[Natural orifices transluminal endoscopic surgery (NOTES) in Germany: summary of the working group reports of the "D-NOTES meeting 2009"]. / Endoskopisches Operieren über natürliche Körperöffnungen (NOTES) in Deutschland: Zusammenfassung der Arbeitsgruppensitzungen der "D-NOTES 2009"

The D-NOTES-group met in June 2009 for an evaluation of ongoing preclinical and clinical activities in natural orifice endoscopic surgery and the further coordination of research in Germany. Different working groups with various topics were formed. Consensus statements among various participants with different scientific and medical background were initiated. In summary, important topics were handled such as the correct handling of bacterial contamination and related complications, the question of the ideal entry point and a secure closure, interdisciplinary cooperation, and matters related to training and education. Furthermore, participants agreed on terminological basics. A to-do-list for medical engineering was formulated.

Experimental trial of transvaginal cholecystectomy: an ex vivo analysis of the learning process for a novel single-port technique.

BACKGROUND: Interest in natural orifice transluminal endoscopic surgery (NOTES) has expanded, and the first experiences with patients using different techniques have been reported. However, no work has addressed the learning process or the limitations of the procedures. The relation between inexperience and complications became a major concern after the introduction of laparoscopic surgery. This study investigates the learning process for a new technique using specially designed instruments in an ex vivo model before clinical application. METHODS: Specially designed instruments and a single-port technique using the Tuebingen Trainer were used to evaluate instrument and surgeon performance (learning curve) in terms of time and errors. A total of 90 procedures performed by three surgeons were evaluated. Group and individual learning curves were plotted. RESULTS: All the surgeons showed a reduction in both mean cholecystectomy time (subject A: 27.2 vs 16.6 min; subject B: 21.4 vs 19.22 min; subject C: 21 vs 19.7 min) and mean errors (subject A: 2.8 vs 1.6; subject B: 3.5 vs 2.6; subject C: 3.5 vs 2). A plateau was reached after approximately 15 procedures. Group learning curve analysis showed a significant reduction in time between the first group (mean, 24.97 +/- 5.8 min) and last group (mean, 19.30 +/- 3.09 min; F[1,28] = 11.83; p = 0.001) for 15 procedures, as well as reduced technical errors in the fifth group, from 3.7 +/- 1.65 to 1.6 +/- 1.04 (F[1,28] = 8.90; p < 0.01), demonstrating a learning effect. The number of optic and access port position changes were recorded, setting a standard for normal instrument performance. CONCLUSION: This study shows that the tasks of cholecystectomy can be learned safely in a reasonable number of simulations with the new instruments. Although this is a new technique, prior laparoscopic surgery experience is helpful. The technique offers an advantage over those using flexible endoscopes.

Laparoscopic intracorporal colorectal sutured anastomosis using the Radius Surgical System in a phantom model.

BACKGROUND: The Radius Surgical System (RSS) is a manipulator with additional degrees of freedom to enhance the dexterity of laparoscopic suturing. Our aim was to determine the feasibility and potentially added value of laparoscopic intracorporal sutured colorectal anastomosis (RSS) compared with suturing with conventional laparoscopic instruments (CLI). METHODS: A total of 72 colorectal anastomoses and 30 single sutures using RSS and CLI were performed in the study. The experiment was divided as follows: One surgeon performed 40 colorectal anastomoses using RSS to assess the learning curve and the feasibility of the technique; The same surgeon performed 10 additional colorectal anastomoses with CLI which were then compared to the last 10 cases of the 40 anastomoses with RSS; Fifteen single sutures in the horizontal plane with RSS and 15 with CLI between two segments of colon were performed to compare the traction force to disrupt the suture; Twelve anastomoses were performed by the other three participants to evaluate ergonomy. RESULTS: Three leakages (7.5%) were found in the 40 anastomoses with RSS but none after the eighth case. There was no stenosis. The mean time for the anastomoses once the learning curve was achieved was 32.7 min. After 21 anastomoses with RSS there was no improvement in the operating time. The quality of the suture was superior with RSS, with a larger anastomosis diameter, higher bursting pressure, and fewer suturing failures being found. The RSS suture withstood a higher traction force. The participants showed more discomfort suturing with CLI. CONCLUSION: This study demonstrated the feasibility of laparoscopic colorectal anastomosis using RSS. Anastomosis with RSS was shown to be safer. The three participants evaluating ergonomy reflected less discomfort in hand/wrist using RSS. Others ergonomic problems were comparable to CLI.

