NCT02846285

Brief Summary

The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.

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 Sep 2013

Shorter than P25 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

September 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

July 21, 2016

Last Update Submit

July 22, 2016

Conditions

Keywords

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Assessment of causes and determine the origin of down gastrointestinal bleedings

    Determine the origine of gastrointestinal bleedings from the below: * Internal hemorrhoidal pathology * Anal Fissure * Perianal Crohn lesions * Cryto-glandular Anal fistula * Thrombosis external hemorrhoidal * Anal condylomata and / or perianal * Syndrome solitary rectal ulcer without prolapse externalized * Ano-radiation proctitis * Anal dermatitis and / or perianal * Complete Rectal prolapse externalized * Ulcerative colitis Recto * other

    Within 4 months after surgery

Interventions

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Exploration was offered to all patients over 45 years and / or when indicated by the pathological context

You may qualify if:

  • All patients with proctological context

You may not qualify if:

  • Patients refusing to participate

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

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • FATHALLA Nadia, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 27, 2016

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations