NCT01388257Unknown不适用
A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")
French Society of Coloproctology30 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 30
- 主要终点
- Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
研究概览
简要总结
The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.
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
- 否
入选标准
- •male or female 18 years or older,
- •women of childbearing age who use an effective contraception method or women incapable of becoming pregnant [(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)],
- •Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,
- •Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,
- •Patient treated with adalimumab for more than 1 month,
- •Patient who agrees to undergo surgery for its drained fistula(s),
- •Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,
- •Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.
排除标准
- •Pregnant or breastfeeding women,
- •Patient having a perineal abscess,
- •Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,
- •Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),
- •Contraindication to proctological surgery on the drained fistula(s),
- •Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,
- •Patient who participate in another clinical trial.
研究组 & 干预措施
Simple seton drain removal
Other
干预措施: Simple seton drain removal (Procedure)
Surgery
Experimental
Seton drain removal is associated with proctological surgery.
干预措施: All types of surgery procedures (Procedure)
结局指标
主要结局
Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease
时间窗: 12 months after seton drain removal
次要结局
- Change in fistula activity assessed by magnetic resonance imaging (MRI)(6, 12 and 24 months after seton drain removal)
- Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI)(3, 6, 12 and 24 months after seton drain removal)
- Change in anal continence assessed by Wexner and Vaizey scores(12 and 24 months after seton drain removal)
- Crohn's Disease Endoscopic Index of Severity (CDEIS)(12 months after seton drain removal)
- Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)(3, 6, 12 and 24 months after seton drain removal)
- Proportion of patients having more than half of their fistulas healed(3, 6, 12 and 24 months after seton drain removal)
- Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)(12 and 24 months after seton drain removal)
研究者
研究点 (30)
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