeneous group of more advanced trainees will result in similar levels of
skills improvement with the 2 systems.

METHODS

Study participants were 16 Tufts University School of Medicine third-year medical students on their General Surgery and Obstetrics and Gynecology clerkships at Baystate Medical Center. The study was exempted from full review by our Institutional Review Board, and informed consent was not required for enrollment. The general study design called for students to undergo a pretraining assessment in laparoscopic intracorporeal suturing and knot tying. Participants were then randomized to train to perform this task using either a VR (n=8) or CE (n=8) simulator. At the end of the 4-week clerkship, a posttraining assessment identical to the pretraining assessment was conducted, and students had to complete an end of study survey   characterizing qualitative aspects of their training experience.

Pre- and Posttraining Assessments

The pre- and posttraining assessments consisted of performance of a laparoscopic suturing and intracorporeal knot tying task in a live anesthetized porcine model (25kg to 30kg, Yorkshire pig sedated with intramuscular ketamine 100mg/kg and xylazine 10mg/kg and maintained under general anesthesia using endotracheal isoflurane) under a specific protocol approved by the Institutional Animal Care and Use Committee. Immediately before both assessments, all participants received standardized didactic instruction explaining task performance as described in the SAGES Fundamentals of Laparoscopic Surgery (FLS) course, and viewed the FLS video demonstration of a suturing and knot tying sequence. This was followed by a brief quiz to assess their understanding of the task and associated errors. In the operating room, each student was given 5 minutes (min) to perform the task, which was video-recorded for subsequent analysis. The specific task consisted of approximation of 2 loops of small intestine using standard instrumentation and laparoscopic port placement. This was accomplished with 2-0 silk suture and SH needle (Ethicon) with an initial surgeon’s knot and then 2 subsequent square throws. The animal was euthanized after the assessments were completed. Although general instructions were provided, no mentoring or feedback was given during student performance of any task.

Simulation Training

VR simulation training was conducted using MIST-Suture software (SimSurgery, AS, Oslo, Norway). “Interrupted Suture” task was run on a MIST-VR simulator (Mentice AB, Göteborg, Sweden) with an Immersion Virtual Laparoscopic Interface (Immersion Medical, Gaithersburg, MD) (Figure 1). Performance metrics consisted of a composite score for time and errors.

CE training was accomplished using a ProMIS simulator (Haptica Ltd., Dublin, Ireland) (Figure 2), and a custom model of 2 adjacent 1-inch Penrose drains that permitted the intracorporeal suturing and knot tying task to be performed with the same technique and instrumentation used for the operating room assessments. This simulator consists of a torso model containing optical motion sensors to detect instrument movement characteristics. Performance metrics consisted of time, instrument path length, and smoothness of motion.

To facilitate distributed learning of the task, students were scheduled for 8 one-hour mentored training sessions over the 4-week rotation, but were permitted to have additional training under the same conditions. VR and CE training was mentored by either the full-time skills lab training technician or a surgeon researcher, both of whom were experts in performing the task. The training objectives for each system were based on the performance scores of 2 fourth- and 2 fifth-year general surgery residents. For the purposes of this study, proficiency was defined as achievement of performance scores within one standard deviation (SD) of the predefined objectives on 3 consecutive task iterations.

End-of-Study Survey

After the posttraining assessment, students completed a survey soliciting demographic information and prior laparoscopic experience (description of specific activities during cases). Qualitative impressions of the importance of simulation training, the importance of haptic cues in simulators, and the educational value of the specific training system used, were surveyed with responses given on a 3-point scale of “very effective,” “effective,” or “not effective.”

Video Analysis

The pre- and posttraining assessment videos were reviewed by 2 independent surgeon raters, blinded to student identity and training status, using a performance assessment tool previously validated at our institution [9]. For the purposes of this analysis, the task was divided into 2 phases. In the “Suturing Phase,” the needle was brought to a functional position, driven through the 2 loops of bowel, and then secured after the suture was pulled through the tissue to the appropriate length to permit knot tying. The “Knot-tying Phase” was defined as the performance of a surgeon’s knot and then 2 successive square simple throws to complete a square knot. Video rating consisted of quantifying discreet events during each phase that pertained to efficiency, expert-defined correct behaviors, and specific errors to produce a summative performance score.

Statistical Analysis

Data are expressed as means with 95% confidence intervals (CI). Comparisons between groups were conducted by Mann Whitney U test and comparisons within groups before and after training by Wilcoxon matched pairs test. Comparisons of achievement of proficiency, task completion rates, and questionnaire data were by Fisher’s exact test. The Mann Whitney U test was performed using Epi Info software (Version 3.3.2, Centers for Disease Control, Atlanta, GA), and Wilcoxon matched pairs test and Fisher exact test were performed using GraphPad Instat software (San Diego, CA). Statistical significance was taken at a P<0.05.

RESULTS

The average age of the participants was 26±1 years, and the sex distribution was 63% (n=10) male and 37% (n=6) female. The participants had minimal prior laparoscopic experience, ranging from no experience to holding the camera.

Training Sessions

Performance curves for the VR and the CE-trained groups had a classic appearance of early, rapid improvement, followed by a more gradual pattern of incremental improvement (Figure 3). There were no significant differences in the proportion of students who reached proficiency [VR 75% (n=6); CE 88% (n=7)] and in percentage compliance for scheduled training sessions (VR 73%; CE 67%) (Table 1). The sum of total recorded task time was comparable between groups [VR 115 min (range, 61 to 169); CE 111 min (85-136); P>0.05]. However, the total number of iterations completed by the VR-trained students was significantly lower compared with that of CE-trained students [VR 17 (8-26); CE 38 (30-45); P<0.05], because the time taken to complete one iteration on the VR trainer was longer than that on the CE trainer (VR 9±2 min; CE 3±1 min). Time taken to reach the predefined proficiency level was significantly shorter in the VR group compared with that in the CE group [VR 43 min (range, 28 to 59); CE 75 min (range, 45 to 104); P<0.05).

