Surg Endosc DOI 10.1007/s00464-014-3956-1
and Other Interventional Techniques
Surgeons’ perceptions of transanal endoscopic microsurgery using minilaparoscopic instruments in a simulator: the thinner the better Sergio Eduardo Alonso Araujo • Carlos Ramon Silveira Mendes Gustavo Lopes Carvalho • Marcos Lyra
•
Received: 23 May 2014 / Accepted: 25 October 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Several issues have limited the widespread adoption of transanal endoscopic microsurgery (TEM). The need for specialized equipment and the steep learning curve represent one of them. To operate on within a 4-cm diameter, rectoscope represents a major technical challenge. However, minilaparoscopic surgery has been introduced to reduce invasiveness and abdominal wall trauma. In TEM, instrument miniaturization may lead to technique optimization. We hypothesized that visualization and maneuverability during TEM performed with 3-mm minilaparoscopic instruments would be superior to TEM performed with conventional 5-mm instruments. Methods Eighteen general and colorectal surgeons with experience with TEM under ten cases were recruited. Two tasks should be accomplished using the TEOÒ-Neoderma simulator. First, using conventional 5-mm TEOÒ curvedtip instruments, a ‘‘polypoid lesion’’ should be excised. Next, closure of the ‘‘rectal’’ defect should be undertaken.
S. E. A. Araujo Department of Gastroenterology, University of Sao Paulo Medical School, Sao Paulo, SP, Brazil S. E. A. Araujo (&) Albert Einstein Medical Center, 627 Albert Einstein Ave, Suite 219, Sao Paulo, SP 05652-901, Brazil e-mail:
[email protected];
[email protected] C. R. S. Mendes Colorectal Surgery Division, Hospital Santa Izabel, Salvador, BA, Brazil G. L. Carvalho M. Lyra Department of Surgery, Federal University of Pernambuco, Recife, PE, Brazil
In the second part, the same participants repeated the same excision/closure tasks using 3-mm minilaparoscopic instruments. After tasks conclusion, participants fulfilled an evaluation questionnaire with seven questions regarding visualization and maneuverability when using 3-mm compared to 5-mm instruments. Results For each one of the seven questions in the questionnaire, the score results were significantly higher for the 3-mm instruments indicating that performance with the 3-mm minilaparoscopic instruments in the TEO simulator was in all cases between ‘‘better than expected’’ and ‘‘much better than expected.’’ Appropriateness of the diameter of the minilaparoscopic instruments was the best evaluated parameter. The question addressing the ease of performing the tasks in the simulator presented the lowest mean score. Conclusions The perceptions of participating surgeons indicated that there is better visualization and maneuverability during basic transanal endoscopic microsurgery tasks conducted in a simulator using 3-mm minilaparoscopic instruments when compared to conventional 5-mm instruments. Keywords Surgical procedures Minimally invasive Rectal neoplasms Surgical procedures, operative Natural orifice endoscopic surgery Surgical instruments The introduction of transanal endoscopic microsurgery (TEM) by Buess et al. [1] in 1983 has renewed the interest in the local treatment of rectal tumors. TEM offers advantages over conventional transanal excision techniques, mainly better visualization and exposure. Moreover, TEM technology enables access to the entire rectum. Ultimately, in comparison to traditional transanal excision techniques, TEM is associated with a higher likelihood of
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achieving clear surgical margins [2, 3] and lower recurrence rate [4]. However, despite its introduction more than 30 years ago, several peculiarities have limited its widespread adoption such as the need for specialized and expensive instruments, the steep learning curve, and the reduced case volume observed in non-specialized centers [5]. Regarding the learning curve associated to the procedure, the major technical challenge is to operate within a cavity with 4 cm in diameter. Traction, counter-traction, dissection, and suturing are difficult to implement. Moreover, using 5-mm curved instruments as provided by the manufacturer adds a very modest effect to general practicability. Some initiatives aiming at reducing learning curve and costs with TEM were attempted. The Trans-Anal Minimally Invasive Surgery (TAMIS) [6] approach combines singleport access surgery with the principles of endoscopic transanal excision. During TAMIS, a single-incision laparoscopic surgery port is introduced in the anal canal, followed by transanal surgery using conventional laparoscopic instruments. Several case series reported technical feasibility and low morbidity associated to the