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Anal fistula plug versus endorectal advancement flap for the closure of high criptoglandular fistula-in-ano: a randomised study

A randomised study to compare the results of the anal fistula plug (AFP) with the endorectal advancement flap (ERAF) in the treatment of high fistula-in-ano of cryptoglandular origin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23974417
Enrollment
186
Registered
2008-11-20
Start date
2007-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula-in-ano of cryptoglandular origin Digestive System Fissure and fistula of anal and rectal regions

Interventions

All patients underwent full mechanical bowel preparation and received antibiotic and antithromboembolic prophylaxis. The patients were operated on under general anaesthesia in the lithotomy position.
the internal fistula orifice was located by injecting hydrogen peroxide. Curettage of the track was not performed. A probe was inserted in the fistula track. The AFP was placed into the tract until re

Sponsors

Hospital Virgen del Camino (Spain) - Public University of Navarra
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years, either sex 2. High fistula-in-ano of cryptoglandular origin (the fistulas were defined as high when they included the upper two-thirds of the external sphincter complex) 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Secondary tracts 2. Horseshoe fistulas 3. Anovaginal fistulas 4. Rectouretral fistulas 5. Human immunodeficiency virus (HIV)-positive patients 6. Diagnosed from Crohn's disease

Design outcomes

Primary

MeasureTime frame
Fistula closure rate; recurrence is defined as the presence of an abscess arising in the area, or by obvious evidence of fistulation. Evaluated at 2, 4, 8, 12 weeks after surgery, and at 6, 9 and 12 months.

Secondary

MeasureTime frame
Continence, evaluated pre- and post-operatively (after one year) using the Wexner score.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026