Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure

Study Overview
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Brief Summary
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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

Detailed Description
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inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache.

Official Title
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Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.

Conditions
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Chronic Anal Fissure

Intervention / Treatment
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* Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). Chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres. Exclusion Criteria: Associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids) Patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression) Cardiopathy Headache and pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Endoanal application | Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)<br>* 375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS<br>|
| Experimental: 2<br>Perianal application | Drug: Rectogesic® (glyceryl trinitrate 0.4% ointment)<br>* 375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache (during eights weeks of treatment) |  | Visual analogical Score | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence or persistence anal fissure (six month) |  | Yes/No | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal fissure, nitroglycerin, medical treatment