technique [7–10]. However, there is some experimental evidence favoring TEM over TAMIS. In a comparative experimental study [11] between TEM and TAMIS in a simulator, there was an increased level of difficulty and a higher failure rate after TAMIS, especially while suturing the rectal defect. Despite of the potential superiority of free scope movement during TAMIS, concerns remain about the unsolved stability of the surgical platform. The use of smaller ports to perform laparoscopic procedures is defined with different names such as ‘‘minilaparoscopy,’’ ‘‘microlaparoscopy,’’ ‘‘miniendoscopic’’ or ‘‘microendoscopic surgery,’’ and ‘‘microinvasive surgery’’ [12]. One of the key aspects of minilaparoscopic surgery is the improvement in optics technology and instrument design [13]. Apart from the clip applier, the ultrasonic shears, and staplers, all instruments are available in 3-mm size still keeping a high standard of performance. Although during minilaparoscopic surgery, smaller instruments may result in a reduced grasping capability and lack of tensile strength; this may not represent an issue in TEM environment, due to reduced specimen size. Moreover, instrument miniaturization may lead to technique optimization. In the present study, we hypothesized that visualization and maneuverability during basic tasks associated with TEM performed with 3-mm minilaparoscopic instruments would be superior when compared to the same tasks performed using conventional 5-mm instruments. Therefore, the perceptions of surgeons recruited in an experimental study over a TEM simulator were gathered and analyzed.
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Materials and methods Subjects General and colorectal surgeons were recruited to participate in the experiment after providing full informed consent The study was accomplished during the 2012 Brazilian Congress of Laparoscopic Surgery of the Brazilian Society of Laparoscopic Surgery. The eligibility criteria were the availability to participate in the study, a personal experience with TEM under 10 cases, and lack of previous experience with TEM performed with 3-mm minilaparoscopic instruments. Study design The study flow diagram is in Fig. 1. Before performing the tasks, all participants were briefed during a 10-min presentation on the simulator about its functioning and the assigned tasks. The tasks were the same for all included subjects and there was no time limit for task completion. The equipment for transanal endoscopic microsurgery was the TEOÒ (Transanal Endoscopic Operations) platform along with the conventional 5-mm TEOÒ instruments and the 3-mm minilaparoscopic instruments (Karl Storz Endoskope, Tuttinglen, Germany). Two parts of the experiment should be completed by each participant using the TEOÒ-Neoderma simulator. In the first part of the experiment, a ‘‘polyp lesion’’ should be excised using conventional 5-mm TEOÒ curved-tip instruments. All included surgeons were asked to maintain polyp integrity and a 5-mm free margin during excision as if done with oncologic intent. Subsequently, closure of the ‘‘rectal’’ defect should be undertaken. For polyp excision, a 5-mm curved grasping forceps was used in the surgeon’s left hand a 5-mm scissors equipped his right hand. For the defect closure, the same 5-mm grasping forceps were used in conjunction with a 5-mm needle-holder. A 2/0 Monocryl (poliglecaprone 25, Ethicon Endo-Surgery) running suture was used and the thread was fixed proximally and distally with laparoscopic clips. In the second part of the experiment, the participants repeated the same excision and defect closure tasks using minilaparoscopic instruments. At this time, for polyp excision, the surgeon had a 3-mm minilaparoscopic grasping forceps on his left hand, and a 3-mm minilaparoscopic scissors on his right hand. For defect closure, a 3-mm needle-holder was used. The TEOÒ-Neoderma simulator A specially designed simulator was developed for this study at the Research and Training Center of the
Surg Endosc
Fig. 1 Study flow
Department of Surgery at Federal University of Pernambuco (Recife, PE, Brazil) using the Transanal Endoscopic Operations (TEOÒ, Karl Storz Endoskope, Tuttinglen, Germany) platform, the TEOÒ-Neoderma simulator (Fig. 2). Neoderma is a synthetic material offering color, touch, consistency and texture similar to human tissues. The TEOÒ-Neoderma simulator consists of a 30 cm-long and 4 cm-wide cylinder, naturally self-expanded and closed at one end, simulating a gas-inflated rectum. The present surgical model is manufactured with three 2 cmsized ‘‘polypoid tumors.’’ The simulator is connected to a complete video system comprising an analog camera, a video monitor and a light source (TelepackÒ, Karl Storz, Tuttlingen, Germany).
