Application of Vitamin E on Anal Fissure

Study Overview
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Brief Summary
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Patients were randomized into 2 groups: Vitamin E: Vitamin E ointment will be applied during 8 weeks Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

Detailed Description
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Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG). Treatments: Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. Healing rate of chronic anal fissure was investigated.

Official Title
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Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure

Conditions
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Pain

Intervention / Treatment
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* Drug: Vitamin E Acetate ointment
* Drug: Glyceryl trinitrate ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of chronic anal fissure Exclusion Criteria: patients with associated anal pathologies intestinal inflammation disorders immunosuppression fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases) patients with a history of headaches, heart disease, or intolerance to nitrates pregnant or lactating women patients with closed angle glaucoma

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E acetate<br>Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. | Drug: Vitamin E Acetate ointment<br>* Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.<br>|
| Active Comparator: Glyceryl trinitrate ointment<br>Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period. | Drug: Glyceryl trinitrate ointment<br>* Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain associated to anal fissure: Visual Analogic Scale | Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving the healing of the fissure | Healing, defined as evidence of fissure reepithelization | 8 weeks |