Visceral Surgery Department, 159 Rue Du Président François Mitterrand, 91160, Longjumeau, France; North Essonne Hospital Group, Longjumeau Site, France; UMRS Unit 1138 Heka/Inria Team Cordeliers Research Center, 15 Rue de l'École de Médecine, 75006, Paris, France.
UMRS Unit 1138 Heka/Inria Team Cordeliers Research Center, 15 Rue de l'École de Médecine, 75006, Paris, France; General and Digestive Surgery Department, Saint-Antoine Hospital, 184 Rue Du Faubourg Saint-Antoine, 75012, Paris, France.
Eur J Surg Oncol. 2024 Oct;50(10):108581. doi: 10.1016/j.ejso.2024.108581. Epub 2024 Aug 3.
To report the 90-day mortality benefit associated with the implementation of the new regulatory reform on oncological surgical digestive authorizations.
New thresholds in digestive cancer surgery were applied in 2023, accrediting centers for major interventions. No evidence has been provided to support their justification.
Any French adult operated for digestive cancer from January 1, 2019 to December 31, 2021 was included from the PMSI. A 90-day mortality logistic regression was performed by adjusting by age, sex, Charlson score, Frailty index, hospital-volume (<5 or ≥5 interventions/year), emergency intervention, specialty.
143,582 patients were identified. Of these, 64,268 underwent surgery of one of the subspecialties subject to the new thresholds (stomach N = 8283, liver N = 18,668, pancreas N = 11,220, esophagus N = 3704, rectum N = 22,393). 4808 (7.5 %) patients underwent surgery in low-volume centers, distributed as follows: stomach 1757/8283 (22.94 %), liver 970/18,668 (5.19 %), pancreas 895/11,220 (7.98 %), esophagus 672/3704 (18.14 %) and rectum 514/22,393 (2.29 %). In univariate analysis, the 90-day mortality rate was significantly lower in high-volume centers, for all subspecialties, gastric: 127/1757 (7.23 %) vs 330/6526 (5.06 %), p = 0.0004, hepatic: 64/970 (6.6 %) vs 824/17,698 (4.66 %), p = 0.006, pancreatic: 74/895 (8, 27 %) vs 608/10,325 (5.89 %), p = 0.004, esophageal: 58/672 (8.63 %) vs 195/3032 (6.43 %), p = 0.04, rectal 26/514 (5.06 %) vs 639/21,879 (2.92 %), p = 0.005. The multivariate analysis, showed a mortality reduction for high-volume centers: OR = 0.78 CI95[0.71-0.87], p < 0.001.
The recent implementation of regulatory decrees appears to be justified. The enforcement of these hospital volume thresholds is likely to contribute to a reduction in postoperative mortality following digestive cancer surgery.
报告实施新的肿瘤外科授权监管改革与 90 天死亡率获益相关的情况。
2023 年,在癌症手术方面采用了新的门槛标准,认可了主要干预措施的中心。目前尚无证据支持其合理性。
从 PMSI 中纳入 2019 年 1 月 1 日至 2021 年 12 月 31 日期间接受过消化系统癌症手术的任何法国成年患者。通过调整年龄、性别、Charlson 评分、虚弱指数、医院容量(<5 或≥5 次/年)、紧急干预、专业情况,对 90 天死亡率进行逻辑回归分析。
共纳入 143582 例患者。其中 64268 例接受了其中一个亚专科手术(胃 N=8283,肝 N=18668,胰腺 N=11220,食管 N=3704,直肠 N=22393)。4808 例(7.5%)患者在低容量中心接受手术,分布如下:胃 1757/8283(22.94%),肝 970/18668(5.19%),胰腺 895/11220(7.98%),食管 672/3704(18.14%)和直肠 514/22393(2.29%)。单因素分析显示,高容量中心所有亚专科的 90 天死亡率均显著降低,胃:127/1757(7.23%)vs 330/6526(5.06%),p=0.0004;肝:64/970(6.6%)vs 824/17698(4.66%),p=0.006;胰腺:74/895(8.27%)vs 608/10325(5.89%),p=0.004;食管:58/672(8.63%)vs 195/3032(6.43%),p=0.04;直肠 26/514(5.06%)vs 639/21879(2.92%),p=0.005。多因素分析显示,高容量中心的死亡率降低:OR=0.78(95%CI95[0.71-0.87]),p<0.001。
最近实施的监管法令似乎是合理的。执行这些医院容量门槛标准可能有助于降低消化系统癌症手术后的死亡率。