Pre- versus Posttraining Assessment Performance

The interrater reliability for video analysis of pre- and posttraining performance was 0.88. The overall task completion rate was significantly higher posttraining for both the VR-trained and CE-trained groups (P<0.01) (Table 2). The time to task completion decreased on the posttraining assessment (P<0.01) for both the VR (P<0.05) and CE (P<0.01) groups. It must be noted that time to task completion did not represent a true value, reflecting completion of the task in all students because the longest possible figure for task time capped at the 300 second limit. This resulted in a larger effect on the pretraining assessment, where 13 of 16 students did not complete the task. Despite this limitation, the decrease in mean time after training was highly significant. Suturing phase time and video analysis score were also compared because all students completed this phase on both pre- and posttraining assessments. A significant improvement was demonstrated for both measures in the VR-trained group but not in the CE-trained group. Comparison of pre- and posttraining total video analysis scores was not feasible due to the very low task completion rate on pretraining assessment (3 of 16 participants). No significant differences were noted between groups on the pretraining assessment with the exception of the suturing phase score, which was higher in the CE group. The 2 groups did not differ in their posttraining assessment time or total video analysis score.

End-of-Study Survey

Survey responses indicated that students had minimal exposure to laparoscopic surgery, ranging from no experience to watching cases and holding the camera. Students generally felt that haptic feedback was important during training on simulators, and that the use of the 2 platforms was effective in increasing their skill levels, without any significant differences in the frequency of “effective” and “very effective” responses between the 2 groups (Table 3). However, all students in the CE group felt that their system simulated reality effectively, compared with only 38% in the VR group, a difference that was statistically significant.

DISCUSSION

Based on results from previous studies [1-4], we assumed that laparoscopic skills in novices would improve with objectives-based training and did not include an untrained control arm in the study design. This reflects our belief that properly implemented training on simulator systems with demonstrated face and construct validity will result in skills transfer to an OR setting and that examination of performance relative to totally untrained individuals does not have to be pursued in every circumstance. The repeated measures model utilizing each subject as his or her own control was selected instead, permitting us to address the study aim with an appropriate number of subjects. Medical students with minimal prior laparoscopic experience achieved a training benefit within the framework of a 4-week clerkship. Survey results indicate that over the course of their rotations, activities during laparoscopic teaching cases contributed minimally to the observed improvement in skills.

Although there were no significant differences in either the magnitude of skills improvement achieved with training on the VR system versus the CE system, or in the absolute levels of measured skills at the end of training, the study may not have been sufficiently statistically powered to detect small differences in the magnitude of skills transfer. Despite this, the skills transfer effects of simulation training to operative performance, can be described as comparable. Although pretraining skills were otherwise homogeneous in the 2 groups, a slightly higher CE-trained group pretraining suture phase scoring was observed. This is likely due to a sampling phenomenon with a fairly small experimental group size. The proficiency targets proved to be achievable for the majority of students, and the fact that 3 students did not achieve these objectives did not hinder demonstration of skills transfer. Because training was conducted on platforms that used different performance metrics (time and error composite scores on the VR trainer, and time, path length, and smoothness on the CE trainer), it is difficult to compare some of the training results. Students in the VR training group took less time to reach the designated proficiency targets compared with the CE training group. However, we cannot conclude that the VR system facilitates faster learning because we did not stop training on either system when the proficiency targets were reached, and some students did additional task iterations after achieving proficiency levels. In addition, as stated above, 3 of the students did not achieve proficiency levels. Performance objectives were based on historical performance of PGY 4 and 5 residents, with objectives for VR established 1 year before CE objectives. It is possible that uneven skill levels between disparate groups of residents may have confounded the simulator performance data on which the objectives were based, and also contributed to the differing times to achieve proficiency targets.

The inability to make comparisons of total video analysis scores pre- and posttraining due to the low task completion rate on the pretraining assessment was a limitation in our study. Although we have given the results of the suturing phase score, this value is limited as it represents only a portion of the task that is arguably less difficult than knot tying. The low task completion rate was probably because the task is a fairly difficult one for novices and task performance time was limited to 5 minutes. Time was capped based on the expectation that all students would be able to complete the task in the posttraining assessment after sufficient training. We felt that it was important not to allow the initial assessment to constitute a training opportunity by allowing essentially unlimited time to complete the task. Though a truncated task completion time may seem problematic, we successfully demonstrated a significant improvement in task completion rate and task completion time during the posttraining assessment.

Several prior studies have compared the effectiveness of videoscopic and VR trainers. These have made recommendations that both systems are effective in improving skills [10], that there may be training value to concurrent use of both system types [11], or that VR training has an advantage [12,13]. The application of performance objectives in our study allowed us, to a great extent, to ensure that desired performance benchmarks on the 2 system types were comparable. Under these circumstances, although a minority of participants (comparable proportions on the 2 systems) did not achieve these objectives, we have demonstrated that comparable levels of performance improvement can be achieved with trainers that are fundamentally different in the experience provided to users.

Although performance results were similar, we have found in our experience that VR trainers offer some practical advantages over videoscopic and CE trainers. These pertain to automated performance metrics that can be easily retrieved and examined, but more importantly, are obtained under very standardized conditions. During self-directed practice, even with the performance measures available with a sophisticated system such as ProMIS (CE trainer), it is impossible to comment on what actually occurred during training unless video recordings are examined. Because VR tasks are, for the most part, rules-based, performance measures reflect achievement of steps specifically defined in the simulator software. Although this facilitates standardization, software-dependent tasks can be less free-form compared with videoscopic and CE trainers, and such constraints can be viewed as a disadvantage.

Both VR and CE training devices are roughly equivalent in price ($35,000 to $50,000), and the number of facilitator hours for training on the respective systems was also approximately the same (despite the small difference in “time to reach proficiency” between the systems). Hence, there does not appear to be an advantage that would steer a program director to one or the other of these systems. However, it is important to note that VR trainers may prove to be more cost-effective when compared with videoscopic trainers (computer-enhanced, or not) due to considerations that enter the usage picture that might influence the quality of the training experience during self-directed practice. These include automation in the course of uniform task setup, consistent qualitative performance metrics, and mentoring cues in more advanced systems. These features allow more effective self-directed practice in VR, and might necessitate the use of a facilitator with all associated costs to achieve a similar effect on a videoscopic (or CE) trainer. Our study was not designed to analyze the cost-benefit ratio of individual systems, but we believe it is an important question that ought to be addressed in our future work.

