Do Antibiotics Prevent Anal Fistulae Formation?

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.

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Key information

Conditions

Anal Fistula Abscess Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Intestinal Fistula Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Numune Teaching and Research Hospital, Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amoxicillin-clavulanate

Drug

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

Other names: Bioment 1 gr BID tablets

Placebo

Drug

oral Placebo tablets two times a day for 10 days

Primary outcomes

Fistula formation

Time frame: 1 year after surgery

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Nov 13, 2009
Registry last updated: Nov 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed