Department of Clinical Medicine and Surgery, Federico II" University of Naples, via Pansini 5, 80131, Naples, Italy.
Division of Gastrointestinal Surgery, San Raffaele Scientific Institute, Milan, Italy.
Surg Endosc. 2022 Oct;36(10):7619-7627. doi: 10.1007/s00464-022-09212-y. Epub 2022 May 2.
Several reports demonstrated a strong association between the level of adherence to the protocol and improved clinical outcomes after surgery. However, it is difficult to obtain full adherence to the protocol into clinical practice and has still not been identified the threshold beyond which improved functional results can be reached.
The ERCOLE (ERas and COLorectal Endoscopic surgery) study was as a cohort, prospective, multi-centre national study evaluating the association between adherence to ERAS items and clinical outcomes after minimally invasive colorectal surgery. The primary endpoint was to associate the percentage of ERAS adherence to functional recovery after minimally invasive colorectal cancer surgery. The secondary endpoints of the study was to validate safety of the ERAS programme evaluating complications' occurrence according to Clavien-Dindo classification and to evaluate the compliance of the Italian surgeons to each ERAS item.
1138 patients were included. Adherence to the ERAS protocol was full only in 101 patients (8.9%), > 75% of the ERAS items in 736 (64.7%) and > 50% in 1127 (99%). Adherence to > 75% was associated with a better functional recovery with 90.2 ± 98.8 vs 95.9 ± 33.4 h (p = 0.003). At difference, full adherence to the ERAS components 91.7 ± 22.1 vs 92.2 ± 31.6 h (p = 0.8) was not associated with better recovery.
Our results were encouraging to affirm that adherence to the ERAS program up to 75% could be considered satisfactory to get the goal. Our study could be considered a call to simplify the ERAS protocol facilitating its penetrance into clinical practice.
多项报告表明,对协议的遵守程度与手术后临床结果的改善之间存在很强的关联。然而,要在临床实践中完全遵守协议,并且尚未确定可以达到改善功能结果的阈值。
ERCOLE(加速康复和结直肠内镜手术)研究是一项队列、前瞻性、多中心的全国性研究,评估了对 ERAS 项目的依从性与微创结直肠手术后临床结果之间的关联。主要终点是将 ERAS 依从率与微创结直肠癌手术后的功能恢复相关联。该研究的次要终点是验证 ERAS 方案的安全性,根据 Clavien-Dindo 分类评估并发症的发生,并评估意大利外科医生对每个 ERAS 项目的依从性。
共纳入 1138 例患者。仅 101 例(8.9%)患者完全遵守 ERAS 方案,736 例(64.7%)患者遵守 ERAS 方案的项目数多于 75%,1127 例(99%)患者遵守 ERAS 方案的项目数多于 50%。遵守 ERAS 方案的项目数多于 75%与更好的功能恢复相关,90.2±98.8 小时与 95.9±33.4 小时(p=0.003)。相比之下,完全遵守 ERAS 方案的所有项目数 91.7±22.1 小时与 92.2±31.6 小时之间没有差异(p=0.8)。
我们的结果令人鼓舞,证明遵守 ERAS 方案达到 75%就可以被认为是令人满意的,可以达到目标。我们的研究可以被认为是简化 ERAS 方案的号召,以促进其在临床实践中的应用。