Do Antibiotics Prevent Anal Fistulae Formation?

Sponsor

Ankara University (Other)

Overall Status

Completed

CT.gov ID

NCT01012843

Collaborator

(none)

151

Enrollment

Locations

Arms

Duration (Months)

50.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Fistula	Drug: Amoxicillin-Clavulanate Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

151 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official 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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotic Patients who received antibiotic treatment after abscess drainage	Drug: Amoxicillin-Clavulanate oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days Other Names: Bioment 1 gr BID tablets
Placebo Comparator: Placebo Patients who received placebo after abscess drainage	Drug: Placebo oral Placebo tablets two times a day for 10 days

Arm

Intervention/Treatment

Active Comparator: Antibiotic

Patients who received antibiotic treatment after abscess drainage

Drug: Amoxicillin-Clavulanate

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

Other Names:

Bioment 1 gr BID tablets

Placebo Comparator: Placebo

Patients who received placebo after abscess drainage

Drug: Placebo

oral Placebo tablets two times a day for 10 days

Outcome Measures

Primary Outcome Measures

Fistula formation [1 year after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ankara Numune Teaching and Research Hospital	Ankara	Turkey	06100
2	Ankara University School of Medicine Department Of General Surgery	Ankara	Turkey	06100
3	Dicle University School of Medicine	Diyarbakir	Turkey