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Research ArticleClinical Studies

Full High-definition Three-dimensional Gynaecological Laparoscopy – Clinical Assessment of a New Robot-assisted Device

BENJAMIN TUSCHY, SEBASTIAN BERLIT, JOACHIM BRADE, MARC SÜTTERLIN and AMADEUS HORNEMANN
In Vivo January 2014, 28 (1) 111-115;
BENJAMIN TUSCHY
1Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Mannheim, Germany
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  • For correspondence: benjamin.tuschy{at}umm.de
SEBASTIAN BERLIT
1Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Mannheim, Germany
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JOACHIM BRADE
2Department of Medical Statistics and Biomathematics, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
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MARC SÜTTERLIN
1Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Mannheim, Germany
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AMADEUS HORNEMANN
1Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Mannheim, Germany
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Abstract

Aim: To investigate the clinical assessment of a full high-definition (HD) three-dimensional robot-assisted laparoscopic device in gynaecological surgery. Patients and Methods: This study included 70 women who underwent gynaecological laparoscopic procedures. Demographic parameters, type and duration of surgery and perioperative complications were analyzed. Fifteen surgeons were postoperatively interviewed regarding their assessment of this new system with a standardized questionnaire. Results: The clinical assessment revealed that three-dimensional full-HD visualisation is comfortable and improves spatial orientation and hand-to-eye coordination. The majority of the surgeons stated they would prefer a three-dimensional system to a conventional two-dimensional device and stated that the robotic camera arm led to more relaxed working conditions. Conclusion: Three-dimensional laparoscopy is feasible, comfortable and well-accepted in daily routine. The three-dimensional visualisation improves surgeons' hand-to-eye coordination, intracorporeal suturing and fine dissection. The combination of full-HD three-dimensional visualisation with the robotic camera arm results in very high image quality and stability.

  • Gynaecological laparoscopy
  • 3D
  • full HD
  • clinical assessment

Laparoscopic surgery has become standard treatment for various malignant and benign gynaecological diseases. Since its introduction, minimally-invasive surgery has been limited by the lack of depth of perception and spatial orientation due to the two-dimensional (2D) visualisation of the intra-abdominal environment. Hence indirect references, such as the motion of the laparoscope, size of anatomical structures and changes in shading and structure, are used to achieve sufficient depth perception. This requires for great expertise on the part of the surgeon and mental processing of the 2D image into a 3D image in order to perform complex tasks, such as intracorporeal suturing or accurate dissection, successfully (1). Since the early 1990s, many 3D systems have been developed and several studies dealing with 3D visualisation in ex vivo settings have been carried out, reporting inconsistent results (2). Early prototypes suffered several technical flaws and some authors criticised the quality of 3D imaging, as a result of low resolution in older-generation 3D technologies. The efficiency of high-definition (HD) resolution in laparoscopic video systems has not been definitively proven, although it is commonly assumed, and all new laparoscopic systems are equipped with HD technology (3). Reports of 3D laparoscopy in clinical settings are scarce. Storz et al. showed a significant difference in favour of 3D visualisation using the “Einstein Vision®” system (B. Braun, Aesculap AG, Tuttlingen, Germany) compared to a 2D laparoscopic system in an ex vivo setting (4). Hence aim of this investigation was to report our experience with a novel full HD 3D robotic-assisted laparoscopic system, and surgeons' perception of this new device.

Patients and Methods

A total of 70 women underwent gynaecological 3D laparoscopy between 06/2012 and 12/2012 at the University Medical Center Mannheim, and were included in this report. Women were prospectively enrolled. The Einstein Vision® system was used for all procedures. This 3D full-HD imaging system consists of a 10 mm outer diameter 30° stereoscopic endoscope, a digital 3D full-HD camera, and a 32-inch 3D full-HD monitor. The endoscope was handled by a robotic arm attached to one (usually the right) side of the operation table and covered by a sterile cover preoperatively. This 16-kg heavy arm has a three-joint aluminium structure. Movement instructions for the robotic arm and camera system are given by the assisting physician, or by the assisting nurse according to the instruction of the surgeon, using the remote control. In general, the camera can be moved to the left, right, up, down, forward and backward. For every procedure, common laparoscopic instruments (B Braun) were used. All laparoscopic surgeries were performed under general anaesthesia. A 10-mm optic trocar was inserted beneath the umbilicus and two 5-mm trocars respectively one 5 and one 10-mm trocar were placed laterally in the lower abdomen. If necessary, an additional 5-mm trocar was inserted suprapubically. In the case of laparoscopic supracervical hysterectomies (LASH) or fibroid resection, a 12-mm trocar was used for incorporation of the morcellator. Intraoperative pressure was at a maximum of 15 mmHg. Surgeons and nurses had to wear special glasses in order to achieve a 3D view on the screen. After surgery, surgeons and assistant physicians completed a standardised questionnaire regarding this novel laparoscopic device. Results were assessed in a standardised itemised scale (Likert scale). Demographic parameters such as patient age, body mass index (BMI) and previous abdominal surgeries, were collected before surgery. Type of surgery, intra- and postoperative complications, duration of surgery and overall hospital stay were evaluated.

