Circular stapler platform and the risk of anastomotic leakage after elective left colectomy and high anterior resection
Stefano Guadagni, Marco Catarci, Francesco Masedu,Abstract
Aim
The impact of different circular stapler platforms on the risk of anastomotic leakage following elective left colectomy and high anterior resection remains poorly defined. We compared the risk of anastomotic leakage across commonly used circular stapler platforms using advanced confounding control methods.
Methods
This pre‐planned post hoc analysis pooled individual patient data from the published iCral‐2 and iCral‐3 studies and from the iCral‐4 study, whose primary results are currently under peer review. Adults undergoing elective left colectomy or high anterior resection with standardized end‐to‐end circular stapled anastomosis were included. Five circular stapler platforms were compared. Confounding was addressed using generalized boosted model–based propensity score weighting targeting the average treatment effect on the treated, with doubly robust outcome modelling. The primary endpoint was overall anastomotic leakage at 60 days.
Results
Among 3,653 patients, overall anastomotic leakage occurred in 2.7% of patients receiving the reference 3‐row platform. After weighting, Platforms 3 and 4 were associated with a significantly increased risk of overall anastomotic leakage (odds ratios >2), whereas no statistically significant differences were observed for Platforms 2 or 5. Because the effective sample size after weighting was substantially reduced for Platform 3 owing to limited covariate overlap, the corresponding effect estimate should be interpreted with appropriate caution.
Conclusions
Selected circular stapler platforms were associated with an increased risk of overall anastomotic leakage. These findings suggest platform‐specific rather than class‐wide differences and warrant confirmation in prospective studies designed to identify the device‐related and procedural factors underlying these associations.
Trial Registration
NCT03771456 for iCral2, NCT04397627 for iCral3 and NCT05227014 for iCral4.