Vilz Tim O, Pantelis Dimitrios, Lingohr Philipp, Fimmers Rolf, Esmann Anke, Randau Thomas, Kalff Jörg C, Coenen Martin, Wehner Sven
Department of Surgery, University of Bonn, Bonn, Germany.
Clinical Study Core Unit, Study Center Bonn (SZB), University of Bonn, Bonn, Germany Institute of Medical Biometrics, Informatics and Epidemiology, Study Center Bonn, University of Bonn, Bonn, Germany.
BMJ Open. 2016 Jul 8;6(7):e011014. doi: 10.1136/bmjopen-2015-011014.
Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill(®), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill(®) immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking.
The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill(®) will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill(®) in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill(®) to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill(®) will be analysed.
The protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations.
NCT02329912; Pre-results.
术后肠梗阻（POI）是腹部手术（AS）后常见的并发症。迄今为止，尚无预防措施或循证疗法。这源于缺乏评估POI严重程度和持续时间的客观参数，导致临床试验质量不高。SmartPill（®）是一种胶囊，吞咽后可频繁测量pH值、温度和腔内压力，为分析体内胃肠道（GI）转运时间和平滑肌活动提供了一种简便的方法。由于该产品的上市许可未涵盖AS术后头几个月患者的使用情况，我们旨在研究术后立即使用SmartPill（®）的安全性和可行性。此外，我们分析促动力药、泻药以及标准化物理治疗对术后肠道收缩性的影响，因为其效果仍缺乏科学证据。
PIDuSA研究是一项前瞻性、单中心、双臂、开放标签试验。SmartPill（®）将应用于55例POI高危的AS患者和10例极少发生POI的非腹部手术患者。主要目标是基于器械不良事件/严重器械不良事件（ADE/SADE）评估SmartPill（®）在术后患者中的安全性。样本量表明，样本中至少有一次80%的把握能观察到概率为3%的事件。次要目标是分析两组患者胃肠道的术后肠道活动。此外，肠道动力障碍的临床体征将与SmartPill（®）测量的数据相关联，以评估其作为评估POI严重程度的客观参数的意义。此外，还将分析促动力药、泻药和物理治疗对SmartPill（®）记录的术后蠕动活动的影响。
该方案已获得联邦当局（94.1.05 - 5660 - 8976）和当地伦理委员会（092/14 - MPG）的批准。研究结果将通过发表文章和会议报告进行传播。
NCT02329912；预结果。
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