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 range18 Years
SexALL
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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 …
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.