aCute HemORrhoidal Disease evALuation International Study
Completed
- Conditions
- Hemorrhoids
- Registration Number
- NCT04578730
- Lead Sponsor
- Servier Affaires Médicales
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3592
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Servier Affaires Medicales
🇫🇷Suresnes, France