NCT00723047已完成3 期
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives27 个研究点 分布在 2 个国家目标入组 77 人开始时间: 2003年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 27
- 主要终点
- Clinical Remission
研究概览
简要总结
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •at least 18 years old
- •CD confirmed by endoscopy and histology.
- •CDAI should be 250 or less
- •at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration
排除标准
- •treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months
- •presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month,
- •presence of anal or rectal stenosis,
- •surgery during the previous month (except seton removal),
- •previous fibrin glue injection,
- •pregnancy.
结局指标
主要结局
Clinical Remission
时间窗: 8 weeks after inclusion
Clinical remission was defined as * the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression , * the absence of perianal pain * and the absence of perianal abscess.
次要结局
- Early Clinical Remission(4 weeks after Inclusion)
- Occurrence of perianal abcess(During whole study)
研究者
研究点 (27)
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