NCT04945408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

June 15, 2021

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 30, 2021

Study Start

June 15, 2020

Primary Completion

June 15, 2021

Study Completion

March 6, 2023

Last Updated

March 7, 2023

Record last verified: 2022-03

Locations