Hemorrhoids
Conditions
Keywords
observationnal, QoL
Brief summary
The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease
Interventions
None listed
Sponsors
Servier Affaires Médicales
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old; * Patient consulting for symptomatic acute phase of hemorrhoidal disease * Confirmed diagnosis of hemorrhoidal disease
Exclusion criteria
* Patient consulting for emergency not related to hemorrhoidal disease; * Patient currently taking any treatment for hemorrhoidal disease; * Any anorectal procedure or surgery planned during the study ; * Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery; * Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal; * Pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global improvement | Week 4 | Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement. |
| Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling | Week 4 | Measured by VAS (Visual analogue scale) and questioning with 4 points rate |
| Quality of Life | Week 4 | Measured by HEMO-FISS QoL |
Countries
France
Outcome results
None listed