Anal Fistula Plug Versus Endorectal Advancement Flap

Study Overview
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Brief Summary
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The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

Detailed Description
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A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

Official Title
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An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Anal Fistula Plug
* Procedure: Endorectal Advancement Flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years of age or more) Single anal fistula Surgically treated with anal fistula plug or endorectal advancement flap Exclusion Criteria: Children or adolescents Pregnancy Patients treated with setons alone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recurrent anal fistula<br>Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap | Procedure: Anal Fistula Plug<br>* Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug<br>* Other names: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA);Procedure: Endorectal Advancement Flap<br>* Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap<br>* Other names: Advancement Mucosa Flap;|
| Active Comparator: No recurrence of anal fistula<br>Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap | Procedure: Anal Fistula Plug<br>* Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug<br>* Other names: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA);Procedure: Endorectal Advancement Flap<br>* Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap<br>* Other names: Advancement Mucosa Flap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal fistula recurrence rate |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | In-hospital costs. Typically 1 to 3 days of hospitalization | 3 days | 
| Complication rate | Classified according to the Clavien-Dindo Classification of Surgical Complications. | 3 days | 
| Length of hospital stay | Typically 1 to 3 days of hospitalization. | 3 days | 
| Independent factors predicting fistula recurrence | Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management. | One year | 
| Independent factors predicting higher costs | Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fistula in ano, anal fistula, recurrence, costs