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Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01145365
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is looking at the advantage of establishing surgical drainage for Crohn's fistulas and abscesses prior to starting medical therapy.

Condition or disease Intervention/treatment
Crohns Disease Fistula Abscess Procedure: Exam under anesthesia (EUA)

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas
Study Start Date : December 2010
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Exam under anesthesia (EUA)
EUA established drainage of perianal fistulas &/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)
No Intervention: Control Group
Patients in this group will begin medical therapy with Cimzia regardless of status of surgically established drainage.

Outcome Measures

Primary Outcome Measures :
  1. Surgical drainage of all perianal fistulas & abscesses prior to start of medical tx improves rate of healing & prevents further abscess formation. [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145365

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-1375
Sponsors and Collaborators
Vanderbilt University Medical Center
UCB Pharma
Principal Investigator: David A Schwartz, MD Vanderbilt University Medical Center
More Information

Responsible Party: David Schwartz, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01145365     History of Changes
Other Study ID Numbers: 100063
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by David Schwartz, Vanderbilt University Medical Center:
Perianal Abscess

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs