Background
The number of robotically assisted hysterectomies is increasing, and therefore, the opportunities for trainees to become competent in performing traditional laparoscopic hysterectomy are decreasing. Simulation-based training is ideal for filling this gap in training.
Objective
The objective of the study was to design a surgical model for training in laparoscopic vaginal cuff closure and to present evidence of its validity and reliability as an assessment and training tool.
Study Design
Participants included gynecology staff and trainees at 2 tertiary care centers. Experienced surgeons were also recruited at the combined International Urogynecologic Association and American Urogynecologic Society scientific meeting. Participants included 19 experts and 21 trainees. All participants were recorded using the laparoscopic hysterectomy cuff closure simulation model. The model was constructed using the an advanced uterine manipulation system with a sacrocolopexy tip/vaginal stent, a vaginal cuff constructed from neoprene material and lined with a swimsuit material (nylon and spandex) secured to the vaginal stent with a plastic cable tie. The uterine manipulation system was attached to the fundamentals of laparoscopic surgery laparoscopic training box trainer using a metal bracket. Performance was evaluated using the Global Operative Assessment of Laparoscopic Skills scale. In addition, needle handling, knot tying, and incorporation of epithelial edge were also evaluated. The Student t test was used to compare the scores and the operating times between the groups. Intrarater reliability between the scores by the 2 masked experts was measured using the interclass correlation coefficient.
Results
Total and annual experience with laparoscopic suturing and specifically vaginal cuff closure varied greatly among the participants. For the construct validity, the participants in the expert group received significantly higher scores in each of the domains of the Global Operative Assessment of Laparoscopic Skills Scale and for each of the 3 added items than did the trainees. The median total Global Operative Assessment of Laparoscopic Skills Scale score (maximum 20) for the experts was 18.8 (range, 11–20), whereas the median total Global Operative Assessment of Laparoscopic Skills Scale score for the trainees was 10 (range, 8–18) ( P = .001). The overall score that included the 3 new domains (maximum 35) was 33 (range, 18–35) for the experts and 17.5 (range, 14–31.5) for trainees ( P = .001). For the face validity testing, the majority of the study participants (32 [85%]) agreed or strongly agreed that the model is realistic and all participants agreed or strongly agreed that the model appears to be useful for improving technique required for this task. For the interrater reliability, the scores assigned by each observer had an interclass correlation coefficient of 0.8 (95% confidence interval, 0.7–0.93).
Conclusion
This model is easily constructed and has an acceptable cost. We have demonstrated evidence of construct validity. This is a valuable education tool that can serve to improve skills, which are essential to the gynecological surgeon but are often lacking in residency training because of national changes in practice patterns.
Vaginal cuff dehiscence after hysterectomy is an uncommon complication but one that is associated with serious morbidity. It is reported to occur in 0.13% of vaginal hysterectomies, 0.2% of abdominal hysterectomies, 0.64% of total laparoscopic hysterectomies, and 1.64% of robotic hysterectomies. The rate appears to be higher after laparoscopic and robotic hysterectomy, and therefore, it is critical to address the training in the surgical skills necessary for this task.
As the number of robotically assisted hysterectomies is increasing, gynecology trainees may have fewer opportunities to become competent in performing hysterectomies using a conventional laparoscopic approach. Simulation-based training is ideal for learning and practicing a skill that is complex yet repetitive, particularly when the surgical volume is lacking.
There are many ways to close the cuff laparoscopically, but we prefer free suturing because of its simplicity, low cost, and transferrable skill set. Laparoscopic suturing is a skill that can be applied in multiple venues beyond vaginal cuff closure: myomectomy, paravaginal defect repair, Burch urethropexy, and cystotomy repair. Unfortunately, there is a paucity of low-fidelity simulators for training learners in gynecology. These models are meant to accelerate learning while improving the safety and quality of care in the operating room. Prior to performing any surgical procedure on patients, surgical trainees should know how to perform the steps required and be confident in their abilities. One way to bridge the gap in knowledge and technical skills is through simulation.
The objective of this study was to design a surgical model for training in laparoscopic vaginal cuff closure and to present evidence of its validity and reliability as an assessment and training tool.
