Long-term Follow-up of Anal Fistula Plug

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Biodesign® anal fistula plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complex transsphincteric anal fistula Exclusion Criteria: ano/rectovaginal fistula
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complex anal fistula<br>Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug. | Procedure: Biodesign® anal fistula plug<br>* 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.<br>* Other names: Collagen plug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula recurrence; Technical failure | Plug fallen out | Week 2 | 
| Fistula recurrence; Infection | Surgical site infection | Week 2 | 
| Fistula recurrence; Infection | Surgical site infection | Month 3 | 
| Fistula recurrence; Infection | Surgical site infection | Month 6-12 | 
| Fistula recurrence; Infection | Surgical site infection | Through study completion, an average of 8 years | 
| Fistula recurrence; New opening | Faeces coming through external opening | Week 2 | 
| Fistula recurrence; New opening | Faeces coming through external opening | Month 3 | 
| Fistula recurrence; New opening | Faeces coming through external opening | Month 6-12 | 
| Fistula recurrence; New opening | Faeces coming through external opening | Through study completion, an average of 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal fistula, fistula-in-ano, surgical plug, collagen plug, complex anal fistula, transsphincteric anal fistula