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临床试验/NCT02585141
NCT02585141已完成不适用

Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Change in recurrence rate

研究概览

简要总结

The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.

详细描述

Anorectal abscess is a common condition, caused by cryptoglandular polymicrobial infection, where the traditional treatment is surgical drainage. Anorectal abscess is associated with recurrence rates between 6-44 % after surgical drainage and persistent subsequent fistula up to 37 %. Inadequate incision, missed abscess components or fistulas can be the cause of recurrence . Surgical drainage is associated with discomfort from prolonged wound healing, affecting the daily activities as well as the potential risk of complicated scaring and fecal incontinence. Less invasive method with pus aspiration under antibiotic cover has been shown to be safe in terms of recurrence rate and subsequent fistula formation and well tolerated by the patients with less morbidity and wound complications and a potential lower risk of fecal incontinence. However, this has been shown only in few studies with small population and no randomized controlled study comparing the two approaches has been conducted or published to our knowledge. The risk factors of recurrence and subsequent fistula formation are not that clear but age below 40 years, absence of diabetes mellitus and recent smoking are shown to be risk factors for developing recurrent abscess and fistula. Applying aspiration and antibiotics method for the treatment of perianal abscess can be an advantage for the society due to a shorter recovering period, quicker return to daily activity and work and avoiding wound healing problems and sphincter damage; thus lower expenses. The results of this study have the potentials to reveal the risk factors of developing fistula after perianal abscess.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 yrs old
  • Perianal abscess (without spontaneous rupture)
  • Abscess larger than 2 cm in diameter
  • Signed informed consent

排除标准

  • Malignancy within 5 yrs
  • Previous radiotherapy of the abdomen and pelvis
  • Recurrent abscess within 6 months
  • Immune suppressed patients
  • Pregnant and lactating women
  • Abscess with horseshoe formation
  • Allergy to Clindamycin

研究组 & 干预措施

aspiration

Experimental

Aspiration of perianal abscess(MEDIPLAST® 13 G, 2,5 x 110 mm) under general anesthesia followed by antibiotic treatment with Clindamycin tablet 300 mg 3 times daily for 7 days

干预措施: MEDIPLAST® (aspiration) (Device)

aspiration

Experimental

Aspiration of perianal abscess(MEDIPLAST® 13 G, 2,5 x 110 mm) under general anesthesia followed by antibiotic treatment with Clindamycin tablet 300 mg 3 times daily for 7 days

干预措施: Clindamycin (Drug)

incision

Active Comparator

Surgical incision of perianal abscess under general anesthesia.

干预措施: incision (Procedure)

结局指标

主要结局

Change in recurrence rate

时间窗: 2,12 and 52 weeks

Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks

次要结局

  • Changes in healing time(2,12 and 52 weeks)
  • Changes in fistulas formation(2,12 and 52 weeks)
  • changes in Quality of life score(2,12 and 52 weeks)
  • Risk factors for fistula formation and abscess recurrence(2,12 and 52 weeks)
  • fecal incontinence(2,12 and 52 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karam Matlub Sørensen

Principal Investigator

University of Southern Denmark

研究点 (1)

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