Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Periana… (NCT01145365) | Clinical Trial Compass
CompletedNot Applicable
Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
United States21 participantsStarted 2010-12
Plain-language summary
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.