A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas
Sponsor study identifier
interventional
21
1 country
3
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2010
Actual (reported)June 16, 2010
Actual (reported)December 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation.
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.
54 weeks
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.
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.
EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Maryland
Baltimore, Maryland, 21201, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-1375, United States
David A Schwartz, MD
Vanderbilt University Medical Center
21 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2010
First Posted
June 16, 2010
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
April 4, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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