Endoscopic Treatment of Complex Anal Fistulas

Study Overview
=================
Brief Summary
-----------------
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

Detailed Description
-----------------
The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Official Title
-----------------
Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Procedure: operation
* Device: VAAFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with complex transsphincteric anal fistulas >18 yrs old. Exclusion Criteria: Crohns fistulas Signs of suppuration or/and branching. Malignancy within 5 yrs. Previous radiotherapy of the abdomen and pelvis. Current Immune- suppressive treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operation<br>the fistula will be excised after dividing the sphincter and primary reconstruction . | Procedure: operation<br>* the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.<br>* Other names: Fistulectomy and primary sphincter reconstruction;|
| Experimental: VAAFT<br>the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures. | Device: VAAFT<br>* Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate of perianal fistula | A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in quality of life score | A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. | baseline and 6 months | 
| changes in fecal incontinence score | A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. | baseline and 6 months | 
| changes in manometric study | A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAAFT, anal fistula, sphincter reconstruction