Status:
TERMINATED
Seton or Glue for Trans-sphincteric Anal Fistulas
Lead Sponsor:
Societa Italiana di Chirurgia ColoRettale
Conditions:
Anal Fistulas
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been a...
Detailed Description
Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature ...
Eligibility Criteria
Inclusion
- medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments
Exclusion
- Crohn's disease
- anal abscesses
- complex fistulas (horse-shoe type or multiple secondary tracts)
- immunosuppression
- diabetes,
- anal fissures
- pregnancy
- anti-coagulant treatments,
- any allergic reaction to the bioglue components.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00929630
Start Date
January 1 2006
End Date
June 1 2007
Last Update
September 16 2009
Active Locations (1)
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1
Dept of Emergency and Organ transplantation - University of Bari
Bari, Italy, 70124