Clinical impact of the triple‐layered circular stapler for reducing the anastomotic leakage in rectal cancer surgery: Porcine model and multicenter retrospective cohort analysis

AIM: To investigate the impact of the triple‐layered circular stapler compared with the double‐layered circular stapler on anastomotic leakage after rectal cancer surgery. METHODS: The bursting pressure was compared between porcine ileocolic anastomoses created using a double‐ or triple‐layered stapler. We also retrospectively analyzed the incidence of severe anastomotic leakage in 194 patients who underwent colorectal anastomosis using a double‐ or triple‐layered circular stapler during rectal cancer resection performed in two cancer centers between January 2015 and April 2021. RESULTS: In the porcine model, the bursting pressure was higher in anastomoses created using the triple‐layered stapler than the double‐layered stapler (end‐to‐end anastomosis: 26.4 ± 6.2 mm Hg vs 14.5 ± 4.3 mm Hg, P = .0031; side‐to‐side anastomosis: 27.7 ± 5.0 mm Hg vs 18.0 ± 2.9 mm Hg, P = .0275). Intersectional leakage occurred in 41% and 83% of anastomoses created using the triple‐ or double‐layered stapler, respectively (P = .0821). In the clinical cohort, the double‐ and triple‐layered stapler was used in 153 and 41 patients, respectively. The incidence of anastomotic leakage was lower for anastomoses created using the triple‐layered stapler vs the double‐layered stapler (0.0% vs 5.8%, P = .0362). In multivariate analysis, the factors independently associated with a lower incidence of anastomotic leakage were female sex (odds ratio: 0.16, 95% confidence interval: 0.01‐0.90, P = .0354) and triple‐layered stapler usage (odds ratio: 0.00, 95% confidence interval: 0.00‐0.96, P = .0465). CONCLUSION: Anastomoses created using a triple‐layered circular stapler had high bursting pressure, which might contribute to a lower incidence of anastomotic leakage after rectal cancer surgery.