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随机对照临床试验:切割闭合器肝切除术与LigaSure™ 肝切除术在择期肝切除术中的比较。

Randomized clinical trial of stapler hepatectomy versus LigaSure™ transection in elective hepatic resection.

机构信息

Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.

Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.

出版信息

Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.

Abstract

BACKGROUND

Previous studies have demonstrated stapler hepatectomy and use of various energy devices to be safe alternatives to the clamp-crushing technique in elective hepatic resection. In this randomized trial, the effectiveness and safety of stapler hepatectomy were compared with those of parenchymal transection with the LigaSure™ vessel sealing system.

METHOD

Patients scheduled for elective liver resection at two tertiary-care centres were randomized during surgery to stapler hepatectomy or transection with the LigaSure™ device. Total intraoperative blood loss was the primary efficacy endpoint. Transection time, duration of operation, perioperative complications and length of hospital stay were recorded as secondary endpoints.

RESULTS

A total of 138 patients were analysed, 69 in the LigaSure™ and 69 in the stapler hepatectomy group. Baseline characteristics were well balanced between the groups. Mean intraoperative blood loss was significantly higher in the LigaSure™ group than the stapler hepatectomy group: 1101 (95 per cent c.i. 915 to 1287) versus 961 (752 to 1170) ml (P = 0·028). The parenchymal transection time was significantly shorter in the stapler group (P = 0·005), as was the total duration of operation (P = 0·027). Surgical morbidity did not differ between the groups, nor did the grade of complications.

CONCLUSION

Stapler hepatectomy was associated with reduced blood loss and a shorter duration of operation than the LigaSure™ device for parenchymal transection in elective partial hepatectomy. Registration number: NCT01858987 (http://www.clinicaltrials.gov).

摘要

背景

先前的研究表明,在择期肝切除术中,吻合器肝切除术和使用各种能量装置是夹闭-挤压技术的安全替代方法。在这项随机试验中,比较了吻合器肝切除术与 LigaSure 血管密封系统进行肝实质离断的效果和安全性。

方法

在两个三级护理中心计划进行择期肝切除术的患者在手术期间被随机分为吻合器肝切除术或 LigaSure 刀离断组。总术中失血量是主要的疗效终点。记录肝实质离断时间、手术时间、围手术期并发症和住院时间作为次要终点。

结果

共分析了 138 例患者,69 例患者采用 LigaSure 刀,69 例患者采用吻合器肝切除术。两组患者的基线特征均衡。LigaSure 刀组的平均术中失血量明显高于吻合器肝切除术组:1101(95%可信区间 915 至 1287)比 961(752 至 1170)ml(P = 0.028)。吻合器组的肝实质离断时间明显缩短(P = 0.005),总手术时间也明显缩短(P = 0.027)。两组手术发病率无差异,并发症的严重程度也无差异。

结论

与 LigaSure 刀进行肝实质离断相比,在择期部分肝切除术中,吻合器肝切除术可减少术中出血量并缩短手术时间。注册号:NCT01858987(http://www.clinicaltrials.gov)。

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