Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial
Not Applicable
Completed
- Conditions
- Chronic anal fissureOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12613000254796
- Lead Sponsor
- Waikato District Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
All patients with chronic anal fissure(CAF) from the Waikato region of New Zealand, with ages ranging from 18-80 years.
Exclusion Criteria
previous surgical treatment for anal fissure, pregnancy (current or planned) & lactation, inflammatory bowel disease, rectal or anal malignancy, unable to self administer medications, unable to complete necessary trial documentation or unable to attend necessary clinical follow up, any history of unexplained syncope or orthostatic hypotension, history of faecal incontinence, tuberculosis, HIV/AIDS, syphilis, peri-anal sepsis or fistulas, immunosuppressant and use of Viagra or other nitrate preparations for IHD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing of anal fissure by direct visualization of fissure area using anal fissure grades. [12 weeks]
- Secondary Outcome Measures
Name Time Method Head aches with GTN by using numeric pain scale with range from 0-10.[6 weeks.]