Ergonomics with the use of curved versus straight laparoscopic graspers during rectosigmoid resection: results of a multiprofile comparative study.

BACKGROUND: A detailed ergonomic comparison of motions and muscular activity in the left upper extremity using a laparoscopic straight or curved grasper in rectosigmoid resection is presented. METHODS: The study had two parts: experimental and clinical. In the experiment part, 30 laparoscopic sigmoid resections were performed under animal organ phantom conditions. The operations were divided into three groups according to instrument and trocar position. Group 1 (n = 10) underwent operations performed with a curved grasper in the excentral trocar position (in relation to the telescope trocar), with the left-hand curved grasper placed in the right flank and the right hand instrument in the right lower quadrant. In group 2 (n = 10), straight forceps were used in the excentral trocar position. Group 3 (n = 10) underwent laparoscopic sigmoid resection performed with a straight grasper in the central position (in relation to the telescope trocar), with the instruments placed at both sides of the lower abdomen. To measure ergonomic aspects during rectosigmoid resection, several overview video cameras, surface electromyography (EMG), an ultrasound tracking system (UTS), and a questionnaire were used. In the clinical part of the study, laparoscopic rectosigmoid resections (n = 5) were performed using a curved instrument in the excentral trocar position. The surgeon's left-hand movement and body posture were recorded for further analysis. RESULTS: The curved grasper required the fewest contractions (group 1) of the measured muscles. A comparison of the UTS analysis in the experimental part of the study and the video analysis in the clinical part showed economy of movements in group 1. According to subjective estimation, both physical activity and mental stress remain at the lowest level when the excentral trocar position is used (groups 1 and 2). CONCLUSIONS: The combination of the curved grasper and the excentral trocar position (in relation to the telescope trocar) is, according to our examinations, the best ergonomic adjustment for laparoscopic rectosigmoid surgery.

Precision in stitches: Radius Surgical System.

BACKGROUND: The Radius Surgical System is a manual manipulator with two additional degrees of freedom compared with conventional laparoscopic instruments (CLIs). This study aimed to compare the performance of laparoscopic suturing tasks with the use of the Radius Surgical System and CLIs, respectively. METHODS: Five experienced laparoscopic surgeons performed laparoscopic surgical tasks in a training box. The tasks consisted of knot-tying, suturing, and needle control tasks. The needle control task was performed to evaluate the precision of the needle drive by analysis of the needle exit point on a suture pad. In the knot-tying and suturing tasks, required time and accuracy value were measured. Needle control tasks were performed on three different angulations of plane. The angles between the instrument plane and the target plane (AIT) were 30 degrees, 60 degrees, and 90 degrees. The distance of the exit point to the center of the target field, the number of actions needed to fulfill a single task, and the required time were recorded and analyzed. RESULTS: In the knot-tying and frontal suturing tasks, there were no significant differences between the two groups. In the sagittal suturing task, the required time in the Radius group was significantly shorter than in the CLI group. In the needle control tasks on 30 degree and 60 degree AIT, the distance was significantly shorter in the Radius group than in the CLI group. There were no significant differences in the number of actions or the required time. In the frontal and sagittal needle control task on 90 degree AIT, the distance was significantly shorter in the Radius group than in the CLI group. The number of actions and the required time were significantly less in the Radius group than in the CLI group. CONCLUSIONS: The two additional degrees of freedom contributed to accurate and controlled needle guidance, especially in difficult spatial situations.

Experimental results of mesh fixation by a manual manipulator in a laparoscopic inguinal hernia repair model.

