Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Overview
- Phase
- Phase 3
- Intervention
- Vitamin E Acetate ointment
- Conditions
- Pain
- Sponsor
- Hospital General Universitario Elche
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Pain associated to anal fissure: Visual Analogic Scale
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche
Eligibility Criteria
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
Arms & Interventions
Vitamin E acetate
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.
Intervention: Vitamin E Acetate ointment
Glyceryl trinitrate ointment
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.
Intervention: Glyceryl trinitrate ointment
Outcomes
Primary Outcomes
Pain associated to anal fissure: Visual Analogic Scale
Time Frame: 8 weeks
Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)
Secondary Outcomes
- Number of participants achieving the healing of the fissure(8 weeks)