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Table I.

Characteristics of the participating physicians (n=15).

Statistics. All data were stored in an MS Excel sheet. After careful review for false data entry, the data were imported into the SAS environment (Version 9.2, SAS Institute Inc., Cary, NC, USA). Data are presented as the mean±standard deviation.

Results

All procedures were successfully performed with this novel device. Thirty patients underwent LASH and seven total laparoscopic hysterectomy (TLH). Seven women had bilateral laparoscopic adnexectomy, 14 laparoscopic myomectomy and two women underwent diagnostic laparoscopy. Fifteen physicians with different levels of training participated in this trial (Table I). Surgical parameters are shown in Table II. Concerning patients' characteristics, the mean age of the participating women was 45.5±10.1 years (range=30-74 years). The mean BMI was 26.8±5.3 kg/m2 (range=19-46 kg/m2). Thirty-seven percent (26/70) of investigated patients did not have prior abdominal surgery. Thirty-one percent (22/70) had undergone prior laparoscopic surgery, 19% (13/70) had had a laparotomy once and 13% of the participants (9/70) had undergone laparotomy more than once. There were no severe intra- or post-operative complications in the study collective. All surgeons achieved a 3D vision by wearing special glasses. Concerning their evaluation of the 3D glasses, three persons (3/15; 20%) stated impairment by wearing the special glasses and found that the glasses were disturbing during surgery. Thirteen of the participants (87%) stated that 3D visualisation improved hand-to-eye coordination, and all physicians were of the opinion that 3D visualisation improved the detection of anatomical structures (e.g. ureter, vessels) (Table III). All physicians (7/7) who performed intracorporeal suturing stated that 3D visualisation facilitated this complex task. Each participant (9/15, 60% strongly agreed; 6/15, 40% agreed) would prefer full-HD 3D visualisation in standard laparoscopic procedures in comparison to conventional 2D device. All physicians (12/15, 80% fully-agreed; 3/15, 20% agreed) stated that the robotic arm produced a more stable image compared to a human assistant, and the majority (9/15, 60% strongly agreed; 3/15, 20% agreed) were of the opinion, that the robotic arm allows for more relaxed working conditions (Table IV). Overall evaluation of the 3D visualisation in combination with the robotic arm revealed that improved image stability and image quality seem to be the major benefits of this novel device (Table V). Furthermore, there wer e no severe intra- or post-operative complications in our study collective. All patients received pain relief according to a fixed schedule, and low-molecular weight heparin for thromboprophylaxis.

