Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.

Detailed Description
-----------------
Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.

Official Title
-----------------
Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study

Conditions
-----------------
Perianal Fistula

Intervention / Treatment
-----------------
* Procedure: Anal fistula treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with fistula involving > 1/3 of the external anal sphincter Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton) Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug) All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up Exclusion Criteria: Fistula tract shorter than 2 cm Complex fistula tract system (branching of the fistula tract) Age < 18 years Pregnancy HIV-positivity Fistula caused by malignancy Tuberculosis Hidrosadenitis suppurativa Pilonidal sinus disease No internal fistula opening found Unable/contra indications to go through MRI scanning Crohn´s disease Ulcerative proctitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advancement flap surgery<br> | Procedure: Anal fistula treatment<br>* A comparison of collagen plug vs advancement flap surgery<br>* Other names: Surgical treatment;|
| Active Comparator: Collagen plug<br> | Procedure: Anal fistula treatment<br>* A comparison of collagen plug vs advancement flap surgery<br>* Other names: Surgical treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anorectal fistula closing rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 1 year |