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腹腔镜入路联合完全快速康复多模式管理是否能降低术后并发症?一项多中心随机对照试验。

Does a Combination of Laparoscopic Approach and Full Fast Track Multimodal Management Decrease Postoperative Morbidity?: A Multicenter Randomized Controlled Trial.

机构信息

*Colorectal Surgery Department, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, University Paris VII, Clichy, France †Colorectal unit, Hôpital Haut Lévêque, CHU Bordeaux, University of Bordeaux, Bordeaux, France ‡Digestive Surgery Department, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Pierre & Marie Curie University (Paris VI), Paris, France §Department of Digestive and Oncological Surgery, Amiens-Picardie University Medical Center, Amiens, France ¶Department of Digestive Surgery, Hôpital Nord, Aix-Marseille University, Marseille, France ||Department of Digestive and Hepato-Pancreato-Biliary Surgery, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre & Marie Curie University (Paris VI), Paris, France **Department of Digestive Surgery, Hôpital Saint-Joseph, Paris, France ††Department of Digestive Surgery, University Hospital of Caen, University of Caen Normandy, Caen, France ‡‡Department of Clinical Research, Hôpital Lariboisière, Assistance publique-Hôpitaux de Paris, University Paris VII, Paris, France.

出版信息

Ann Surg. 2017 Nov;266(5):729-737. doi: 10.1097/SLA.0000000000002394.

DOI:10.1097/SLA.0000000000002394
PMID:28806303
Abstract

OBJECTIVE

The aim of this study was to assess whether association of laparoscopic approach and full fast track multimodal (FFT) management can reduce postoperative morbidity after colorectal cancer surgery, as compared to laparoscopic approach with limited fast-track program (LFT).

SUMMARY OF BACKGROUND DATA

Recent advances in colorectal cancer surgery are introduction of laparoscopy and FFT implementation.

METHODS

Patients eligible for elective laparoscopic colorectal cancer surgery were randomized into 2 groups: FFT or LFT care (with only early oral intake and mobilization starting on Day 1). Primary outcome was postoperative 30-day morbidity, according to Clavien-Dindo classification.

RESULTS

Two hundred seventy patients were randomized and 263 were analyzed: 130 in FFT group and 133 in LFT group, including 106 colon (FFT: n = 52 and LFT: n = 54) and 157 rectal cancer (FFT: n = 78 and LFT: n = 79). Postoperative 30-day mortality was nil. Overall postoperative 30-day morbidity did not show any difference between the groups (FFT: 35% vs LFT: 29%, P = 0.290), neither regarding the overall population, nor in the colon (FFT: 23% vs LFT: 19%, P = 0.636) or rectal (FFT: 44% vs LFT: 35%, P = 0.330) cancer subgroups. Severe postoperative morbidity was also not different between groups (FFT: 12% vs LFT: 8%, P = 0.266). After multivariate regression analysis, only early intravenous catheter removal (on day 2) [odds ratio: 0.390; 95% confidence interval: (95% CI 0.181-0.842); P = 0.017] and the absence of intraoperative lidocaine intravenous perfusion (odds ratio: 0.182, 95% CI 0.042-0.788; P = 0.019) were identified as independent predictive factors of reduced postoperative morbidity.

CONCLUSION

Addition of FFT multimodal management to laparoscopic approach with early oral intake and mobilization does not reduce postoperative morbidity after colorectal cancer surgery.

摘要

目的

本研究旨在评估与腹腔镜联合有限快速通道方案(LFT)相比,腹腔镜联合完整快速通道多模式(FFT)管理是否可以降低结直肠癌手术后的术后发病率。

背景资料概要

结直肠癌手术的最新进展是腹腔镜和 FFT 的应用。

方法

符合择期腹腔镜结直肠癌手术条件的患者被随机分为两组:FFT 或 LFT 护理(仅在第 1 天开始早期口服摄入和活动)。主要结局是根据 Clavien-Dindo 分类的术后 30 天发病率。

结果

270 名患者被随机分组,263 名患者被纳入分析:FFT 组 130 例,LFT 组 133 例,其中结肠癌 106 例(FFT:n=52,LFT:n=54),直肠癌 157 例(FFT:n=78,LFT:n=79)。术后 30 天无死亡。两组术后 30 天总发病率无差异(FFT:35% vs LFT:29%,P=0.290),无论是总体人群还是结肠癌(FFT:23% vs LFT:19%,P=0.636)或直肠癌(FFT:44% vs LFT:35%,P=0.330)亚组。两组严重术后发病率也无差异(FFT:12% vs LFT:8%,P=0.266)。多变量回归分析后,仅早期静脉导管去除(第 2 天)[比值比:0.390;95%置信区间(95%CI):(0.181-0.842);P=0.017]和术中无利多卡因静脉灌注[比值比:0.182,95%CI 0.042-0.788;P=0.019]被确定为降低术后发病率的独立预测因素。

结论

腹腔镜联合早期口服摄入和活动的 FFT 多模式管理并不能降低结直肠癌手术后的术后发病率。

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