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

Abscess Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145365
• Other study ID #: 100063
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: April 1, 2017
• Start date: December 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Crohn Disease
• Crohns Disease
• Fistula

Intervention

Procedure:
• Exam under anesthesia (EUA)
EUA established drainage of perianal fistulas &/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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