XXXX related to transanal irrigation.

@entity1 @entity3501 @entity322 @entity29 @entity1142
PURPOSE: Transanal irrigation is increasingly used against chronic @entity1142 and fecal @entity322 in selected @entity1 . The aims were to estimate the incidence of irrigation-related @entity29 in @entity1 using the Peristeen Anal Irrigation(  ) system, and to explore @entity1 - and procedure-related factors associated with perforation. METHODS: External independent expert audit on the complete set of global vigilance data related to Peristeen Anal Irrigation from 2005 to 2013. RESULTS: In total, 49 reports of @entity29 had been recorded. Based on sales figures, this corresponds to an average risk of @entity29 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 @entity1 with @entity3501 , 11 out of 15 (73  %) had a history of pelvic organ surgery compared to 5 out of 26 (19  %) in @entity3501 . In 11 of 46 (24  %) evaluable cases, burst of the rectal balloon was reported. CONCLUSION: 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 @entity1 with prior pelvic organ surgery. Careful @entity1 selection, @entity1 evaluation and proper training of @entity1 are critical to safe practice of this technique.
