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OpenTrials
Completed

NCT Number: NCT04578730

aCute HemORrhoidal Disease evALuation International Study

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

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servier Affaires Medicales

Suresnes, 92284, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Global improvement

    Time frame: Week 4

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

  2. 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

  3. Quality of Life

    Time frame: Week 4

    Measured by HEMO-FISS QoL

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Official study title

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

Acronym: CHORALIS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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