NCT03961984

Long-term Follow-up of Anal Fistula Plug

Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.

Detailed description

A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2019-05-23
• Last updated: 2019-05-23

Locations

1 site across 1 country: Sweden