Problem: inexperience increases risk for complications

The loop electrosurgical excision procedure (LEEP) is a diagnostic and potentially therapeutic technique. Widely used for the treatment of high-grade cervical intraepithelial neoplasia (CIN) and microinvasive cervical cancer, it is one of the most frequently performed procedures in gynecology (GYN).

Major intraoperative complications are uncommon during LEEP specifically conization. Nevertheless, minor complications, such as intra- and postoperative bleeding, uterine perforation, and infection occur in up to 10% of patients. LEEP is usually performed by GYN residents at an early stage of surgical education when complications typically occur more frequently.

The procedure is considered successful when the lesion and the entire transformation zone is completely resected, using the smallest possible cone size. Incomplete CIN resection can lead to subsequent surgery, resulting in pregnancy-related complications; specifically, cervical insufficiency and premature rupture of the membranes. Therefore, accurate pretherapeutic assessment and correct execution of the procedure are crucial.

Increasing evidence suggests that surgeons can learn many fundamental skills and specific procedures with the use of simulators and training models. We conducted a prospective study to investigate the feasibility of a hands-on LEEP training program that included a unique teaching model.

Our solution

The investigation was conducted during the Gynecologic Neoplasia Workshop 2010. A 2.5-day intensive surgical skills workshop with simulation-based training emphasized colposcopy, local anesthesia, punch biopsy of the uterine cervix and vulva, LEEP, and management of intraoperative bleeding. In each session, a didactic presentation by an attending gynecologist was followed by supervised hands-on training in groups of 3-4 physicians. Their demographics and previous surgical experience were documented through a survey. Before and after training, all participants completed a test on diagnosis and treatment of gynecologic neoplasia and a technical skills assessment using the LEEP simulation model. Before the study, institutional review board (IRB) approval was obtained from the Ethics Committee of the Medical University of Vienna (IRB-no: 2009-1163).

The LEEP training model was constructed as follows: a porcine sausage, approximately 2.2 inches in diameter, was inserted into a central incision in the bottom of an empty yogurt cup; the cup represented the speculum and the vaginal wall. One end of the sausage substituted for the ectocervical part of the uterine cervix, and a “cervical canal” was created, using a Hegar dilator. Cervical leukoplakia was marked on the “ectocervical” part of the sausage using white correction fluid ( Figure 1 ) .

A novel training model for the loop electrosurgical excision procedure is illustrated.

Hefler. Loop electrosurgical excision procedure training model. Am J Obstet Gynecol 2012.

Colposcopy was performed before surgical removal of the lesion. Then, the neutral electrode was positioned on the simulated endocervix. An electrosurgical unit was set at 30-40 watts on blend 1, and an isolated handpiece with loops of different sizes was used for electrosurgical excision. The loop was carefully passed simultaneously around and under the transformation zone. After the transformation zone was removed, a Hegar dilator was used to explore the cervical canal. Additional tissue was excised from the cervix using a rectangular loop with a smaller diameter, an optional step. Endocervical curettage was performed after completion of the excision, and hemostasis was obtained with a Ball electrode ( Video ).

The participants’ performance was appraised by trained evaluators who used an objective structured assessment of technical skills (OSATS) in a dry laboratory. Procedure sequence, handling of instruments, and selection of performance speed, technical settings, and loop size were all assessed in judging the physicians’ performance. Success of the procedure was based on preservation of the entire ectocervix and endocervical canal and complete resection of the cervical lesion. To grade each subject’s skills, evaluators added the scores given for each step on the task-specific checklist; higher scores indicated greater proficiency ( Figure 2 ) .

The objective structured assessment of technical skills (OSATS) measures each element of the procedure.

Hefler. Loop electrosurgical excision procedure training model. Am J Obstet Gynecol 2012.

Knowledge of diagnosis and therapy was evaluated with a multiple-choice test before and after completion of the workshop. A team of board-certified GYN surgeons used international guidelines to compose 30 test questions. Fifteen questions were asked at inclusion; 30 at the final assessment. All participants were asked to evaluate the content and clinical relevance of the workshop on a 10-point scale.

Statistical analysis was performed using Student paired t tests with a significance level set at 0.05. A multivariate regression model was computed to test whether the training effect was independent of participants’ previous surgical expertise (ie, number of performed LEEPs, training status) and personal characteristics (ie, age, sex). Values were given as a mean or percentage. We used the statistical software package IBM SPSS Statistics 18 for Windows (IBM Corporation, Armonk, NY) for all analyses.

