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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01012843
Enrollment
151
Registered
2009-11-13
Start date
2005-09-30
Completion date
2008-01-31
Last updated
2009-11-16

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

Conditions

Anal Fistula

Keywords

Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal

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.

Interventions

oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days

DRUGPlacebo

oral Placebo tablets two times a day for 10 days

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Fistula formation1 year after surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026