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Validation of Hemorrhoidal Bleeding Score

This study is currently recruiting participants.
Verified February 2017 by Groupe Hospitalier Paris Saint Joseph
Sponsor:
ClinicalTrials.gov Identifier:
NCT03060616
First Posted: February 23, 2017
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
  Purpose

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 .


Condition
Hemorrhoid Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Hemorrhoidal Bleeding Score

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

Primary Outcome Measures:
  • assessment of bleeding score [ Time Frame: 1 day ]

Estimated Enrollment: 100
Actual Study Start Date: September 1, 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
every patient consulting for hemorrhoidal bleeding
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • paraplegic or hemiplegic patient
  • Misunderstanding of the French language
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060616


Contacts
Contact: Nadia FATHALLAH, MD 01 44 12 71 83 nfathallah@hpsj.fr

Locations
France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: BEAUSSIER Helene, PhD, PharmD    +33 1 44 12 70 38    hbeaussier@hpsj.fr   
Contact: CRC    +33 1 44 12 70 33    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Study Director: Hélène BEAUSSIER, Pharm-D CRC
  More Information

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03060616     History of Changes
Other Study ID Numbers: SCORE_SG-hémorroide
First Submitted: February 16, 2017
First Posted: February 23, 2017
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhage
Hemorrhoids
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases