Do Antibiotics Prevent Anal Fistulae Formation?

Anal Fistula Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012843
• Other study ID #: AUTF-001
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: November 13, 2009
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: November 2009
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• Amoxicillin-Clavulanate
oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days
• Placebo
oral Placebo tablets two times a day for 10 days

Locations

Country	Name	City	State
Turkey	Ankara Numune Teaching and Research Hospital	Ankara
Turkey	Ankara University School of Medicine Department Of General Surgery	Ankara
Turkey	Dicle University School of Medicine	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. Epub 2005 Aug 10. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula formation		1 year after surgery