Do Antibiotics Prevent Anal Fistulae Formation? - Full Text View

Purpose

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	Intervention
Anal Fistula	Drug: Amoxicillin-Clavulanate Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Fistulas

Drug Information available for: Amoxicillin Amoxicillin sodium

U.S. FDA Resources

Further study details as provided by Ankara University:

Primary Outcome Measures:

Fistula formation [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

Enrollment:	151
Study Start Date:	September 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Other Name: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012843

Locations

Turkey
Ankara University School of Medicine Department Of General Surgery
Ankara, Turkey, 06100
Ankara Numune Teaching and Research Hospital
Ankara, Turkey, 06100
Dicle University School of Medicine
Diyarbakir, Turkey

Sponsors and Collaborators

Ankara University

Investigators

Study Chair:

Ulas Sozener, M.D.

Ankara University School of Medicine

More Information

Publications:

Nunoo-Mensah JW, Balasubramaniam S, Wasserberg N, Artinyan A, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr, Vukasin P. Fistula-in-ano: do antibiotics make a difference? Int J Colorectal Dis. 2006 Jul;21(5):441-3. Epub 2005 Aug 10.

Hämäläinen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2.

Ramanujam PS, Prasad ML, Abcarian H, Tan AB. Perianal abscesses and fistulas. A study of 1023 patients. Dis Colon Rectum. 1984 Sep;27(9):593-7.

Vasilevsky CA, Gordon PH. The incidence of recurrent abscesses or fistula-in-ano following anorectal suppuration. Dis Colon Rectum. 1984 Feb;27(2):126-30.

Responsible Party:	Dr. Ulas Sozener, Ankara University School of Medicine Department of General Surgery
ClinicalTrials.gov Identifier:	NCT01012843 History of Changes
Other Study ID Numbers:	AUTF-001
Study First Received:	November 12, 2009
Last Updated:	November 13, 2009
Health Authority:	Turkey: Ethics Committee Turkey: Ministry of Health

Keywords provided by Ankara University:

Perianal
Abscess
Fistulae in ano
Antibiotic
Anorectal

Additional relevant MeSH terms:

Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Amoxicillin

Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013