Chronic Anal Fissure Clinical Trial
Official title:
Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.
Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in
patients with anal fissure. However, nitroglycerin has not been universally accepted for
this application because of inconsistency of efficacy and side effects. Recent studies (Dis
Colon Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products
compounded by pharmacies did not meet the USP specifications for potency and/or content
uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results
raise significant issues as to whether the patient is put at undue risk relative to the
relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006
Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a
significantly greater reduction in sphincteric pressure and lower incidence of headaches
than with perianal administration of the same dose of ointment.
Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials
and is effective in healing chronic anal fissures. It assures exactly dose and concentration
of nitroglycerin.
Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must
reduced headache and the final recurrence.
The purpose of this study is:
1. Principal end-point: to compare perianal vs endoanal application of Rectogesic and
evaluate the different morbidity of the two presentation
inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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