Global audit on bowel perforations related to transanal irrigation.

PURPOSE: 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(®) system, and to explore patient- 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 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.

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 patients with prior pelvic organ surgery. Careful patient selection, patient evaluation and proper training of patients are critical to safe practice of this technique.