Department of General Surgery, Peking University First Hospital, 8 Xishiku Street, Xicheng District, Beijing, 100034, China.
Department of General Surgery, the Third People's Hospital of Datong, Datong, 037001, China.
J Gastrointest Surg. 2021 Dec;25(12):3218-3229. doi: 10.1007/s11605-021-04982-7. Epub 2021 Apr 26.
The purpose of this study was to determine the risk factors for the development of a permanent stoma in laparoscopic intersphincteric resection (LS-ISR) for ultralow rectal adenocarcinoma and to develop and validate a prediction model to predict the probability of permanent stoma after surgery.
A primary cohort consisting of 301 consecutive patients who underwent LS-ISR was enrolled in this study. Multivariable logistic regression analysis was used to identify risk factors and develop the nomogram. The performance of the nomogram was assessed with respect to its calibration, discrimination, and clinical usefulness. An independent validation cohort contained 91 consecutive patients from January 2012 to January 2019.
The permanent stoma rate was 11.3% (34/301) in the primary cohort and 18.7% (17/91) in the validation cohort. Multivariable analysis revealed that nCRT (OR, 3.195; 95% CI, 1.169-8.733; P=0.024), ASA score of 3 (OR, 5.062; 95% CI, 1.877-13.646; P=0.001), distant metastasis (OR, 14.645; 95% CI, 3.186-67.315; P=0.001), and anastomotic leakage (OR, 11.308; 95% CI, 3.650-35.035; P<0.001) were independent risk factors for permanent stoma, and a nomogram was established. The AUCs of the nomogram were 0.842 and 0.858 in the primary and validation cohorts, respectively. The calibration curves showed good calibration in both cohorts. Decision curve analysis demonstrated that the nomogram was clinically useful.
We developed and validated a nomogram for ultralow rectal adenocarcinoma patients who underwent LS-ISR, and the nomogram could help surgeons identify which patients are at a higher risk of a permanent stoma after surgery.
本研究旨在确定腹腔镜经括约肌间切除术（LS-ISR）治疗超低位直肠腺癌中永久性造口的风险因素，并开发和验证一种预测模型以预测术后永久性造口的概率。
本研究纳入了 301 例连续接受 LS-ISR 治疗的患者，这些患者组成了一个初级队列。采用多变量逻辑回归分析来确定风险因素，并建立列线图。使用校准、区分和临床实用性来评估列线图的性能。一个独立的验证队列包含了 2012 年 1 月至 2019 年 1 月期间的 91 例连续患者。
在初级队列中，永久性造口的发生率为 11.3%（34/301），在验证队列中为 18.7%（17/91）。多变量分析显示，新辅助放化疗（OR，3.195；95%CI，1.169-8.733；P=0.024）、ASA 评分 3 分（OR，5.062；95%CI，1.877-13.646；P=0.001）、远处转移（OR，14.645；95%CI，3.186-67.315；P=0.001）和吻合口漏（OR，11.308；95%CI，3.650-35.035；P<0.001）是永久性造口的独立危险因素，并建立了一个列线图。该列线图在初级和验证队列中的 AUC 分别为 0.842 和 0.858。校准曲线显示两个队列均具有良好的校准。决策曲线分析表明该列线图具有临床实用性。
我们为接受 LS-ISR 治疗的超低位直肠腺癌患者开发并验证了一个列线图，该列线图可以帮助外科医生识别术后发生永久性造口的风险较高的患者。
