The role of the Anal Fistula Plug combined with infliximab in the treatment of perianal fistula due to Crohn*s disease. -a randomised controlled trial-

The role of the Anal Fistula Plug combined with infliximab in the treatment of perianal fistula due to Crohn*s disease. -a randomised controlled trial- - inflixiPLUG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29741

Enrollment

Registered

2006-11-10

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

anorectal fistula perianal fistula

Interventions

insertion of the anal fistula plug

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Crohn*s disease Infliximab treatment and chronic loose seton drainage > 2 months High anorectal fistula (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal) Informed consent

Exclusion criteria

Exclusion criteria: Cryptoglandular fistula Age

Design outcomes

Primary

Measure	Time frame
1. Anorectal fistula closure rate 2. Continence	—

Secondary

Measure	Time frame
1. Morbidity 2. Quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)