Hemorrhoid BleedingNCT03060616
Validation of Hemorrhoidal Bleeding Score
An observational study of Hemorrhoid Bleeding, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included. Even if there was some rare score including bleeding in literature , none of them were validated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoid Bleeding
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 15 Mar 2018
- 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: every patient consulting for hemorrhoidal bleeding
Who may be able to join
- Age>18 years
- consulting for hemorroidal bleeding
- accept to participate
Who cannot join
- paraplegic or hemiplegic patient
- Misunderstanding of the French language
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included.
Even if there was some rare score including bleeding in literature , none of them were validated.
The aim of the study is first validation of bleeding score .
- Conditions
- Hemorrhoid Bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of bleeding score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Sep 2016
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoid BleedingStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BEAUSSIER, Pharm-D, Study director, CRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060616
- Sponsor's protocol ID
- SCORE_SG-hémorroide
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Hemorrhoidal Bleeding Score
- ClinicalTrials.gov ID
- NCT03060616
- Acronym / sponsor ID
- SCORE_SG-hémorroide
- Conditions
- Hemorrhoid Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 23 Feb 2017 (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 principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included.
Even if there was some rare score including bleeding in literature , none of them were validated.
The aim of the study is first validation of bleeding score .
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
- every patient consulting for hemorrhoidal bleeding
Key inclusion criteria (3 listed)
- Age>18 years
- consulting for hemorroidal bleeding
- accept to participate
Key exclusion criteria (2 listed)
- paraplegic or hemiplegic patient
- Misunderstanding of the French language
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
assessment of bleeding score
Time frame: 1 day
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 27 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Hélène BEAUSSIER, Pharm-D study director
CRC
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 Hemorrhoid Bleeding, run by Fondation Hôpital Saint-Joseph 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 2 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 27 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?
assessment of bleeding score (time frame: 1 day). 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 27 Apr 2023.