BACKGROUND: Laparoscopic mesh fixation using a stapler can lead to complications such as nerve injury and bowel injury. However, mesh fixation by suturing with conventional laparoscopic instruments (CLI) is difficult because of limited degrees of freedom. A manual manipulator--Radius Surgical System (Radius)--whose tip can deflect and rotate, gives the surgeon two additional degrees of freedom. The aim of this study is to evaluate the introduction of Radius to mesh fixation in laparoscopic inguinal hernia repair. METHODS: A model for inguinal hernia repair was prepared using animal organs in a trainer. Mesh fixation was performed using Radius, stapler, and CLI. Tensile strength during extraction of mesh toward the vertical direction, and execution time, were measured. RESULTS: The mean number of fixation points of Radius, stapler, and CLI was 9.3 +/- 1.5, 8.5 +/- 1.4, and 9.0 +/- 1.0, respectively. The mean tensile strength of fixation of mesh of Radius, stapler, and CLI was 140.7 +/- 48.9, 73.1 +/- 23.4, and 53.6 +/- 31.5 (N), respectively. The mean tensile strength per one fixation point by Radius, stapler, and CLI was 16.5 +/- 5.3, 8.7 +/- 2.8, and 6.3 +/- 3.6 (N), respectively. The mean execution time of Radius, stapler, and CLI was 479 +/- 108, 54 +/- 31, and 431 +/- 77 (sec), respectively. CONCLUSIONS: The mesh fixation by Radius was stronger than that by staples and CLI. Two additional degrees of freedom were useful in difficult angles. The introduction of Radius is feasible and facilitates the fixation of mesh with sutures in laparoscopic inguinal hernia repair.

Ergonomic testing of two different types of handles via virtual reality simulation.

BACKGROUND: Ergonomics in laparoscopic surgery is an unsolved problem. Deficiencies of the instrument handles are well-known and described in several reports and studies. Today, virtual training modules for laparoscopic surgery are available. The aim of this study was to evaluate the ability of a virtual reality (VR) simulator to determine the ergonomic properties of two different laparoscopic instrument handles. METHODS: Two different types of handles, a ring and an axial handle from Richard Wolf, were used to perform the short clip and cut task of the Xitact 500 LS simulator. The task was repeated every 2 days for a period of 5 weeks. After every trial the volunteers were asked structured questions about their preferences while using the two handles. RESULTS: The axial handle was superior or equal to the ring handle in all criteria. Learning curves over the entire time and day by day were similar. No differences were found for travel distances and error rates, but task times were different for both handles. The subjects preferred the axial handle at the end of the study. CONCLUSION: It is possible to determine differences in ergonomics of handle design with a VR trainer. In this study, the Richard Wolf axial handle was superior to the ring handle.

Experimental assessment of a new mechanical endoscopic solosurgery system: Endofreeze.

BACKGROUND: The assistance received by the surgeon from support personnel during operative laparoscopy is extremely important. This includes retraction of instruments and endoscope positioning. However, human assistance is costly and often does not provide satisfaction for the surgeon. The aim of this study was to develop a mechanical arm capable of allowing easy handling and holding of laparoscopic instruments under the surgeon's control. METHODS: We designed a system, named Endofreeze, based on a particular kinematical construction that maintains an invariant point of constraint motion just above the trocar puncture site through the abdominal wall. The goal was to develop this way a highly intuitive mechanical holding system for laparoscopic instruments, with sufficient precision of action, activated by a single hand movement. We tested a couple of prototypes with different holding arms while performing cholecystectomy in phantom models with swine inserts and compared the results obtained in similar conditions using different holding and positioning systems. RESULTS: The system allows transparent and intuitive operation, and its setup is easy and quick. It may be adapted either as an instrument retractor or as an optic positioning device. Compared to different systems available or prototypes previously tested, such as AESOP 2000, ENDOASSIST, FIPS Endoarm, TISKA Endoarm, and the Martin Arm, in similar conditions, it was more intuitive, allowing shorter time for completion of surgery. CONCLUSION: Endofreeze is a new intuitive mechanical positioning system for endoscopic solo surgery. In phantom models, it demonstrated a shorter time requirement for completion of surgery when compared to other systems available. In our opinion, it represents a valid compromise between human and robotic control for conventional laparoscopic instruments.

Monitor position in laparoscopic surgery.

