Long-term Follow-up of Anal Fistula Plug
- Conditions
- Anal Fistula
- Interventions
- Procedure: Biodesign® anal fistula plug
- Registration Number
- NCT03961984
- Lead Sponsor
- Region Skane
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- complex transsphincteric anal fistula
- ano/rectovaginal fistula
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Complex anal fistula Biodesign® anal fistula plug Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug.
- Primary Outcome Measures
Name Time Method Fistula recurrence; New opening Through study completion, an average of 8 years Faeces coming through external opening
Fistula recurrence; Technical failure Week 2 Plug fallen out
Fistula recurrence; Infection Through study completion, an average of 8 years Surgical site infection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Skåne University Hospital
🇸🇪Malmo, Sweden