HemorrhoidsDeLPHNCT04945408
Longitudinal Description of Hemorrhoidal Pathology
An observational study of Hemorrhoids, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 6 Mar 2023
- 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: Consecutive patients consulting for hemorrhoidal disease in the proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) between January 1st 2020 and April 30th 2020
Who may be able to join
- Patient whose age is ≥ 18 years
- Consecutive patients consulting for hemorrhoidal disease at the proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) between January 1, 2020 and April 30, 2020
- French-speaking patient
Who cannot join
- Patient objecting to participation in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
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
Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.
Read the detailed description
Hemorrhoidal disease significantly alters the quality of life, can be life threatening in case of heavy bleeding and has a significant economic impact.
However, there are still many unknowns regarding the different types of hemorrhoidal disease, its symptoms, its natural history, its etiology, its triggering and promoting factors, the associated pathologies, the therapeutic indications, etc.
In addition, the therapeutic management is not consensual, especially since the therapeutic arsenal is constantly expanding over the last 20 years with the advent of minimally invasive surgical techniques.
The aim of the work is to answer some of these questions on the basis of a prospective cohort of patients.
- Conditions
- Hemorrhoids
- Medical subject headings
- Hemorrhoids
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Average prolapse score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
Measured: 6 months
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Average bleeding score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
Measured: 6 months
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Average quality of life score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
Measured: 6 months
Secondary outcomes (4)
Evaluate the proportion of patients consulting for hemorrhoidal disease in the general proctology consultation of a specialized center that also receives emergencies
Proportion of patients in the proctology department consulting for hemorrhoidal disease
Measured: 6 months
Describe the various symptoms of hemorrhoidal disease
Proportions of various symptoms of hemorrhoidal disease
Measured: 6 months
Search for proctological pathologies associated with hemorrhoidal disease
Prevalence of proctological pathologies associated with hemorrhoidal disease
Measured: 6 months
Determine potential risk factors for hemorrhoidal disease
Correlations between potential risk factors and the development of hemorrhoidal disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start15 Jun 2020
- Primary completion15 Jun 2021
- Study completion6 Mar 2023
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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945408
- Sponsor's protocol ID
- DeLPH Cohort
- Acronym
- DeLPH
- Status last verified
- Mar 2022
- First submitted
- 15 Jun 2021
- Last updated
- 7 Mar 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Description of Hemorrhoidal Pathology
- ClinicalTrials.gov ID
- NCT04945408
- Acronym / sponsor ID
- DeLPH / DeLPH Cohort
- Conditions
- Hemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 30 Jun 2021 (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.
Hemorrhoidal disease is a common cause of gastroenterology visits. In the United States, it is considered the 3rd most common gastrointestinal diagnosis with nearly 4 million scheduled or emergency visits. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.
Detailed description
Hemorrhoidal disease significantly alters the quality of life, can be life threatening in case of heavy bleeding and has a significant economic impact.
However, there are still many unknowns regarding the different types of hemorrhoidal disease, its symptoms, its natural history, its etiology, its triggering and promoting factors, the associated pathologies, the therapeutic indications, etc.
In addition, the therapeutic management is not consensual, especially since the therapeutic arsenal is constantly expanding over the last 20 years with the advent of minimally invasive surgical techniques.
The aim of the work is to answer some of these questions on the basis of a prospective cohort of patients.
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
- Consecutive patients consulting for hemorrhoidal disease in the proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) between January 1st 2020 and April 30th 2020
Key inclusion criteria (3 listed)
- Patient whose age is ≥ 18 years
- Consecutive patients consulting for hemorrhoidal disease at the proctology department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) between January 1, 2020 and April 30, 2020
- French-speaking patient
Key exclusion criteria (4 listed)
- Patient objecting to participation in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
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
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Time frame: 6 months
Average prolapse score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Time frame: 6 months
Average bleeding score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)
Time frame: 6 months
Average quality of life score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).
4 secondary outcomes
Evaluate the proportion of patients consulting for hemorrhoidal disease in the general proctology consultation of a specialized center that also receives emergencies
Time frame: 6 months
Describe the various symptoms of hemorrhoidal disease
Time frame: 6 months
Search for proctological pathologies associated with hemorrhoidal disease
Time frame: 6 months
Determine potential risk factors for hemorrhoidal disease
Time frame: 6 months
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 7 Mar 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 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 4 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 7 Mar 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?
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both) (time frame: 6 months). 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 7 Mar 2023.