Department of Surgery, University of Auckland, Auckland, New Zealand.
J Gastrointest Surg. 2013 May;17(5):962-72. doi: 10.1007/s11605-013-2148-y. Epub 2013 Feb 2.
There is a lack of an internationally accepted standardised clinical definition for postoperative ileus (POI). This has made it difficult to estimate incidence and identify risk factors and has compromised external validity of clinical trials.
To clarify terminology of POI and propose concise, clinically quantifiable definitions.
A systematic review extracted definitions from randomised trials published between 1996 and 2011 investigating POI after abdominal surgery. This was followed by a global survey seeking opinions of those who have published in the field.
Definitions were extracted from 52 identified trials. Responses were received in the survey from 45 of 118 corresponding authors. Data were amalgamated to synthesise the following definitions: postoperative ileus (POI) "interval from surgery until passage of flatus/stool AND tolerance of an oral diet"; prolonged POI "two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, distension, radiologic confirmation occurring on or after day 4 postoperatively without prior resolution of POI"; recurrent POI "two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, distension, radiologic confirmation, occurring after apparent resolution of POI". Concordance of the latter two definitions with survey responses were ≥75 %.
We have proposed standardised endpoints for use in future studies to facilitate objective comparison of competing interventions.
目前缺乏国际公认的术后肠梗阻(POI)标准化临床定义。这使得难以估计发病率和确定风险因素,并影响临床试验的外部有效性。
阐明 POI 的术语,并提出简洁、可临床量化的定义。
系统综述从 1996 年至 2011 年期间发表的关于腹部手术后 POI 的随机试验中提取定义。随后进行了全球调查,征求了该领域发表意见的人的意见。
从 52 项已确定的试验中提取了定义。调查收到了 118 位相应作者中的 45 位的回复。对数据进行了合并,以综合出以下定义:术后肠梗阻(POI)“从手术到排气/排便以及能够耐受口服饮食的时间间隔”;延长的 POI“恶心/呕吐、不能耐受 24 小时以上的口服饮食、24 小时以上无肛门排气、腹胀、术后第 4 天或之后出现影像学证实,而之前没有 POI 缓解”;复发性 POI“恶心/呕吐、不能耐受 24 小时以上的口服饮食、24 小时以上无肛门排气、腹胀、影像学证实,在 POI 明显缓解后出现”。后两个定义与调查回复的一致性≥75%。
我们提出了标准化的终点,用于未来的研究,以促进竞争干预措施的客观比较。