Comparison of the technologies under assessment
A comparative analysis of technologies between 2D and 3D systems used in the Italian market was undertaken using the technical characteristics provided by manufacturers/suppliers. Four different providers of the new 3D technology were contacted and, upon request, made available data on the standard 2D and the new 3D equipment. No significant differences were found between the various 2D systems. All the 3D technologies utilised full-HD 3D (≥ 1920 × 1080 pixels) with a 26″–32″ monitor. All systems were provided with “light and comfortable” passively polarized glasses and did not require synchronisation with the video images (as with earlier 3D systems ). The main characteristics of 2D and 3D systems (visual resolution, images distribution and optics) were comparable and superimposable. The systems consisted of a camera, monitor, light source and image processor: no collateral accessories were considered in the comparative cost and performance analysis. Data on median costs of the laparoscopic columns (based on the industries’ sales catalogues) were 64,774.36 euro for the 2D column and 107,577.54 euro for the 3D column. Data on dissemination of the 3D systems in Italy showed a penetration in Italian surgical units of around 15% (from a total of 876 surgical units, data extracted from an Italian national database ). Also considered was that the potential penetration of the new technology could reach approximately 100%, since all surgical units in Italy have a 2D laparoscopic column in their operating theatres.
Efficacy, safety and organisational results: evidence from the literature review
Seven systematic reviews were accomplished, each supported by 8–44 papers (comprehending systematic reviews, randomised controlled studies, comparative studies or prospective–retrospective cohort studies) after a selection by titles and abstract, removal of duplicates and exclusion of non-pertinent studies after full-text retrieval, as shown by Prisma flow diagrams in Online Appendix 1. Summary of findings and results for each selected study have been drafted and the data were summarised for each EuNetHTA dimension.
General relevance of the pathology
The relevance of the health problem was determined by comparing articles related to different operations for 3D vs. 2D laparoscopy in the three settings of general, urologic and gynaecologic surgery. The analysed operations were cholecystectomy, colectomy, adrenalectomy, hepatic resection, pulmonary resection, obesity surgery in the context of general surgery; hysterectomy and pelvic lymphectomy for gynaecological surgery; radical transperitoneal and retroperitoneal prostatectomy, pyeloplasty, urethroplasty and radical cystectomy for urologic surgery. A hypothetical representative pool of patients, who had undergone these surgical procedures, was defined as a general case mix of a standard and generic Italian hospital. The hypothesised case mix was derived from a recent survey performed in Campania Region . In this specific setting, in the year 2014, 8566 patients underwent some kind of general, gynaecologic or urologic surgery. Out of these, 3544 patients (41.38%) underwent one of the laparoscopic operations described (Table 1).
Evaluation of outcomes
Two clinical settings and 4 simulated settings were explored:
3D vs. 2D in the clinical setting of general surgery: 9 comparative studies (4 randomised controlled studies—RCTs) out of 235 screened papers;
3D vs. 2D in the clinical setting of gynaecology and urology: 35 comparative studies (1 systematic review—SR and 12 RCTs) out of 667 screened papers;
3D vs. 2D, pitfalls and drawbacks in simulated settings: 8 comparative studies (5 RCTs) out of 56 screened papers;
3D vs. 2D, value in teaching for simulated settings: 44 comparative studies (1 SR and 36 RCTs) out of 267 screened papers;
3D vs. 2D, surgeons’ confidence and comfort: 12 comparative studies out of 187 screened papers;
3D vs. 2D, surgeons’ performances in the simulated setting: 34 studies (1 SR and 26 RCTs) out of 149 screened papers.
Significativity was investigated with Excel’s descriptive Statistics tool (Microsoft®).
Results in clinical settings concerning morbidity reported a significant difference in urinary continence favouring 3D in radical prostatectomy and cystectomy (p < 0.02 and 0.05), and a substantial overlap in safety issues for other surgeries.
Haemorrhages were significantly lower for 3D pelvic lymphectomy (38 vs. 65 ml, p = 0.033) and radical prostatectomy (p < 0.05), though similar in other surgical contexts.
The surgeons’ safety and comfort in the clinical setting had been examined only by three Italian studies [12,13,14,15] and demonstrated a significant advantage in terms of less visual fatigue and neck pain in 3D laparoscopy. Simulated settings failed to show statistically significant differences in the surgeons’ perspective between the two visual systems, even if results seemed inverse favouring the 2D setting but with a discomfort (in particular, related to dizziness and physical discomfort, worse in the 3D setting in 2 out of 19 studies [16, 17]) that was described as “tolerable”.
The efficacy value used in the analysis was the operating time, related to the two comparators. No significant differences emerged in the clinical setting of general surgery, even if 3D seemed to shorten the median time. This was particularly evident in laparoscopic cholecystectomy and when isolating the subgroup of “non-expert” or novice surgeons, in which the operating time significantly shortened.
