The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo.
Anorectal Crohn's disease is one of the most problematic and debilitating conditions encountered in colorectal practise. The condition is usually chronic, debilitating, and frequently refractory to current medications. Failure to respond to medical therapy may ultimately result in proctocolectomy and ileostomy, even in the absence of more proximal colonic disease. Isolated anorectal Crohn's disease is reported in 3 to 5% of Crohn's patients. In Crohn's patients as a whole, anorectal involvement is reported in up to one third to one half of patients, in addition to either colonic or enteric Crohn's disease. In spite of the previously reported painless nature of anorectal Crohn's disease, it is the author's experience that the condition can be inordinately painful due to deeply eroding fissures, oedematous skin tags, and painful induration of the perianal region.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
Washington University School of Medicine
St Louis, Missouri, United States
Derby City General Hospital
Derby, Derbyshire, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, United Kingdom
To evaluate the effect of 10% metronidazole ointment, applied topically three times a day, in and around the anus, on the change in perianal Crohn's disease activity.
Perianal Crohn's Disease Activity Index
Time frame: Four weeks
To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo.
Perianal Crohn's Disease Activity Index plus Visual Analogue Scale for perianal pain
Time frame: 4 weeks
To evaluate and compare Patient Global Impression of Improvement
Patient Global Impression of Improvement (numerical scale)
Time frame: 4 weeks
To compare visual improvement (using photographic documentation assessed by a blinded independent observer)
Photographic record
Time frame: 4 weeks
To compare Quality of Life assessments
Short Form 12 Questionnaire
Time frame: 4 weeks
To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group
Usage of analgesics during the treatment period
Time frame: 4 weeks
To evaluate and compare fistula healing
Visual assessment of fistula healing
Time frame: 4 weeks
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Monklands Hospital
Airdrie, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
University Hospital of Warwick and Coventry
Coventry, United Kingdom
St Marks Hospital
Harrow, United Kingdom
St Thomas Hospital
London, United Kingdom
...and 1 more locations