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OpenTrials
Completed

NCT Number: NCT04945408

Longitudinal Description of Hemorrhoidal Pathology

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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

    Proportion of patients in the proctology department consulting for hemorrhoidal disease

  2. Describe the various symptoms of hemorrhoidal disease

    Time frame: 6 months

    Proportions of various symptoms of hemorrhoidal disease

  3. Search for proctological pathologies associated with hemorrhoidal disease

    Time frame: 6 months

    Prevalence of proctological pathologies associated with hemorrhoidal disease

  4. Determine potential risk factors for hemorrhoidal disease

    Time frame: 6 months

    Correlations between potential risk factors and the development of hemorrhoidal disease

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: DeLPH

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jun 30, 2021
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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