The absence of haptic feedback features on the VR system we used permitted some information to be gleaned on the value of these characteristics in this type of training. The presence of “haptic cues,” defined as “sense of touch” or tactile characteristics associated with interactions between physical objects, may have contributed to the higher perceived level of realism associated with the CE trainer. The end-of-study survey results for the 2 systems were comparable, except that CE trainees were more likely to feel that their system simulated reality effectively compared with VR trainees. Because subjects performed pre- and posttests with real laparoscopic instruments in live porcine models, they were able to compare their simulation training experience with “reality,” despite the fact that laparoscopic surgical exposure was limited. Our results are supported by other studies comparing videoscopic trainers and nonhaptic VR trainers [12,14,15]. We hypothesize that this is due to both realism and familiarity issues that do not necessarily result in a degraded training experience. Although the ability to appreciate tactile features of objects with which a surgeon interacts may be perceived as an essential component of learning, there is no compelling evidence to show that it is necessary for the types of skills acquisition we have studied. Despite a clear perception among the participants, irrespective of the training platform used, that haptic features are important in a simulator, the performance results of our study do not substantiate this belief. Because VR trainers at an approximate price point less than $80,000 do not feature haptic user interfaces, this finding is an important one, irrespective of any preconceived beliefs. Considerable development efforts are required to achieve believable force feedback interactions, and newer generation high-fidelity VR simulators that offer this feature are quite expensive [6]. It may be that this higher level of fidelity will be shown to be important for full procedural simulations, but for basic manipulative skills training, the haptic component of fidelity appears to be dispensable. The newest full haptic VR trainers may offer force feedback interactions of sufficiently high quality to permit a comparison of training effectiveness with nonhaptic VR systems to be made using identical software platforms. This would remove the variable of fundamentally different operating environments from the comparison.

CONCLUSION

Based on this study’s data, we conclude that novice surgical trainees can acquire complex laparoscopic skills using fundamentally different simulation systems provided that training is objectives based and ample opportunities are given to achieve these objectives. However, it is not possible to recommend one simulator type over another. Given the devices that are currently available, it is our belief that expected performance outcomes are more tightly linked to the quality of training and to the clinical assessment methodology, than to the specific features of the simulator. Although the assumption that haptic feedback is important for simulator fidelity may be supportable, it appears that use of a VR system with a nonhaptic user interface permits very similar training results to that achieved with a CE system that allows interaction with real physical objects. Based on our use of these 2 systems, we feel that either can be used in a formative training program with the expectation of a good training effect. The results of future use in routine training activities should provide additional opportunities to confirm the achievement of training goals with virtual reality and hybrid, computer-enhanced training platforms.

Figure 1.  MIST-VR simulator (Mentice AB, Göteborg, Sweden) with Immersion Virtual Laparoscopic Interface (Immersion Medical, Gaithersburg, MD) (A). This device was set up to run MIST-Suture software (SimSurgery, AS, Oslo, Norway) on the “Interrupted Suture” task (B).

Figure 2.  The ProMIS computer-enhanced simulator (Haptica Ltd., Dublin, Ireland) (A). This device was set up for users to approximate 2 segments of Penrose drain with an interrupted suture (B).

Figure 3.  Performance curves for trainees on both virtual reality and computer-enhanced devices had a classic appearance of early, rapid improvement, followed by a more gradual pattern of incremental improvement. Virtual reality device: MIST-VR (A); Computer-enhanced device: ProMIS (B, C, D).

Reprinted from JSLS, Journal of the Society of Laparoendoscopic Surgeons. 2008;12(3):219–226.

Baystate Medical Center, Department of Surgery, Tufts University School of Medicine, Springfield, Massachusetts, USA (Drs Kanumuri, Ganai, Wohaibi, Seymour, Mr Bush).

Baystate Medical Center, Department of Obstetrics and Gynecology, Tufts University School of Medicine, Springfield, Massachusetts, USA (Dr Grow).

Correspondence: Neal E. Seymour, MD, Associate Professor of Surgery, Tufts University School of Medicine, Vice Chairman, Department of Surgery, Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199, USA. Telephone: 413 794 4025, Fax: 413 794 1764, E-mail: neal.seymour@bhs.org

References

1. Seymour NE, Gallagher AG, Roman SA, et al. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002;236:458-463.

2. Grantcharov TP, Kristiansen VB, Bendix J, et al. Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg. 2004;91:146-150.

3. Hyltander A, Liljegren E, Rhodin PH, Lonroth H. The transfer of basic skills learned in a laparoscopic simulator to the operating room. Surg Endosc. 2002;16:1324-1328.

4. Ganai S, Donroe JA, St Louis MR, et al. Virtual-reality training improves angled telescope skills in novice laparoscopists. Am J Surg. 2007;193:260-265.

5. Schijven MP, Jakimowicz JJ, Broeders IA, Tseng LN. The Eindhoven laparoscopic cholecystectomy training course--improving operating room performance using virtual reality training: results from the first E.A.E.S. accredited virtual reality training curriculum. Surg Endosc. 2005;19:1220-1226.

6. Schijven M, Jakimowicz J. Virtual reality surgical laparoscopic simulators. Surg Endosc. 2003;17:1943-1950.

7. Stylopoulos N, Cotin S, Maithel SK, et al. Computer-enhanced laparoscopic training system (CELTS): bridging the gap. Surg Endosc. 2004;18:782-789.

8. Gallagher AG, Ritter EM, Champion H, et al. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005;241:364-372.

9. Thompson RE, Earle DB, Kuhn JN, et al. Use of a new performance assessment tool for a complex laparoscopic task. Surg Endosc. 2006;20(suppl 1):S342.

10. Munz Y, Kumar BD, Moorthy K, et al. Laparoscopic virtual reality and box trainers: is one superior to the other? Surg Endosc. 2004;18:485-494.

11. Madan AK, Frantzides CT. Prospective randomized controlled trial of laparoscopic trainers for basic laparoscopic skills acquisition. Surg Endosc. 2007;21:209-213.

