MedTrace Logo

Do Antibiotics Prevent Anal Fistulae Formation?

NCT01012843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2009-11-16

No results posted yet for this study

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.

Conditions

  • Anal Fistula

Interventions

DRUG

Amoxicillin-Clavulanate

oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days

DRUG

Placebo

oral Placebo tablets two times a day for 10 days

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Ulas Sozener, M.D. · Ankara University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012843 on ClinicalTrials.gov