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Seton or glue for transfinteric anal fistulas? Prospective randomised trial - ND

Seton or glue for transfinteric anal fistulas? Prospective randomised trial - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013027-31-IT
Enrollment
Unknown
Registered
2010-12-31
Start date
2009-10-26
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

transfinteric anal fistulas MedDRA version: 9.1 Level: SOC Classification code 10042613

Interventions

Trade Name: TISSUCOL Pharmaceutical Form: Sealant INN or Proposed INN: APROTININA CAS Number: 9004-04-0 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 1- INN or P

Sponsors

AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with medium or high trans-sphincteric fistulas. Any sex and age 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: neoplasm, HIV, diabetes, anal fissures, anal abscesses, anti-coagulant treatments, immunosuppression, complex fistulas, Crohn’s disease, pregnancy, , any allergic reaction to the bioglue components.

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluate the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment.;Secondary Objective: Reduction of healing time and length of hospitalization;Primary end point(s): percentage of healing—

Countries

Italy

Outcome results

None listed

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