TEOÒ with minilaparoscopic instruments Transanal endoscopic microsurgery with the TEOÒ platform routinely requires using 5-mm curved-tip instruments during the operation. To verify the hypothesis of the present study, regarding the use of minilaparoscopic 3-mm instruments, an adjustment was made. Since TEO platform has been designed for the use of 5-mm instruments, using 3-mm instruments would result in air leak from the pneumorectum in the real clinical scenario. To prevent this, low-friction minilaparoscopic trocars were used in combination with the 3-mm minilaparoscopy set (Karl Storz, Tuttinglen, Germany)—Figs. 3 and 4—in the simulator exactly as they would be used in the clinical setting. A
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impression according to pre-task expectations, (5) ease of performing the tasks, (6) instrument flexibility according to task performance, and (7) quality of visualization. In this study, to avoid double inquiring each surgeon it was agreed that the score result for each one of the seven questions regarding the experience with the conventional 5-mm instruments would be equal to 3 (neutral). Therefore, the evaluation regarding the experience with the 3-mm instruments was compared to a hypothetical neutral (score value 3) evaluation of the 5-mm instruments. Statistical analysis
Fig. 2 The TEOÒ-Neoderma simulator used in the study
Regarding each one of the seven questions about the experience with the 3-mm instruments, a non-parametric Wilcoxon’s test was conducted to determine if the results were different from 3 (neutral). To determine if there is variation among the questions regarding score results, an analysis of variance for repeated measures (ANOVA) was conducted. The analysis was conducted because it represents a test that takes into account that the same surgeon answered more than one question. Next, a Multiple Comparison Analysis using the Tukey method was used to determine which questions presented a different variation according to score results distribution. The significance level of 0.05 was considered for testing, which equates to a 95 % confidence.
Results
Ò
Fig. 3 TEO platform set-up with minilaparoscopic instruments passed through low-friction trocars
special feature of these trocars is the absence of silicone valves. This feature enables a frictionless and more precise insertion of instruments during surgery. Questionnaire assessment The sole endpoint of the present study was the surgeons’ perceptions on visualization and maneuverability over task performance on the simulator when using minilaparoscopic 3-mm instruments compared to conventional 5-mm instruments. After tasks conclusion using 5-mm instruments followed by 3-mm instruments, the participants were asked to fulfill an evaluation questionnaire (Table 1). Seven questions in the instrument were about the following issues: (1) adequacy of instrument diameter, (2) movement response to command, (3) comfort during task performance, (4) global
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The questionnaire’s score results (mean and media values) for the seven questions according to the answers of 18 participating surgeons are summarized in Table 2. For each one of the seven questions addressed in the questionnaire, the score results were significantly higher than 3 (neutral) indicating that performance with the 3-mm minilaparoscopic instruments in the TEO simulator was superior to the performance using conventional 5-mm instruments (between ‘‘better than expected’’ and ‘‘much better than expected’’). The median scores for each question and the Wilcoxon’s test results are displayed in Table 3. Question 1, regarding the issue on adequacy of minilaparoscopic instruments diameter, presented the highest mean score (4.89) indicating that participating surgeons have identified the characteristic of smaller instrument diameter as the most distinguished feature of the minilaparoscopic equipment when compared to conventional equipment. On the other hand, question 5, that addressed the ease of performing the tasks (‘‘resection’’ and ‘‘suture’’) in the simulator, presented the lowest mean score (4.28) (Table 2; Fig. 5), indicating a significant but possibly lesser difference of
Surg Endosc Fig. 4 Photographic view of transanal endoscopic microsurgery in the TEOÒNeoderma simulator performed with conventional 5-mm surgical instruments (CONVENTIONAL) and with 3-mm minilaparoscopic instruments (TEO ? MINI)
Table 1 Evaluation questionnaire Analyze the parameters listed below in the left column. Consider for each, rating your task experience with conventional 5-mm instruments HERE Now rate your impressions with 3-mm minilaparoscopic instruments (choose one alternative for each parameter) Parameter
Much worst than expected 1
Worst than expected 2
Similar 3
Better than expected 4
Much better than expected 5
Question 1 Adequacy of instrument diameter Question 2 Movement response to command Question 3 Comfort during task performance Question 4 The result is in accordance to my expectation Question 5 Ease of performing the tasks Question 6 Instrument flexibility according to task performance Question 7 Quality of visualization
minilaparoscopic instruments over conventional 5-mm equipment. ANOVA results depicted in Table 4 demonstrate that the mean score results of the seven questions have varied between themselves (p = 0.0108) regarding its distance
from the neutral (score value 3) value which was, by convention, defined as the 5-mm instruments performance. A significant difference between the mean scores of questions 1 (addressing instrument diameter) and 5 (addressing ease of task performance) was observed, as
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Surg Endosc Table 2 Score results for the seven questions according to 18 participating surgeons Questions
Mean
Median
Standard deviation
Minimum value
Maximum value
Number of answers
Question 1
4.89
5.0
0.32
4
5
18
4.50
4.5
0.51
4
5
18
4.44
4.5
0.62
3
5
18
Question 4 The result is in accordance to my expectation
4.50
5.0
0.62
3
5
18
Question 5
4.28
5.0
1.07
1
5
18
4.56
5.0
0.78
2
5
18
4.78
5.0
0.43
4
5
18
Adequacy of instrument diameter Question 2 Movement response to command Question 3 Comfort during task performance
Ease of performing the tasks Question 6 Instrument flexibility according to task performance Question 7 Quality of visualization
Table 3 Wilcoxon’s test results for each one of seven questions in the questionnaire evaluation according to the answers of 18 participating surgeons Visualizaon
Question
Median
CI 95 %
p
Question 1
5.0
(5.0; 5.0)
\0.001
Question 2
4.5
(4.0; 5.0)
\0.001
Question 3 Question 4
4.5 4.5
(4.0; 5.0) (4.0; 5.0)
\0.001 \0.001
Question 5
4.5
(4.0; 5.0)
0.003
Question 6
4.5
(4.5; 5.0)
\0.001
Question 7
5.0
(4.5; 5.0)
\0.001
CI 95 % means confidence interval
demonstrated by the Tukey method used for multiple comparisons (Table 5).
Discussion TEM is a minimally invasive surgical technique that offers exposure and access to rectal lesions better than conventional transanal excision [14]. Compared to transanal excision specimens, TEM-derived lesions are more likely to be resected in one piece and with clear margins. Therefore, when colorectal surgeons master TEM techniques, they are not likely to resort to conventional transanal excision. Moreover, for selected rectal cancers, TEM is associated with reduced complication rates when compared to total mesorectal excision [15]. Although the late Professor Gerhard Buess first published TEM in 1983, it evolved with slow acceptance due
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Instrument diameter 5 4 3 2 1 0
Instrument flexibility
Comfort
Ease of performance Mean
Response to command
Accordance to expectaons
Similarity to convenonal instruments
Fig. 5 Assessment questionnaire’s answers scores of surgeons’ perceptions of performance in the TEO simulator with 3-mm minilaparoscopic instruments and their relation to similarity to conventional 5-mm instruments (score 3)
to its perceived difficulty, the cost of the equipment, and limited indications [16]. As a matter of fact, worldwide experience with the procedure may be still reduced. For example, the number of patients treated by Buess and coworkers for 15 years after the introduction of the technique was only 500 [17]. TEM requires specific technical capabilities. It is our opinion that this concept may be the precise cause for the lowest mean score observed for question 5, which has addressed the ease of performing the tasks. Not even using minilaparoscopic instruments can turn TEM into a much easier procedure. Working within a 4.0-cm wide surgical rectoscope results in a dramatic limitation of maneuverability, possibly worst than observed during single-port
Surg Endosc Table 4 Analysis of variance (ANOVA) for repeated measures results of mean answer scores Sum of squares Questions Error
Degrees of freedom
Mean squares
F-stat
p
2.949
0.0108
4,603
6
0.767
26,540
102
0.260
Table 5 Descriptive levels (p values) for multiple comparisons using the Tukey method Question 1 Question 1
Question 2 0.2604
Question 3
Question 4
Question 5
Question 6
Question 7
0.1327
0.2604
0.0089
0.4461
0.9948
0.9999
1.0000
0.8473
0.9999
0.6611
Question 2
0.2604
Question 3
0.1327