12. Hamilton EC, Scott DJ, Fleming JB, et al. Comparison of video trainer and virtual reality training systems on acquisition of laparoscopic skills. Surg Endosc. 2002;16:406-411.

13. Youngblood PL, Srivastava S, Curet M, et al. Comparison of training on two laparoscopic simulators and assessment of skills transfer to surgical performance. J Am Coll Surg. 2005;200:546-551.

14. Madan AK, Frantzides CT, Tebbit C, Quiros RM. Participants' opinions of laparoscopic training devices after a basic laparoscopic training course. Am J Surg. 2005;189:758-761.

15. Botden SM, Buzink SN, Schijven MP, Jakimowicz JJ. Augmented versus virtual reality laparoscopic simulation: what is the difference?: a comparison of the ProMIS Augmented Reality Laparoscopic Simulator versus LapSim Virtual Reality Laparoscopic Simulator. World J Surg. 2007;31:764-772.

NOTES: Issues and Technical Details With Introduction of NOTES Into a Small General Surgery Residency Program

Pick From JSLS, Journal of the Society of Laparoendoscopic Surgeons

MICHAEL S. KAVIC, MD, BRIAN MIRZA, MD, WALTER HORNE, DVM, JESSE B. MOSKOWITZ, MD

INTRODUCTION

An unprecedented revolution occurred in general surgery with Reddick and Olsen’s, McKernan and Saye’s, (and others) introduction of laparoscopic cholecystectomy in the United States in 1988 [1]. Since that time, many operative interventions in the abdominal and thoracic cavity have been adapted to a laparoscopic approach. Less invasive methods of diagnosis and therapy have been applied to a wide variety of diseases. It has become apparent that minimally invasive surgery has been associated with faster recovery, earlier return to full activity, less suppression of the immune system, and fewer adhesions [2-7]. In addition, most would agree that the small incisions of laparoscopic surgery are associated with a more cosmetic outcome than is possible with open laparotomy [8].

A similar revolution has quietly been going on in the field of flexible intralumenal endoscopy. Initially, endoscopic evaluation of the GI tract was one of diagnosis and very limited therapy. However, endoscopic biopsy and the snaring of polyps was a marked advance over previous methods of management, which often involved open exploration. Interventional endoscopists have recently broadened the indications for endoscopic therapeutic manipulation, and there seems to be a convergence of the once separate paths of endoscopy and gastrointestinal surgery. Endoscopists now perform procedures once solely reserved for the gastrointestinal surgeon [9-12].

Further convergence of the gastrointestinal interventionist and GI tract surgeon may involve a melding of the endoscopic and laparoscopic experience. Natural orifice translumenal endoscopic surgery  (NOTES) offers the potential to utilize the expertise of gastroenterologists and surgeons to develop a new, more minimally invasive approach to intercavitary operative intervention. There are no abdominal incisions with NOTES. Access to the peritoneal cavity is gained by transgressing a hollow viscus, which may include the stomach, colon, vagina, or urinary bladder. The elimination of abdominal incisions may lessen return to full activity, lessen up-regulation of the immune response, reduce abdominal wall incisional hernias, and improve cosmesis of the operative procedure. In addition, there may be benefits to be gained from not transgressing a scarred or obese abdominal wall and avoiding the necessity of incurring a surgical wound in the presence of abdominal wall infection [13].

Leaders of the American Society of Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) formed a working group called the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) of which the senior author is a member. NOSCAR identified challenges that NOTES practitioners would have to address before NOTES could be addressed in clinical practice.

The challenges or potential barriers to NOTES adoption in clinical practice include:
•    Access to the peritoneal cavity
•    Gastric (intestinal) closure
•    Prevention of infection
•    Development of a suturing device
•    Development of an anastomotic (nonsuturing) device
•    Development of a multitasking platform to accomplish procedures
•    Control of intraperitoneal hemorrhage
•    Management of iatrogenic intraperitoneal complications
•    Physiologic untoward events
•    Compression syndromes
•    Training other providers [14]

Several studies have now demonstrated that NOTES can be performed. But, there is a question of whether NOTES procedures can be performed safely. Also, specific issues exist that concern the NOTES practitioner regarding secure closure of the translumenal access site and development of endoscopic instrumentation suitable for surgical procedures.

With the above in mind, the authors determined to explore NOTES technology and determine whether now is the time to introduce this concept into a small general surgery residency program.

METHODS

Approval for this project was obtained from the Northeastern Ohio Universities College of Medicine and Pharmacy (NEOUCOM/COP) IACUC (Institutional Animal Care and Use Committee). St. Elizabeth Health Center (SEHC) is one of several major teaching facilities for NEOUCOM, a medical school comprising a consortium of 3 state universities in northeast Ohio. All animal laboratory experiments were conducted in the NEOUCOM/COP Comparative Medicine Unit.

From January 2007 through July 2007 at approximately monthly intervals, a large animal laboratory session was conducted at NEOUCOM/COP to study NOTES intervention.

Five female mixed breed farm swine were selected for the experimental model because of their size and close approximation of human anatomy. The swine varied in weight from 37 kg to 42.1 kg. Animals were fasted for 24 hours before the laboratory procedure, but allowed water ad libitum. Swine were preanesthetized with Telazol administered intramuscularly at a dose of approximately 6.6 mg/kg and atropine at a dose of 0.04 mg/kg. Animals were subsequently intubated, and anesthesia was maintained with isoflurane delivered at 1% to 2% of inspired gas (pure oxygen). Animals were ventilated at a rate of 10 breaths per minute using a tidal volume of approximately 11 mg/kg and an inspiratory ratio of 1:2.

Endoscopic equipment was supplied by the Fujinon Corporation (Omiya, Japan) and consisted of a 0.8-cm Fujinon EVE endoscope with one working channel and an irrigation/suction channel. The control module was set for 12:00 orientation. Surgical images were captured on a 512 MB memory card and saved in JPEG format.

A Karl Storz (Tuttlingen, Germany) laparoscope, insufflator, light source, and display were used for laparoscopic monitoring of the NOTES procedure and also used for a “hybrid” (NOTES and laparoscopic techniques) intervention. Five-mm trocars and cannula were used for laparoscopic visualization of NOTES maneuvers.