Discussion

Due to a steady increase in the number of minimally-invasive procedures, surgeons are increasingly faced with the disadvantages of 2D imaging systems. The loss of depth perception is of particular interest in complex procedures, such as laparoscopic intracorporeal suturing or dissection of pelvic and para-aortic lymph nodes. The first report of a 3D laparoscopic device in human surgery was published in 1993 by Becker et al. (5). The first 3D laparoscopic systems were limited by poor image quality, eyestrain and cumbersome laparoscopic devices. In 1996, Volz et al. stated that the 3D laparoscopic system of that time had advantages for microsurgical procedures but was unsuitable for surgery of the uterus or adnexal masses (6). This conclusion can be attributed to the low quality of the early generation of 3D laparoscopic systems. In our study, all surgeries were completed successfully, with consistently positive assessment by surgeons, and no conversion to laparotomy or 2D visualisation was necessary. This reflects the development of better visual and laparoscopic techniques and the fact that previous technical flaws were eliminated. Our investigation shows that the full-HD 3D laparoscopic device used here is comfortable and suitable even for extensive laparoscopic surgery. The loss of spatial depth using a 2D system can be compensated for by the experience of the surgeon and by the ability of the human brain to process additional information (secondary spatial depth cues) to achieve spatial orientation (4). In the 3D visualisation, the mental workload previously required for transformation of indirect references, such as motion of the laparoscope, size of anatomic structures and changes in shading and texture, can be used for enhanced concentration. This may result in a significant gain in precision for difficult surgical tasks and significantly increase the speed of tasks, as shown by Storz et al. in an ex vivo setting (4). In the future full-HD 3D approaches might offer the possibility not only of performing surgery faster but also performing them with more safety due to easier identification of anatomical structures. Phantom task setups simulate partial surgical procedures but do not reflect the complexity of real clinical conditions. To the best of our knowledge, this is the first clinical report of gynaecological laparoscopic surgeries performed with a 3D robot-assisted laparoscopic system in HD quality. Previous studies showed that the error rates in in vitro settings were increased and that more movements of the laparoscopic instruments were necessary to complete laparoscopic tasks successfully using 2D visualisation (2, 7). Interestingly, the more complex the tasks, the more 3D visualisation enhanced task performance, independently of the laparoscopic experience of the surgeon (8). Kong et al. stated that 3D systems could help physicians to perform surgical procedures more accurately and safely, which is confirmed by our findings that all participants rated, 3D visualisation as improving detection of anatomical structures and facilitating complex laparoscopic procedures. Except for one person in our study, who was affected by headache and eye fatigue, no one felt visual discomfort or suffered nausea. These favourable results regarding visual comfort may be partially attributed to the full-HD visualisation. Higher dizziness rates were reported in earlier studies dealing with 3D laparoscopy but without the usage of full-HD visualisation (2). The beneficial results in our study regarding full HD visualisation in 3D are consistent with the results of other investigations dealing with HD quality both for 2D and 3D laparoscopy (4, 9). Hagiike et al. showed that HD visualisation compared to conventional standard visualisation provides a superior image and leads to a reduced time for laparoscopic knot tying (9). The combination of full HD and 3D visualisation is favourable regarding time and error rate compared to full-HD 2D laparoscopy, as shown by Storz et al. (4). The physicians who were negatively-affected by wearing the special glasses for 3D vision did not wear glasses in daily life. Therefore, it is not surprising that wearing glasses in the unusual setting of the operation theatre during surgery was rated as disturbing. As previously shown by Honeck et al., the use of a laparoscopic device, as also used in our series, leads to a significant benefit regarding missed grasps and the loss of working materials in an in vitro setting (1). So it is not surprising that the majority of surgeons felt an improvement of the hand-to-eye coordination and all of them believed that 3D imaging may widen the operative spectrum of laparoscopic surgery. Additionally, the robotic camera arm is particularly useful for performing complex tasks when more than two hands are needed. On the occasions in which the assistant physician would normally have to handle the camera, they can now assist actively with two laparoscopic instruments or in other ways. Besides these advantages, there are some disadvantages to be noted. A major drawback of the system used in this study is the significantly higher acquisition costs compared to standard laparoscopic systems. Studies dealing with 3D laparoscopy report inconsistent results and investigations in clinical settings with 3D full-HD laparoscopy are scarce (4, 10). Our results show that a broad range of gynaecological surgery could be performed successfully and 3D visualisation in combination with a robot-assisted laparoscope holder reached high satisfaction rates. We are aware of the limitations of our study. The questionnaire used in the present study reflects subjective impressions of the participating surgeons and no direct comparison of 2D versus 3D approaches were performed. Moreover, the evaluation of a novel technique is affected by the surgeon's level of experience and their subjective attitude towards innovation. Nevertheless our study included surgeons with different levels of training, giving a detailed assessment of a novel laparoscopic system. We believe that this technique seems to be a promising and innovative alternative to conventional laparoscopic devices. This is strengthened by the fact that all participants stated they would prefer 3D in standard gynaecological laparoscopic procedures and that 3D visualisation should be used more frequently. Nevertheless, it remains debatable if robot-assisted 3D systems should be used in short, uncomplicated or purely diagnostic procedures, bearing in mind the time required for attachment of the robotic arm, costs of the system and tight surgical schedules. Whether this technique will become more popular, as has already been shown in the steadily-increasing number of 3D cinema movies and 3D products in the home entertainment segment, remains to be seen.

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Table II.

Type of laparoscopic surgery performed.

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Table III.

Assessment of the 3D visualisation; n=15.

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Table IV.

Assessment of the robotic arm.

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Table V.

Overall assessment of the Einstein Vision® system.

  • Received September 29, 2013.
  • Revision received November 7, 2013.
  • Accepted November 8, 2013.
  • Copyright © 2014 The Author(s). Published by the International Institute of Anticancer Research.

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Full High-definition Three-dimensional Gynaecological Laparoscopy – Clinical Assessment of a New Robot-assisted Device
BENJAMIN TUSCHY, SEBASTIAN BERLIT, JOACHIM BRADE, MARC SÜTTERLIN, AMADEUS HORNEMANN
In Vivo Jan 2014, 28 (1) 111-115;

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Full High-definition Three-dimensional Gynaecological Laparoscopy – Clinical Assessment of a New Robot-assisted Device
BENJAMIN TUSCHY, SEBASTIAN BERLIT, JOACHIM BRADE, MARC SÜTTERLIN, AMADEUS HORNEMANN
In Vivo Jan 2014, 28 (1) 111-115;
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