To determine the safety and superiority of three-dimensional (3D) laparoscopic gastrectomy (LG) compared with two-dimensional (2D) laparoscopic in patients with gastric cancer.
A large-scale, phase 3, prospective randomized controlled trial was conducted. The primary end point was operation time. Morbidity within 30 postoperative days and surgical outcomes were compared to evaluate the safety and efficacy of 3D LG as a secondary end point.
A total of 438 patients were randomized (3D group 219 cases; 2D group 219 cases) between January 1, 2015 and April 1, 2016. Nineteen patients were excluded. Finally, a total of 419 patients were analyzed (3D group 211 cases, 2D group 208 cases). There were no significant differences between the two groups regarding the operation time (3D vs 2D, 175.52±35.53 min vs 173.63±37.00 min, p = 0.596). The operation time was further stratified analysis by BMI and operative region which showed that when BMI is larger than 25kg/m2 the 3D group in the Splenic Hilar regional lymph node cleaning time was significantly lower than the 2D group (29.4±7.8 min vs 23.3±6.4 min, p = 0.024). The intra-operative blood loss in the 3D group was significantly lower than the 2D group (61.37±82.99 ml vs 81.54±119.44 ml, P = 0.045). Furthermore analysis suggested that 3D laparoscopic was a protect factor for excessive blood loss (≥200ml). The postoperative complication rates of the 3D and 2D groups were 17.1% (36/211) and 13.9% (29/208), respectively, p = 0.378. No patients died during the postoperative hospital stay. Postoperative questionnaire survey showed that the surgeon experienced better depth perception with the 3D system and there was no significant difference in postoperative strain between the two groups.
3D LG not only can significantly reduce the lymph node dissection time at complicated regional, but also has a benefit of less intra-operative blood loss and lower occurrence of excessive bleeding incidence compared with conventional 2D surgery. (Number NCT02327481)
Clinical trial identification
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All authors have declared no conflicts of interest.