Overview

This trial is active, not recruiting.

Condition anal fistula
Treatments anal fistula plug, endorectal advancement flap
Sponsor University of Zurich
Start date May 2007
End date September 2013
Trial size 71 participants
Trial identifier NCT01931371, AFPERAF, KEK-ZH-Nr. 2013-XYZ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
anal fistula plug Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
endorectal advancement flap Advancement Mucosa Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
(Active Comparator)
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
anal fistula plug Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
endorectal advancement flap Advancement Mucosa Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap

Primary Outcomes

Measure
Anal fistula recurrence rate
time frame: One year

Secondary Outcomes

Measure
Cost
time frame: 3 days
Complication rate
time frame: 3 days
Length of hospital stay
time frame: 3 days
Independent factors predicting fistula recurrence
time frame: One year
Independent factors predicting higher costs
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
Principal investigator Oliver M Fisher, MD
Description A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University of Zurich.