Study to determine how safe and effective is a therapy for the treatment of anal fistula, compared with another treatment that is considered of choice for this disease

• Conditions: Anal and criptoglandular fistula; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-002579-16-ES
• Lead Sponsor: C. HOSPITALARIO VIRGEN DEL ROCIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Signed consent
Older than 18 years
Cryptoglandular anal fistulas. There may be at most 3 external orifices open and a maximum one inner hole.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Filed or coexisting undrained collections.
ASA IV
History of radiation therapy in the perineal area
No internal opening
Pregnant (IF POSSIBLE PREGNANCY PREGNANCY TEST DO)
immunosuppression
Patients with active neoplasia or neoplasia has had a less than a year.
HIV
Simple fistula (submucosal / subcutaneous / low intersphincteric)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified