2024-520193-35-00招募中4 期
Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula. A randomized, double-blind clinical trial.
MARIANO ARTES CASELLES1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月14日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of patients who develop perianal fistula.
研究概览
简要总结
To determine the efficacy of antibiotic therapy after surgical drainage of the perianal abscess in the development of perianal fistula.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patients of at least 18 years of age.
- •First episode of perianal abscess.
- •Oral feeding.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Signed written informed consent in accordance with ICH/GCP and local legislation, obtained prior to any study procedure.
排除标准
- •Allergy or intolerance to amoxicillin/clavulanic acid.
- •Contraindication to the performance of any of the study procedures.
- •History of previous perianal surgery.
- •Any clinical condition, and/or analytical alteration that, in the opinion of the investigator, is considered clinically significant enough to participate in the study. The following are considered as such: a) Previous perianal fistula or fistula diagnosed during surgery. b) Complex abscess. c) Marked cellulitis after surgical drainage. d) History of inflammatory bowel disease. e) History of anal cancer. f) Previous trauma or radiotherapy. g) Diabetes mellitus. h) Immunosuppressed: oncology patients, chronic corticosteroid treatment or other immunosuppressants, chronic kidney disease. i) Prosthetic valves. j) Morbid obesity (BMI>40). k) Signs of severe sepsis
- •Women with positive pregnancy test result or breast-feeding.
- •Unwillingness or inability to follow the procedures described in the protocol.
- •Inability to give written informed consent.
结局指标
主要结局
Percentage of patients who develop perianal fistula.
Percentage of patients who develop perianal fistula.
次要结局
- Time to onset of fistula (months).
- Complexity of the fistula according to the St James´s classification.
- Presence of new episode of perianal abscess at follow-up.
- Need for scheduled surgery for perianal fistula treatment (number of interventions, time since initial event and technique used).
- Quality of life questionnaire after the onset of perianal fistula (QoLAF-Q questionnaire).
研究者
VERÓNICA POLAINO MORENO
Scientific
MARIANO ARTES CASELLES
研究点 (1)
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