Nepogodiev Dmitri, Chapman Stephen J, Glasbey James C D, Kelly Michael, Khatri Chetan, Fitzgerald J Edward, Bhangu Aneel
Norwich Academic Foundation Programme, Norwich, UK.
University of Leeds Medical School, Leeds, UK.
BMJ Open. 2014 Jun 27;4(6):e005164. doi: 10.1136/bmjopen-2014-005164.
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs' safety profile following gastrointestinal resection.
This prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use.
Following the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks.
非甾体类抗炎药（NSAIDs）被手术加速康复协会推荐用于术后镇痛。近期研究引发了人们对结直肠吻合术后使用NSAIDs可能会增加吻合口漏风险的担忧。这项多中心研究旨在确定胃肠道切除术后NSAIDs的安全性。
这项前瞻性、多中心队列研究将采用协作方法，在两周内进行。纳入接受开放或腹腔镜、择期或急诊胃肠道切除的连续成年患者。主要终点将是使用Clavien-Dindo分类法评估的30天发病率。本研究将通过医学生网络进行推广，预计至少招募900名患者。该研究将有足够的能力检测出使用NSAIDs后并发症发生率增加10%的情况。
经过研究伦理委员会主席审查后，获得了正式豁免。本研究将在各参与医院注册为临床审计或服务评估。推广将通过先前描述的新型研究协作网络进行。
