Longitudinal Description of Hemorrhoidal Pathology

Completed

• Conditions: Hemorrhoids

• Registration Number: NCT04945408
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief 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.

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 Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-06-15
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-30
• Status Verified: 2022-03
• Study Completion: 2023-03-06
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)	6 months	Average quality of life score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).

Secondary Outcome Measures

Name	Time	Method
Evaluate the proportion of patients consulting for hemorrhoidal disease in the general proctology consultation of a specialized center that also receives emergencies	6 months	Proportion of patients in the proctology department consulting for hemorrhoidal disease
Describe the various symptoms of hemorrhoidal disease	6 months	Proportions of various symptoms of hemorrhoidal disease
Search for proctological pathologies associated with hemorrhoidal disease	6 months	Prevalence of proctological pathologies associated with hemorrhoidal disease
Determine potential risk factors for hemorrhoidal disease	6 months	Correlations between potential risk factors and the development of hemorrhoidal disease

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, Ile-de-France, France