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腹腔镜与小切口开放性供肾切除术的比较:单盲随机对照临床试验

Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

作者信息

Kok Niels F M, Lind May Y, Hansson Birgitta M E, Pilzecker Desiree, Mertens zur Borg Ingrid R A M, Knipscheer Ben C, Hazebroek Eric J, Dooper Ine M, Weimar Willem, Hop Wim C J, Adang Eddy M M, van der Wilt Gert Jan, Bonjer Hendrik J, van der Vliet Jordanus A, IJzermans Jan N M

机构信息

Department of Surgery, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, Netherlands.

出版信息

BMJ. 2006 Jul 29;333(7561):221. doi: 10.1136/bmj.38886.618947.7C. Epub 2006 Jul 17.

Abstract

OBJECTIVES

To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function.

DESIGN

Single blind, randomised controlled trial.

SETTING

Two university medical centres, the Netherlands.

PARTICIPANTS

100 living kidney donors.

INTERVENTIONS

Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy.

MAIN OUTCOME MEASURES

The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival.

RESULTS

Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy).

CONCLUSIONS

Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.

摘要

目的

确定活体供肾肾切除术的最佳方法,以尽量减少供体的不适并提供良好的移植肾功能。

设计

单盲随机对照试验。

地点

荷兰的两家大学医学中心。

参与者

100名活体肾供体。

干预措施

参与者被随机分配接受腹腔镜供肾肾切除术或小切口肌肉劈开开放式供肾肾切除术。

主要观察指标

主要结局是使用多维疲劳量表20(MFI-20)评估的身体疲劳。次要结局包括使用SF-36评估的身体功能、术后住院时间、疼痛、手术时间、受者移植肾功能和移植物存活率。

结果

未发生术式转换。与小切口开放式供肾肾切除术相比,腹腔镜供肾肾切除术的皮肤到皮肤时间更长(中位数221对164分钟,P<0.001),热缺血时间更长(6对3分钟,P<0.001),失血量更少(100对240毫升,P<0.001),并发症数量相似(术中12%对6%,P = 0.49,术后均为6%)。腹腔镜肾切除术后,供体需要的吗啡更少(16对25毫克,P = 0.005),住院时间更短(3对4天,P = 0.003)。在一年的随访中,腹腔镜肾切除术后平均身体疲劳程度更低(差值-1.3,95%置信区间-2.4至-0.1),身体功能更好(差值6.2,2.0至10.3)。一年时经死亡校正的移植物功能和受者移植物存活率无差异(腹腔镜肾切除术后为100%,开放式肾切除术后为98%)。

结论

与小切口开放式供肾肾切除术相比,腹腔镜供肾肾切除术可带来更好的生活质量,但安全性和移植肾功能相当。

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