Charvier K, Bonniaud V, Waz D, Desprez C, Leroi A-M
Department of Physical Medicine and Rehabilitation, Henry Gabrielle Hospital, Lyon University Hospital Center, 69230, St Genis Laval, France.
Department of Physical Médicine and Rehabilitation, Le Bocage Hospital, Dijon Regional University Hospital Center, Dijon, France.
Tech Coloproctol. 2020 Jul;24(7):731-740. doi: 10.1007/s10151-020-02212-x. Epub 2020 Apr 21.
The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set.
An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study's primary efficacy criterion was successful TAI, defined as (i) use of the patient's usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety.
Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device.
In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.
本研究的目的是评估使用一种新型医疗设备（IryPump®R套装，一种带有电动泵的设备）进行经肛门灌洗（TAI）的可行性。
在法国的三家大学医院开展了一项关于TAI的干预性、前瞻性、开放标签、非对照、多中心试点研究。纳入有TAI经验的患者，为期1个月，在此期间使用IryPump®R套装（德国贝朗医疗公司，梅尔松根）连续进行5次TAI。该研究的主要疗效标准为TAI成功，定义为：（i）使用患者常用的灌洗水量；（ii）粪便排出；（iii）两次TAI之间无渗漏。主要分析中不考虑前两次TAI。次要结局指标为设备可接受性、肠道功能障碍评分、耐受性和安全性。
2016年11月至2017年5月纳入15例患者，主要分析中评估了14例。TAI成功率为72.4%（29次操作中有21次成功）。研究结束时的肠道功能障碍评分与纳入时记录的评分相比无显著差异。高比例患者（>70%）报告使用该新型医疗设备进行TAI是可行的。未发生严重不良事件或与设备相关的不良事件。研究结束时，50%的参与者愿意考虑进一步使用该新型设备。
对于熟悉TAI的患者，使用一种带有电动泵的新型医疗设备是可行的。患者满意度较高，尤其是在使用舒适度和TAI期间的安全感方面。
