NCT03060616

Brief Summary

The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included. Even if there was some rare score including bleeding in literature , none of them were validated. The aim of the study is first validation of bleeding score .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

February 16, 2017

Last Update Submit

April 26, 2023

Conditions

Hemorrhoid Bleeding

Outcome Measures

Primary Outcomes (1)

  • assessment of bleeding score

    1 day

Eligibility Criteria

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

every patient consulting for hemorrhoidal bleeding

You may qualify if:

  • Age\>18 years
  • consulting for hemorroidal bleeding
  • accept to participate

You may not qualify if:

  • paraplegic or hemiplegic patient
  • Misunderstanding of the French language

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

Study Officials

  • Hélène BEAUSSIER, Pharm-D

    CRC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

September 1, 2016

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)