Feasibility and safety of the synchroseal articulating bipolar energy-based device for robotic gastrectomy in patients with gastric cancer: a prospective single-arm clinical trial with historical controls

TL;DR

A new device called Synchroseal was tested for robotic stomach surgery in gastric cancer patients, showing reduced inflammation and shorter operation times compared to traditional tools.

Contribution

The study introduces and evaluates the Synchroseal device as a novel bipolar energy-based tool for robotic gastrectomy.

Findings

Synchroseal reduced postoperative C-reactive protein levels compared to conventional ultrasonic shears.

The device showed shorter operation times and lower serum amylase levels.

Both Synchroseal and ultrasonic shears achieved adequate lymph node dissection.

Abstract

This study evaluated the feasibility and safety of Synchroseal (SS), a new articulating bipolar energy-based device, in da Vinci robotic gastrectomy for gastric cancer. A prospective study of 25 patients using SS was compared with retrospective data from 218 patients treated with conventional ultrasonic shears (US). Propensity score matching (PSM) ensured comparability. Metrics analyzed included C-reactive protein (CRP) levels, operative time, lymph nodes (LNs) retrieved, intraoperative blood loss, laboratory tests, hospital stay duration, and complication rates. PSM yielded a balanced comparison between the two groups (standardized differences < 0.1). SS (n = 25) significantly reduced CRP levels on postoperative days 2, 4, and 6 compared to US (n = 123) [7.67 ± 4.73 vs. 10.18 ± 5.66, (p = 0.040), 5.11 ± 3.33 vs. 6.65 ± 4.23, (p = 0.090), 2.74 ± 2.10 vs. 4.26 ± 3.78, (p = 0.001)]. Additionally, SS showed lower serum amylase levels and shorter operation times than US [67.60 ± 48.31 vs. 168.66 ± 316.92, (p = 0.027) and 234.52 ± 65.03 vs. 274.75 ± 54.90, (p = 0.002)]. Although SS retrieved fewer total LNs (31.80 ± 9.5 vs. 36.88 ± 14.96, p = 0.034), both groups achieved adequate LN dissection (> 30 LNs). No significant differences were observed in other parameters. SS led to lower postoperative CRP and serum amylase levels, shorter operation time, and adequate LN dissection, suggesting reduced postoperative inflammation and faster sealing function as potential benefits.

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