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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 3
- 主要终点
- Fistula formation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of anorectal abscess
排除标准
- •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.
研究组 & 干预措施
Antibiotic
Patients who received antibiotic treatment after abscess drainage
干预措施: Amoxicillin-Clavulanate (Drug)
Placebo
Patients who received placebo after abscess drainage
干预措施: Placebo (Drug)
结局指标
主要结局
Fistula formation
时间窗: 1 year after surgery
次要结局
未报告次要终点