To evaluate the organisational impact for general surgery, the differences in operating time were recalculated in terms of median values, considering only the articles with a significant difference between 2D and 3D (Tables 2 and 3). Tables 2 and 3 show a significant advantage in implementing the 3D technologies, both in general surgery and urology. However, no significant differences were found within the ob-gyn setting. These results, deriving from the literature evidence, were the differential values (if reported) used in the budget impact analysis in order to estimate the overall economic savings assuming the hospital point of view.
No significant differences were found between 2D and 3D technologies considering the hospital stay.
Significant differences were observed in depth perception [16, 19,20,21,22] and eye–hand coordination [23, 24], favouring the 3D approach.
The experimental setting reported better performances (speed, accuracy) with 3D vision, both in the expert and in the novice surgeons [19, 21, 25,26,27,28,29]. The reduction in time was related to various tasks at the simulator (peg transfer, shape, and paper cutting, suturing, rope passing, needle capping), all statistically significant, and some studies evidenced a reduction of the error rate . This is particularly significant for the novice surgeons [20, 32] who are able to perform difficult tasks more easily and feel more comfortable, and reflects on learning curves with a significant advantage in the performance of the surgical practices overall. Collateral effects (nausea, eye fatigue, visual disturbances) did not show any statistical difference between the two technologies.
Since no evidence was found concerning the economic impact of 3D technology (from 42 records screened, 27 articles assessed, 27 articles excluded), this dimension was investigated through the implementation of an activity-based cost analysis (ABC) [35,36,37], considering a 12-month time horizon and assuming the hospital point of view. In particular, the economic evaluation of each patient undergoing a surgical procedure considered both the “surgical pathway” and the “medical pathway” in terms of length of stay, laboratory tests and other diagnostic procedures. Data included direct costs of personnel working in the operating theatre (surgeons, nurses, anaesthetists, auxiliary personnel and technical staff).
The median cost of the surgical pathway (divided in operating room costs and personnel costs) and of medical pathway is summarised in Table 4. It had been established that the median life of a laparoscopic column is approximately 8 years that provided a cost per year of 8.096,80 euro for the 2D system, and 13.447,19 euro for the 3D system. A patient’s related cost for the two technologies is shown in Table 5. The ABC, in the analysed/optimised context, reported savings ranging from 1.173 to 1.341% per year, in urology and general surgery, while an increase of 0.232% of cost per year was realised in gynaecology.
From a budget impact point of view, the introduction of a new health technology in a specific setting needs a budget impact analysis (BIA) to support the policy makers’ decisions, in different contexts, from health system regulation to the hospital sustainability, both settings with limited economic resources . In this case, laparoscopic operations were compared, presuming that they would all be performed using either 2D or 3D technology, in the same context (high-volume hospital with all medical specialties) as analysed previously. Over 1 year of activity of the three surgical branches, the adoption of a 3D system of vision would lead to an economic saving of 255,035.05 euro (− 12,451%), based on a reduction in the operating time.
To ensure the robustness of the results, a sensitivity analysis was performed, by changing the data on the reduction of the operating time using 3D technology, based on the level of evidence and recommendation of the literature data. In particular, data extracted from articles regarding general surgery, general and gynaecologic surgeries were classified with a strength between 1 and 2 (randomised controlled studies and meta-analysis [12, 13, 39, 40]), and general and gynaecologic surgery classified between 3 and 4 (comparative non-randomised or case series [42,43,44,45,46]). Results of the budget impact sensitivity analysis confirmed the convenience of the 3D systems, with economic advantages ranging from 1.14 to 1.37%.
Organisational, equity, ethical, social and legal impacts: evidence from the professionals’ perceptions
These dimensions were investigated with the support of qualitative questionnaires administered to experts in the field of surgery. The results are summarised in Table 6.
With regard to the qualitative assessment of the organisational dimension, it emerged that, over a time horizon of 12 months, the introduction of the innovative technology required the institutionalisation of specific training courses devoted to the healthcare professionals and support staff directly involved in the procedure. These had a positive impact on both the internal and the purchasing processes. Furthermore, the innovative technology could be considered as the preferable surgical strategy, in particular for its ability to accelerate the learning curve of the operators involved and its manageability, thus positively affecting the operating theatre time.
From an equity point of view, the adoption of the innovative technology would generate health migration phenomena and would lead to a significant decrease in waiting lists, thus improving access to care in order to meet the citizens’ health needs.
With regard to the ethical and social impact, clinicians declared that patients were able to experience a positive impact from the use of the innovative technology due to a decrease in the post-surgical pain procedure and to a lower risk in developing future complications.
The analysis of the legal implications reported that the two technologies under assessment could be considered superimposable in their measurement, both considering the indication of use for all the surgical procedures and for all the categories of patients, and the presence of authorisations for use.