Long-term Follow-up of Anal Fistula Plug

Region Skane

Status: Completed

Conditions: Anal Fistula

Treatments: Procedure: Biodesign® anal fistula plug

Study type: Observational

Funder types: Other

Identifiers

NCT03961984

Plug follow-up 2006

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• complex transsphincteric anal fistula

Exclusion criteria

• ano/rectovaginal fistula

Trial design

95 participants in 1 patient group

Complex anal fistula

Description:

Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug.

Treatment:

Procedure: Biodesign® anal fistula plug