Materials and Methods
This study involved 2 tertiary care centers: Hartford Hospital and University of Colorado Anschutz Medical Campus. The study was approved by the institutional review board at both institutions. The study has 2 phases: model construction and validity testing.
Model construction
The model design is demonstrated in the Figure . Materials used for the model were as follows: repurposed RUMI Advanced Uterine Manipulation System (Cooper Surgical, Inc, Trumbull, CT), sacrocolopexy tip/vaginal stent (Cooper Surgical, Inc), and a vaginal cuff constructed from neoprene material and lined with a swimsuit material (nylon and spandex) secured to the vaginal stent with a plastic cable tie.
The setup also includes the Fundamentals of Laparoscopic Surgery (FLS) laparoscopic training box trainer. A similar model with a different attachment was previously developed for training in laparoscopic suturing for sacrocolpopexy, and validity testing was performed. We elected to use the same model with a different attachment to expand on the utilization of one model for more than one procedure.
The FLS box trainer was chosen because of its presence in most academic surgical training programs in the United States, and its availability facilitates generalizability and acceptance of the model. The RUMI vaginal manipulator was affixed to the lower portion of the box trainer via a metal bracket (custom made, available upon request). The neoprene material simulates the thickness of the vaginal cuff and the swimsuit material lining simulates vaginal epithelium. The lining is sewn inside the neoprene cuff 1 cm from the edge to optimally simulate the closure technique in which the epithelial edge has to be incorporated into the cuff closure and to serve as a distance marker. The combination of the materials closely represents the pliability of the vaginal tissue, yet the model is durable enough to be reused multiple times.
Materials and their corresponding costs are given in Table 1 . The model ideally should be used on a table of adjustable height for ergonomic purposes.
| Item | Cost, $ |
|---|---|
| RUMI Advanced Uterine Manipulation System (repurposed) | 100 |
| Sacrocolopexy tip, model SACRO-1 | 50 |
| Vaginal cuff sleeve a | 10 |
| Bracket | 20 |
| Total b | 180 |
a Tip cover is made from neoprene material, repurposed from neoprene can holder, $2.99, makes 2 sleeves; the inner epithelium is made from swimsuit material (nylon and spandex), $28 for a sheet of fabric sufficient for 14 items. Plastic cable tie, used to attach the sleeve to the plastic tip; $0.50 per tie. $7 is added for labor if the tip cover is to be custom made
b Does not include the price for the FLS box trainer, surgical instruments, mesh, and suture.
Model acceptability and validity
Eligible participants included gynecology staff and trainees at 2 tertiary care centers. Gynecologic surgeons were also recruited at the combined International Urogynecologic Association (IUGA) and American Urogynecologic Society (AUGS) scientific meeting, on July 22, 2014.
Participants met inclusion criteria if they perform laparoscopic total hysterectomies as part of their training or practice. Participants were divided into 2 groups: experts and trainees. Participants for the experts group were recruited at the IUGA/AUGS scientific meeting. Unfortunately, given the change in practice with a shift to supracervical hysterectomies for sacrocolpopexy to minimize the risk of mesh erosion and the practice of vaginal cuff closure via a vaginal approach after a laparoscopic hysterectomy, we could not use the number of annual surgical procedures as our criteria for inclusion for the expert group.
We relied on the participants in the expert group to self-identify as laparoscopic experts defined as surgeons who perform laparoscopic gynecologic surgery routinely as part of their practice and instruct residents and/or fellows. Trainees consisted of senior residents and fellows in female pelvic medicine and reconstructive surgery (postgraduate years 3–7).
All participants completed a questionnaire on their characteristics including surgical experience. The participants were then asked to place 2 interrupted stitches with 4 extracorporeal throws to close the vaginal cuff. A 0-0 polyglactin 910 suture on a CT-1 needle was used. All participants received instructions on the task and were allowed to practice and get accustomed to the FLS set up. Adjustable height tables were used at the tertiary care centers. At the AUGS scientific meeting, an adjustable table was not available.