A commercial US Endoscopy (Mentor, OH) esophageal overtube (19.5 mm OD, 50cm length) for human use was initially used to facilitate repeat passage of the endoscope. This overtube was found to lack sufficient length for NOTES studies in a large animal model. Clear plastic tubing 5/8” in diameter was substituted for the US Endoscopy overtube and cut to 70 cm to 80 cm lengths depending on animal size and anatomy. The proximal obturator of the US Endoscopy tube was taped to the longer clear plastic tube to prevent egress of insufflated air and GI content.

A Jorgensen 24 Fr veterinary oral gastric tube (ID 14 Fr, OD 23 Fr, length 76 cm) (Jorgensen Laboratories, Loveland, CO) was used to decompress the stomach. In our swine model, the oral gastric tube served as a guide for overtube passage. A long suture was affixed to the proximal end of the oral gastric tube and secured distally to a long, straightened coat hanger. Once it was determined to pass the overtube, the straightened coat hanger was passed through the over tube. The overtube was advanced over the oral gastric tube, and the oral gastric tube was removed by withdrawing the long suture that had been previously attached to its proximal end.

Chlorhexidine solution diluted to 0.5% was used to wash and cleanse the oralpharynx (130 mL) and stomach (200 mL). Each site was washed and suctioned 3 times during the preoperative preparation. Aerobic and anaerobic cultures were taken after preparation.

Boston Scientific (Natick, MA) Glidewires, 450 cm in length and 0.035” in diameter, were used to guide passage of endoscopic instruments and dilators. Boston Scientific microvasive C-R-E balloon dilators were capable of dilating the gastric track 10 mm to 12 mm in diameter. Lubrication of all channels was secured with sterile water or saline. Water-soluble gel was used to lubricate the overtube.

Boston Scientific provided biopsy forceps and endoscopic clips.

“Safe tract” passage of a spinal needle with attached syringe was used to rule out the presence of a hollow viscus anterior to the anterior gastric wall [15]. Anterior abdominal pressure with a 20 mL syringe barrel was used to help determine endoscopic orientation within the gastric lumen. Pressure was maintained to help orient the operator to the anterior surface of the stomach. A mound of stomach mucosa was produced with anterior abdominal wall pressure and helped provide a “target” for the needle knife. In addition, abdominal wall/stomach pressure provided counterresistance for advancement of the needle knife and application of electrosurgical energy.

An overtube was used to guide the needle knife to the target site on the anterior gastric wall. The overtube supplies necessary rigidity for the flexible endoscope to appropriately address the stomach wall. A Boston Scientific needle knife was used to perform all gastrotomies. After safe tract maneuvers suggested that no viscera intervened between the anterior abdominal wall and stomach, a mound of gastric mucosa was developed as described above. Under direct visualization of the gastric mound by the endoscopist, the endoscope, made rigid at its distal end by the overtube, was guided to the gastric mound (Figure 1). Contact was then made with the gastric mound. Electrosurgical energy was supplied to the needle knife, and the needle knife wire and knife body were thrust through the gastric wall. Immediately prior to gastric wall penetration, electrical surgical power was discontinued and the needle knife wire withdrawn. Failure to perform this maneuver in a precise fashion can cause inadvertent injury to the anterior abdominal wall, mesentery, intestine, or viscera (Figure 2).

A 450-cm glidewire was then advanced through the needle knife (Figure 3). It is important to have sufficient length of glidewire to enable passage of endoscopic instruments. A dilating balloon was then exchanged over the glidewire and the gastrotomy site dilated to 12 mm (Figure 4).

The endoscope was advanced through the dilated gastrotomy site and intraabdominal endoscopic examination was performed (Figure 5). At this point, it is important to monitor intraabdominal pneumoperitoneum to avoid excessive abdominal pressures. A 5- mm trocar and cannula were effective in monitoring intraabdominal pressure and evacuation of pneumoperitoneum as required.

It was noted that during prolonged periods of gastric insufflation, air passed through the pylorus and distended the entire small bowel. Dilatation of the small bowel from this cause limited intraabdominal examination and could hamper endoscopic intraabdominal procedures. A pyloric obturator using a human baby nipple and plastic skirt was fashioned, but proved to be difficult to pass down the confines of an overtube (Figures 6 and 7 ). Further work to develop an appropriate obturator is ongoing in our lab.

Solid organ biopsy was performed during our studies along with attempted endoscopic clip closure of the gastrotomy site and simulated appendectomy (fallopian tube model). (Figure 8).

RESULTS

Preprocedure placement of an oral gastric tube (Jorgensen 24 Fr, Jorgensen Laboratories, Loveland, CO) was useful in decompressing the stomach. In addition, placement of an oral gastric tube facilitated passage of the overtube. Use of an overtube in this animal model reduced operator-induced trauma to the oral pharynx and esophagus and reduced the potential for transporting oralpharyngeal bacteria into the abdominal cavity.

Chlorhexidine solution (0.5%) wash of the oral pharynx and stomach was efficient in cleansing these areas and providing asepsis. No aerobic or anaerobic organisms were retrieved on culture.

In the 5 animals studied, 4 had normal swine anatomy. Gastric perforation with a needle knife and dilation of the gastrotomy tract was accomplished in these animals (#1 – 4). Intraabdominal exploration with the flexible endoscope was similarly successful.

Animal #5, however, had extensive adhesions in the epigastrium and left upper quadrant. These adhesions were of undetermined origin. In this animal, adhesions hindered adequate abdominal access and visualization. There was extensive distortion of intraabdominal anatomy. The spleen was tethered to the greater curvature of the stomach. Because the spleen was also fixed to the mid epigastrium, inadvertent injury to the spleen occurred with passage of the needle knife, glidewire, and endoscope.

A steep learning curve was encountered with the initial laboratory experiments. Four to 5 hours were required in the initial studies to gain endoscopic access to the intraabdominal cavity. Because of the lengthy time required to actually perform NOTES maneuvers, the authors learned to withhold anesthetizing animals until all members of the team were present and all instruments checked and made ready. With practice and experience, time to gain intraabdominal endoscopic access was reduced to less than one hour.