In this prospective observational study, 51 participants received the described training. Their characteristics are shown in the Table. Correct test answers were significantly more frequent after workshop completion (50.5% [standard deviation or SD, 15.5] vs 72.8% [SD, 15.9]; P < .001). LEEP performance was significantly better after conclusion of the program ( P < .001). Before and after training, participants’ mean scores were 18 (SD, 3.5) and 23.4 (SD, 2.1), respectively ( Figure 3 ) . The entire ectocervix and endocervical canal of the specimen were preserved in an average 19.6% of attempts before training and 74.4% after training ( P < .001). Multivariate analysis revealed that these effects were independent of previous surgical expertise (number of performed LEEPs [ P = .8] and training status [ P = .6]) and participants’ characteristics (age [ P = .7] and sex [ P = .6]).

Objective structured assessment of technical skills scores rose after completion of training.

Hefler. Loop electrosurgical excision procedure training model. Am J Obstet Gynecol 2012.

At the end of the workshop, participants graded the experience: good overall impression, 9.5 (SD = 0.6), high relation to practice, 9.0 (SD = 1.2), and high clinical relevance, 9.2 (SD = 1.0); most would recommend the workshop to colleagues (9.8; SD = 0.6).

Evaluating performance in the operating room is difficult, and most efforts have focused on assessment of surgical procedures in a laboratory setting. A number of studies have reported on the high practical value of training models in the surgical education of gynecologists. Most of these focused on the training of open, laparoscopic, and hysteroscopic procedures.

We showed that a 2.5-day workshop that incorporated an innovative LEEP training model has a positive effect on physicians’ skills. Participants had significantly higher OSATS scores after training was completed. About one third of participants were trainees; the rest were specialists. Interestingly, the effect of training was independent of surgical experience and training status in multivariate analysis. For that reason, our findings seem to be applicable not only to GYN residents but also to gynecologists at higher educational levels.

Training on inexpensive low-fidelity models has proven comparable to that achieved with expensive high-fidelity virtual reality models. Our model is easy to reproduce, and each one cost significantly less than $10 (US). The most expensive element, the disposable neutral electrode, was reused for multiple models. It offers realistic simulation of the LEEP and enables physicians to practice several different technical patterns.

Performing the procedure at the correct speed is crucial for successful surgery. The loop should glide through the cervix from one side to the other, allowing the cutting current to divide the tissue. If the surgeon attempts to pull quickly through the cervix, the loop will drag, bend, or adhere to the tissue, resulting in a shallower excision than intended. If the loop moves too slowly, thermal damage to the specimen can occur. Once the procedure is started, it is difficult to interfere with or discontinue it before finishing.

It is also essential to choose an adequate loop size and to determine whether it is necessary to resect an additional endocervical cone. Complete resection of the lesion is crucial for surgical success and affects the recurrence rate. Furthermore, the route—side to side or rear to front—has to be individualized, depending on colposcopy findings, lesion size, location, and histologic grade. The patient’s age and fertility must be considered as well. Correct LEEP planning will reduce the rate of unnecessarily high cone volumes. This is important, as many patients undergoing a LEEP are young and may wish to become pregnant. If the preoperative evaluation showed that the lesion did not extend into the endocervical canal, excision of an additional endocervical cone should not be necessary after satisfactory colposcopy. Avoidance of excessive excision may be possible.

Our study design had limitations. First, we did not use a control group of physicians who received conventional training. All participants used the hands-on training model and were instructed by experienced GYN surgeons. We chose to have unblinded examiners after a recent study found no significant differences in OSATS scoring between blinded and unblinded assessors. All OSATS examinations were carried out by experienced GYN surgeons who had received prior training in gauging technical skills, and each group had a different examiner before and after the training. Our study design was prospective, and a relatively large group of participants (51) was included in the statistical analysis. Consequently, we think that the study results have potential clinical value.

The LEEP model has since been integrated into our GYN residency and fellowship programs and is well accepted by the staff members. We will continue to evaluate the effects of training. A prospective study comparing the use of the training model with conventional training could identify the clinical impact of the replica on the success of the procedure and the rate of complications, such as intraoperative bleeding and injury of the vaginal cuff, as has similarly been described for laparoscopic procedures.

In conclusion, our findings suggest that the presented training model is a useful, realistic, and inexpensive tool that improves LEEP training. We think that it could easily be used in different GYN training programs. It has previously been shown that skills acquired during training can be transferred to real surgeries, resulting in better performance. We suggest that a simulation of LEEP training be considered in GYN training programs.