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.

Keywords: Anastomotic leakage; Colon cancer resection; Severity; Treatment.

© 2025. The Author(s).

背景： 吻合口漏（AL）是结肠癌切除术后常见的严重并发症，但研究各种治疗策略和影响结果的因素却很少。

目的： (1) 确定与患者在结肠癌切除术后发生吻合口漏后90天内死亡率及Clavien-Dindo 4-5级并发症相关的预测因素，并在此基础上建立和验证预测模型；(2) 探索并比较不同治疗策略对结肠癌切除术后吻合口漏的效果，同时根据手术类型、泄漏实体以及患者个体特征进行调整。

方法： TENTACLE - Colon 是一项国际多中心回顾性队列研究。该研究将纳入2018年1月1日至2022年12月31日期间，在参与研究中心接受结肠癌切除术后发生吻合口漏的连续患者，计划样本量为2000名患者。主要结局是90天内死亡率，共同主要复合终点是Clavien-Dindo 4-5级并发症。次要结局包括：住院时间和重症监护病房（ICU）住院时间、一年内放射学和外科再干预次数、院内死亡率、30天死亡率、1年死亡率、综合并发症指数以及1年内无造口生存率。对于目标(1)，将使用回归模型来识别与90天内死亡率及4-5级并发症相关的预测因素。对于目标(2)，将对各种治疗策略进行比较分析，针对指定的结局，并根据患者的个体特征、肿瘤特性、切除术和泄漏特性进行调整。

试验注册： 该研究已在clinicaltrials.gov 注册（NCT06528054），注册日期为2024年7月30日。

关键词： 吻合口漏；结肠癌切除术；严重程度；治疗。