Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report

Objective In this study, we evaluated the short-term outcomes following three-dimensional (3D) or two-dimensional (2D) laparoscopic surgery for patients with gastric cancer. Background There is a lack of prospective evidence regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for patients with gastric cancer. Therefore, we conducted a phase III single-center, prospective, randomized, controlled trial to compare 3D and 2D laparoscopic surgery for patients with gastric cancer. Methods We compared operation time, intraoperative blood loss, number of lymph node dissections, morbidity, and mortality between the 3D and 2D groups following laparoscopic surgery for gastric cancer. The study is registered at ClinicalTrials.gov with ID number NCT02327481. Results A total of 228 patients were randomized (3D group 115 cases; 2D group 113 cases) between January 1, 2015 and September 1, 2015. Seven patients who underwent exploratory operations were excluded. Finally, a total of 221 patients were analyzed (3D group 109 cases, 2D group 112 cases). There were no significant differences between the two groups regarding the clinical pathological characteristics, operating time (3D vs. 2D, 184 +/- 36 vs. 178 +/- 37 min, P = 0.288), number of lymph node dissections (36 +/- 14 vs. 37 +/- 13, P = 0.698), time to first ambulation (2.27 +/- 1.60 vs. 2.04 +/- 0.84, P = 0.18), flatus (3.89 +/- 1.49 vs. 3.69 +/- 1.12, P = 0.255), liquid diet (4.88 +/- 1.88 vs. 4.79 +/- 1.57, P = 0.684), or duration of postoperative hospital stay (12.52 +/- 4.83 vs. 12.63 +/- 7.32, P = 0.903). The postoperative complication rates of the 3D and 2D groups were 18.3 and 16.1%, respectively, P = 0.723. No patients died during the postoperative hospital stay. However, the intraoperative blood loss in the 3D group was significantly lower than the 2D group (58 +/- 75 vs. 78 +/- 72 ml, P = 0.047). Conclusion There was no significant difference in operation time and number of lymph node harvested between the 3D and 2D groups; however, 3D laparoscopic surgery may reduce the intraoperative blood loss compared to 2D procedure. Therefore, we conclude that this trial is safe and is thus ongoing.