Longitudinal Description of Hemorrhoidal Pathology

Hemorrhoids Clinical Trial

— DeLPH  

Official title:

Longitudinal Description of Hemorrhoidal Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945408
• Other study ID #: DeLPH Cohort
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. In France, self-reported questionnaires estimate that one person in five has suffered at least one hemorrhoidal attack in the past year.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 6, 2023
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient objecting to participation in the study

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

Related Conditions & MeSH terms

• Hemorrhoids

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Primary	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).	6 months
Primary	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).	6 months
Secondary	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	6 months
Secondary	Describe the various symptoms of hemorrhoidal disease	Proportions of various symptoms of hemorrhoidal disease	6 months
Secondary	Search for proctological pathologies associated with hemorrhoidal disease	Prevalence of proctological pathologies associated with hemorrhoidal disease	6 months
Secondary	Determine potential risk factors for hemorrhoidal disease	Correlations between potential risk factors and the development of hemorrhoidal disease	6 months