title: Global audit on bowel perforations related to transanal irrigation.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital, Tage Hansens Gade 2, 8000, Aarhus, Denmark. petchris@rm.dk.
authors.forename: P
authors.initials: P
authors.lastname: Christensen
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Krogh
authors.affiliation: University Hospital of Nantes, St Jacques Hospital, Nantes, France.
authors.forename: B
authors.initials: B
authors.lastname: Perrouin-Verbe
authors.affiliation: Chirurgische Klinik, Beckenbodenzentrum, Munich, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Leder
authors.affiliation: Montecatone Rehabilitation Institute, University of Bologna, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Bazzocchi
authors.affiliation: Coloplast A/S, Humlebæk, Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Petersen Jakobsen
authors.affiliation: Department of GI Physiology, University College London, London, UK.
authors.forename: A V
authors.initials: AV
authors.lastname: Emmanuel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal; D002648:Child; D003248:Constipation / Q000503:physiopathology / Q000628:therapy; D004733:Enema / Q000009:adverse effects* / Q000379:methods; D005242:Fecal Incontinence / Q000503:physiopathology / Q000628:therapy; D005260:Female; D006801:Humans; D007416:Intestinal Perforation / Q000209:etiology*; D007422:Intestines / Q000293:injuries* / Q000503:physiopathology; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D007507:Therapeutic Irrigation / Q000009:adverse effects*; D055815:Young Adult
keywords: Constipation; Devices; Functional GI diseases; Large intestine; Outcomes research; Surgery