Title
Do Antibiotics Prevent Anal Fistulae Formation?
Does Adjuvant Antibiotic Treatment After Drainage of Anorectal Abscess Prevent the Development of Anal Fistulae? A Prospective Randomized, Placebo Controlled, Double Blind, Multi-Center Clinical Study
Phase
N/ALead Sponsor
University of AnkaraStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Anal FistulaIntervention/Treatment
procaine benzylpenicillin clavulanate ...Study Participants
151Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses.
Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.
oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days
oral Placebo tablets two times a day for 10 days
Patients who received antibiotic treatment after abscess drainage
Inclusion Criteria: Presence of anorectal abscess Exclusion Criteria: Allergy to penicillin derivatives Treatment with any antimicrobial agent in the week before enrolment Recognized other infection at the time of surgery Previous anorectal surgery Presence of inflammatory bowel disease Suspicion of Fournier's gangrene Secondary and recurrent anorectal abscesses Presence of an internal opening Any additional surgical procedure performed in the same session or during follow-up Antibiotic prophylaxis indicated for another reason Immunosuppressive and/or anticoagulant drug treatment being taken at the time of surgery Diabetes mellitus Known chronic disabling disease Pregnancy Lactation.
