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Do Antibiotics Prevent Anal Fistulae Formation?

Primary Purpose

Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Amoxicillin-Clavulanate
Placebo
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anal Fistula focused on measuring Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ankara Numune Teaching and Research Hospital
  • Ankara University School of Medicine Department Of General Surgery
  • Dicle University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antibiotic

Placebo

Arm Description

Patients who received antibiotic treatment after abscess drainage

Patients who received placebo after abscess drainage

Outcomes

Primary Outcome Measures

Fistula formation

Secondary Outcome Measures

Full Information

First Posted
November 12, 2009
Last Updated
November 13, 2009
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT01012843
Brief Title
Do Antibiotics Prevent Anal Fistulae Formation?
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ankara University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic
Arm Type
Active Comparator
Arm Description
Patients who received antibiotic treatment after abscess drainage
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who received placebo after abscess drainage
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-Clavulanate
Other Intervention Name(s)
Bioment 1 gr BID tablets
Intervention Description
oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral Placebo tablets two times a day for 10 days
Primary Outcome Measure Information:
Title
Fistula formation
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulas Sozener, M.D.
Organizational Affiliation
Ankara University
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Numune Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University School of Medicine Department Of General Surgery
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dicle University School of Medicine
City
Diyarbakir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
6697831
Citation
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. doi: 10.1007/BF02553995.
Results Reference
background
PubMed Identifier
16091913
Citation
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. doi: 10.1007/s00384-005-0022-4. Epub 2005 Aug 10.
Results Reference
result
PubMed Identifier
9823799
Citation
Hamalainen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. doi: 10.1007/BF02237048.
Results Reference
result
PubMed Identifier
6468199
Citation
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. doi: 10.1007/BF02553848.
Results Reference
result

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Do Antibiotics Prevent Anal Fistulae Formation?

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