Anal Fistula Plug Versus Endorectal Advancement Flap

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: Anal Fistula Plug; Procedure: Endorectal Advancement Flap

• Registration Number: NCT01931371
• Lead Sponsor: University of Zurich

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Status Verified: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Study First Posted: 2013-08-29
• Last Update Posted: 2013-08-29
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Adults (18 years of age or more)
• Single anal fistula
• Surgically treated with anal fistula plug or endorectal advancement flap

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Exclusion Criteria

• Children or adolescents
• Pregnancy
• Patients treated with setons alone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recurrent anal fistula	Endorectal Advancement Flap	Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
No recurrence of anal fistula	Anal Fistula Plug	Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Recurrent anal fistula	Anal Fistula Plug	Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
No recurrence of anal fistula	Endorectal Advancement Flap	Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap

Primary Outcome Measures

Name	Time	Method
Anal fistula recurrence rate	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland