TreatmENT of AnastomotiC LeakagE after colon cancer resection: the TENTACLE - Colon study.

BACKGROUND

Anastomotic leakage (AL) is a common and severe complication after colon cancer resection, but studies investigating various treatment strategies and factors influencing outcomes are scarce.

OBJECTIVES

(1) To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection with subsequent development and validation of prediction models, and (2) to explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, adjusting for type of index surgery, different leak entities and patient factors.

METHODS

The TENTACLE - Colon is an international multicentre retrospective cohort study. Consecutive patients with AL after colon cancer resection operated between 1 January 2018 and 31 December 2022 from participating centres will be included. The planned sample size is 2000 patients. The primary outcome is 90-day mortality and the co-primary composite endpoint is Clavien-Dindo grade 4-5 complications. Secondary outcomes include: hospital and intensive care unit length of stay, number of radiological and surgical reinterventions within one year after resection, mortality (in-hospital, 30-day, and 1-year), the comprehensive complication index, and 1-year stoma-free survival. For objective 1, regression models will be used to identify predictors associated with 90-day mortality and grade 4-5 complications. For objective 2, comparative analyses of various treatment strategies will be performed for the specified outcomes, adjusting for patient, tumour, resection and leakage characteristics.

TRIAL REGISTRATION

This study is registered at clinicaltrials.gov (NCT06528054) since July 30th, 2024.