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

Completed

• Conditions: Fistula-in-ano of cryptoglandular origin; Digestive System; Fissure and fistula of anal and rectal regions

• Registration Number: ISRCTN23974417
• Lead Sponsor: Hospital Virgen del Camino (Spain) - Public University of Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Continence, evaluated pre- and post-operatively (after one year) using the Wexner score.