aCute HemORrhoidal Disease evALuation International Study (CHORALIS)

April 12, 2023 updated by: Servier Affaires Médicales

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Suresnes, France, 92284
        • Servier Affaires Medicales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients suffering from hemorrhoidal disease in the acute phase

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Affaires Médicales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2021

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

November 25, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIM-05682-006-INT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhoids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe