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Validation of Hemorrhoidal Bleeding Score

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Groupe Hospitalier Paris Saint Joseph
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT03060616
First received: February 16, 2017
Last updated: March 6, 2017
Last verified: February 2017
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 16, 2017
Last Updated: March 6, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017