HemorrhoidsCHORALISNCT04578730
aCute HemORrhoidal Disease evALuation International Study
An observational study of Hemorrhoids, run by Servier Affaires Médicales at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- How many people
- 3,592 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to 25 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from hemorrhoidal disease in the acute phase
Who may be able to join
- Age ≥18 years old;
- Patient consulting for symptomatic acute phase of hemorrhoidal disease
- Confirmed diagnosis of hemorrhoidal disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hemorrhoids
- Keywords
- observationnal, QoL
- Medical subject headings
- Hemorrhoids
What is being measured
The primary outcome is the main question the study is designed to answer.
Global improvement
Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.
Measured: 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
Measured: Week 4
Quality of Life
Measured by HEMO-FISS QoL
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start16 Apr 2021
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578730
- Sponsor's protocol ID
- DIM-05682-006-INT
- Acronym
- CHORALIS
- Status last verified
- Apr 2023
- First submitted
- 15 Sep 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT04578730
- Acronym / sponsor ID
- CHORALIS / DIM-05682-006-INT
- Conditions
- Hemorrhoids
- Keywords
- observationnal, QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,592 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from hemorrhoidal disease in the acute phase
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Patient consulting for symptomatic acute phase of hemorrhoidal disease
- Confirmed diagnosis of hemorrhoidal disease
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global improvement
Time frame: 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
Time frame: Week 4
Measured by VAS (Visual analogue scale) and questioning with 4 points rate
Quality of Life
Time frame: Week 4
Measured by HEMO-FISS QoL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids, run by Servier Affaires Médicales at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global improvement (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.