Elsevier

Surgery

Volume 163, Issue 2, February 2018, Pages 300-304
Surgery

Stomach
Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial

https://doi.org/10.1016/j.surg.2017.09.053Get rights and content

Abstract

Objective

To determine the relative safety and efficacy of 3D laparoscopic gastrectomy and 2D laparoscopic surgery in patients with gastric cancer.

Background

There is still a lack of randomized controlled trials regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for gastric cancer.

Methods

A large-scale, phase 3, prospective, randomized controlled trial was conducted. (ClinicalTrials.gov number NCT02327481).

Results

A total of 438 patients were randomized (3D group: 219 cases; 2D group: 219 cases) between January 1, 2015, and April 1, 2016; 19 patients were excluded. Finally, data from 419 patients were analyzed (3D group: 211 cases; 2D group: 208 cases). There were no differences between the 2 groups regarding the operation time (3D versus 2D, 176 ± 35 min vs. 174 ± 33 min, P = .562). The intraoperative blood loss in the 3D group was somewhat less than in the 2D group (61 ± 83 mL vs. 82 ± 119 mL, P = .045). Further analysis suggested that the use of 3D laparoscopic surgery was a protective factor against excessive blood loss (≥200 mL).

Conclusion

3D laparoscopic gastrectomy did not shorten the operation time compared with 2D laparoscopic gastrectomy, but provided the benefit of less intraoperative blood loss and a lesser occurrence of excessive bleeding than the conventional 2D laparoscopic gastrectomy; the clinical value of the difference is limited.

Section snippets

Study design and patients

This prospective, phase 3 RCT (ClinicalTrials.gov number NCT02327481) was conducted in accordance with the protocol that was approved by the institutional review boards of our hospital before the initiation of the study. All the candidates were well informed and gave their full consent after they had received a verbal explanation of the study and an information document. The primary end point was the duration of operation time. Secondary end points included postoperative complications,

Case inclusion

Between January 1, 2015, and April 1, 2016, 438 patients were included in this study and were divided randomly into the 2D group (219 cases) or the 3D group (219 cases). A total of 19 patients met the exclusion criteria; 11 were in the 2D group (4 patients with tumor invasion in the head of the pancreas and 7 with peritoneal metastases) and 8 were in the 3D group (1 patient withdrew informed consent, 3 had tumor invasion in the head of the pancreas, and 4 had peritoneal metastases). Finally,

Discussion

The use of 3D laparoscopic technology was reported as early as 20 years ago, and several authors have described the theoretical advantages of 3D laparoscopic viewing systems.30, 31 In the early years, 3D laparoscopic technology was not applied widely for laparoscopic surgery, partly due to technological limitations,32 leading to a decline in the quality of the picture and increased operation costs.11, 31, 33 In recent years, 3D laparoscopic technology has developed rapidly, its technical

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