Do Antibiotics Prevent Anal Fistulae Formation?

Not Applicable

Completed

• Conditions: Anal Fistula
• Interventions: Drug: Amoxicillin-Clavulanate; Drug: Placebo

• Registration Number: NCT01012843
• Lead Sponsor: Ankara University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Submitted: 2009-11-13
• Last Update Posted: 2009-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic	Amoxicillin-Clavulanate	Patients who received antibiotic treatment after abscess drainage
Placebo	Placebo	Patients who received placebo after abscess drainage

Primary Outcome Measures

Name	Time	Method
Fistula formation	1 year after surgery

Trial Locations

Locations (3)

Ankara Numune Teaching and Research Hospital; 🇹🇷 Ankara, Turkey

Dicle University School of Medicine; 🇹🇷 Diyarbakir, Turkey

Ankara University School of Medicine Department Of General Surgery; 🇹🇷 Ankara, Turkey