Anal Fistula Plug Versus Endorectal Advancement Flap

Anal Fistula Clinical Trial

— AFPERAF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01931371
• Other study ID #: AFPERAF
• Secondary ID: KEK-ZH-Nr. 2013-
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2013
• Last updated: August 22, 2013
• Start date: May 2007
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Anal Fistula Plug
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
• Endorectal Advancement Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal fistula recurrence rate		One year	No
Secondary	Cost	In-hospital costs. Typically 1 to 3 days of hospitalization	3 days	No
Secondary	Complication rate	Classified according to the Clavien-Dindo Classification of Surgical Complications.	3 days	Yes
Secondary	Length of hospital stay	Typically 1 to 3 days of hospitalization.	3 days	No
Secondary	Independent factors predicting fistula recurrence	Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.	One year	No
Secondary	Independent factors predicting higher costs	Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.	One year	No