The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

Detailed Description
-----------------
Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Official Title
-----------------
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study

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

Intervention / Treatment
-----------------
* Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with age of or above 18 years. Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric. Patients sable to comply to with the study protocol. Exclusion Criteria: Patients with low perianal fistula Patients with preoperative incontinence. Patients with comorbidities such as TB , malignancy or inflammatory bowel disease. Patients diagnosed with acute anal sepsis Recurrent cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cutting seton<br>A piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal. | Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure<br>* Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Cure of high perianal fistulas -Reduce incontinence rate | Cure from the main problem of the patient and prevent its recurrence | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutting seton, Fistulectomy