首页> 外文期刊>European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery >A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm - results of a pilot study and lessons learned for future studies.
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A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysm - results of a pilot study and lessons learned for future studies.

机译:腹主动脉瘤破裂的血管内和开放手术的随机试验-一项初步研究的结果以及为将来的研究所汲取的教训。

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INTRODUCTION: EVAR has the potential to improve outcome after ruptured abdominal aortic aneurysm (AAA). Published series have been based upon selected populations. METHODS: An interim analysis of a single centre prospective randomised controlled trial comparing endovascular aneurysm repair (EVAR) with open aneurysm repair (OAR) in patients with ruptured AAA was performed. Patients who had a ruptured AAA and who were considered fit for open repair were randomised to EVAR or OAR after consent had been obtained. Those in the EVAR group had pre-operative spiral computed tomographic angiography (CTA). The primary endpoint was operative (30-day) mortality and secondary endpoints were moderate or severe operative complications, hospital stay and time between diagnosis and operation. A power study calculation required 100 patients to be recruited. RESULTS: Between September 2002 and December 2004, 103 patients were admitted with suspected ruptured AAA. Only 32 patients were recruited to the study. Of these, four patients died before receiving surgical treatment. On an intention to treat basis the 30-day mortality rate was 53% in the EVAR group and 53% in the OAR group. Moderate or severe operative complications occurred in 77% in the EVAR group and in 80% in the OAR group. Median total hospital stay in the EVAR group was 10 days (inter-quartile range 6-28) and 12 days (4-52) in the OAR group. Median time between diagnosis and operation was 75 minutes (64-126) in the EVAR group and 100 minutes (48-138) in the OAR group. CONCLUSIONS: Despite the relative high operative mortality in the EVAR group, these preliminary results show that it is possible to recruit patients to a randomised trial of OAR and EVAR in patients with ruptured AAA. CT scanning does not delay treatment.
机译:简介:EVAR有可能改善腹主动脉瘤(AAA)破裂后的预后。出版的系列是基于选定的人群。方法:对一项单中心前瞻性随机对照试验进行了中期分析,比较了破裂性AAA患者的血管内动脉瘤修复(EVAR)与开放性动脉瘤修复(OAR)。 AAA破裂且被认为适合进行开放式修复的患者在获得患者同意后被随机分为EVAR或OAR。 EVAR组的患者术前进行了螺旋计算机断层血管造影(CTA)。主要终点为手术(30天)死亡率,次要终点为中度或重度手术并发症,住院时间以及诊断和手术间隔时间。功效研究计算需要招募100名患者。结果:2002年9月至2004年12月之间,有103例疑似AAA破裂的患者入院。仅招募了32名患者参加研究。其中,四名患者在接受手术治疗前死亡。以治疗为基础,EVAR组的30天死亡率为53%,OAR组为53%。 EVAR组为77%,OAR组为80%,为中度或重度手术并发症。 EVAR组的中位住院总时间中位数为10天(四分位之间为6-28),OAR组为12天(4-52)。 EVAR组诊断和手术之间的中位时间为75分钟(64-126),OAR组为100分钟(48-138)。结论:尽管EVAR组手术死亡率较高,但这些初步结果表明,有可能招募患者参加AAA破裂患者的OAR和EVAR随机试验。 CT扫描不会延迟治疗。

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