0.9999
Question 4
0.2604
1.0000
0.9999
0.9999
0.9572
0.9948
0.4461
0.8473
0.9999
0.6611
Question 5
0.0089
0.8473
0.9572
0.8473
Question 6
0.4461
0.9999
0.9948
0.9999
0.6611
0.6611
Question 7
0.9948
0.6611
0.4461
0.6611
0.0599
0.0599 0.8473
0.8473
Results italicized indicate a significant difference between the mean scores of questions 1 and 5
laparoscopic surgery. Therefore, equipment miniaturization may play a role on reducing technical difficulty. We hypothesized that visualization and maneuverability during TEM operations performed with 3-mm minilaparoscopic instruments would be superior when compared to conventional 5-mm instruments. In this pilot experimental study conducted in a simulator, it was demonstrated that surgeons inexperienced or novice to TEM have confirmed suitability of 3-mm minilaparoscopic over conventional 5-mm instruments. All answers measured in the evaluation questionnaire indicated that performance using minilaparoscopic instruments was superior to conventional instruments. Moreover, even when mean scores did not indicate a ‘‘much better than expected’’ perception, which was the case for questions 1 and 5, in all other questions, the average obtained score was above ‘‘better than expected.’’ As far as we can ascertain, this study was the first to evaluate the potential benefits of visualization and maneuverability using minilaparoscopic instruments to perform TEM. Although we have not evaluated the two fundamental steps of resection and suturing separately in the present study, the most critical issue in TEM is suturing. An ideal technique has not been described. The use of interrupted sutures with extracorporeal knot tying with a knot-pusher [18], barbed sutures [19], or robotic assistance [20] has been utilized. In the present study, an uninterrupted running suture was accomplished using laparoscopic clips to secure its ends. Clashing instruments during suture represents one of the most challenging limitations of this surgical step. Working with smaller instruments may again play a role in facilitating suturing.
The present study has several limitations. It was a small pilot experiment and represented an embryonic initiative. Since real clinical experience with the 3-mm minilaparoscopic instruments could not be provided, it is impossible to draw definite conclusions on its superiority over conventional 5-mm instruments. On the other hand, reliability of TEM simulators similar to the ones used in the present study has been demonstrated during training and credentialing initiatives worldwide [11, 21]. Moreover, the series consisted of few surgeons with limited number of cases. However, it is our belief that the magnitude of the findings may be easily reproducible since surgeons’ perceptions about the 3-mm instruments far exceeded our expectations. Moreover, despite participants were not experienced surgeons, the slightest familiarity with the technique may have increased the sensitivity in the perception of tools designed to facilitate procedure execution. Ultimately, another important limitation of the present study is that variables objectively associated to the hypothesis, such as operative time and quality of the resected ‘‘specimen’’ and suture, were not addressed as they were in a previous similar study comparing TEM and TAMIS experimentally [11]. Nevertheless, the objective evaluation of complex tasks like suturing during TEM may be difficult to reproduce. In conclusion, the analyzed perceptions of surgeons participating in this study have demonstrated that there is better visualization and maneuverability during basic TEM tasks conducted in a simulator using 3-mm minilaparoscopic instruments when compared to conventional 5-mm instruments. However, our data should be interpreted with caution, since a small experimental study is insufficient to validate the introduction of a new technology associated to
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TEM, which remains an exceptional platform for the minimally invasive surgical treatment of rectal lesions. Further studies should include surgeons experienced in transanal surgery techniques. These surgeons should be recruited to evaluate the use of minilaparoscopic instruments during TEM regarding immediate and late outcomes, preferably in comparison with TEM using conventional 5-mm curved-tip instruments. Disclosure Sergio Eduardo Alonso Araujo, Carlos Ramon Silveira Mendes, Gustavo Lopes Carvalho, and Marcos Lyra have no conflicts of interest or financial ties to disclose.
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13. 14.
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