aCute HemORrhoidal Disease evALuation International Study

Hemorrhoids Clinical Trial

— CHORALIS  

Official title:

A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578730
• Other study ID #: DIM-05682-006-INT
• Status: Completed
• Start date: April 16, 2021
• Est. completion date: November 25, 2022

Study information

• Verified date: April 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3592
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhoids

Locations

Country	Name	City	State
France	Servier Affaires Medicales	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global improvement	Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.	Week 4
Primary	Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling	Measured by VAS (Visual analogue scale) and questioning with 4 points rate	Week 4
Primary	Quality of Life	Measured by HEMO-FISS QoL	Week 4