NCT04578730

Brief Summary

The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

September 15, 2020

Last Update Submit

April 12, 2023

Conditions

Hemorrhoids

Keywords

observationnalQoL

Outcome Measures

Primary Outcomes (3)

  • Global improvement

    Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.

    Week 4

  • Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling

    Measured by VAS (Visual analogue scale) and questioning with 4 points rate

    Week 4

  • Quality of Life

    Measured by HEMO-FISS QoL

    Week 4

Eligibility Criteria

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

patients suffering from hemorrhoidal disease in the acute phase

You may qualify if:

  • Age ≥18 years old;
  • Patient consulting for symptomatic acute phase of hemorrhoidal disease
  • Confirmed diagnosis of hemorrhoidal disease

You may not qualify if:

  • Patient consulting for emergency not related to hemorrhoidal disease;
  • Patient currently taking any treatment for hemorrhoidal disease;
  • Any anorectal procedure or surgery planned during the study ;
  • Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery;
  • Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal;
  • Pregnant or breastfeeding woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servier Affaires Medicales

Suresnes, 92284, 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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

October 8, 2020

Study Start

April 16, 2021

Primary Completion

November 25, 2022

Study Completion

November 25, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

FR(1)