The application value of Da Vinci linear powered stapler SureForm in robotic sphincter-preserving surgery for rectal cancer: a prospective randomized clinical trial.

BACKGROUND: Anastomotic leakage remains a major complication after robotic low anterior resection for rectal cancer. Technological advancements in stapling devices may influence clinical outcomes. This study aimed to evaluate whether the novel da Vinci SureForm robotic linear stapler reduces anastomotic complications compared with conventional articulating laparoscopic staplers. METHODS: This single-center, prospective randomized clinical trial was conducted from December 30, 2022, to December 20, 2024. A total of 276 patients with rectal cancer scheduled for robotic sphincter-preserving anterior resection were randomly assigned to undergo rectal transection and anastomosis using either the da Vinci SureForm robotic linear stapler (intervention group) or conventional laparoscopic articulating linear staplers (control group). The primary outcome was the 30-day incidence of anastomotic leakage. RESULTS: The intervention group had a lower incidence of anastomotic leakage than the control group (6.67 vs. 14.07%, P=0.046), and this trend was also evident for severe cases (Clavien-Dindo grade ≥ II: 1.48 vs. 6.67%, P=0.031). Intention-to-treat analysis suggested a lower leakage rate in the intervention group (6.57 vs. 14.39%, P=0.034). The number of linear stapler cartridges required for rectal transection was lower in the intervention group (1.95±0.67 vs. 2.32±0.85, P<0.001), and the rate of using ≥3 cartridges was also lower (18.50 vs. 37.00%, P<0.001). Multivariate analysis identified stapler cartridges >2 (P=0.002), tumor location (P<0.001), and anastomotic hemorrhage (P=0.013) as independent risk factors for anastomotic leakage. CONCLUSIONS: The novel da Vinci SureForm linear powered stapler demonstrated a favorable safety profile with a potentially lower incidence of anastomotic leakage and reduced cartridge requirements compared with conventional staplers in robotic sphincter-preserving surgery for rectal cancer.