“Safe tract” proved to be a useful maneuver. It was, however, not foolproof in our experience. Other techniques such as ultrasound or CT would facilitate the determination of intraabdominal visceral relationships. Palpation on the anterior abdominal wall after endoscopic access to the stomach and gastric insufflation helped orient the operator to the anterior stomach wall and provided a “target” (gastric mound) for penetration by the needle knife. Additionally, the resistance afforded by anterior abdominal/stomach wall pressure enabled the operator to more easily thrust the needle knife through the gastric wall.

However, the supposed midgastric position of gastrotomy was frequently inaccurate. Most of our gastrotomies were sited closer to the GE junction than anticipated.

Intraabdominal orientation of the gastroscope proved to be difficult. To visualize the liver and gallbladder, the endoscope had to be “J’ed” back upon itself. This maneuver caused several authors to feel as if they were operating “over their shoulders.” Electronic image inversion (conversion to a familiar 12:00 o’clock orientation) reduced this problem.

The presence of one endoscopic operating channel precluded all but the most simple of diagnostic and therapeutic procedures. Two channels would have allowed for grasping a target tissue, fixing it, and performing other maneuvers (cutting, coagulation, biopsy, and others) through the second channel. A limitation of this setup, however, would be the small amount of distance between the 2 channels hindering appropriate triangulation of the instruments. Most of the time, the 2 channels would require that endoscopic instruments be passed just about parallel with one another making manipulation at the target site difficult. “Sword fighting,” as noted when laparoscopic trocars are spaced close together, would result between the instruments. A potential solution to this problem would be the development of articulating endoscopic instruments that could appose one another with a reasonable degree of separation.

Secure closure of the gastrotomy site is relatively straightforward if a PEG device is used. However, this type of closure is limited by subsequent fixation of the stomach to the undersurface of the abdominal wall and formation of adhesions. The stomach being fixed to the anterior abdominal wall would compromise future NOTES procedures.

Interestingly, the endoscopic clip applier used to close the gastrotomy site was found to be difficult to manipulate. The clips are approved for hemostasis of mucosal and submucosal defects <3 mm, bleeding ulcers, polyps <1.5 mm in diameter, and securing colonic diverticula. They are also approved as a supplementary method to close GI track lumenal perforations <20 mm that can be treated conservatively. In our hands, it was difficult to place the endoscopic clips with accuracy in relationship to the gastrotomy site. In addition, it was difficult to manipulate ends of the endoscopic clips on the gastrotomy site to oppose one side of the gastrotomy incision to the other (Figures 9 and 10).

During the course of our studies, several glidewires and endoscopic instruments were used more than once. We found that it was very important to lubricate all channels used to pass instruments with the appropriate agent, water-soluble gel or liquid. The close tolerances of endoscopic instruments and operating channels mandated that generous lubrication be used and that the operating channels be kept as straight as possible to facilitate instrument passage.

Because of the unanticipated steep and prolonged learning curve, all animals were euthanized at the conclusion of the NOTES procedure while still under anesthesia. Subsequent necropsy revealed the soundness of this decision as many relationships, particularly orientation and spatial relationships, became apparent only after open exploration of the abdominal cavity and 3-dimensional visualization.

DISCUSSION

Despite the long, steep learning curve, difficulties with operative orientation, and inadequate instrumentation, this laboratory study was found to be instructive and useful in introducing the concept of NOTES intervention to a small general surgery residency program. There were several lessons learned, many of which have been articulated by the early NOSCAR enthusiasts [13].

Perhaps the most important lesson relearned was that the initiation of a NOTES program requires the special skills and experience of both surgeons and therapeutic endoscopists. Each group has particular expertise specific to that specialty, and this combined expertise is necessary for the successful development of translumenal, intercavitary surgery.

The matter of endoscopic orientation was an issue from the very first. It was interesting to find that palpation of the anterior abdominal wall and safe tract maneuvers resulted in the anterior stomach wall appearing in many positions other than a 12:00 o’clock orientation. Orientation was further challenged when the endoscope was J’ed to look back at the liver and gallbladder from an anterior gastrotomy site. In this position, the 12:00 o’clock and 6:00 o’clock positions were frequently reversed, and it was difficult to torque the endoscope around to right matters. Future instrument development should incorporate endoscopic electronic readjustment capability to “normalize” the visual field for proper triangulation of operative or diagnostic interventions.

Chlorhexidine (0.5%) wash of the oral pharynx and stomach after intubation appeared to be successful in removing particulate matter and providing an aseptic state. Although aerobic and anaerobic cultures of these areas were negative after cleansing, it will be necessary for animal survival studies to show whether dislodgement of bacteria from the oral pharynx during passage of endoscopic instruments is a factor of clinical significance.

The nonsurvival mode of the animal study benefited the development of our NOTES skill. There is a long and steep learning curve for NOTES methodology. By performing an immediate necropsy, we were able to correlate endoscopic impressions with actual anatomic reality.

We found that an in situ oral gastric tube served as an excellent guide for passage of the overtube. Because of the short commercial overtubes available, we utilized commonly available thin-walled clear plastic tubing of 5/8” diameter cut to a length of 70 cm to 80 cm. An overtube of clear plastic was of value in subsequent passage(s) of the endoscope because esophageal and gastric anatomy could be identified through the clear plastic wall. The gastroesophageal junction, an important anatomic landmark and reference point, was easily identified through the overtube. However, we found that an overtube in the porcine, large animal model must be at least 70 cm long to assist in positioning and stabilizing the endoscope for gastric procedures.

The use of an overtube allows for repeated passage of the endoscope with minimal potential for injury to the oral pharynx and esophagus. In addition, there is a decreased risk of dislocating bacteria from the oral cavity and oral pharynx to the operative site(s). It was necessary to secure the open end of the improvised overtube with the obturator available on commercial overtubes. The makeshift obturator prevented efflux of insufflated air and gastric content (Figure 11).

Our improvised overtube was stiff and had a small amount of curve inherent in the plastic material (Figure 11). These qualities augmented our ability to direct the endoscope to a target site and to stabilize it during thrusting and retraction maneuvers. In effect, the overtube stiffened the flexible tip of the distal endoscope and allowed us to have more control when thrusting and manipulating endoscopic instruments was necessary. However, a “soft” tip applied to the distal end of the overtube will help prevent unnecessary trauma to the gastric wall.

