Do Antibiotics Prevent Anal Fistulae Formation?

Ankara University

Status: Completed

Conditions: Anal Fistula

Treatments: Drug: Amoxicillin-Clavulanate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01012843

AUTF-001

Details and patient eligibility

About

Purpose: 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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

151 participants in 2 patient groups, including a placebo group

Antibiotic

Active Comparator group

Description:

Patients who received antibiotic treatment after abscess drainage

Treatment:

Drug: Amoxicillin-Clavulanate

Placebo

Placebo Comparator group

Description:

Patients who received placebo after abscess drainage

Treatment:

Drug: Placebo