用于直肠癌低位前切除术预防性造口使用的随机临床试验的吻合口风险评分的开发与验证

Development and validation of an anastomotic risk score for use in a randomized clinical trial on defunctioning stoma use in low anterior resection for rectal cancer.

作者信息

Rutegård Martin, Myrberg Ida Hed, Nordenvall Caroline, Landerholm Kalle, Jörgren Fredrik, Matthiessen Peter, Park Jennifer, Segelman Josefin, Buchwald Pamela, Häggström Jenny

机构信息

Department of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.

Division of Clinical Epidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.

出版信息

Colorectal Dis. 2025 Apr;27(4):e70089. doi: 10.1111/codi.70089.

DOI:10.1111/codi.70089

PMID:40211676

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11986403/

Abstract

AIM

The selective use of defunctioning stomas in anterior resection for rectal cancer hinges on accurately predicting anastomotic leakage. The aim of this study was to develop a prediction model for use in a prospective randomized clinical trial.

METHOD

Colorectal Cancer Database (CRCBaSe) Sweden was used to identify patients who underwent low anterior resection for rectal cancer 2007-2021. Eligibility criteria mirrored the forthcoming SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA) trial, including patients <80 years of age and with American Society of Anaesthesiologists' (ASA) physical status grade of <III; further, patients without a defunctioning stoma were excluded. The outcome comprised anastomotic leakage within 30 days or in-hospital. Candidate predictors included age, sex, ASA grade, cardiovascular disease, diabetes, body mass index (BMI), tumour stage, tumour height, and neoadjuvant therapy. Seven models were developed and internally validated using bootstrapping. A threshold of a predicted leakage risk of ≤10% was chosen for trial implementation. Validation was conducted using chart-reviewed data from a nested cohort.

RESULTS

Of the 2727 eligible patients, 199 (7.3%) were registered with an anastomotic leakage. All models demonstrated similar performance, with prediction instability observed for risks exceeding 12.5%. The preferred model included three significant predictors: male sex (OR 2.00; 95% CI: 1.45-2.75), BMI >30 kg/m (OR 1.82; 95% CI: 1.21-2.74), and radiotherapy (OR 1.90; 95% CI: 1.35-2.69). The bootstrapped area under the curve (AUC) was 0.64 (95% CI: 0.62-0.65), with a negative predictive value of 94.6% (95% CI: 93.7%-95.6%). For the validation cohort, the corresponding estimates were 0.66 (95% CI: 0.59-0.74) and 89.5% (95% CI: 86.2%-92.5%).

CONCLUSION

Accuracy of anastomotic leakage prediction using registry-based data is moderate; however, the model's ability to rule out a >10% risk is considered appropriate for trial use.

摘要

目的

直肠癌前切除术中转流造口的选择性应用取决于准确预测吻合口漏。本研究的目的是开发一种用于前瞻性随机临床试验的预测模型。

方法

利用瑞典结直肠癌数据库（CRCBaSe）识别2007年至2021年期间接受直肠癌低位前切除术的患者。纳入标准与即将开展的直肠癌低位前切除术中转流造口的选择性应用（SELSA）试验一致，包括年龄<80岁且美国麻醉医师协会（ASA）身体状况分级<III级的患者；此外，排除未行转流造口的患者。结局指标为30天内或住院期间的吻合口漏。候选预测因素包括年龄、性别、ASA分级、心血管疾病、糖尿病、体重指数（BMI）、肿瘤分期、肿瘤高度和新辅助治疗。开发了7个模型并使用自抽样法进行内部验证。选择预测漏出风险≤10%的阈值用于试验实施。使用来自一个嵌套队列的经图表审核的数据进行验证。

结果

在2727例符合条件的患者中，199例（7.3%）记录有吻合口漏。所有模型表现相似，风险超过12.5%时观察到预测不稳定。首选模型包括三个显著预测因素：男性（比值比[OR]2.00；95%置信区间[CI]：1.45 - 2.75）、BMI>30 kg/m²（OR 1.82；95% CI：1.21 - 2.74）和放疗（OR 1.90；95% CI：1.35 - 2.69）。自抽样法得到的曲线下面积（AUC）为0.64（95% CI：0.62 - 0.65），阴性预测值为94.6%（95% CI：93.7% - 95.6%）。对于验证队列，相应的估计值为0.66（95% CI：0.59 - 0.74）和89.5%（95% CI：86.2% - 92.5%）。