Bleeding Anal, Pain, Stings
Conditions
Brief summary
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: * Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus * Control group: Patients will receive a treatment with corticoid ointment, with endoanal application Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
Detailed description
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: * Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days. * Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days. Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
Interventions
DRUGVitamin E ovules
Endoanal vitamin E ovules will be prescribed
DRUGPrednisolone ointment
Endoanal Prednisolone ointment will be prescribed
Sponsors
Hospital General Universitario Elche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Symptoms will be assessed by a nurse blinded to the prescribed treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Grade II and III hemorrhoids
Exclusion criteria
* Grade I or IV hemorrhoids * Patients with previous anal surgeries * Patients having received previous pharmacological treatments for hemorrhoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of patients with Bleeding | 14 days after beginning the treatment | The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anal pain assessed by Visual Analogic Scale | 14 days after beginning the treatment | The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain) |
| % of patients with Stinging | 14 days after beginning the treatment | The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0) |
Contacts
Primary ContactJaime Ruiz-Tovar
Backup ContactCarolina LLavero Garrido
Outcome results
None listed