Long-term Follow-up of Anal Fistula Plug

CompletedOBSERVATIONAL
Enrollment

95

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Anal Fistula
Interventions
PROCEDURE

Biodesign® anal fistula plug

Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage.

Trial Locations (1)

Unknown

Skåne University Hospital, Malmo

All Listed Sponsors
lead

Region Skane

OTHER

NCT03961984 - Long-term Follow-up of Anal Fistula Plug | Biotech Hunter | Biotech Hunter