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腹腔镜联合快速通道多模式管理是结肠手术患者最佳围手术期策略:一项随机临床试验(LAFA 研究)。

Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study).

机构信息

Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands.

出版信息

Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

Abstract

OBJECTIVE

To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer.

SUMMARY BACKGROUND DATA

Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care, both focusing on faster recovery.

METHODS

In a 9-center trial, patients eligible for segmental colectomy were randomized to laparoscopic or open colectomy, and to FT or standard care, resulting in 4 treatment groups. Primary outcome was total postoperative hospital stay (THS). Secondary outcomes were postoperative hospital stay (PHS), morbidity, reoperation rate, readmission rate, in-hospital mortality, quality of life at 2 and 4 weeks, patient satisfaction and in-hospital costs. Four hundred patients were required to find a minimum difference of 1 day in hospital stay.

RESULTS

Median THS in the laparoscopic/FT group was 5 (interquar-tile range: 4-8) days; open/FT 7 (5-11) days; laparoscopic/standard 6 (4.5-9.5) days, and open/standard 7 (6-13) days (P < 0.001). Median PHS in the laparoscopic/FT group was 5 (4-7) days; open/FT 6 (4.5-10) days; laparoscopic/standard 6 (4-8.5) days and open/standard 7 (6-10.5) days (P < 0.001). Secondary outcomes did not differ significantly among the groups. Regression analysis showed that laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity.

CONCLUSIONS

Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program. If open surgery is applied, it is preferentially done in FT care. This study was registered under NTR222 (www.trialregister.nl).

摘要

目的

探讨腹腔镜或开腹手术联合快速康复(FT)或标准护理治疗在结肠癌节段切除术患者中的应用效果,以寻找最佳围手术期治疗方案。

背景资料概述

择期结直肠手术的重要进展包括腹腔镜的引入和 FT 护理的实施,两者均侧重于更快的恢复。

方法

在一项 9 中心试验中,符合节段性结肠切除术条件的患者被随机分为腹腔镜或开腹 colectomy,以及 FT 或标准护理,共分为 4 个治疗组。主要结局是总术后住院时间(THS)。次要结局包括术后住院时间(PHS)、发病率、再次手术率、再入院率、院内死亡率、术后 2 周和 4 周的生活质量、患者满意度和住院费用。需要 400 名患者才能发现住院时间至少相差 1 天。

结果

腹腔镜/FT 组的中位 THS 为 5(四分位距:4-8)天;开腹/FT 组为 7(5-11)天;腹腔镜/标准组为 6(4.5-9.5)天,开腹/标准组为 7(6-13)天(P<0.001)。腹腔镜/FT 组的中位 PHS 为 5(4-7)天;开腹/FT 组为 6(4.5-10)天;腹腔镜/标准组为 6(4-8.5)天,开腹/标准组为 7(6-10.5)天(P<0.001)。各组间次要结局无显著差异。回归分析表明,腹腔镜是唯一能降低住院时间和发病率的独立预测因素。

结论

结肠癌节段切除术患者的最佳围手术期治疗是腹腔镜切除联合 FT 方案。如果应用开腹手术,优选在 FT 护理下进行。本研究在 NTR222(www.trialregister.nl)注册。

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