BACKGROUND: One of the key problems in laparoscopy is the ergonomic positioning of the monitor. In this study we tested task performance and muscle strain of subjects in relation to monitor position during laparoscopic surgery. METHODS: Eighteen subjects simulated laparoscopic suturing by threading tiny pearls with a curved needle. This was repeated in three monitor positions (15 min each): frontal at eye level (A), frontal in height of the operating field (B), and 45 degrees to the right side at eye level (C). Subjects were not allowed to turn their heads during these sessions. After the test they were asked for their preferred monitor position. During all tests the electromyographic (EMG) activity of the main neck muscles was recorded and the number of pearls was counted. RESULTS: The EMG activity was significantly lower for position A compared to positions C and B (p < 0.05). No significant difference was found between positions B and C. The number of threaded pearls as an indicator for task performance was highest for position B. The difference was statistically significant compared to position C (p = 0.0008) but not between positions A and C (p = 0.0508) or A and B (p = 0.0575). When asked for the preferred monitor position, nine subjects chose two monitors in the frontal positions A and B. No subject preferred the monitor at the side position (C). CONCLUSION: Regarding EMG data, the monitor positioned frontal at eye level is preferable. Reflecting personal preferences of subjects and task performance, it should be of advantage to place two monitors in front of the surgeon: one in position A for lowest neck strain and the other in position B for difficult tasks with optimal task performance. The monitor position at the side is not advisable.

An innovative trainer for surgical procedures using animal organs.

Since 1990, almost 3000 surgeons have absolved the training course for minimally invasive surgery in our training center. A phantom trainer using animal organs has been used as a training device. Based on this experience, we have developed an innovative trainer for surgical procedures using animal organs. The form of this trainer was copied from a human body with gas insufflation; abdominal organs from the slaughterhouse can be integrated into this trainer. Surgeons can repeat operations such as laparoscopic cholecystectomy, appendectomy, fundoplication, colon resection and transanal endoscopic microsurgery in a realistic way and acquire a training effect in a short time.

New model for skills assessment and training progress in minimally invasive surgery.

BACKGROUND: With the spread of minimally invasive surgery and training in this field, development of metrics for skills assessment and training progress has become increasingly important. Our approach was to use the tracking of motion for the definition of objectives metrics. METHODS: We have developed an inanimate model and tracked the 3D coordinates of the instrument tips with an ultrasound system. Besides already validated parameters (time, error time, and distance efficiency ratio) we examined the transit and the speed profile for their evidentiary power. Performances of experts (who have already performed >100 laparoscopic operations) and novices (<20 laparoscopic operations) were evaluated. RESULT: The standardized time, the error time as a precision indicator, and the transit profile parameter for spatial perception could significantly ( p < 0.05) distinguish between experts and novices. Furthermore, these parameters and the distance efficiency ratio improved significantly during a training course in laparoscopic surgery. CONCLUSION: Our model showed changes of the mentioned parameters with experience. According to our results, it can be used for skills assessment and as a training progress measurement system. We propose transit profile as an additional important parameter for assessment.

Laparoscopic sutured anastomosis of the bowel.

BACKGROUND: Even though the safety and efficacy of sutured anastomosis have been proved in open surgery, laparoscopic sutured anastomosis is rarely performed because it is difficult and time-consuming. We aim at description of a standardized technique for laparoscopic sutured anastomosis of the bowel and definition of its learning curve. METHODS: Fifty-six laparoscopic sutured anastomoses of cow small intestine were performed in a laparoscopic simulator. In a survival animal trial, 10 end-to-end, 2 gastrojejunostomy, 2 cholecystojejunostomy, 2 colocolic, and one side-to-side anastomoses were performed, using the same technique. RESULTS: In the survival cases, we had no leaks or obstruction, minimal adhesions, and only one stenotic gastrojejunostomy. The mean end-to-end anastomotic time was 50 min. The technique was suitable for most sites in the GIT. The learning phase required 40 anastomoses in the simulator. CONCLUSIONS: The described technique seems relatively fast, safe, and universal, and it needs about 40 anastomoses to be mastered.

Transanal endoscopic microsurgery.

Transanal endoscopic microsurgery, although technically challenging, offers a viable and perhaps superior outcome to radical abdominal or traditional transanal excision of rectal neoplasia. Appropriate training and case selection, as with any new technology, are mandatory to help ensure optimal results.

[Dissection technique--is ultrasound the best method?]. / Dissektionstechnik--Ist der Ultraschall das beste Medium?

