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临床试验/NCT03643198
NCT03643198招募中不适用

Oral Antibiotics for Anal Abscess to Diminish the Developement of Perianal Fistula

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
1
主要终点
Perianal fistula incidence

研究概览

简要总结

BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.

详细描述

METHODS This project is a 3-year study.

Trial Design:

This is a multicentre, double-blind placebo trial to investigate the effect of oral antibiotics after anal abscess drainage to diminish the development of an anal fistul.

This Clinical Trial will consist of two parallel study groups with a (1:1) randomization, masking by double-blind technique and placebo control.

Participants:

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Adult patients over 18 years old
  • Clinical diagnosis of perianal abscess

排除标准

  • Participants who have a history of previous perianal abscesses.
  • Inflammatory bowel disease
  • Patients who already have a perianal fistula
  • Patients with perianal cancer and / or pelvic radiotherapy
  • Perianal trauma
  • Immunodeficiency
  • Pregnancy or lactation
  • Valvular heart disease or prosthetic valve carriers
  • Spontaneous drainage
  • Previous use of antibiotics
  • Patients with a known allergy to Ciprofloxacin or Metronidazole.

研究组 & 干预措施

CONTROL

Sham Comparator

The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.

干预措施: CONTROL (Other)

TREATMENT

Active Comparator

In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days.

干预措施: ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) (Drug)

TREATMENT

Active Comparator

In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days.

干预措施: CONTROL (Other)

结局指标

主要结局

Perianal fistula incidence

时间窗: 12 months

Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.

次要结局

  • Improving on Quality of life(12 months)

研究者

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

David Parés MD, PhD

David parés. MD, PhD. Consultant Surgeon. Associate professor

Germans Trias i Pujol Hospital

研究点 (1)

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