Added value of 3D-vision during laparoscopic biotissue pancreatico- and hepaticojejunostomy (LAELAPS 3D2D): an international randomized cross-over trial

It is currently unclear what the added value is of 3D-laparoscopy during pancreatic and biliary surgery. 3D-laparoscopy could improve procedure time and/or surgical performance, for instance in demanding anastomoses such as pancreatico- and hepaticojejunostomy. The impact of 3D-laparoscopy could be negligible in more experienced surgeons. We conducted a randomized controlled cross-over trial including 20 expert laparoscopic surgeons and 20 surgical residents from 9 countries (Argentina, Estonia, Israel, Italy, the Netherlands, South Africa, Spain, UK, USA). All participants performed a pancreaticojejunostomy (PJ) and a hepaticojejunostomy (HJ) using 3D- and 2D-laparoscopy on biotissue organ models according to the Pittsburgh method. Primary endpoint was the time required to complete both anastomoses. Secondary endpoint was the objective structured assessment of technical skill (OSATS; range 12–60) rating. Observers were blinded for 3D/2D and expertise. A total of 40 participants completed 144 PJs and HJs. 3D-laparoscopy reduced the operative time with 15.5 min (95%CI 10.2–24.5 min), from 81.0 to 64.4 min, p = 0.001. This reduction was observed for both experts and residents (13.0 vs 22.2 min, intergroup significance p = 0.354). The OSATS improved with 5.1 points, SD ± 6.3, with 3D-laparoscopy, p = 0.001. This improvement was observed for both experts and residents (4.6 vs 5.6 points, p = 0.519). Of all participants, 37/39 participants stated to prefer 3D laparoscopy whereas 14/39 reported side effects. Minor side effects were reported by 10/39 participants whereas 2/39 participants reported severe side effects (both severe eye strain). 3D-laparoscopy, as compared to 2D-laparoscopy, reduced the operative time and improved surgical performance for PJ and HJ anastomoses in both experts and residents with mostly minor side effects.