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胰腺手术中的术中液体限制:一项双盲随机对照试验

Intraoperative Fluid Restriction in Pancreatic Surgery: A Double Blinded Randomised Controlled Trial.

作者信息

van Samkar Ganapathy, Eshuis Wietse J, Bennink Roelof J, van Gulik Thomas M, Dijkgraaf Marcel G W, Preckel Benedikt, de Hert Stefan, Gouma Dirk J, Hollmann Markus W, Busch Olivier R C

机构信息

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

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

出版信息

PLoS One. 2015 Oct 14;10(10):e0140294. doi: 10.1371/journal.pone.0140294. eCollection 2015.

Abstract

BACKGROUND

Perioperative fluid restriction in a variety of operations has shown improvement of: complications, recovery of gastrointestinal function and length of stay (LOS). We investigated effects of crystalloid fluid restriction in pancreatic surgery. Our hypothesis: enhanced recovery of gastrointestinal function.

METHODS

In this double-blinded randomized trial, patients scheduled to undergo pancreatoduodenectomy (PD) were randomized: standard (S:10ml/kg/hr) or restricted (R:5ml/kg/hr) fluid protocols.

PRIMARY ENDPOINT

gastric emptying scintigraphically assessed on postoperative day 7.

RESULTS

In 66 randomized patients, complications and 6-year survival were analyzed. 54 patients were analyzed in intention to treat: 24 S-group and 30 R-group. 32 patients actually underwent a PD and 16 patients had a palliative gastrojejunostomy bypass operation in the full protocol analysis. The median gastric emptying time (T½) was 104 minutes (S-group, 95% confidence interval: 74-369) versus 159 minutes (R-group, 95% confidence interval: 61-204) (P = 0.893, NS). Delayed gastric emptying occurred in 10 patients in the S-group and in 13 patients in the R-group (45% and 50%, P = 0.779, NS). The primary outcome parameter, gastric emptying time, did not show a statistically significant difference between groups.

CONCLUSION

A fluid regimen of 10ml/kg/hr or 5ml/kg/hr during pancreatic surgery did not lead to statistically significant differences in gastric emptying. A larger study would be needed to draw definite conclusions about fluid restriction in pancreatic surgery.

TRIAL REGISTRATION

ISRCTN62621488.

摘要

背景

在各种手术中,围手术期液体限制已显示出在以下方面有所改善:并发症、胃肠功能恢复及住院时间(LOS)。我们研究了晶体液限制在胰腺手术中的效果。我们的假设:增强胃肠功能恢复。

方法

在这项双盲随机试验中,计划接受胰十二指肠切除术(PD)的患者被随机分为:标准(S组:10ml/kg/小时)或限制(R组:5ml/kg/小时)液体方案。

主要终点

术后第7天通过胃排空闪烁扫描评估。

结果

对66例随机分组患者的并发症和6年生存率进行了分析。按意向性分析纳入54例患者:24例S组和30例R组。在全方案分析中,32例患者实际接受了PD手术,16例患者接受了姑息性胃空肠吻合术旁路手术。胃排空中位时间(T½)为104分钟(S组,95%置信区间:74 - 369),而R组为159分钟(95%置信区间:61 - 204)(P = 0.893,无统计学意义)。S组10例患者发生胃排空延迟,R组13例患者发生胃排空延迟(45%和50%,P = 0.779,无统计学意义)。主要结局参数胃排空时间在两组间未显示出统计学显著差异。

结论

胰腺手术期间10ml/kg/小时或5ml/kg/小时的液体方案在胃排空方面未导致统计学显著差异。需要进行更大规模的研究才能对胰腺手术中的液体限制得出明确结论。

试验注册号

ISRCTN62621488

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