Do Antibiotics Prevent Anal Fistulae Formation?

This study has been completed.
Sponsor:
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01012843
First received: November 12, 2009
Last updated: November 13, 2009
Last verified: November 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014