Global audit on bowel perforations related to transanal irrigation
Global audit on bowel perforations related to transanal irrigation
复制标题
DOI：
10.1007/s10151-015-1400-8
复制
发表时间：
2016-02-01
影响因子：
3.3
通讯作者：
Emmanuel, A. V.
中科院分区：
文献类型：
--
作者：
Christensen, P.;Krogh, K.;Emmanuel, A. V.
经肛门冲洗越来越多地用于治疗选定患者的慢性便秘和大便失禁。目的是估计使用Peristeen肛门冲洗（A（R））系统的患者中与冲洗相关的肠穿孔的发生率，并探索与穿孔相关的患者和手术相关因素。外部独立专家对2005年至2013年期间与Peristeen肛门冲洗相关的全套全球警戒数据进行审计。共记录了49例肠穿孔报告。根据销售数据，这相当于每百万例手术中有6例肠穿孔的平均风险。最新的两年数据表明，每百万例手术中有2例的风险。在43例可评价病例中，有29例（67%）在治疗开始后的前8周内发生穿孔。8周后，长期使用的估计风险低于百万分之二。在非神经源性肠功能障碍患者中，15例患者中有11例（73%）有盆腔器官手术史，而神经源性肠功能障碍患者中有5例（19%）有盆腔器官手术史。在46例可评价病例中，有11例（24%）报告了直肠球囊破裂。灌肠引起的穿孔是Peristeen肛门冲洗经肛门冲洗的罕见并发症，这增加了支持进一步使用经肛门冲洗的受益风险比。在治疗开始期间和既往接受过盆腔器官手术的患者中，风险增加。仔细的患者选择、患者评估和患者的适当培训对于该技术的安全实践至关重要。
Transanal irrigation is increasingly used against chronic constipation and fecal incontinence in selected patients. The aims were to estimate the incidence of irrigation-related bowel perforation in patients using the Peristeen Anal Irrigation(A (R)) system, and to explore patient- and procedure-related factors associated with perforation.External independent expert audit on the complete set of global vigilance data related to Peristeen Anal Irrigation from 2005 to 2013.In total, 49 reports of bowel perforation had been recorded. Based on sales figures, this corresponds to an average risk of bowel perforation of 6 per million procedures. The latest two-year data indicate a risk of 2 per million procedures. In 29 out of 43 evaluable cases (67 %), perforation happened within the first 8 weeks since start of treatment. After 8 weeks, long-term use has an estimated risk of less than 2 per million procedures. Among patients with non-neurogenic bowel dysfunction, 11 out of 15 (73 %) had a history of pelvic organ surgery compared to 5 out of 26 (19 %) in neurogenic bowel dysfunction. In 11 of 46 (24 %) evaluable cases, burst of the rectal balloon was reported.Enema-induced perforation is a rare complication to transanal irrigation with Peristeen Anal Irrigation, which increases the benefit risk ratio in support of the further use of transanal irrigation. Increased risk is present during treatment initiation and in patients with prior pelvic organ surgery. Careful patient selection, patient evaluation and proper training of patients are critical to safe practice of this technique.