NCT01145365

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

A Prospective Multicenter Trial Evaluating the Benefit of INitial Surgically Established Drainage Prior to Medical Therapy for the Treatment for Crohn's Perianal Fistulas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Crohns Disease
• Fistula
• Abscess

Interventions

Type	Name	Description
PROCEDURE	Exam under anesthesia (EUA)	EUA established drainage of perianal fistulas \&/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-06-16
• Last updated: 2017-04-04

Locations

3 sites across 1 country: United States