During the course of our exercises, we consistently performed the gastrotomy puncture closer to the GE junction than anticipated. The more proximal position of the gastrotomy incision suggested the use of a longer overtube and positioning safe track pressure in a more caudal site on the abdominal wall (between the third and fourth nipple) to the right of the midline.

Besides helping orient our team to endoscopic findings, postprocedure necropsy revealed needle knife superficial injuries to the anterior abdominal wall, mesentery, and small bowel that might have been missed if the animal had been allowed to survive the initial procedure.

We also observed that concurrent 2-mm or 5-mm laparoscopic surveillance was an aid to selecting a gastrotomy site and monitoring passage of the glidewire and endoscope. It was our impression that laparoscopic visualization improved the ease and safety of gastric wall penetration and intraabdominal visceral manipulation. Laparoscopic surveillance, initiated by the Hasson technique, may also aid in safe passage of the endoscope through the stomach wall in those patients suspected of having abdominal adhesions. The addition of small 1-mm or 2-mm laparoscopic ports can allow for laparoscopic instrument introduction to assist NOTES procedures in a “hybrid” manner.

Retroflexion of the endoscope introduced through a gastrotomy site caused difficulty with targeting and triangulating an organ in the upper abdomen. In many instances, it was difficult to obtain proper image orientation and perform subsequent instrument manipulation. Because of these challenges, it may be more advantageous to perform NOTES procedures in the upper abdomen by accessing the abdominal cavity from a more caudad site in the colon, vagina, or urinary bladder.

Interestingly, the development of pneumoperitoneum after hollow viscus penetration may improve safety and deter glidewire or endoscopic instrument injury to intraabdominal content by increasing the distance from the stomach gastrotomy site to these structures.

CONCLUSION

Our study suggests that NOTES intervention is a feasible and appropriate “next step” in the evolution of minimally invasive surgical access. There was, however, a long and steep learning curve for our team. We conclude that any investigation of NOTES should involve a multidisciplinary approach with experienced laparoendoscopic surgeons and interventional gastroenterologists collaborating together. These investigations should begin in a controlled, laboratory environment before procedures are attempted on human patients. Finally, we conclude that NOTES investigation is beneficial for a small general surgery residency program to stimulate creativity, explore the limits of technology, gain insight into the design and use of improved NOTES surgical instrumentation, and improve the diffusion of surgical knowledge.

Figure Legends
Figure 1. Needle knife.
Figure 2. Abdominal wall injury.
Figure 3. Glidewire advanced through needle knife gastrotomy.
Figure 4. Dilating balloon.
Figure 5. Intraabdominal endoscopic examination.
Figure 6. Pyloric obturator.
Figure 7. The pyloric obturator was delivered via endoscope.
Figure 8. Liver biopsy.
Figure 9. Open endoscopic clip.
Figure 10. Endoscopic clip closure of gastrotomy site.
Figure 11. Improvised overtube with obturator.

References

1. Reddick EJ, Olsen D, Daniel J, et al. Laparoscopic laser cholecystectomy. Laser Med Surg News Adv. 1989;7:38-40.
2. Burpee SE, Kurian M, Murakame Y, et al. The metabolic and immune response to laparoscopic versus open liver resection. Surg Endosc. 2002;16:889-904.
3. Karayiannakis AJ, Makri GG, Mantzioka A, et al. Systemic stress response after laparoscopic or open cholecystectomy: a randomized trial. Br J Surg. 1997;84:467-471.
4. Grande M, Tucci GF, Adorisio O, et al. Systemic acute-phase response after laparoscopic and open cholecystectomy. Surg Endosc. 2002;16:313-316.
5. Hasukic S, Mesic D, Dizdarevic E, et al. Pulmonary function after laparoscopic and open cholecystectomy. Surg Endosc. 2002;16:163-154.
6. Milingos S, Kallipolitis G, Loutradis D, et al. Adhesions: laparoscopic surgery versus laparotomy. Ann N Y Acad Sci. 2000;900:272-285.
7. Swank DJ, Van Etp WF, Repelaer Van Driel OH, et al. A prospective analysis of predictive factors on the results of laparoscopic adhesiolysis in patients with chronic abdominal pain. Surg Laparosc Endosc Percutan Tech. 2003;13:88-94.
8. Litynski GS. Highlights in the History of Laparoscopy. Frankfurt/Main: Barbara Bernert Verlag; 1996.
9. Cotton PB. Fading boundary between gastroenterology and surgery. J Gastroenterol Hepatol. 2000;15(suppl):G34-G37.
10. Kozarek RA, Brayko CM, Harlan J, et al. Endoscopic drainage of pancreatic pesudocysts. Gastrointest Endosc. 1985;31:322-327.
11. Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004;60:114-117.
12. Franklin ME, Leyva-Alvizo A, Abrego-Medina D, et al. Laparoscopically monitored colonoscopic polypectomy: an established form of endoluminal therapy for colorectal polyps. Surg Endosc. 2007;21:1650-1653.
13. Kavic MS. Natural orifice translumenal endoscopic surgery: “NOTES.” JSLS. 2006;10:133-134.
14. Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery (NOTES). Surg Endosc. 2006;20:329-333.
15. Foutch PG, Talbert GA, Waring JP, Sanowski RA. Percutaneous endoscopic gastrostomy in patients with prior abdominal surgery: virtues of the safe tract. Am J Gastroent. 1988;83(2):147-150.

Reprinted from JSLS, Journal of the Society of Laparoendoscopic Surgeons. 2008;12(1):37-45.

St. Elizabeth Health Center, NEOUCOM for HMHP, Department of Surgery, Northeastern Ohio Universities College of Medicine, Rootstown, Ohio, USA (Dr Kavic).

NEOUCOM, Bariatric and Surgical Associate of Central, Virginia, Mary Washington Hospital, Fredericksburg, Virginia (Dr Mirza).

Northeastern Ohio Universities College of Medicine, Rootstown, Ohio (Dr Horne).

St. Elizabeth Health Center, Youngstown, Ohio (Dr Moskowitz).

Partial support for this project was obtained through a grant from the SEHC Department of Medical Research.

