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Anal Fistula Plug Versus Endorectal Advancement Flap (AFPERAF)

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Unknown

Conditions

Anal Fistula

Treatments

Procedure: Endorectal Advancement Flap
Procedure: Anal Fistula Plug

Study type

Interventional

Funder types

Other

Identifiers

NCT01931371
KEK-ZH-Nr. 2013-XYZ (Other Identifier)
AFPERAF

Details and patient eligibility

About

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.

Full description

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

Enrollment

71 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

71 participants in 2 patient groups

Recurrent anal fistula
Active Comparator group
Description:
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Treatment:
Procedure: Anal Fistula Plug
Procedure: Endorectal Advancement Flap
No recurrence of anal fistula
Active Comparator group
Description:
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Treatment:
Procedure: Anal Fistula Plug
Procedure: Endorectal Advancement Flap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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