Each performance was videotaped without sound, with each recording being identified using a randomly assigned, nonconsecutive study identification number. After completing the procedure, participants were asked to assess the realism and utility of the model and its perceived acceptability and educational effect by responding to a questionnaire using a 5 item Likert response scale.
The primary outcome of the study was the total score using the valid and reliable Global Operative Assessment of Laparoscopic Skills (GOALS) Scale. The GOALS scale assesses general tasks deemed essential to laparoscopy in 5 domains: depth perception, bimanual dexterity, efficiency, tissue handling, and autonomy, with a maximum of 5 points for each domain (total maximum of 25 points).
For the purpose of this study, the autonomy domain was not included; thus, the maximum GOALS score was 20 points. In addition, we included 3 items that we believed to be important for the assessment of competency in vaginal cuff closure (5 points each): needle handling, knot tying, and incorporation of the epithelial edge. A total global score for the procedure was therefore 35. Scoring was performed by 2 blinded experts (E.T. and T.M.) using anonymous, silent video recordings. Different time points were collected: needle loading, first stitch placement, and completion of 4 extracorporeal knot ties.
Statistical analysis
The Student t test was used to compare the scores and the operating times between the groups. The performance scores were calculated as a mean between the 2 blinded examiners. All data are described in terms of median and range. Intrarater reliability between the scores by the 2 masked experts was measured using the interclass correlation coefficient. Sample size was calculated on the basis of the study evaluating model for laparoscopic sacrocolpopexy in which the difference in total GOALS score between the expert and trainee group was 7 points.
From these data, a group sample size of 22 per group was required to achieve 90% power to detect a difference of 7.0 points between the 2 groups, assuming a total GOALS score of 13 for the trainees group and a score of 20 for the experts, with estimated equal group standard deviations of 10 and an alpha value of 0.05 using a 2-sided Student t test. Statistics were calculated using JMP 11.0 (SAS Institute, Cary, NC).
Results
Participant demographic characteristics and surgical experience are given in Table 2 . Total and annual experience with laparoscopic suturing and specifically vaginal cuff closure varied greatly among the participants. The majority of experts reported that they utilize extracorporeal knot-tying technique when suturing laparoscopically most of the time (13 [68.4%]). Trainees reported that they more frequently perform intracorporeal knot-tying technique during conventional laparoscopy (10 [47.6%]); 2 [10.5%], and 5 [23.8%] of experts and trainees, respectively, reported that they practice both techniques at an equal rate). When asked “what is your preferred method for vaginal cuff closure after a total laparoscopic hysterectomy,” the majority of trainees reported vaginal closure (14 [66.7%]), whereas only 3 experts [15.8%] chose vaginal closure as their answer.
| Variable | Experts (n = 19) | Trainees (n = 21) |
|---|---|---|
| Age, y | 39 (34-50) | 31 (27-37) |
| Male/female | 7/12 | 2/19 |
| Right/left handed | 17/1 | 19/2 |
| Completed FPMRS fellowship | 13 (68.4%) | N/A |
| Completed gynecology/oncology fellowship | 3 (15.8%) | N/A |
| Surgical experience beyond training, y | 12 (3-23) | N/A |
| Laparoscopic vaginal cuff closure (total since residency) a | 55 (10 to > 150) | N/A |
| Procedures requiring laparoscopic suturing (total since residency) a | 60 (10 to > 150) | N/A |
| Laparoscopic vaginal cuff closures in 1 y a | 4 (0 to > 20) | 2 (0 to > 20) |
| Procedures requiring laparoscopic suturing in 1 y a | 8 (0 to > 20) | 0 (0-8) |
| Laparoscopic/robotic vaginal cuff closures in 1 y a | 15 (0 to > 20) | 8 (0 to > 20) |
| Frequency of extracorporeal/intracorporeal knot tying b | 13 (68.4%)/3 (15.8%) | 6 (28.6%)/10 (47.6%) |
| Preferred method of vaginal cuff closure | ||
| Intracorporeal | 0 (0%) | 0 (0%) |
| Extracorporeal | 10 (52.3%) | 0 (0%) |
| Vaginal closure | 3 (15.8%) | 14 (66.7%) |
| Robotically assisted | 6 (31.6%) | 7 (33.3%) |
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