Clinical trial NCT01012843: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Keywords: Perianal
Abscess
Fistulae in ano
Antibiotic
Anorectal
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Fistula formation
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Teaching and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department Of General Surgery
city: Diyarbakir
country: Turkey
facility: Dicle University School of Medicine
Study officials:
affiliation: Ankara University
name: Ulas Sozener, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.
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.