Correspondence: Michael S. Kavic, MD, Director of Education, General Surgery, St. Elizabeth Health Center, 1044 Belmont Ave, PO Box 1790, Youngstown, OH, 44501-1790, USA. Telephone: 330 480 3124, Fax: 330 489 3640, Email: michael_kavic@hmis.org

Competency, Proficiency, and the Next Generation of Skills Training and Assessment Curricula Using Simulators

RICHARD M. SATAVA, MD

With the origins of objective assessment of psychomotor skills for surgical residents by leaders like Richard Reznick et al [1] and Gerald Fried et al [2] in the 1990s, the foundation of the revolution in teaching surgical procedures was introduced. Initially, and to a greater extent still today, the assessment is of basic tasks and simple procedures; the more complicated full surgical procedures await further advances in the technology of simulators as well as assessment tools. Nevertheless, enormous progress has been made in quantifying performance, and validation has been successful not only for the laboratory, but Seymour et al [3] and others have also validated that virtual reality training in the laboratory translates into improved performance in the operating theater.

As with all scientific research, when the scientific evidence supports a new approach, the next step is incorporation into practice. Because of the validation, there is now a requirement for simulation-based training with objective assessment to be part of the skills training of surgeons. The Accreditation Council on Graduate Medical Education (ACGME), the Residency Review Committee (RRC), the Association of Program Directors in Surgery (APDS), the American College of Surgeons (ACS), and American Board of Surgery (ABS) have worked hard to reach consensus, establish, and adopt the 6 areas of competency that all residents must achieve (Table 1). Although certain areas of skills training are well validated, some areas like communication skills and professionalism are still being developed.

Now that the areas for competency have been agreed upon, the difficult task begins of developing the curricula that will support the training and assessment of these skills. One of the major benefits of the development of curricula is that this forms the beginning of the standardization of skills training. Once again, the ACS, ABS, and APDS have united to develop the skills curricula. As of September 2008, the required curriculum for the first 20 basic skills and simple procedures has been released (Table 2). This has completed Phase 1 of curriculum development; Phases 2 and 3 will be developed over the next 2 years (Table 3). All surgical residency training programs are now required to have these fundamental skills-training curricula with assessment of the outcomes; what has not been mandated is the manner in which the training and assessment will occur. This provides the training program directors some latitude for presenting the training. However, this also leaves a gap in achieving a uniform curriculum on a national basis (see below).

In preparation for the establishment of curricula, the ACS has developed a certification process for a skills-training center. These ACS Accredited Education Institutes (ACS-AEI) will form the nucleus of cooperation in bringing a standardization to the training and assessment process. The initial steps have been to develop the criterion for an ACS-AEI, an application process, a survey instrument, the teams of surveyors to evaluate the applicant training centers, an evaluation methodology, and the certification award process. This has all been accomplished between 2005 and today. Surveys have been conducted, and now 18 ACS-AEI centers have been certified.

In May 2007, the first meeting of the ACS-AEI centers occurred to establish the Consortium of ACS-AEI. The goals are to establish shared, uniform resources (databases, learning management software, networking, etc), to evaluate the ACS-APDS curricula with the intent of adopting a common implementation of the curricula, to develop uniform outcomes for the curricula, and to develop a research agenda to further the scientific pursuit of education, training, and assessment (Table 4). This will allow the ACS-AEIs to become regional resources for disseminating information throughout the region, to provide a resource to “train the trainers” for other institutions in their region, and to provide resident (student and surgeons) training for those institutions that do not have their own training centers and still need to meet the ACGME and RRC requirements.

The types of training and assessment that the centers will address must be comprehensive and include students, residents, and practicing surgeons. The purposes include initial assessment of fundamental abilities (aptitude), basic skills and established procedures, new procedures (for both students and established surgeons, maintenance of certification (MoC), retraining (or re-entry training) of skills after absence from performing surgery, and when necessary, remediation (Table 5).

The new directions for the ACS-AEI will be in (1) forming networks of centers to integrate and collaborate; (2) establishing a research agenda in application and validation of new training and assessment methods; (3) performing multi-center trials of new procedures and techniques (such as NOTES); (4) developing/evaluation of new simulators and curricula with their appropriate outcomes and assessment tools; and (5) distributing (over the Internet) all of the above information.

The challenge is enormous, but the opportunities are even more exciting than ever. We are in a complete revolution in surgical education. If history serves us well, such a revolution occurs only once every hundred years, as evidenced by the fact that the last revolution began in 1908 with the Flexner Report. Whatever is established during these next 10 years is likely to endure for the next century.

The opinions or assertions contained herein are the private views of the author(s) and are not to be construed as official, or as reflecting the views of the Departments of the Army, Navy, or Air Force, the Defense Advanced Research Projects Agency, or the Department of Defense.

Correspondence: Richard M. Satava, MD, FACS, Department of Surgery, University of Washington Medical Center, 1959 Pacific St NE, Seattle, Washington, 98195, USA. Telephone: 206 616 2250, Fax: 206 616 9138, E-mail: rsatava@u.washington.edu

Richard Satava, MD, FACS, is Professor of Surgery at the University of Washington Medical Center, and Senior Science Advisor at the US Army Medical Research and Materiel Command in Ft. Detrick, MD. He has served on the White House Office of Science and Technology Policy (OSTP) Committee on Health, Food and Safety. He is currently a member of the Emerging Technologies and Resident Education, and Informatics committees of the American College of Surgeons (ACS), is past president of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), past president of the Society of Laparoendoscopic Surgeons (SLS), and is on the Board of Governors of the National Board of Medical Examiners (NBME) as well as on a number of surgical societies. He has more than 200 publications and book chapters in diverse areas of advanced surgical technology.

References

1.  Martin JA, Regehr G, Reznick R, et al. Objective Structured Assessment of Technical Skill (OSATS) for surgical residents. Br J Surg. 1997;84:273-278.

2.  Derossis AM, Antoniuk M, Fried GM. Evaluation of laparoscopic skills: a 2-year follow-up during residency training. Can J Surg. 1999;42(4):293-296.

3. Seymour NE, Gallagher AG, Roman SA, et al. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002;236:458-463.