Pain
Conditions
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.
Interventions
DRUGVitamin E Acetate ointment
Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
Sponsors
Hospital General Universitario Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated to anal fissure: Visual Analogic Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieving the healing of the fissure | 8 weeks | Healing, defined as evidence of fissure reepithelization |
Countries
Spain
Outcome results
None listed