Three-dimensional Stereoscopic Vision System Laparoscopy Using Monitors in Gastroenterological, Thoracic, Urologic and Gynecological Conditions

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Laparoscopic surgery consists in performing small incisions in the abdomen or chest assisted by avideo camera used to visualize the surgical field and perform the intervention. The operating roomequipment includes monitors where the images produced by the video camera can be seen. Animportant issue when performing a minimally invasive procedure is the correct visualization of thesurgical field. Endoscopic surgeons depend on the visual feedback to control their movements.TechnologySeveral stereoscopic laparoscopic visual systems have been developed to improve the surgicalskills through depth perception. There are several types of stereoscopic vision systems: monitorsshowing stereoscopic images which are observed through glasses with filters, displays mountedon the head with independent images for each eye, and robotic-assisted surgical systems.It has been proposed that using three-dimensional images with a monitor in laparoscopic surgeryfor several indications such as gastroenterology, chest, urology and gynecology will pose anincreased benefit and less surgical stress for the surgeon. The three-dimensional robotic surgeryand the devices mounted for stereoscopic vision on the surgeon?s head were not considered in thepresent report.PurposeThe purpose of this report is to assess the available evidence on the efficacy, coverage policiesand safety aspects related to laparoscopic surgery with 3D monitors for gastroenterological,thoracic, urologic and gynecological conditions.MethodsA bibliographic search was carried out on the main bibliographic databases (MEDLINE, Cochrane,DARE, NHS EED), in general Internet search engines, in sanitary technology evaluation agenciesand health suppliers, using the following key words: ?laparoscopy? and ?SEV? or ?threedimensional?and its abbreviations in plain text and MeSH descriptors. Priority was given tosystematic reviews, meta-analysis, randomized controlled clinical trials, clinical practice guidelines,health technology assessments, financial assessments, and coverage policies..ResultsOne systematic review from the Cochrane Collaboration was identified, which included an RCT,another additional RCT not included in the SR, and observational studies, one in real patients andseveral in training sessions.One systematic review published in 2011 compared the benefits and risks of using threedimensionalimages versus traditional images for laparoscopic cholecystectomy. It identified asingle RCT conducted in 1997 where 60 surgeries were randomly assigned to one of the imagemonitors, two-dimensional or three-dimensional (30 per method). The surgeries were performedby four specialists as part of their advanced surgical training. The principal assessment criteriawere surgical time and mistakes made during the procedure. The secondary endpoints weresubjective assessment of image quality and adverse effects on the surgeon. There were nodifferences between the Standard Endoscopic Vision (SEV) and three- dimensional StereoscopicVisualization (SV) in mean execution time (average difference = -1.00 minute; 95% CI -17.7 to15.7, p =0.2) or the surgeon?s mistakes rate. The study had moderate methodological quality,mainly due to lack of blinding.Additionally, a second RCT published in 2007 comparing a new computer system with a standardvision monitor during gynecological laparoscopic surgery was identified. The VS-1 system wasanalyzed in terms of surgical results and surgical satisfaction. Eighty eight patients who underwentlaparoscopic surgery of different levels of difficulty and performed by three different surgeons,ranging from novel to experienced, were randomly assigned to the computer VS-1 vision imagingsystem or the conventional system with endoscopic vision; 44 patients to each group. Controllingby variables such as surgeon?s experience and level of surgery difficulty in a multilevel analysis,the length difference in minutes for short surgeries reached clinical significance (39 vs. 36 minutesp <0.02). In this study, patient follow-up or surgery characteristics are not well specified.Furthermore, there was no blinding.Also several studies performed during test or training sessions, not real patients, are described.One health technology assessment from 2006 carried out in Spain evaluated three-dimensionaltechniques in laparoscopic surgery, but no additional studies other than those in SEV aboutmonitors were identified.Coverage PoliciesAs regards regulatory aspects, no documents of coverage policies were found specifically referringto 3D laparoscopy performed with monitor systems.ConclusionsLittle evidence of moderate methodological quality was identified. Although two small randomizedtrials, in a few clinical conditions showed minimal positive differences a surgical times and surgicalmistake rate, at present there is not enough evidence favoring three-dimensional imaging throughmonitors over two-dimensional imaging for the studied indications. The systems are much moreexpensive than the conventional ones. A larger number of randomized clinical trials are requiredto complete this technology assessment.