aCute HemORrhoidal Disease evALuation International Study

Servier Affaires Médicales3,592 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

3,592

Conditions

Hemorrhoids

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Servier Affaires Medicales

Suresnes, France

Outcomes

Primary Outcomes

Global improvement

Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.

Time frame: Week 4

Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling

Measured by VAS (Visual analogue scale) and questioning with 4 points rate

Time frame: Week 4

Quality of Life

Measured by HEMO-FISS QoL

Time frame: Week 4

Data from ClinicalTrials.gov

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