Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

January 31, 2012

Conditions
Complex Anal Fistula
Interventions
PROCEDURE

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.

Trial Locations (1)

4031 & 9007

University of Basel & Kantonsspital St.Gallen, Basel & St.Gallen

All Listed Sponsors
collaborator

Unity Health Toronto

OTHER

collaborator

Women's College Hospital

OTHER

collaborator

St. Claraspital AG

OTHER

collaborator

Mount Sinai Hospital, Canada

OTHER

lead

University Hospital, Basel, Switzerland

OTHER

NCT01612195 - Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula | Biotech Hunter | Biotech Hunter