A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.
研究概览
简要总结
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.
详细描述
Currently the importance of surgically established drainage of Crohn's perianal fistulas prior to medical therapy is controversial. Several retrospective studies have suggested a benefit to this approach. (1, 2) However, there have been no prospective studies performed to answer this important question. This study aims to definitively answer this question. Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.
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 and Female aged 18 years or older;
- •A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas;
- •Patient's standard of care treatment plan includes the following options: a) surgical intervention with an exam under anesthesia (EUA) by colorectal surgeon, seton placement and drainage of fistula prior to initiating Certolizumab or b) initiating Certolizumab without surgical intervention;
- •Patient has had recent colonoscopy to determine disease activity and extent; and
- •Patient has had either rectal EUS or pelvic MRI (type of test based on investigator site preference) which has identified one or more perianal fistulas.
排除标准
- •Any of Inclusion Criteria is not met;
- •Females who are pregnant or breast feeding;
- •Anti-TNF use within 6 weeks prior to study entry;
- •Patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; Unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator.
- •Patients who cannot take, or refuse to take concomitant antibiotic therapy;
- •Patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal EUS;
- •Patients who cannot take or refuse to take certolizumab;
- •Patients with active or latent tuberculosis;
- •Patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections;
- •Patients concurrently taking anakinra (Kineret);
- •Patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinomain-situ of the cervix;
- •Patients with chronic hematologic problems such as bleeding dyscrasias;
- •Patients with a history of demyelinating disease (i.e. multiple sclerosis); and
- •Patients with congestive heart failure
研究组 & 干预措施
Combination Therapy Group
Patients in this arm will have surgically established drainage of their Crohns perianal fistulas and/or abscesses (exam under anesthesia (EUA)) done BEFORE beginning medical therapy with Cimzia.
干预措施: Exam under anesthesia (EUA) (Procedure)
Control Group
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.
结局指标
主要结局
Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.
时间窗: 54 weeks
Our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.
次要结局
未报告次要终点
研究者
David Schwartz
Principal Investigator
Vanderbilt University Medical Center