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首页> 外文期刊>International journal of colorectal disease. >Randomised multicentre trial of circular stapling devices
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Randomised multicentre trial of circular stapling devices

机译：圆形吻合器的随机多中心试验

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Purpose In a register study, the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4% difference between the two brands used. Based on those data, a randomised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device. Methods Patients above 18 years with a rectal cancer, able to give informed consent, and scheduled for an anterior resection were eligible for the study. Perioperative randomisation was to Ethicon? PROXIMATE? ILS? or Autosuture? Premium Plus CEEA?. Anastomotic leakage was defined as a clinically manifest leak. Results Five hundred twenty-nine patients were randomised (58% male). A leak occurred in 8.3%. The anastomoses created by PROXIMATE? ILS? leaked in 25/265 (9.4%) anastomoses, and the Premium Plus CEEA? leaked in 19/ 260 (7.3%), p=.419. Conclusion No difference in the leak rate could be revealed. Several centres replaced one of the staplers by anew product, and the study was ended before the stipulated number of patients was reached. In the future, surgical devices may have to prove superiority in randomised trials or be monitored in quality registers before they can be introduced into day to day surgical practice. The study was registered at ClinicalTrials.gov: NCT00399009.
机译：目的在一项登记研究中，吻合口漏的风险与选择圆形吻合器有关，两个使用的品牌之间的差异为4％。基于这些数据，开始了一项随机的多中心研究，以探索基于手术器械的吻合口漏的风险。方法18岁以上患有直肠癌，能够给予知情同意并计划进行前切除术的患者符合研究条件。围手术期随机分配给了Ethicon？接近？ ILS？还是自动缝合？ Premium Plus CEEA？吻合口渗漏被定义为临床上明显的渗漏。结果529例患者被随机分组​​（男性占58％）。泄漏率为8.3％。由PROXIMATE创建的吻合？ ILS？ 25/265（9.4％）吻合口漏了，Premium Plus CEEA？泄漏19/260（7.3％），p = .419。结论泄漏率无差异。几个中心用一种新产品替换了一个订书机，并且在达到规定的患者人数之前就结束了研究。将来，外科手术设备可能必须在随机试验中证明其优越性，或者在将其引入日常外科手术之前在质量记录器中进行监控。该研究已在ClinicalTrials.gov上注册：NCT00399009。

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