Multicenter Randomized Controlled Clinical Trial Comparing Conventional and Lateral Invagination Techniques for Double Stapling Colorectal Anastomosis: The ILAC Trial

Background: Anastomotic leakage is a severe complication in colorectal surgery, occurring in up to 20% of all procedures. The double stapling technique is among the most commonly preferred methods, although the extremes of the linear suture line (called “dog ears”) and the number of staple lines may affect the leak rate. Observational retrospective studies point out the lateral invagination of the anastomotic edges as a potential solution.

Methods: The ILAC trial is a multicenter, randomized, single-blind superiority study designed with the intent of evaluating the effectiveness and safety of the lateral invagination technique for the double-stapled colorectal anastomosis. Two groups (conventional, group 1; and lateral invagination, group 2) will be compared. All adult patients admitted to the participating centers with an indication for elective resection of the left colon, sigmoid or upper rectum will be included. With an alpha risk of 0.05 and a beta risk of 0.20 with bilateral contrast, we aim to include 393 patients per group. The analyses will be performed by the intention to treat principle. The primary outcome is the rate of anastomotic leakage. Secondary outcomes include duration of surgery, perioperative morbidity using the Clavien- Dindo classification, hospital stay, hospital readmissions and reinterventions.

Discussion: Aiming to reduce controllable factors related to suture dehiscence rates, different intraoperative technique modifications have been developed. The lateral invagination of the “dog-ears” in double-stapled colorectal anastomosis appears to be a potentially beneficial modification in reducing anastomosis failure. However, no clinical trials have been developed to prove this. In response to these needs, the present study aims to evaluate the role of the lateral invagination technique in a randomized and controlled trial.

Author(s): Carolina González-Abós, Paula Domínguez-Garijo, Yoelimar Guzmán, Ana Otero-Piñeiro, Raquel Bravo, Antonio M. Lacy and F. Borja de Lacy

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