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临床试验/NCT04945408
NCT04945408已完成不适用

Longitudinal Description of Hemorrhoidal Pathology

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patient objecting to participation in the study
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection

结局指标

主要结局

Evaluate the effectiveness of the different treatments proposed according to the type of hemorrhoidal disease (internal, external or both)

时间窗: 6 months

Average quality of life score before and after treatment according to the type of hemorrhoidal disease (internal, external or both).

次要结局

  • Evaluate the proportion of patients consulting for hemorrhoidal disease in the general proctology consultation of a specialized center that also receives emergencies(6 months)
  • Describe the various symptoms of hemorrhoidal disease(6 months)
  • Search for proctological pathologies associated with hemorrhoidal disease(6 months)
  • Determine potential risk factors for hemorrhoidal disease(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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