Do Antibiotics Prevent Anal Fistulae Formation?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01012843
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : November 16, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anal Fistula Drug: Amoxicillin-Clavulanate Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : September 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Amoxicillin

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 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

Primary Outcome Measures :
  1. Fistula formation [ Time Frame: 1 year after surgery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01012843

Ankara Numune Teaching and Research Hospital
Ankara, Turkey, 06100
Ankara University School of Medicine Department Of General Surgery
Ankara, Turkey, 06100
Dicle University School of Medicine
Diyarbakir, Turkey
Sponsors and Collaborators
Ankara University
Study Chair: Ulas Sozener, M.D. Ankara University School of Medicine

Publications of Results:
Other Publications:
Responsible Party: Dr. Ulas Sozener, Ankara University School of Medicine Department of General Surgery Identifier: NCT01012843     History of Changes
Other Study ID Numbers: AUTF-001
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009

Keywords provided by Ankara University:
Fistulae in ano

Additional relevant MeSH terms:
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action