Systemic assessment of manual circular stapler versus powered circular stapler for anastomosis in rectal cancer: A multicenter prospective cohort study.

person Xinxiang Li Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China info_outline Xinxiang Li, Yikuan Chen, Ruijia Zhang, Dakui Luo, Fangqi Liu

Authors person Xinxiang Li Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China info_outline Xinxiang Li, Yikuan Chen, Ruijia Zhang, Dakui Luo, Fangqi Liu Organizations Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China, Fudan University Shanghai Cancer Center, Shanghai, China, Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, China, 270 Dong'an Road, China Abstract Disclosures Research Funding National Natural Science Foundation of China Shanghai Medical Innovation Research Project Background: Mechanical anastomosis offers several advantages over traditional hand-sutured anastomosis. However, complications such as anastomotic leaks, strictures, and bleeding persist due to factors like interactions between staples and tissue. Powered circular anastomosis is an effective method to address these issues. Currently, there are no domestic studies on the application of powered-anastomosis technology in colorectal anastomosis. Methods: The study adopted a multicenter, randomized, parallel-controlled, non-inferiority study design, with a 1:1 random allocation ratio. The study involved 187 patients with rectal cancer who underwent Dixon surgery using IntoCare™ disposable powered circular stapler (ICS), and 195 patients who received similar process with manual circular stapler (MCS). The efficacy of stapler was evaluated by anastomosis success rate, anastomosis-related adverse events, anastomosis device performance assessment, operation time, anastomosis time, and postoperative recovery. Safety evaluation indicators included adverse events, vital signs, and laboratory tests. Results: Baseline demographic characteristics showed no notable disparities between two groups (Table 1). A high proportion of patients, 99.47% in the MCS group and 99.49% in the ICS group, successfully completed anastomosis. In the MCS group, the average anastomosis duration was clocked at 2.84 minutes (min) (±2.3), with a median time of 2.0 min (ranging from 1.0 to 22.0 min). In contrast, the ICS group exhibited a slightly quicker average anastomosis duration of 2.40 min (±1.7), and a comparable median time of 2.0 min (but with a narrower range from 1.0 to 15.0 min). Adverse events did not differ significantly between two groups. Conclusions: The results uncovered the powered stapler could considerably reduce stapling time while maintaining a safety profile. Notably, the incidence of patients with anastomotic leakage one month post-surgery, and anastomotic stricture six months post-surgery in the powered stapler group, was lower than those in the manual stapler group. This suggests that the anastomosis created by the powered stapler is more stable and promotes more effective postoperative anastomotic healing. Clinical trial information: NCT05879172. MCS (N = 187) ICS (N = 195) P Successful anastomosis 185 (99.47%) 194 (99.49%) 0.9763 Anastomosis time (min) 2.84 (±2.3) 2.40 (±1.7) 0.0324* Anastomotic bleeding 1 (0.53%) 1 (0.51%) > 0.9999 Volume of bleeding (ml) 45.04 (±68.34) 42.34 (±22.64) 0.8242 Distance from Anal Verge (cm) 3.75 (±1.84) 3.89 (±1.70) 0.9734 Diverting Ostomy Created 76 (40.64%) 81 (41.54%) 0.9172 Operation time (min) 148.3 (±46.88) 155.5 (±44.35) 0.2117 Recovery time (day) 7.39 (±3.59) 7.40 (±3.20) 0.7439 Reoperation 2 (1.07%) 1 (0.51%) 0.6163

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