Preventive hemostasis is extremely important in endoscopic surgery. Ultrasonic dissectors are used very often. We tested the occlusion safety of bipolar forceps and ultrasonic dissector for porcine vessels. Thermographic videos showed maximum temperature up to 200 degrees C when using one ultrasonic dissector. The lateral damage zone in vivo and in vitro measured between 2 and 6 mm.

[Robotic and systems technology for advanced endoscopic procedures]. / Tecnologia robotica e dei sistemi per procedure endoscopiche avanzate.

The advent of endoscopic techniques changed surgery in many regards. This paper intends to describe an overview about technologies to facilitate endoscopic surgery. The systems described have been developed for the use in general surgery, but an easy application also in other fields of endoscopic surgery seems realistic. The introduction of system technology and robotic technology enables today to design a highly ergonomic solo-surgery platform. This consists of a system of devices for endoscopic surgery (HF, light source, etc...) with which the surgeon interacts directly, positioning systems for optic and instruments that the surgeon drives as the likes without assistance, and a chair to increase the comfort of the surgeon during surgery. The system of endoscopic devices named OREST (Dornier, München) designed already in 1992 opened the way to a number of systems available today that allow to the surgeon a direct control of the instrumentation. A considerable step ahead in endoscopic technology is the introduction of robotic technology to design assisting systems for solo-surgery and microsurgical instrument manipulators. Results of a number of experimental trials on combinations of different positioning devices are presented and commented. A further step in the employment of robotic technology is the design of "master-slave manipulators" to provide the surgeon with additional degrees of freedom of instrumentation. In 1996 a first prototype of an endoscopic manipulator system, named ARTEMIS, designed in cooperation with the Research Center in Karlsruhe, could be used in experimental applications. Clinical use of the system, however, will require further development of the arm mechanics and the control system. The combination with the implementation of telecommunication technology will open new frontiers, such as teleconsulting, teleassistance and telemanipulation.

Experimental trial on solo surgery for minimally invasive therapy: comparison of different systems in a phantom model.

BACKGROUND: Robotic aid in minimally invasive surgery (MIS) is becoming more and more common. We designed an experimental trial in a phantom model to verify the feasibility of solo surgery for MIS. By performing laparoscopic cholecystectomy on a phantom model, we compared combinations of different systems available in terms of safety, comfort, and time requirements. METHODS: Two surgeons skilled in endoscopic procedures tested the following systems as endoscope holders: the robotic system (AESOP), foot-controlled (AESOP 1000), and voice-controlled (AESOP 2000); the remote controlled FIPS Endoarm, electrically driven and controlled by a finger-ring joystic; the passive system TISKA Endoarm, a mechanical arm moved by hand and fixed by electromagnetical brakes. All of these systems combined with a second TISKA Endoarm as an instrument holder. A combination of two mechanical Martin arms, c, also was tested. The results were compared with those from a control group involving an assistant surgeon. A total of 70 experiments were performed. RESULTS: The shortest dissection time was registered by the combination of two TISKA Endoarms, with a statistically significant difference as compared with the control group (p < 0.05) and experiments using AESOP 1000 (p < 0.05). The TISKA Endoarm also proved to be more comfortable when used as an instrument holder (p < 0.001 vs Martin arm), and rated second only to AESOP 2000 as an endoscope holder. The rating of AESOP 2000 as endoscope holder was significantly higher than that of all other groups (p < 0.001). The study proved the feasibility of solo surgery. The time needed for dissection was shortest when two TISKA Endoarms were used, demonstrating the possible advantages of solo surgery. The TISKA Endoarm received a subjective positive rating when used as both endoscope holder and instrument holder. The voice control of AESOP 2000 seemed to be a major improvement in the development of an optimal man-machine interface. Nevertheless, the system presents considerable space requirements and does not supply control of 30 degrees optics. The principle of the finger-ring joystick adopted by the FIPS Endoarm seemed very intuitive but lacking in ergonomy. CONCLUSION: Laparoscopic solo surgery can be considered a safe procedure, although further technologic developments should lead to improved ergonomy, intuitiveness of handling, and architecture of the systems, offering the surgeon better control, increased precision of action, and reduction in operation time.