Colorectal Surgery, CHU Bordeaux, Bordeaux, France.
Bordeaux Colorectal Institute, Bordeaux, France.
Colorectal Dis. 2024 Sep;26(9):1683-1692. doi: 10.1111/codi.17095. Epub 2024 Jul 19.
Diverting stomas are routinely used in restorative surgery following total mesorectal exicision (TME) for rectal cancer to mitigate the clinical risks of anastomotic leakage (AL). However, routine diverting stomas are associated with their own complication profile and may not be required in all patients. A tailored approach based on personalized risk of AL and selective use of diverting stoma may be more appropriate. The aim of the TAilored SToma policY (TASTY) project was to design and pilot a standardized, tailored approach to diverting stoma in low rectal cancer.
A mixed-methods approach was employed. Phase I externally validated the anastomotic failure observed risk score (AFORS). We compared the observed rate of AL in our cohort to the theoretical, predicted risk of the AFORS score. To identify the subset of patients who would benefit from early closure of the diverting stoma using C-reactive protein (CRP) we calculated the Youden index. Phase II designed the TASTY approach based on the results of Phase I. This was evaluated within a second prospective cohort study in patients undergoing TME for rectal cancer between April 2018 and April 2020.
A total of 80 patients undergoing TME surgery for rectal cancer between 2016 and 2018 participated in the external validation of the AFORS score. The overall observed AL rate in this cohort of patients was 17.5% (n = 14). There was a positive correlation between the predicted and observed rates of AL using the AFORS score. Using ROC curves, we calculated a CRP cutoff value of 115 mg/L on postoperative day 2 for AL with a sensitivity of 86% and a negative predictive value of 96%. The TASTY approach was designed to allocate patients with a low risk AFORS score to primary anastomosis with no diverting stoma and high risk AFORS score patients to a diverting stoma, with early closure at 8-14 days, if CRP values and postoperative CT were satisfactory. The TASTY approach was piloted in 122 patients, 48 (39%) were identified as low risk (AFORS score 0-1) and 74 (61%) were considered as high risk (AFORS score 2-6). The AL rate was 10% in the low-risk cohort of patient compared to 23% in the high-risk cohort of patients, p = 0.078 The grade of Clavien-Dindo morbidity was equivalent. The incidence of major LARS was lowest in the no stoma cohort at 3 months (p = 0.014).
This study demonstrates the feasibility and safety of employing a selective approach to diverting stoma in patients with a low anastomosis following TME surgery for rectal cancer.
在直肠系膜全切除术（TME）后，为减轻吻合口漏（AL）的临床风险，常规使用转流造口术进行直肠肿瘤的修复手术。然而，常规转流造口术存在自身并发症，并可能并非所有患者都需要。基于 AL 的个体化风险和选择性使用转流造口术的量身定制方法可能更为合适。TAilored SToma policY（TASTY）项目旨在设计并试行一种标准化、针对低位直肠癌的转流造口术的量身定制方法。
采用混合方法。第一阶段对外验证吻合失败观察风险评分（AFORS）。我们将我们队列中的 AL 实际观察率与 AFORS 评分的理论预测风险进行比较。为了确定使用 C 反应蛋白（CRP）早期关闭转流造口术的患者受益的亚组，我们计算了约登指数。第二阶段根据第一阶段的结果设计了 TASTY 方法。该方法在 2018 年 4 月至 2020 年 4 月期间接受 TME 手术治疗直肠肿瘤的第二组前瞻性队列研究中进行了评估。
共有 80 名 2016 年至 2018 年期间接受 TME 手术治疗直肠肿瘤的患者参与了 AFORS 评分的外部验证。该队列患者的整体观察到的 AL 发生率为 17.5%（n=14）。AFORS 评分预测和观察到的 AL 发生率之间存在正相关。使用 ROC 曲线，我们计算出术后第 2 天 CRP 为 115mg/L 的截断值，AL 的灵敏度为 86%，阴性预测值为 96%。TASTY 方法旨在将低风险 AFORS 评分的患者分配至无需转流造口术的一期吻合，高风险 AFORS 评分患者分配至转流造口术，并在 CRP 值和术后 CT 结果满意时在 8-14 天内进行早期关闭。TASTY 方法在 122 名患者中进行了试点，其中 48 名（39%）被确定为低风险（AFORS 评分 0-1），74 名（61%）被认为是高风险（AFORS 评分 2-6）。低风险组患者的 AL 发生率为 10%，而高风险组患者的 AL 发生率为 23%，p=0.078。Clavien-Dindo 发病率分级相当。在 3 个月时，无造口组的主要 LARS 发生率最低（p=0.014）。
本研究证明了在直肠系膜全切除术（TME）后进行直肠肿瘤修复手术时，对低位吻合的患者采用选择性转流造口术的可行性和安全性。
