46
Participants
Start Date
January 31, 2007
Primary Completion Date
March 31, 2009
Study Completion Date
January 31, 2012
Anal fistula plug
All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.
University of Basel & Kantonsspital St.Gallen, Basel & St.Gallen
Unity Health Toronto
OTHER
Women's College Hospital
OTHER
St. Claraspital AG
OTHER
Mount Sinai Hospital, Canada
OTHER
University Hospital, Basel, Switzerland
OTHER